Meta-analysis shows PCI beats medical therapy for late reperfusion
28 February 2008
Patients who undergo percutaneous coronary intervention more than 12 hours after suffering an acute myocardial infarction have improved cardiac function and survival compared with those who receive medical management, a meta-analysis indicates.
Chest pain causes sustained psychological distress
28 February 2008
Chest pain causes significant anxiety and depression even after people have been told that is not due to cardiovascular disease, say UK researchers.
Eye disease more than doubles MI risk
28 February 2008
The progressive eye disease age-related macular degeneration doubles the risk for death due to cardiovascular disease, reveals a study from Australia.
Showing posts with label PCI. Show all posts
Showing posts with label PCI. Show all posts
Thursday, February 28, 2008
Monday, February 18, 2008
Restricted clopidogrel access linked to increased mortality after PCI
18 February 2008
Medical insurance restricting access to clopidogrel can delay or stop patients receiving treatment with the drug after percutaneous coronary intervention with stenting, which in turn may increase their risk for dying, a Canadian study suggests.
Medwire News: Restricted clopidogrel access linked to increased mortality after PCI
Medical insurance restricting access to clopidogrel can delay or stop patients receiving treatment with the drug after percutaneous coronary intervention with stenting, which in turn may increase their risk for dying, a Canadian study suggests.
Medwire News: Restricted clopidogrel access linked to increased mortality after PCI
Friday, January 4, 2008
Single-lead ST-segment deviation after primary angioplasty
Single-lead ST-segment deviation after primary angioplasty
By Caroline Price
04 January 2008
Heart 2008; 94: 44-47
MedWire News: Residual ST-segment deviation in a single lead 3 hours after primary angioplasty in ST-elevation myocardial infarction (STEMI) patients is an “easy and accurate” predictor of 1-year mortality, cardiologists report.
Electrocardiography (ECG) is a simple way to measure reperfusion outcomes, with ST-segment deviation providing better prognostic accuracy than ST-segment resolution, explain A van’t Hof (Hospital De Weezenlanden, Zwolle, The Netherlands) and team.
To evaluate the prognostic role of postprocedural single-lead ST-segment deviation (STD) in primary angioplasty, relative to single-lead ST-segment resolution and elevation, and 12-lead ST-segment deviation, the researchers prospectively studied 1660 STEMI patients undergoing the procedure between 1997 and 2002.
Successful reperfusion was defined as postprocedural thrombolysis in myocardial infarction (TIMI) 3 flow, residual stenosis <50%, and myocardial blush grade (MBG) 2-3. ECGs were recorded at 3 hours after the procedure.
As reported in the journal Heart, maximal residual STD correlated well with postprocedural MBG 3, distal embolization, enzymatic infarct size, and predischarge left ventricular ejection fraction.
At 1 year of follow-up, 63 (3.8%) patients had died. In multivariate analysis, after correction for baseline characteristics, maximal residual single-lead STD was the strongest predictor of mortality of all postprocedural ECG measures, at a hazard ratio of 1.87 (p<0.001).
Using receiver operating characteristic curves, the researchers identified ≥2 mm as the optimal threshold for maximal single-lead STD.
“The simple evaluation of maximal residual STD in a single lead 3 hours after the procedure is the best electrocardiographic measure for the evaluation of myocardial perfusion and prognostic stratification of patients with STEMI treated with primary angioplasty,” the authors write.
Link: http://heart.bmj.com/cgi/content/abstract/94/1/44
By Caroline Price
04 January 2008
Heart 2008; 94: 44-47
MedWire News: Residual ST-segment deviation in a single lead 3 hours after primary angioplasty in ST-elevation myocardial infarction (STEMI) patients is an “easy and accurate” predictor of 1-year mortality, cardiologists report.
Electrocardiography (ECG) is a simple way to measure reperfusion outcomes, with ST-segment deviation providing better prognostic accuracy than ST-segment resolution, explain A van’t Hof (Hospital De Weezenlanden, Zwolle, The Netherlands) and team.
To evaluate the prognostic role of postprocedural single-lead ST-segment deviation (STD) in primary angioplasty, relative to single-lead ST-segment resolution and elevation, and 12-lead ST-segment deviation, the researchers prospectively studied 1660 STEMI patients undergoing the procedure between 1997 and 2002.
Successful reperfusion was defined as postprocedural thrombolysis in myocardial infarction (TIMI) 3 flow, residual stenosis <50%, and myocardial blush grade (MBG) 2-3. ECGs were recorded at 3 hours after the procedure.
As reported in the journal Heart, maximal residual STD correlated well with postprocedural MBG 3, distal embolization, enzymatic infarct size, and predischarge left ventricular ejection fraction.
At 1 year of follow-up, 63 (3.8%) patients had died. In multivariate analysis, after correction for baseline characteristics, maximal residual single-lead STD was the strongest predictor of mortality of all postprocedural ECG measures, at a hazard ratio of 1.87 (p<0.001).
Using receiver operating characteristic curves, the researchers identified ≥2 mm as the optimal threshold for maximal single-lead STD.
“The simple evaluation of maximal residual STD in a single lead 3 hours after the procedure is the best electrocardiographic measure for the evaluation of myocardial perfusion and prognostic stratification of patients with STEMI treated with primary angioplasty,” the authors write.
Link: http://heart.bmj.com/cgi/content/abstract/94/1/44
Thursday, December 20, 2007
Rationale and design of the Trial of Routine ANgioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSF
Rationale and design of the Trial of Routine ANgioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI).
Am Heart J. 2008 Jan;155(1):19-25. Epub 2007 Oct 25.
BACKGROUND: Most patients with ST-elevation myocardial infarction present to hospitals without percutaneous coronary intervention (PCI) facilities and receive fibrinolysis. The role of routine early PCI after fibrinolysis, using stents and contemporary pharmacotherapy, has not been studied in a large adequately powered randomized trial.
OBJECTIVE: To compare a pharmacoinvasive strategy of transfer for routine PCI within 6 hours after fibrinolysis with standard treatment after fibrinolysis (including predefined criteria for rescue PCI and delayed cardiac catheterization for patients who do not require rescue PCI).
METHODS: A total of 1200 patients with high-risk ST-elevation myocardial infarction
presenting to non-PCI centers will be randomized to a pharmacoinvasive strategy (transfer for routine PCI within 6 hours of fibrinolysis) or to standard treatment after fibrinolysis. The primary end point is the 30-day composite of death, reinfarction, recurrent ischemia, heart failure, or shock.
RESULTS: More than 900 patients have been enrolled as of April 2007. An interim safety analysis of the first 536 patients demonstrated no safety concerns. Enrolment is expected to be completed in late 2007.
CONCLUSIONS: This study will provide important data on whether routine early PCI within 6 hours after fibrinolysis is safe and superior to the standard treatment of fibrinolysis with rescue PCI or delayed cardiac catheterization.
Ref:
http://www.cardiosource.com/guidelines/PCI_Focused_Update.pdf
Am Heart J. 2008 Jan;155(1):19-25. Epub 2007 Oct 25.
BACKGROUND: Most patients with ST-elevation myocardial infarction present to hospitals without percutaneous coronary intervention (PCI) facilities and receive fibrinolysis. The role of routine early PCI after fibrinolysis, using stents and contemporary pharmacotherapy, has not been studied in a large adequately powered randomized trial.
OBJECTIVE: To compare a pharmacoinvasive strategy of transfer for routine PCI within 6 hours after fibrinolysis with standard treatment after fibrinolysis (including predefined criteria for rescue PCI and delayed cardiac catheterization for patients who do not require rescue PCI).
METHODS: A total of 1200 patients with high-risk ST-elevation myocardial infarction
presenting to non-PCI centers will be randomized to a pharmacoinvasive strategy (transfer for routine PCI within 6 hours of fibrinolysis) or to standard treatment after fibrinolysis. The primary end point is the 30-day composite of death, reinfarction, recurrent ischemia, heart failure, or shock.
RESULTS: More than 900 patients have been enrolled as of April 2007. An interim safety analysis of the first 536 patients demonstrated no safety concerns. Enrolment is expected to be completed in late 2007.
CONCLUSIONS: This study will provide important data on whether routine early PCI within 6 hours after fibrinolysis is safe and superior to the standard treatment of fibrinolysis with rescue PCI or delayed cardiac catheterization.
Ref:
http://www.cardiosource.com/guidelines/PCI_Focused_Update.pdf
Friday, December 14, 2007
Guideline Update for Percutaneous Coronary Intervention - 2007
2007 Focused Update of the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines
Date Posted: 12/13/2007
Author(s): King S, Smith S, Hirschfeld JW, et al.
J Am Coll Cardiol. 2008;51:[Epub ahead of print].
Perspective: The following are 10 points to remember about this guideline update for percutaneous coronary intervention (PCI):
1. In patients with unstable angina (UA)/non–ST-elevation myocardial infarction (NSTEMI), an early invasive strategy is favored in the presence of recurrent angina or ischemia at rest or with low-level activities despite intensive medical therapy, elevated cardiac biomarkers (troponin T or troponin I), new or presumably new ST-segment depression, signs or symptoms of heart failure or new or worsening mitral regurgitation, high-risk findings from noninvasive testing, hemodynamic instability, sustained ventricular tachycardia, PCI within the prior 6 months, prior coronary artery bypass graft surgery or a high-risk score (e.g., TIMI, GRACE), or reduced left ventricular function (left ventricular ejection fraction <40%).
2. PCI is not indicated for a persistently occluded infarct-related artery after NSTEMI or STEMI older than 24 hours in a stable patient.
3. Creatinine clearance should be estimated in UA/NSTEMI patients, and medication dosage should be adjusted appropriately in patients with altered renal function.
4. In patients with chronic kidney disease undergoing coronary angiography or intervention, isosmolar contrast agents should be preferentially used (Level of Evidence: A).
5. In patients with STEMI, a planned reperfusion strategy using full-dose fibrinolytic therapy followed by immediate PCI may be harmful, and is not advocated.
6. A strategy of coronary angiography with intent to perform revascularization is recommended for patients who have received fibrinolytic therapy and are in cardiogenic shock and candidates for revascularization, and have severe heart failure or pulmonary edema or hemodynamically significant ventricular arrhythmias.
7. Rescue PCI should be considered in patients with STEMI who have received a fibrinolytic agent, have evidence of failed reperfusion (ST-segment resolution <50%) 90 minutes after initiation of fibrinolytic therapy, and have a moderate or large area of myocardium at risk.
8. Given the risk of catheter thrombosis, fondaparinux should not be used as the sole anticoagulant to support PCI. For patients who undergo PCI with prior treatment with fondaparinux, additional intravenous treatment with an anticoagulant possessing anti-IIa activity (such as unfractionated heparin) should be used.
9. Before implanting a drug-eluting stent (DES), the physician should discuss with the patient the need for and duration of dual antiplatelet therapy, and confirm the patient’s ability to comply with the recommended therapy. In patients who are likely to require invasive or surgical procedures for which antiplatelet must be interrupted during the next 12 months after PCI, consideration should be given to implantation of a bare-metal stent or performance of balloon angioplasty with a provisional stent implantation.
10. Continuation of clopidogrel therapy beyond 1 year may be considered in patients treated with DES.
Hitinder S. Gurm, M.B.B.S., F.A.C.C.
Date Posted: 12/13/2007
Author(s): King S, Smith S, Hirschfeld JW, et al.
J Am Coll Cardiol. 2008;51:[Epub ahead of print].
Perspective: The following are 10 points to remember about this guideline update for percutaneous coronary intervention (PCI):
1. In patients with unstable angina (UA)/non–ST-elevation myocardial infarction (NSTEMI), an early invasive strategy is favored in the presence of recurrent angina or ischemia at rest or with low-level activities despite intensive medical therapy, elevated cardiac biomarkers (troponin T or troponin I), new or presumably new ST-segment depression, signs or symptoms of heart failure or new or worsening mitral regurgitation, high-risk findings from noninvasive testing, hemodynamic instability, sustained ventricular tachycardia, PCI within the prior 6 months, prior coronary artery bypass graft surgery or a high-risk score (e.g., TIMI, GRACE), or reduced left ventricular function (left ventricular ejection fraction <40%).
2. PCI is not indicated for a persistently occluded infarct-related artery after NSTEMI or STEMI older than 24 hours in a stable patient.
3. Creatinine clearance should be estimated in UA/NSTEMI patients, and medication dosage should be adjusted appropriately in patients with altered renal function.
4. In patients with chronic kidney disease undergoing coronary angiography or intervention, isosmolar contrast agents should be preferentially used (Level of Evidence: A).
5. In patients with STEMI, a planned reperfusion strategy using full-dose fibrinolytic therapy followed by immediate PCI may be harmful, and is not advocated.
6. A strategy of coronary angiography with intent to perform revascularization is recommended for patients who have received fibrinolytic therapy and are in cardiogenic shock and candidates for revascularization, and have severe heart failure or pulmonary edema or hemodynamically significant ventricular arrhythmias.
7. Rescue PCI should be considered in patients with STEMI who have received a fibrinolytic agent, have evidence of failed reperfusion (ST-segment resolution <50%) 90 minutes after initiation of fibrinolytic therapy, and have a moderate or large area of myocardium at risk.
8. Given the risk of catheter thrombosis, fondaparinux should not be used as the sole anticoagulant to support PCI. For patients who undergo PCI with prior treatment with fondaparinux, additional intravenous treatment with an anticoagulant possessing anti-IIa activity (such as unfractionated heparin) should be used.
9. Before implanting a drug-eluting stent (DES), the physician should discuss with the patient the need for and duration of dual antiplatelet therapy, and confirm the patient’s ability to comply with the recommended therapy. In patients who are likely to require invasive or surgical procedures for which antiplatelet must be interrupted during the next 12 months after PCI, consideration should be given to implantation of a bare-metal stent or performance of balloon angioplasty with a provisional stent implantation.
10. Continuation of clopidogrel therapy beyond 1 year may be considered in patients treated with DES.
Hitinder S. Gurm, M.B.B.S., F.A.C.C.
Tuesday, December 11, 2007
Based Upon the Results of the COURAGE Clinical Trial, What Is the Best Treatment for Stable Angina?
Based Upon the Results of the COURAGE Clinical Trial, What Is the Best Treatment for Stable Angina?
Raymond J. Gibbons, MD; George D. Lundberg, MD
Medscape General Medicine. 2007;9(4):49. ©2007 Medscape
Posted 12/05/2007
Dr. Lundberg: It was a forerunner of a lot of good things. Let's talk about cardiology, and let's talk about angina pectoris: stable, unstable. Stable is more common?
Dr. Gibbons: Stable is much more common, and I think it's of more current interest. Our management of stable angina has obviously consisted of medications. But we knew from randomized trials in bypass surgery conducted 20 years ago that certain patients with very severe problems, particularly left main disease and 3-vessel disease with prior abnormal ventricular function, benefited from surgery from the standpoint of survival. As percutaneous coronary intervention [PCI] came along, we thought that patients who had less severe coronary artery disease probably would benefit, from the standpoint of survival and myocardial infarction, from PCI.
Dr. Lundberg: That's sensible.
Dr. Gibbons: And that was incorporated into national guidelines. This year, however, there have been 2 studies that have been published, OAT and COURAGE, that have both challenged that assumption. I think the study that is most pertinent to chronic stable angina is COURAGE. In a large trial conducted in the VA [Veterans Administration], certain other academic medical centers in the United States, including my own, and Canada, the investigators showed that with optimal medical therapy.
Dr. Lundberg: Okay. What do you call that? What is optimal medical therapy?
Dr. Gibbons: Well, previous trials had focused on just relieving angina. That trial had a different comprehensive approach: risk factor reduction. They just didn't treat angina, they also treated the risk factors very aggressively, and did very well even after 5 years at meeting targets for LDL [low density lipoprotein], for blood pressure, getting patients to stop smoking, getting them to exercise. And compared to optimal therapy, optimal therapy plus PCI did not convey an advantage with respect to heart attack or death. That was news, challenging the assumption that we had all along. It has led to a decrease, already, in the use of stents in the country. And I think it poses a challenge for practicing physicians to do as well with medical therapy in treating risk factors and symptoms, as occurred in the trial.
Dr. Lundberg: And of course, one of the things they have to do is handle patient compliance in terms of long-term use of whatever they're supposed to do.
Dr. Gibbons: I think they need to be very clear on educating the patient about the importance of, not just treatment for their chest pain, but treatment for the plaque and underlying coronary artery disease to prevent events. The patients have to understand the importance of taking aspirin, the importance of lowering their cholesterol to appropriate targets -- ideally an LDL of less than 100 -- and also not to smoke.
Dr. Lundberg: Of course, we live in a society with a medical-industrial complex with huge amounts of money that flow through the system into lots of people's pockets. If you're going to do surgery, or if you're going to do percutaneous stent implants, etc, it probably accrues a lot more money to people who are doing it, and it costs the insurance companies and the government a lot more to do that. So, there must be a tension developing there.
Dr. Gibbons: There's a clear tension, and I think there is an undercurrent of concern raised about the trial. For example, there's a tendency to point out there was a modest difference in pain relief, but it was modest. It was less than 10% of the patients had more complete pain relief by PCI at a year, and that [number] diminished over subsequent management of the patients. And a very comprehensive quality-of-life cost-effectiveness analysis presented here at the American Heart Association meeting this year by Dr. Weintraub, an expert in cost-effectiveness, showed that no matter what assumption you made, the effect on quality of life was minimal and very cost-ineffective.
Dr. Lundberg: So, for a stable angina at this time, optimal medical therapy is the best way to go?
Dr. Gibbons: It's clearly the best way to go. The challenge for all of us in the healthcare system is to do the best job we can of getting patients to comply with guideline-indicated medications.
Dr. Lundberg: There you are. Thank you all for being with us today. We've been talking with Dr. Raymond Gibbons, professor of medicine at the Mayo Clinic College of Medicine and a former president of the American Heart Association. Thank you for being with us. And thank you for being with us.
Reader Comments on: Based Upon the Results of the COURAGE Clinical Trial, What Is the Best Treatment for Stable Angina?See reader comments on this article and provide your own.
Readers are encouraged to respond to the author at gibbons.raymond@mayo.edu or to Paul Blumenthal, MD, Deputy Editor of MedGenMed, for the editor's eyes only or for possible publication as an actual Letter in MedGenMed via email: pblumen@stanford.edu
Raymond J. Gibbons, MD, Arthur M. and Gladys D. Gray Professor of Medicine, Mayo Clinic, Rochester, MinnesotaGeorge D. Lundberg, MD, Editor-in-Chief, Medscape General Medicine; Adjunct Professor of Health Policy, Harvard School of Public Health, Boston, Massachusetts; Consulting Professor, Stanford University School of Medicine, Stanford, CaliforniaAuthor's email: gibbons.raymond@mayo.edu
Raymond J. Gibbons, MD; George D. Lundberg, MD
Medscape General Medicine. 2007;9(4):49. ©2007 Medscape
Posted 12/05/2007
Dr. Lundberg: It was a forerunner of a lot of good things. Let's talk about cardiology, and let's talk about angina pectoris: stable, unstable. Stable is more common?
Dr. Gibbons: Stable is much more common, and I think it's of more current interest. Our management of stable angina has obviously consisted of medications. But we knew from randomized trials in bypass surgery conducted 20 years ago that certain patients with very severe problems, particularly left main disease and 3-vessel disease with prior abnormal ventricular function, benefited from surgery from the standpoint of survival. As percutaneous coronary intervention [PCI] came along, we thought that patients who had less severe coronary artery disease probably would benefit, from the standpoint of survival and myocardial infarction, from PCI.
Dr. Lundberg: That's sensible.
Dr. Gibbons: And that was incorporated into national guidelines. This year, however, there have been 2 studies that have been published, OAT and COURAGE, that have both challenged that assumption. I think the study that is most pertinent to chronic stable angina is COURAGE. In a large trial conducted in the VA [Veterans Administration], certain other academic medical centers in the United States, including my own, and Canada, the investigators showed that with optimal medical therapy.
Dr. Lundberg: Okay. What do you call that? What is optimal medical therapy?
Dr. Gibbons: Well, previous trials had focused on just relieving angina. That trial had a different comprehensive approach: risk factor reduction. They just didn't treat angina, they also treated the risk factors very aggressively, and did very well even after 5 years at meeting targets for LDL [low density lipoprotein], for blood pressure, getting patients to stop smoking, getting them to exercise. And compared to optimal therapy, optimal therapy plus PCI did not convey an advantage with respect to heart attack or death. That was news, challenging the assumption that we had all along. It has led to a decrease, already, in the use of stents in the country. And I think it poses a challenge for practicing physicians to do as well with medical therapy in treating risk factors and symptoms, as occurred in the trial.
Dr. Lundberg: And of course, one of the things they have to do is handle patient compliance in terms of long-term use of whatever they're supposed to do.
Dr. Gibbons: I think they need to be very clear on educating the patient about the importance of, not just treatment for their chest pain, but treatment for the plaque and underlying coronary artery disease to prevent events. The patients have to understand the importance of taking aspirin, the importance of lowering their cholesterol to appropriate targets -- ideally an LDL of less than 100 -- and also not to smoke.
Dr. Lundberg: Of course, we live in a society with a medical-industrial complex with huge amounts of money that flow through the system into lots of people's pockets. If you're going to do surgery, or if you're going to do percutaneous stent implants, etc, it probably accrues a lot more money to people who are doing it, and it costs the insurance companies and the government a lot more to do that. So, there must be a tension developing there.
Dr. Gibbons: There's a clear tension, and I think there is an undercurrent of concern raised about the trial. For example, there's a tendency to point out there was a modest difference in pain relief, but it was modest. It was less than 10% of the patients had more complete pain relief by PCI at a year, and that [number] diminished over subsequent management of the patients. And a very comprehensive quality-of-life cost-effectiveness analysis presented here at the American Heart Association meeting this year by Dr. Weintraub, an expert in cost-effectiveness, showed that no matter what assumption you made, the effect on quality of life was minimal and very cost-ineffective.
Dr. Lundberg: So, for a stable angina at this time, optimal medical therapy is the best way to go?
Dr. Gibbons: It's clearly the best way to go. The challenge for all of us in the healthcare system is to do the best job we can of getting patients to comply with guideline-indicated medications.
Dr. Lundberg: There you are. Thank you all for being with us today. We've been talking with Dr. Raymond Gibbons, professor of medicine at the Mayo Clinic College of Medicine and a former president of the American Heart Association. Thank you for being with us. And thank you for being with us.
Reader Comments on: Based Upon the Results of the COURAGE Clinical Trial, What Is the Best Treatment for Stable Angina?See reader comments on this article and provide your own.
Readers are encouraged to respond to the author at gibbons.raymond@mayo.edu or to Paul Blumenthal, MD, Deputy Editor of MedGenMed, for the editor's eyes only or for possible publication as an actual Letter in MedGenMed via email: pblumen@stanford.edu
Raymond J. Gibbons, MD, Arthur M. and Gladys D. Gray Professor of Medicine, Mayo Clinic, Rochester, MinnesotaGeorge D. Lundberg, MD, Editor-in-Chief, Medscape General Medicine; Adjunct Professor of Health Policy, Harvard School of Public Health, Boston, Massachusetts; Consulting Professor, Stanford University School of Medicine, Stanford, CaliforniaAuthor's email: gibbons.raymond@mayo.edu
Thursday, November 22, 2007
Treatment delays in reperfusion therapy increase mortality in STEMI patients
Treatment delays in reperfusion therapy increase mortality in STEMI patients
By Sara Carrillo de Albornoz
22 November 2007
Heart 2007; 93: 1552-1555
MedWire News: Patients presenting with ST-segment elevation myocardial infarction (STEMI) who experience long reperfusion therapy delays are at increased risk for death at 6 months, study findings indicate.
This higher 6-month mortality rate is more "critical" in patients receiving fibrinolytic therapy than in those undergoing primary percutaneous coronary intervention (PCI), Kim Eagle (University of Michigan Cardiovascular Center, Ann Arbor, USA) and colleagues add.
"Understanding the overall association between treatment delays and outcomes in reperfusion therapy for STEMI is critical for improving the selection and delivery of both fibrinolytic therapy and primary PCI in individual patients," the authors write in the journal Heart.
Eagle and team analyzed data from the multinational GRACE (Global registry of acute coronary events) trial to determine the association between treatment delays and 6-month mortality in 3959 STEMI patients treated with reperfusion therapy.
Of these, 1786 (45.1%) received fibrinolytic therapy and 2173 (54.9%) underwent primary PCI.
Patients receiving fibrinolytic therapy had a mean door-to-needle time of 35 minutes, while patients undergoing PCI had a mean door-to-balloon time of 78 minutes.
Multivariate analysis accounting for mortality risk factors such as age, cardiac arrest, and ST-changes showed that reperfusion treatment delays were associated with an increased 6-month mortality rate in both treatment groups (p<0.001).
Patients receiving fibrinolytic therapy had an 0.30% increase in 6-month mortality per 10-minute delay in door-to-needle time between 30 and 60 minutes, and those who underwent PCI had a 0.18% increased 6-month mortality per 10-minute delay in door-to-balloon time between 90 and 150 minutes.
Eagle et al conclude: "Although treatment delays are longer in primary PCI, their relationship with clinical outcomes is more gradual than that seen with fibrinolytic therapy.
"This important differential effect of treatment delays on outcome may influence the selection between these two reperfusion strategies in STEMI patients."
Free abstract
By Sara Carrillo de Albornoz
22 November 2007
Heart 2007; 93: 1552-1555
MedWire News: Patients presenting with ST-segment elevation myocardial infarction (STEMI) who experience long reperfusion therapy delays are at increased risk for death at 6 months, study findings indicate.
This higher 6-month mortality rate is more "critical" in patients receiving fibrinolytic therapy than in those undergoing primary percutaneous coronary intervention (PCI), Kim Eagle (University of Michigan Cardiovascular Center, Ann Arbor, USA) and colleagues add.
"Understanding the overall association between treatment delays and outcomes in reperfusion therapy for STEMI is critical for improving the selection and delivery of both fibrinolytic therapy and primary PCI in individual patients," the authors write in the journal Heart.
Eagle and team analyzed data from the multinational GRACE (Global registry of acute coronary events) trial to determine the association between treatment delays and 6-month mortality in 3959 STEMI patients treated with reperfusion therapy.
Of these, 1786 (45.1%) received fibrinolytic therapy and 2173 (54.9%) underwent primary PCI.
Patients receiving fibrinolytic therapy had a mean door-to-needle time of 35 minutes, while patients undergoing PCI had a mean door-to-balloon time of 78 minutes.
Multivariate analysis accounting for mortality risk factors such as age, cardiac arrest, and ST-changes showed that reperfusion treatment delays were associated with an increased 6-month mortality rate in both treatment groups (p<0.001).
Patients receiving fibrinolytic therapy had an 0.30% increase in 6-month mortality per 10-minute delay in door-to-needle time between 30 and 60 minutes, and those who underwent PCI had a 0.18% increased 6-month mortality per 10-minute delay in door-to-balloon time between 90 and 150 minutes.
Eagle et al conclude: "Although treatment delays are longer in primary PCI, their relationship with clinical outcomes is more gradual than that seen with fibrinolytic therapy.
"This important differential effect of treatment delays on outcome may influence the selection between these two reperfusion strategies in STEMI patients."
Free abstract
Wednesday, November 7, 2007
Efficacy of CABG vs. Percutaneous Coronary Intervention
Efficacy of CABG vs. Percutaneous Coronary Intervention
CABG increases rates of relief of angina (NNT 12 at 1 year, NNT 20 at 5 years) and decreases rates of repeat revascularization (NNT 5 at 1 year, NNT 3 at 5 years) compared to percutaneous coronary intervention (PCI), but no difference in overall survival (level 1 [likely reliable] evidence), based on a systematic review of 23 randomized trials in 9,963 patients. CABG increased 30-day risk of stroke (NNH 167). PCI included balloon angioplasty or stents in most trials; only 1 small trial used drug-eluting stents
(Ann Intern Med 2007 Nov 20;147(10):early online full-text, AHRQ Comparative Effectiveness Review 2007 Oct:9 PDF).
Systematic Review: The Comparative Effectiveness of Percutaneous Coronary Interventions and Coronary Artery Bypass Graft Surgery
Bravata DM, Gienger AL, McDonald KM, Sundaram V, Perez MV, Varghese R, Kapoor JR, Ardehali R, Owens DK, Hlatky MA.
the Center for Primary Care and Outcomes Research and Stanford University School of Medicine, Stanford, and Veterans Affairs Palo Alto Health Care System, Palo Alto, California
20 November 2007 Volume 147 Issue 10
Background: The comparative effectiveness of coronary artery bypass graft (CABG) surgery and percutaneous coronary intervention (PCI) for patients in whom both procedures are feasible remains poorly understood.
Purpose: To compare the effectiveness of PCI and CABG in patients for whom coronary revascularization is clinically indicated.
Data Sources: MEDLINE, EMBASE, and Cochrane databases (1966–2006); conference proceedings; and bibliographies of retrieved articles.
Study Selection: Randomized, controlled trials (RCTs) reported in any language that compared clinical outcomes of PCI with those of CABG, and selected observational studies.
Data Extraction: Information was extracted on study design, sample characteristics, interventions, and clinical outcomes.
Data Synthesis: We identified 23 RCTs in which 5019 patients were randomly assigned to PCI and 4944 patients were randomly assigned to CABG. The difference in survival after PCI or CABG was less than 1% over 10 years of follow-up. Survival did not differ between PCI and CABG for patients with diabetes in the 6 trials that reported on this subgroup. Procedural strokes were more common after CABG than after PCI (1.2% vs. 0.6%; risk difference, 0.6%; P = 0.002). Angina relief was greater after CABG than after PCI, with risk differences ranging from 5% to 8% at 1 to 5 years (P < 0.001). The absolute rates of angina relief at 5 years were 79% after PCI and 84% after CABG. Repeated revascularization was more common after PCI than after CABG (risk difference, 24% at 1 year and 33% at 5 years; P < 0.001); the absolute rates at 5 years were 46.1% after balloon angioplasty, 40.1% after PCI with stents, and 9.8% after CABG. In the observational studies, the CABG–PCI hazard ratio for death favored PCI among patients with the least severe disease and CABG among those with the most severe disease.
Limitations: The RCTs were conducted in leading centers in selected patients. The authors could not assess whether comparative outcomes vary according to clinical factors, such as extent of coronary disease, ejection fraction, or previous procedures. Only 1 small trial used drug-eluting stents.
Conclusion: Compared with PCI, CABG was more effective in relieving angina and led to fewer repeated revascularizations but had a higher risk for procedural stroke. Survival to 10 years was similar for both procedures.
Editors' Notes
Context
The relative benefits and harms of coronary artery bypass surgery (CABG) versus percutaneous coronary intervention (PCI) are sometimes unclear.
Contribution
This systematic review of 23 randomized trials found that survival at 10 years was similar for CABG and PCI, even among diabetic patients. Procedural strokes and angina relief were more common after CABG (risk difference, 0.6% and about 5% to 8%, respectively), whereas repeated revascularization procedures were more common after PCI (risk difference, 24% at 1 year).
Caution
Only 1 small trial used drug-eluting stents, and Few patients with extensive coronary disease or poor ventricular function were enrolled.
CABG increases rates of relief of angina (NNT 12 at 1 year, NNT 20 at 5 years) and decreases rates of repeat revascularization (NNT 5 at 1 year, NNT 3 at 5 years) compared to percutaneous coronary intervention (PCI), but no difference in overall survival (level 1 [likely reliable] evidence), based on a systematic review of 23 randomized trials in 9,963 patients. CABG increased 30-day risk of stroke (NNH 167). PCI included balloon angioplasty or stents in most trials; only 1 small trial used drug-eluting stents
(Ann Intern Med 2007 Nov 20;147(10):early online full-text, AHRQ Comparative Effectiveness Review 2007 Oct:9 PDF).
Systematic Review: The Comparative Effectiveness of Percutaneous Coronary Interventions and Coronary Artery Bypass Graft Surgery
Bravata DM, Gienger AL, McDonald KM, Sundaram V, Perez MV, Varghese R, Kapoor JR, Ardehali R, Owens DK, Hlatky MA.
the Center for Primary Care and Outcomes Research and Stanford University School of Medicine, Stanford, and Veterans Affairs Palo Alto Health Care System, Palo Alto, California
20 November 2007 Volume 147 Issue 10
Background: The comparative effectiveness of coronary artery bypass graft (CABG) surgery and percutaneous coronary intervention (PCI) for patients in whom both procedures are feasible remains poorly understood.
Purpose: To compare the effectiveness of PCI and CABG in patients for whom coronary revascularization is clinically indicated.
Data Sources: MEDLINE, EMBASE, and Cochrane databases (1966–2006); conference proceedings; and bibliographies of retrieved articles.
Study Selection: Randomized, controlled trials (RCTs) reported in any language that compared clinical outcomes of PCI with those of CABG, and selected observational studies.
Data Extraction: Information was extracted on study design, sample characteristics, interventions, and clinical outcomes.
Data Synthesis: We identified 23 RCTs in which 5019 patients were randomly assigned to PCI and 4944 patients were randomly assigned to CABG. The difference in survival after PCI or CABG was less than 1% over 10 years of follow-up. Survival did not differ between PCI and CABG for patients with diabetes in the 6 trials that reported on this subgroup. Procedural strokes were more common after CABG than after PCI (1.2% vs. 0.6%; risk difference, 0.6%; P = 0.002). Angina relief was greater after CABG than after PCI, with risk differences ranging from 5% to 8% at 1 to 5 years (P < 0.001). The absolute rates of angina relief at 5 years were 79% after PCI and 84% after CABG. Repeated revascularization was more common after PCI than after CABG (risk difference, 24% at 1 year and 33% at 5 years; P < 0.001); the absolute rates at 5 years were 46.1% after balloon angioplasty, 40.1% after PCI with stents, and 9.8% after CABG. In the observational studies, the CABG–PCI hazard ratio for death favored PCI among patients with the least severe disease and CABG among those with the most severe disease.
Limitations: The RCTs were conducted in leading centers in selected patients. The authors could not assess whether comparative outcomes vary according to clinical factors, such as extent of coronary disease, ejection fraction, or previous procedures. Only 1 small trial used drug-eluting stents.
Conclusion: Compared with PCI, CABG was more effective in relieving angina and led to fewer repeated revascularizations but had a higher risk for procedural stroke. Survival to 10 years was similar for both procedures.
Editors' Notes
Context
The relative benefits and harms of coronary artery bypass surgery (CABG) versus percutaneous coronary intervention (PCI) are sometimes unclear.
Contribution
This systematic review of 23 randomized trials found that survival at 10 years was similar for CABG and PCI, even among diabetic patients. Procedural strokes and angina relief were more common after CABG (risk difference, 0.6% and about 5% to 8%, respectively), whereas repeated revascularization procedures were more common after PCI (risk difference, 24% at 1 year).
Caution
Only 1 small trial used drug-eluting stents, and Few patients with extensive coronary disease or poor ventricular function were enrolled.
Monday, November 5, 2007
AHa - 2007: Drug-eluting stents: Do the outcomes justify their use?
Drug-eluting stents: Do the outcomes justify their use?
MedWire - AHA (Orlando, Florida, USA), November 4, 2007: This session on the second day of the American Heart Association Congress focused on controversies in clinical cardiology, with speakers arguing for and against the motion. The highlight was a debate on the value of drug-eluting stents (DES), which is summarized below.
Yes
Gregg Stone, Columbia University Medical Center, New York, NY, USA
Dr. Stone spoke in favor of DES, which he described as a “transforming technology” in view of their proven ability to reduce restenosis compared with bare-metal stents (BMS). “It is a misconception that restenosis is benign,” he commented. “Restenosis negatively impacts quality of life and leads to symptoms as well as to repeat angioplasty and acute coronary syndromes (ACS) in a substantial number of patients.”
The “flipside” of the benefit of DES on restenosis is the risk of late stent thrombosis, which can be a devastating and even fatal complication in a “really small minority” of patients. However, he stressed that this risk needs to be put into perspective.
Dr. Stone then reviewed the data that triggered concerns about the safety of DES, much of which was presented at the annual European Society of Cardiology (ESC) congress in Barcelona, Spain, in 2006. In an episode dubbed the “ESC firestorm”, Salim Yusuf told ESC delegates that widespread use of DES is “an epidemic of madness”. DES use has since markedly declined in Europe and Canada.
At today’s session, Dr. Stone said that the studies presented at the ESC 2006 were methodologically flawed. Two of the meta-analyses used data from abstracts and the internet rather than primary sources and had never been subjected to peer review. Another study was retracted following publication, while another failed to adjust fully for potential confounders.
In December 2006, the US Food and Drug Administration reviewed the most robust available data, including registry studies and updated meta-analyses. The panel concluded that DES are not associated with an increased risk of death or myocardial infarction (MI) when used according to the labeled indication.
Dr. Stone then showed an assortment of new registry data, much of which was presented at the recent Transcatheter Cardiovascular Therapeutics 2007 meeting in Washington DC. These studies consistently found that DES are associated with a lower risk of mortality/MI when compared with BMS, as well as confirming their marked superiority in preventing restenosis.
“These findings still need to be confirmed in prospective randomized controlled trials,” Dr. Stone admitted. “Three such studies are currently underway.”
No
Salim Yusuf, McMaster University, Hamilton, ON, Canada
Dr. Yusuf was billed as the antagonist in the debate over whether or not outcomes justify the use of DES. However, he said the debate was “irrelevant” as it failed to address a “more important question”, namely, whether routine percutaneous intervention (and all its associated paraphernalia) justifies the widespread use of stents in stable and unstable coronary artery disease (CAD). “The real issue is what is good for patients and society, not what makes doctors feel good,” he said.
Instead of arguing against the use of DES, Dr. Yusuf discussed the broader question of how best to manage CAD. He said there were four main reasons for using any medical therapy: To improve survival; to reduce morbidity; to improve symptoms and quality of life; and/or to reduce costs.
In patients with CAD, angioplasty of the culprit lesion is of proven value in two settings: ST-elevation MI (in place of thrombolytics) to reduce mortality, stroke, and probably reinfarction; and in high-risk non-ST-elevation ACS to reduce new MI and avoid repeated rehospitalization for unstable angina. “In both these acute conditions, timely PCI in selected patients is an important advance,” Dr. Yusuf stated.
The problem, according to Dr. Yusuf, is that PCI is now routinely performed outside these two acute settings. In the United States, the use of PCI increased by 5,946% between 1987 and 2004, compared with a rise of 102% in coronary artery bypass surgery. “In 2005 over one million PCIs were performed,” he said. “Most of these were in patients with stable CAD.”
Dr. Yusuf said that neither epidemiology nor pathophysiology support the use of PCI in stable disease. Post-mortem studies show that most MIs originate from non-critical lesions that would not be considered suitable for stenting. Atherosclerosis is generalized, even when only one lesion is apparent on an angiogram. Furthermore, dilating a lesion - akin to “crushing” it - is not physiologic and can destabilize the lesion. Indeed, he said that stents actually worsen endothelial vascular dysfunction.
Since PCI is associated with both short- and long-term risks, these must be weighed against the small increased risk associated with stable angina. Studies comparing PCI with medical therapy in stable disease have found that the approaches are equivalent for reducing the risk of death and MI, but that PCI has much higher costs. In addition, stents have not been shown to reduce angina, improve quality of life, or prevent CABG. DES definitely reduces the rate of angiographic restenosis but this is merely a surrogate endpoint, and Dr. Yusuf warned against formulating clinical practice around surrogates.
“The overall cost of PCI plus DES plus prolonged dual antiplatelet therapy (possibly plus intravascular ultrasound to enhance stent deployment) is astronomical compared to initial medical therapy - but with little clinical gain,” Dr. Yusuf stated. “Prolonged antiplatelet therapy is also associated with an increased risk of bleeding, of a magnitude associated with warfarin therapy.”
Accordingly, he proposed that patients with stable CAD should be treated with medical therapy in the first instance, and that PCI and stenting should be reserved for those who remain symptomatic on maximal medical therapy. If stents are used, there is no evidence that DES offer clinical benefits over BMS, while they are undoubtedly associated with increased costs.
Dr. Yusuf ended by calling for patients with stable CAD to be managed with evidence-based pharmacologic therapy and lifestyle modification, and for a more selective use of PCI and stenting. “We are being seduced by technology,” he concluded. “We need to close down 50% of cath labs and retrain interventional cardiologists in the use of drugs and lifestyle modification.”
MedWire - AHA (Orlando, Florida, USA), November 4, 2007: This session on the second day of the American Heart Association Congress focused on controversies in clinical cardiology, with speakers arguing for and against the motion. The highlight was a debate on the value of drug-eluting stents (DES), which is summarized below.
Yes
Gregg Stone, Columbia University Medical Center, New York, NY, USA
Dr. Stone spoke in favor of DES, which he described as a “transforming technology” in view of their proven ability to reduce restenosis compared with bare-metal stents (BMS). “It is a misconception that restenosis is benign,” he commented. “Restenosis negatively impacts quality of life and leads to symptoms as well as to repeat angioplasty and acute coronary syndromes (ACS) in a substantial number of patients.”
The “flipside” of the benefit of DES on restenosis is the risk of late stent thrombosis, which can be a devastating and even fatal complication in a “really small minority” of patients. However, he stressed that this risk needs to be put into perspective.
Dr. Stone then reviewed the data that triggered concerns about the safety of DES, much of which was presented at the annual European Society of Cardiology (ESC) congress in Barcelona, Spain, in 2006. In an episode dubbed the “ESC firestorm”, Salim Yusuf told ESC delegates that widespread use of DES is “an epidemic of madness”. DES use has since markedly declined in Europe and Canada.
At today’s session, Dr. Stone said that the studies presented at the ESC 2006 were methodologically flawed. Two of the meta-analyses used data from abstracts and the internet rather than primary sources and had never been subjected to peer review. Another study was retracted following publication, while another failed to adjust fully for potential confounders.
In December 2006, the US Food and Drug Administration reviewed the most robust available data, including registry studies and updated meta-analyses. The panel concluded that DES are not associated with an increased risk of death or myocardial infarction (MI) when used according to the labeled indication.
Dr. Stone then showed an assortment of new registry data, much of which was presented at the recent Transcatheter Cardiovascular Therapeutics 2007 meeting in Washington DC. These studies consistently found that DES are associated with a lower risk of mortality/MI when compared with BMS, as well as confirming their marked superiority in preventing restenosis.
“These findings still need to be confirmed in prospective randomized controlled trials,” Dr. Stone admitted. “Three such studies are currently underway.”
No
Salim Yusuf, McMaster University, Hamilton, ON, Canada
Dr. Yusuf was billed as the antagonist in the debate over whether or not outcomes justify the use of DES. However, he said the debate was “irrelevant” as it failed to address a “more important question”, namely, whether routine percutaneous intervention (and all its associated paraphernalia) justifies the widespread use of stents in stable and unstable coronary artery disease (CAD). “The real issue is what is good for patients and society, not what makes doctors feel good,” he said.
Instead of arguing against the use of DES, Dr. Yusuf discussed the broader question of how best to manage CAD. He said there were four main reasons for using any medical therapy: To improve survival; to reduce morbidity; to improve symptoms and quality of life; and/or to reduce costs.
In patients with CAD, angioplasty of the culprit lesion is of proven value in two settings: ST-elevation MI (in place of thrombolytics) to reduce mortality, stroke, and probably reinfarction; and in high-risk non-ST-elevation ACS to reduce new MI and avoid repeated rehospitalization for unstable angina. “In both these acute conditions, timely PCI in selected patients is an important advance,” Dr. Yusuf stated.
The problem, according to Dr. Yusuf, is that PCI is now routinely performed outside these two acute settings. In the United States, the use of PCI increased by 5,946% between 1987 and 2004, compared with a rise of 102% in coronary artery bypass surgery. “In 2005 over one million PCIs were performed,” he said. “Most of these were in patients with stable CAD.”
Dr. Yusuf said that neither epidemiology nor pathophysiology support the use of PCI in stable disease. Post-mortem studies show that most MIs originate from non-critical lesions that would not be considered suitable for stenting. Atherosclerosis is generalized, even when only one lesion is apparent on an angiogram. Furthermore, dilating a lesion - akin to “crushing” it - is not physiologic and can destabilize the lesion. Indeed, he said that stents actually worsen endothelial vascular dysfunction.
Since PCI is associated with both short- and long-term risks, these must be weighed against the small increased risk associated with stable angina. Studies comparing PCI with medical therapy in stable disease have found that the approaches are equivalent for reducing the risk of death and MI, but that PCI has much higher costs. In addition, stents have not been shown to reduce angina, improve quality of life, or prevent CABG. DES definitely reduces the rate of angiographic restenosis but this is merely a surrogate endpoint, and Dr. Yusuf warned against formulating clinical practice around surrogates.
“The overall cost of PCI plus DES plus prolonged dual antiplatelet therapy (possibly plus intravascular ultrasound to enhance stent deployment) is astronomical compared to initial medical therapy - but with little clinical gain,” Dr. Yusuf stated. “Prolonged antiplatelet therapy is also associated with an increased risk of bleeding, of a magnitude associated with warfarin therapy.”
Accordingly, he proposed that patients with stable CAD should be treated with medical therapy in the first instance, and that PCI and stenting should be reserved for those who remain symptomatic on maximal medical therapy. If stents are used, there is no evidence that DES offer clinical benefits over BMS, while they are undoubtedly associated with increased costs.
Dr. Yusuf ended by calling for patients with stable CAD to be managed with evidence-based pharmacologic therapy and lifestyle modification, and for a more selective use of PCI and stenting. “We are being seduced by technology,” he concluded. “We need to close down 50% of cath labs and retrain interventional cardiologists in the use of drugs and lifestyle modification.”
AHA - 2007: Study compares cost, health outcomes in clearing coronary blockages
Study compares cost, health outcomes in clearing coronary blockages
Late-Breaking Clinical Trials News Release 12
ORLANDO, Nov. 5 – In a follow-up analysis of a major clinical study presented last year, researchers found that percutaneous coronary intervention (PCI) with stenting at 3-28 days after a heart attack was not an economically efficient way to improve health outcomes in people with coronary blockage, according to late-breaking clinical trial results announced at the American Heart Association’s Scientific Sessions 2007.
The Occluded Artery Trial (OAT) was an NHLBI-funded prospective, randomized, multicenter trial comparing late PCI (at 3 to 28 days) with medical therapy alone in 2,166 heart attack patients with a totally blocked major heart artery. Patients were eligible for OAT if they had not received effective therapy (early PCI or clot-buster medicine) to open the blocked artery within the first 12 hours after symptom onset.
“The overall goal of this study was to compare cost and quality of life outcomes in patients randomized to the two arms of OAT,” said Daniel Mark, M.D., substudy lead author and professor of medicine and director of outcomes research at Duke Clinical Research Institute in Durham, N.C.
Patients received either state-of-the art medical therapy alone (which included daily aspirin, beta-blockers, ACE inhibitors and cholesterol-lowering drugs) or medical therapy plus PCI with stenting. Patients’ median age was 59 years, 83 percent were Caucasian, and 78 percent were male. All patients were considered high-risk but stable and without evidence of severe ischemia.
Researchers obtained quality of life data from 951 OAT patients at the start of the study, then again during follow-up interviews at four months, one year and two years after enrollment. They also collected medical resource-use data (all OAT patients) and detailed healthcare costs data (U.S. patients only) out to two years. All comparisons were done according to the principal of intention-to-treat., so patients assigned to medical treatment were analyzed as belonging to that group, even if they later crossed over and had a PCI.
Two principal quality of life outcomes were compared: PCI was associated with a clinically significant benefit in physical functioning (what patients are able to do) at four months, but this benefit was not sustained at one year or beyond. There were no significant effects on psychological well being. Of the secondary quality of life outcomes, PCI was associated with a modestly lower level of heart pains (angina) at four months and one year but these benefits also diminished over time.
In the 469 U.S. OAT patients, 30-day costs (hospital + physician) were about $10,000 higher in the PCI arm than the medical arm. At the end of two years, the cost difference had narrowed somewhat to $7,000. In cost effectiveness analysis, PCI had higher costs and worse health outcomes than medicine.
“This analysis showed that in OAT eligible patients, a strategy of routine late (3-28 day) PCI was substantially more expensive than optimal medical therapy alone when the results were examined over a two year period and the small symptom benefits provided were insufficient to make PCI an economically attractive strategy,” Mark said.
Support for this substudy was provided by Boston Scientific (Argentina), Cordis, Eli Lilly and Guidant.
Statements and conclusions of study authors that are presented at American Heart Association scientific meetings are solely those of the study authors and do not necessarily reflect association policy or position. The American Heart Association makes no representation or warranty as to their accuracy or reliability.
Late-Breaking Clinical Trials News Release 12
ORLANDO, Nov. 5 – In a follow-up analysis of a major clinical study presented last year, researchers found that percutaneous coronary intervention (PCI) with stenting at 3-28 days after a heart attack was not an economically efficient way to improve health outcomes in people with coronary blockage, according to late-breaking clinical trial results announced at the American Heart Association’s Scientific Sessions 2007.
The Occluded Artery Trial (OAT) was an NHLBI-funded prospective, randomized, multicenter trial comparing late PCI (at 3 to 28 days) with medical therapy alone in 2,166 heart attack patients with a totally blocked major heart artery. Patients were eligible for OAT if they had not received effective therapy (early PCI or clot-buster medicine) to open the blocked artery within the first 12 hours after symptom onset.
“The overall goal of this study was to compare cost and quality of life outcomes in patients randomized to the two arms of OAT,” said Daniel Mark, M.D., substudy lead author and professor of medicine and director of outcomes research at Duke Clinical Research Institute in Durham, N.C.
Patients received either state-of-the art medical therapy alone (which included daily aspirin, beta-blockers, ACE inhibitors and cholesterol-lowering drugs) or medical therapy plus PCI with stenting. Patients’ median age was 59 years, 83 percent were Caucasian, and 78 percent were male. All patients were considered high-risk but stable and without evidence of severe ischemia.
Researchers obtained quality of life data from 951 OAT patients at the start of the study, then again during follow-up interviews at four months, one year and two years after enrollment. They also collected medical resource-use data (all OAT patients) and detailed healthcare costs data (U.S. patients only) out to two years. All comparisons were done according to the principal of intention-to-treat., so patients assigned to medical treatment were analyzed as belonging to that group, even if they later crossed over and had a PCI.
Two principal quality of life outcomes were compared: PCI was associated with a clinically significant benefit in physical functioning (what patients are able to do) at four months, but this benefit was not sustained at one year or beyond. There were no significant effects on psychological well being. Of the secondary quality of life outcomes, PCI was associated with a modestly lower level of heart pains (angina) at four months and one year but these benefits also diminished over time.
In the 469 U.S. OAT patients, 30-day costs (hospital + physician) were about $10,000 higher in the PCI arm than the medical arm. At the end of two years, the cost difference had narrowed somewhat to $7,000. In cost effectiveness analysis, PCI had higher costs and worse health outcomes than medicine.
“This analysis showed that in OAT eligible patients, a strategy of routine late (3-28 day) PCI was substantially more expensive than optimal medical therapy alone when the results were examined over a two year period and the small symptom benefits provided were insufficient to make PCI an economically attractive strategy,” Mark said.
Support for this substudy was provided by Boston Scientific (Argentina), Cordis, Eli Lilly and Guidant.
Statements and conclusions of study authors that are presented at American Heart Association scientific meetings are solely those of the study authors and do not necessarily reflect association policy or position. The American Heart Association makes no representation or warranty as to their accuracy or reliability.
Sunday, November 4, 2007
AHA - 2007: MASS Stent
Study looks at differences in drug-eluting vs. bare metal stents
American Heart Association Scientific Sessions Late-Breaking News:
ORLANDO, Nov. 4 – Drug-eluting stents to open blocked coronary arteries caused no more risks for death or heart attack than bare metal stents, according to a late-breaking outcomes trial presented at the American Heart Association’s Scientific Sessions 2007.
The Massachusetts stent (MASS Stent) trial compared death rates between patients who received drug-eluting stents (stents coated with a drug to reduce restenosis or re-narrowing of the artery) and those who received bare metal stents (stents not coated with a drug). They reviewed records of all adults undergoing percutaneous coronary intervention (PCI) with stenting between April 1, 2003 and December 31, 2004 at all acute care non-U.S. governmental hospitals in Massachusetts. Using this criterion, they identified 20,654 patients from a state database with mandatory follow-up after PCI.
“This is the largest study of patients comparing drug-eluting stents and bare metal stents for long-term outcomes in the U.S.,” said Laura Mauri, M.D., principal investigator of the trial and assistant professor of medicine at Harvard Medical School and Brigham and Women’s Hospital in Boston, Mass.
PCI, also called angioplasty, is done in patients who have blocked or narrowed heart arteries. During the procedure, a thin tube called a catheter is inserted into a blood vessel in the groin or leg, and then threaded through to the blocked coronary artery. A small balloon at the tip of the wire is then inflated to push back the blockage and allow more blood flow to the heart. Often, a tiny wire mesh tube called a stent is put in place to hold the vessel open and prevent restenosis (reclosing of the artery). However, stent thrombosis (blood clots forming inside the stent) is possible. Patients are prescribed anti-clotting drugs after the procedure to lessen the chance of stent thrombosis.
“It was previously established that drug-eluting stents make it less likely that patients will need repeat procedures within the first year after a stent procedure,” Mauri said. “What we were less certain about before this study was the long-term safety of drug-eluting stents compared to bare metal.”
Mauri adds that this trial has several benefits for addressing this issue. “It is a very large study with long-term follow up, it reflects contemporary U.S. practice – where most patients receive drug-eluting stents – and it includes all patients who were undergoing PCI – not just those who would have qualified for a randomized trial.”
Patients were followed up for at least two years after receiving a stent. Researchers compared the number of deaths, heart attacks, and revascularization procedures (either bypass surgery or another PCI) between the two groups. The adjusted incidence of mortality at two years was 9.4 percent for those with drug-eluting stents and 11.9 percent for those with bare metal stents.
Statements and conclusions of study authors that are presented at American Heart Association scientific meetings are solely those of the study authors and do not necessarily reflect association policy or position. The American Heart Association makes no representation or warranty as to their accuracy or reliability.
American Heart Association Scientific Sessions Late-Breaking News:
ORLANDO, Nov. 4 – Drug-eluting stents to open blocked coronary arteries caused no more risks for death or heart attack than bare metal stents, according to a late-breaking outcomes trial presented at the American Heart Association’s Scientific Sessions 2007.
The Massachusetts stent (MASS Stent) trial compared death rates between patients who received drug-eluting stents (stents coated with a drug to reduce restenosis or re-narrowing of the artery) and those who received bare metal stents (stents not coated with a drug). They reviewed records of all adults undergoing percutaneous coronary intervention (PCI) with stenting between April 1, 2003 and December 31, 2004 at all acute care non-U.S. governmental hospitals in Massachusetts. Using this criterion, they identified 20,654 patients from a state database with mandatory follow-up after PCI.
“This is the largest study of patients comparing drug-eluting stents and bare metal stents for long-term outcomes in the U.S.,” said Laura Mauri, M.D., principal investigator of the trial and assistant professor of medicine at Harvard Medical School and Brigham and Women’s Hospital in Boston, Mass.
PCI, also called angioplasty, is done in patients who have blocked or narrowed heart arteries. During the procedure, a thin tube called a catheter is inserted into a blood vessel in the groin or leg, and then threaded through to the blocked coronary artery. A small balloon at the tip of the wire is then inflated to push back the blockage and allow more blood flow to the heart. Often, a tiny wire mesh tube called a stent is put in place to hold the vessel open and prevent restenosis (reclosing of the artery). However, stent thrombosis (blood clots forming inside the stent) is possible. Patients are prescribed anti-clotting drugs after the procedure to lessen the chance of stent thrombosis.
“It was previously established that drug-eluting stents make it less likely that patients will need repeat procedures within the first year after a stent procedure,” Mauri said. “What we were less certain about before this study was the long-term safety of drug-eluting stents compared to bare metal.”
Mauri adds that this trial has several benefits for addressing this issue. “It is a very large study with long-term follow up, it reflects contemporary U.S. practice – where most patients receive drug-eluting stents – and it includes all patients who were undergoing PCI – not just those who would have qualified for a randomized trial.”
Patients were followed up for at least two years after receiving a stent. Researchers compared the number of deaths, heart attacks, and revascularization procedures (either bypass surgery or another PCI) between the two groups. The adjusted incidence of mortality at two years was 9.4 percent for those with drug-eluting stents and 11.9 percent for those with bare metal stents.
Statements and conclusions of study authors that are presented at American Heart Association scientific meetings are solely those of the study authors and do not necessarily reflect association policy or position. The American Heart Association makes no representation or warranty as to their accuracy or reliability.
Monday, October 15, 2007
Systematic Review: The Comparative Effectiveness of Percutaneous Coronary Interventions and Coronary Artery Bypass Graft Surgery
Systematic Review: The Comparative Effectiveness of Percutaneous Coronary Interventions and Coronary Artery Bypass Graft Surgery
Annals of Internal Medicine
20 November 2007 Volume 147 Issue 10
Dena M. Bravata, MD, MS; Allison L. Gienger, BA; Kathryn M. McDonald, MM; Vandana Sundaram, MPH; Marco V. Perez, MD; Robin Varghese, MD, MS; John R. Kapoor, MD, PhD; Reza Ardehali, MD, PhD; Douglas K. Owens, MD, MS; and Mark A. Hlatky, MD
Background: The comparative effectiveness of coronary artery bypass graft (CABG) surgery and percutaneous coronary intervention (PCI) for patients in whom both procedures are feasible remains poorly understood.
Purpose: To compare the effectiveness of PCI and CABG in patients for whom coronary revascularization is clinically indicated.
Data Sources: MEDLINE, EMBASE, and Cochrane databases (1966–2006); conference proceedings; and bibliographies of retrieved articles.
Study Selection: Randomized, controlled trials (RCTs) reported in any language that compared clinical outcomes of PCI with those of CABG, and selected observational studies.
Data Extraction: Information was extracted on study design, sample characteristics, interventions, and clinical outcomes.
Data Synthesis: We identified 23 RCTs in which 5019 patients were randomly assigned to PCI and 4944 patients were randomly assigned to CABG. The difference in survival after PCI or CABG was less than 1% over 10 years of follow-up. Survival did not differ between PCI and CABG for patients with diabetes in the 6 trials that reported on this subgroup. Procedural strokes were more common after CABG than after PCI (1.2% vs. 0.6%; risk difference, 0.6%; P = 0.002). Angina relief was greater after CABG than after PCI, with risk differences ranging from 5% to 8% at 1 to 5 years (P < 0.001). The absolute rates of angina relief at 5 years were 79% after PCI and 84% after CABG. Repeated revascularization was more common after PCI than after CABG (risk difference, 24% at 1 year and 33% at 5 years; P < 0.001); the absolute rates at 5 years were 46.1% after balloon angioplasty, 40.1% after PCI with stents, and 9.8% after CABG. In the observational studies, the CABG–PCI hazard ratio for death favored PCI among patients with the least severe disease and CABG among those with the most severe disease.
Limitations: The RCTs were conducted in leading centers in selected patients. The authors could not assess whether comparative outcomes vary according to clinical factors, such as extent of coronary disease, ejection fraction, or previous procedures. Only 1 small trial used drug-eluting stents.
Conclusion: Compared with PCI, CABG was more effective in relieving angina and led to fewer repeated revascularizations but had a higher risk for procedural stroke. Survival to 10 years was similar for both procedures
Annals of Internal Medicine
20 November 2007 Volume 147 Issue 10
Dena M. Bravata, MD, MS; Allison L. Gienger, BA; Kathryn M. McDonald, MM; Vandana Sundaram, MPH; Marco V. Perez, MD; Robin Varghese, MD, MS; John R. Kapoor, MD, PhD; Reza Ardehali, MD, PhD; Douglas K. Owens, MD, MS; and Mark A. Hlatky, MD
Background: The comparative effectiveness of coronary artery bypass graft (CABG) surgery and percutaneous coronary intervention (PCI) for patients in whom both procedures are feasible remains poorly understood.
Purpose: To compare the effectiveness of PCI and CABG in patients for whom coronary revascularization is clinically indicated.
Data Sources: MEDLINE, EMBASE, and Cochrane databases (1966–2006); conference proceedings; and bibliographies of retrieved articles.
Study Selection: Randomized, controlled trials (RCTs) reported in any language that compared clinical outcomes of PCI with those of CABG, and selected observational studies.
Data Extraction: Information was extracted on study design, sample characteristics, interventions, and clinical outcomes.
Data Synthesis: We identified 23 RCTs in which 5019 patients were randomly assigned to PCI and 4944 patients were randomly assigned to CABG. The difference in survival after PCI or CABG was less than 1% over 10 years of follow-up. Survival did not differ between PCI and CABG for patients with diabetes in the 6 trials that reported on this subgroup. Procedural strokes were more common after CABG than after PCI (1.2% vs. 0.6%; risk difference, 0.6%; P = 0.002). Angina relief was greater after CABG than after PCI, with risk differences ranging from 5% to 8% at 1 to 5 years (P < 0.001). The absolute rates of angina relief at 5 years were 79% after PCI and 84% after CABG. Repeated revascularization was more common after PCI than after CABG (risk difference, 24% at 1 year and 33% at 5 years; P < 0.001); the absolute rates at 5 years were 46.1% after balloon angioplasty, 40.1% after PCI with stents, and 9.8% after CABG. In the observational studies, the CABG–PCI hazard ratio for death favored PCI among patients with the least severe disease and CABG among those with the most severe disease.
Limitations: The RCTs were conducted in leading centers in selected patients. The authors could not assess whether comparative outcomes vary according to clinical factors, such as extent of coronary disease, ejection fraction, or previous procedures. Only 1 small trial used drug-eluting stents.
Conclusion: Compared with PCI, CABG was more effective in relieving angina and led to fewer repeated revascularizations but had a higher risk for procedural stroke. Survival to 10 years was similar for both procedures
Monday, September 3, 2007
ESC Congrss - News - A randomized multicenter trial: PRAGUE-8.
Hotlines and Clinical Trial Updates - Optimal pre-PCI clopidogrel loading: 600mg before every coronary angiography vs. 600 mg in cath-lab only for PCI patients. A randomized multicenter trial: PRAGUE-8.:
Conclusion:
Routine clopidogrel pretreatment before elective coronary angiography is not justified – it increases the risk of bleeding complications, while the benefit on periprocedural infarction is not significant. Clopidogrel should be given only to patients with known coronary angiography who undergo PCI and this can be done safely in the catheterization laboratory between the two procedures.
Conclusion:
Routine clopidogrel pretreatment before elective coronary angiography is not justified – it increases the risk of bleeding complications, while the benefit on periprocedural infarction is not significant. Clopidogrel should be given only to patients with known coronary angiography who undergo PCI and this can be done safely in the catheterization laboratory between the two procedures.
ESC Congress News - Immediate emergency angioplasty can save the lives of those experiencing MI (CARESS)
ESC Daily Congress News
Immediate emergency angioplasty can save the lives of those experiencing MI
Authors:
Professor Carlo Di MarioUnited KingdomTel: +44 207 351 8616Fax+44 207 351 8629E-mail: c.dimario@rbht.nhs.uk
Hot Line II, CARESS in AMI Combined Abciximab RE-teplase Stent Study in Acute Myocardial Infarction, 707005
Vienna, Austria, 3 September 2007: We have demonstrated that patients who have an acute myocardial infarction and are admitted to a hospital which has no possibility to perform direct angioplasty, benefit from being transferred immediately after having received thrombolytics to a hospital where angioplasty (percutaneous coronary intervention, PCI, often including stent implantation) can be immediately performed.
Patients who are transferred and receive angioplasty immediately after thrombolytics are much more likely (4.1% vs. 11.1% at 30 days, p<0.001)> This advantage was present despite the fact that all the patients (36% of the entire conservative group) randomized to the group of more conservative treatment (no immediate transfer) were also promptly referred during the first hours post treatment if there was no evidence in their ECG/clinical status that the lytic drugs had open the occluded artery.
Clinical implications: When a patient cannot receive direct angioplasty, which unfortunately still includes the majority of the patients with acute myocardial infarction in most European countries, the current practice in most hospitals in Europe is to administer lytics and to wait, watching the effect of the drug on ECG and patient’s symptoms. It appears that this practice is wrong and all patients should be transferred immediately for angioplasty after thrombolysis is started. The reason why this does not happen, despite the fact that an ESC Guideline advises the practice, is because there was evidence from recent trials, namely ASSENT-4, reported in Lancet 2006; 367:569-68, that lytics immediately before PCI can be deleterious and increase the risk of adverse events, especially bleedings but also death and need for new emergency angioplasty.
We had an opposite result and we believe the reason is the type of lytic treatment used -- not just a thrombolytic drug, but a cocktail of a powerful intravenous anti-platelet agent called abciximab, and a reduced dose of a fibrin specific lytic drug called reteplase. This combination is very powerful and rapid in its action, with a synergistic effect demonstrated in previous trials and in in-vitro models, and achieved restoration of flow in the occluded artery in 85% of cases by the time patients reached the hospital where angioplasty was performed. Its main advantage is, however, the ability to inactivate platelets during the subsequent angioplasty, the opposite of the result observed when only lytics are given which tend to activate platelets instead.
IMPORTANT NOTE: This study will be presented immediately after a larger trial of almost 2,000 patients called FINESSE, with a PI from the Cleveland Clinic, Dr Stephen Ellis. The results of this second trial in AMI will be complementary to the CARESS results because FINESSE compares direct (primary) angioplasty with facilitated angioplasty using only abciximab or using the same combination of drugs we used in this trial. I expect the combined presentation of these 2 trials, with ours clearly positive and reaching unquestionable statistical significance with a favourable effects on all the endpoints (death, re-AMI and refractory ischaemia) will represent one of the highlights of this year’s ESC congress.
Immediate emergency angioplasty can save the lives of those experiencing MI
Authors:
Professor Carlo Di MarioUnited KingdomTel: +44 207 351 8616Fax+44 207 351 8629E-mail: c.dimario@rbht.nhs.uk
Hot Line II, CARESS in AMI Combined Abciximab RE-teplase Stent Study in Acute Myocardial Infarction, 707005
Vienna, Austria, 3 September 2007: We have demonstrated that patients who have an acute myocardial infarction and are admitted to a hospital which has no possibility to perform direct angioplasty, benefit from being transferred immediately after having received thrombolytics to a hospital where angioplasty (percutaneous coronary intervention, PCI, often including stent implantation) can be immediately performed.
Patients who are transferred and receive angioplasty immediately after thrombolytics are much more likely (4.1% vs. 11.1% at 30 days, p<0.001)> This advantage was present despite the fact that all the patients (36% of the entire conservative group) randomized to the group of more conservative treatment (no immediate transfer) were also promptly referred during the first hours post treatment if there was no evidence in their ECG/clinical status that the lytic drugs had open the occluded artery.
Clinical implications: When a patient cannot receive direct angioplasty, which unfortunately still includes the majority of the patients with acute myocardial infarction in most European countries, the current practice in most hospitals in Europe is to administer lytics and to wait, watching the effect of the drug on ECG and patient’s symptoms. It appears that this practice is wrong and all patients should be transferred immediately for angioplasty after thrombolysis is started. The reason why this does not happen, despite the fact that an ESC Guideline advises the practice, is because there was evidence from recent trials, namely ASSENT-4, reported in Lancet 2006; 367:569-68, that lytics immediately before PCI can be deleterious and increase the risk of adverse events, especially bleedings but also death and need for new emergency angioplasty.
We had an opposite result and we believe the reason is the type of lytic treatment used -- not just a thrombolytic drug, but a cocktail of a powerful intravenous anti-platelet agent called abciximab, and a reduced dose of a fibrin specific lytic drug called reteplase. This combination is very powerful and rapid in its action, with a synergistic effect demonstrated in previous trials and in in-vitro models, and achieved restoration of flow in the occluded artery in 85% of cases by the time patients reached the hospital where angioplasty was performed. Its main advantage is, however, the ability to inactivate platelets during the subsequent angioplasty, the opposite of the result observed when only lytics are given which tend to activate platelets instead.
IMPORTANT NOTE: This study will be presented immediately after a larger trial of almost 2,000 patients called FINESSE, with a PI from the Cleveland Clinic, Dr Stephen Ellis. The results of this second trial in AMI will be complementary to the CARESS results because FINESSE compares direct (primary) angioplasty with facilitated angioplasty using only abciximab or using the same combination of drugs we used in this trial. I expect the combined presentation of these 2 trials, with ours clearly positive and reaching unquestionable statistical significance with a favourable effects on all the endpoints (death, re-AMI and refractory ischaemia) will represent one of the highlights of this year’s ESC congress.
Thursday, August 16, 2007
Cardiologists' Use of Percutaneous Coronary Interventions for Stable Coronary Artery Disease
Cardiologists' Use of Percutaneous Coronary Interventions for Stable Coronary Artery Disease
Grace A. Lin, MD; R. Adams Dudley, MD, MBA; Rita F. Redberg, MD, MSc
Arch Intern Med. 2007;167:1604-1609.
ABSTRACT
Background Percutaneous coronary intervention (PCI) is commonly performed in patients with stable coronary artery disease, despite current evidence suggesting that such patients derive minimal benefit from the procedure. We sought to determine the influences on cardiologists' decision to perform elective PCI in patients with stable coronary artery disease.
Methods We conducted a qualitative study using 3 focus groups of interventional and noninterventional cardiologists in California. Participants discussed issues surrounding the decision to perform PCI using hypothetical case scenarios. We analyzed the data according to the principles of grounded theory.
Results Despite acknowledging data showing that PCI offers no reduction in the risk of death or myocardial infarction in patients with stable coronary artery disease, cardiologists generally believed that PCI would benefit such patients. Reasons given for performing PCI included belief in the benefits of treating ischemia and the open artery hypothesis, especially with drug-eluting stents; potential regret for not intervening if a cardiac event could be averted; alleviation of patient anxiety; and medicolegal considerations. Participants believed that, in patients undergoing coronary angiography, an "oculostenotic reflex" prevailed and all significant amenable stenoses would receive intervention, even in asymptomatic patients.
Conclusions The widespread application of PCI in stable coronary artery disease for indications unsupported by evidence may reflect discordance between cardiologists' clinical knowledge and their beliefs about the benefits of PCI. Nonclinical factors appear to have substantial influence on physician decision making. Future studies should focus on the development of methods to help providers more fully incorporate clinical evidence into their medical decision making.
Wednesday, July 25, 2007
Specific Gene Suppressor Described As A 'Dictator With A Conscience'
Specific Gene Suppressor Described As A 'Dictator With A Conscience'
25 Jul 2007 University of New South Wales (UNSW) researchers have uncovered an important naturally occurring mechanism in the body where "bad" cells that cause blockages in our blood vessels are kept under strict growth control, while "good" cells that keep our blood vessels free of clots and growths are left unaffected.
The discovery is expected to benefit those who will need heart coronary bypass surgery, an angioplasty -- the mechanical widening of a narrowed or totally blocked blood vessel -- or will undergo haemodialysis.
Professor Levon Khachigian, from UNSW's Centre for Vascular Research, who previously pioneered "molecular assassin" drug technology, describes this novel mechanism he discovered as "a molecular dictatorship with a conscience".
"The dictator is a specific gene suppressor called YY1, which has the therapeutically appealing capacity to differentiate between certain cell types when it goes about its activity," says Professor Khachigian.
This key finding has just been published in the world's premier cardiovascular research journal, Circulation Research.
Professor Khachigian's research provides new hope in tackling the global problems of coronary bypass graft failure, and restenosis -- the closing or narrowing of an artery that was previously opened by a procedure such as angioplasty.
"While the most effective way to head off restenosis is a drug-coated stent, the drugs that sit on these stents inhibit the growth of good cells as well as the bad.
"If you had to have catheter intervention to re-open an occluded artery, for sustained symptom-free benefit you would be hoping for suppressed smooth muscle cell growth, without affecting endothelial cell growth," says Professor Khachigian.
"And that's exactly what happens when we simply top up blood vessels with the body's natural reserves of YY1."
Article adapted by Medical News Today from original press release.
25 Jul 2007 University of New South Wales (UNSW) researchers have uncovered an important naturally occurring mechanism in the body where "bad" cells that cause blockages in our blood vessels are kept under strict growth control, while "good" cells that keep our blood vessels free of clots and growths are left unaffected.
The discovery is expected to benefit those who will need heart coronary bypass surgery, an angioplasty -- the mechanical widening of a narrowed or totally blocked blood vessel -- or will undergo haemodialysis.
Professor Levon Khachigian, from UNSW's Centre for Vascular Research, who previously pioneered "molecular assassin" drug technology, describes this novel mechanism he discovered as "a molecular dictatorship with a conscience".
"The dictator is a specific gene suppressor called YY1, which has the therapeutically appealing capacity to differentiate between certain cell types when it goes about its activity," says Professor Khachigian.
This key finding has just been published in the world's premier cardiovascular research journal, Circulation Research.
Professor Khachigian's research provides new hope in tackling the global problems of coronary bypass graft failure, and restenosis -- the closing or narrowing of an artery that was previously opened by a procedure such as angioplasty.
"While the most effective way to head off restenosis is a drug-coated stent, the drugs that sit on these stents inhibit the growth of good cells as well as the bad.
"If you had to have catheter intervention to re-open an occluded artery, for sustained symptom-free benefit you would be hoping for suppressed smooth muscle cell growth, without affecting endothelial cell growth," says Professor Khachigian.
"And that's exactly what happens when we simply top up blood vessels with the body's natural reserves of YY1."
Article adapted by Medical News Today from original press release.
Saturday, July 14, 2007
Impact of multivessel disease on reperfusion success and clinical outcomes in patients undergoing primary percutaneous coronary intervention for acute myocardial infarction -- Sorajja et al. 28 (14): 1709 -- European Heart Journal
Impact of multivessel disease on reperfusion success and clinical outcomes in patients undergoing primary percutaneous coronary intervention for acute myocardial infarction --
Sorajja et al. 28 (14): 1709 -- European Heart Journal
Aims: We sought to investigate the impact of multivessel coronary artery disease (CAD) on reperfusion success and prognosis following primary percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI). The influence of multivessel disease on myocardial reperfusion and subsequent survival after primary PCI has not been studied.
Conclusion: Patients with extensive CAD in vessels remote from the infarct-related artery have reduced reperfusion success and an adverse prognosis following primary PCI in AMI. Future studies regarding the optimal treatment of patients with multivessel disease and AMI are warranted.
Sorajja et al. 28 (14): 1709 -- European Heart Journal
Aims: We sought to investigate the impact of multivessel coronary artery disease (CAD) on reperfusion success and prognosis following primary percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI). The influence of multivessel disease on myocardial reperfusion and subsequent survival after primary PCI has not been studied.
Conclusion: Patients with extensive CAD in vessels remote from the infarct-related artery have reduced reperfusion success and an adverse prognosis following primary PCI in AMI. Future studies regarding the optimal treatment of patients with multivessel disease and AMI are warranted.
Wednesday, July 11, 2007
PCI benefits over fibrinolysis found in diabetic patients
MedWire News - Cardiology - PCI benefits over fibrinolysis found in diabetic patients
PCI benefits over fibrinolysis found in diabetic patients
11 July 2007
Arch Intern Med 2007; 167: 1353-1359
MedWire News: The beneficial effects of primary percutaneous coronary intervention (PCI) over reperfusion therapy in diabetic patients with ST-segment elevation myocardial infarction (STEMI) are consistent with those for non-diabetic patients, meta-analysis findings indicate.
Writing in the Archives of Internal Medicine, Jan Paul Ottervanger (Isala Klinieken, Zwolle, The Netherlands) and colleagues note that an increasing amount of evidence indicates that primary PCI improves outcomes of STEMI compared with fibrinolysis in the general population. But effects of both reperfusion and fibrinolysis may differ in diabetic patients, they say, and previous trials comparing the strategies in diabetic patients have produced conflicting data.
"In our analysis including a large number of patients, it was more clearly demonstrated that primary PCI is associated with improved survival after 30 days in both patients with and without diabetes," the team reports.
The researchers analyzed data from 19 trials that compared primary PCI with fibrinolysis for STEMI in a total of 6315 patients, 877 (14%) of whom had diabetes.
At 30 days, 401 (6.3%) patients had died. Mortality was significantly higher in patients with than without diabetes (9.4% vs 5.9%, p<0.001).
Primary PCI was associated with lower mortality than fibrinolysis in both non-diabetic patients (4.8% vs 6.9%, unadjusted odds ratio [OR]=0.69; p=0.001) and diabetic patients (6.6% vs 12.4%, OR=0.49; p=0.001).
Recurrent MI and stroke were also less common with PCI in patients with and without diabetes, with corresponding ORs of 0.33 and 0.60, and 0.58 and 0.40.
After adjusting for potential confounders, including age, gender, time to randomization, treatment delay, systolic blood pressure, anterior MI, previous MI, heart rate, and randomized treatment, primary PCI was independently associated with reduced 30-day survival (OR=0.64). This association held true in patients with diabetes (OR=0.50) and without diabetes (OR=0.68).
The authors note that these point estimates indicate a greater benefit of PCI in diabetic patients, in whom the absolute risk is higher than in non-diabetic patients.
"This observation may be the result of delay in initiation of therapy and longer ischemic time in diabetic patients, which may be related in part to atypical symptoms," they write. "In particular, thrombolytic therapy seems to be negatively influenced by longer time to initiation of therapy."
They add that impairment of microvascular flow after fibrinolysis in diabetic patients could also contribute to a more favorable effect with PCI.
"Wider application of timely primary PCI could be an important strategy to improve outcomes in the high-risk population of diabetic patients," Timmer and co-authors conclude.
Free abstract
PCI benefits over fibrinolysis found in diabetic patients
11 July 2007
Arch Intern Med 2007; 167: 1353-1359
MedWire News: The beneficial effects of primary percutaneous coronary intervention (PCI) over reperfusion therapy in diabetic patients with ST-segment elevation myocardial infarction (STEMI) are consistent with those for non-diabetic patients, meta-analysis findings indicate.
Writing in the Archives of Internal Medicine, Jan Paul Ottervanger (Isala Klinieken, Zwolle, The Netherlands) and colleagues note that an increasing amount of evidence indicates that primary PCI improves outcomes of STEMI compared with fibrinolysis in the general population. But effects of both reperfusion and fibrinolysis may differ in diabetic patients, they say, and previous trials comparing the strategies in diabetic patients have produced conflicting data.
"In our analysis including a large number of patients, it was more clearly demonstrated that primary PCI is associated with improved survival after 30 days in both patients with and without diabetes," the team reports.
The researchers analyzed data from 19 trials that compared primary PCI with fibrinolysis for STEMI in a total of 6315 patients, 877 (14%) of whom had diabetes.
At 30 days, 401 (6.3%) patients had died. Mortality was significantly higher in patients with than without diabetes (9.4% vs 5.9%, p<0.001).
Primary PCI was associated with lower mortality than fibrinolysis in both non-diabetic patients (4.8% vs 6.9%, unadjusted odds ratio [OR]=0.69; p=0.001) and diabetic patients (6.6% vs 12.4%, OR=0.49; p=0.001).
Recurrent MI and stroke were also less common with PCI in patients with and without diabetes, with corresponding ORs of 0.33 and 0.60, and 0.58 and 0.40.
After adjusting for potential confounders, including age, gender, time to randomization, treatment delay, systolic blood pressure, anterior MI, previous MI, heart rate, and randomized treatment, primary PCI was independently associated with reduced 30-day survival (OR=0.64). This association held true in patients with diabetes (OR=0.50) and without diabetes (OR=0.68).
The authors note that these point estimates indicate a greater benefit of PCI in diabetic patients, in whom the absolute risk is higher than in non-diabetic patients.
"This observation may be the result of delay in initiation of therapy and longer ischemic time in diabetic patients, which may be related in part to atypical symptoms," they write. "In particular, thrombolytic therapy seems to be negatively influenced by longer time to initiation of therapy."
They add that impairment of microvascular flow after fibrinolysis in diabetic patients could also contribute to a more favorable effect with PCI.
"Wider application of timely primary PCI could be an important strategy to improve outcomes in the high-risk population of diabetic patients," Timmer and co-authors conclude.
Free abstract
Tuesday, June 5, 2007
Specialist care cuts heart deaths
Specialist care cuts heart deaths
Swift treatment to re-open the arteries at a specialist centre significantly increases the chances of surviving a heart attack, a study has found.
Doctors at Harefield Hospital found under 3% of patients treated with angioplasty at the specialist heart centre had died after 30 days.
But of those patients taken first to a general hospital before referral to the centre, more than 10% died.
The study was presented at a British Cardiovascular Society Conference.
This gives better long-term results - time is muscle Dr Miles Dalby
The British Heart Foundation estimates that 230,000 people in the UK have a heart attack each year, and that about 30% of these are fatal.
Dr Miles Dalby, a consultant cardiologist at Harefield Hospital, and colleagues looked at 180 patients who received direct primary angioplasty at their hospital.
Fast treatment
The patients were taken there directly by ambulance staff trained to identify patients who would benefit from the treatment.
Dr Dalby says patients at the hospital's heart attack centre receive treatment and have their blood flow restored within an average of 24 minutes after arrival.
They compared these with 181 patients who had received the treatment after being referred to the centre from a general hospital.
Cardiologists perform primary angioplasty to clear blockages in the heart's arteries - the artery is unblocked using a thin tube, then opened by inflating a small balloon, and held open with a metal tube, or stent.
In non-specialist centres treatment is often by thrombolysis drugs which dissolve the blood clots, but the study found in patients treated with thrombolysis in the preceding two years, around 9% died.
Dr Dalby said prompt treatment is vital for effective primary angioplasty, and that taking patients directly to heart attacks centres could reduce the number of deaths "significantly."
He said: "During a heart attack, blood flow to the heart muscle is blocked which damages it.
"The sooner the patient receives treatment enabling the blood flow to return to the coronary arteries, the less damage occurs.
"This gives better long-term results - time is muscle."
More detail needed
Dr Clive Weston, associate director of Royal College of Physician's Myocardial Infarction National Audit Project, which collects data on heart attack patients, said the results were "quite remarkable".
However he warned that in rural areas, where it make take some time to travel to a specialist centre, methods such as delivering thrombolytic treatments in ambulances could be more effective.
And he said the data needed to be explored in more detail to check there were no biases.
Thrombolysis is very effective if delivered soon after heart attack symptoms develop.
However, as time passes, angioplasty becomes the more effective treatment.
And Dr Weston said another benefit of primary angioplasty was that it allowed to doctors to see more of the coronary anatomy so they could see what had caused the heart attack and help prevent future attacks.
Judy O'Sullivan, cardiac nurse at the British Heart Foundation, said: "The study published by the Harefield team shows promising results for recent advances in the treatment of heart attacks at such specialist centres."
She said in the future angioplasty was likely to supercede thrombolysis as the treatment of choice for heart attacks,and added that patients' speed of response in dialling 999 could also affect their survival chances.
Story from BBC NEWS:
http://news.bbc.co.uk/go/pr/fr/-/1/hi/health/6719075.stm
Published: 2007/06/05 07:31:17 GMT
Swift treatment to re-open the arteries at a specialist centre significantly increases the chances of surviving a heart attack, a study has found.
Doctors at Harefield Hospital found under 3% of patients treated with angioplasty at the specialist heart centre had died after 30 days.
But of those patients taken first to a general hospital before referral to the centre, more than 10% died.
The study was presented at a British Cardiovascular Society Conference.
This gives better long-term results - time is muscle Dr Miles Dalby
The British Heart Foundation estimates that 230,000 people in the UK have a heart attack each year, and that about 30% of these are fatal.
Dr Miles Dalby, a consultant cardiologist at Harefield Hospital, and colleagues looked at 180 patients who received direct primary angioplasty at their hospital.
Fast treatment
The patients were taken there directly by ambulance staff trained to identify patients who would benefit from the treatment.
Dr Dalby says patients at the hospital's heart attack centre receive treatment and have their blood flow restored within an average of 24 minutes after arrival.
They compared these with 181 patients who had received the treatment after being referred to the centre from a general hospital.
Cardiologists perform primary angioplasty to clear blockages in the heart's arteries - the artery is unblocked using a thin tube, then opened by inflating a small balloon, and held open with a metal tube, or stent.
In non-specialist centres treatment is often by thrombolysis drugs which dissolve the blood clots, but the study found in patients treated with thrombolysis in the preceding two years, around 9% died.
Dr Dalby said prompt treatment is vital for effective primary angioplasty, and that taking patients directly to heart attacks centres could reduce the number of deaths "significantly."
He said: "During a heart attack, blood flow to the heart muscle is blocked which damages it.
"The sooner the patient receives treatment enabling the blood flow to return to the coronary arteries, the less damage occurs.
"This gives better long-term results - time is muscle."
More detail needed
Dr Clive Weston, associate director of Royal College of Physician's Myocardial Infarction National Audit Project, which collects data on heart attack patients, said the results were "quite remarkable".
However he warned that in rural areas, where it make take some time to travel to a specialist centre, methods such as delivering thrombolytic treatments in ambulances could be more effective.
And he said the data needed to be explored in more detail to check there were no biases.
Thrombolysis is very effective if delivered soon after heart attack symptoms develop.
However, as time passes, angioplasty becomes the more effective treatment.
And Dr Weston said another benefit of primary angioplasty was that it allowed to doctors to see more of the coronary anatomy so they could see what had caused the heart attack and help prevent future attacks.
Judy O'Sullivan, cardiac nurse at the British Heart Foundation, said: "The study published by the Harefield team shows promising results for recent advances in the treatment of heart attacks at such specialist centres."
She said in the future angioplasty was likely to supercede thrombolysis as the treatment of choice for heart attacks,and added that patients' speed of response in dialling 999 could also affect their survival chances.
Story from BBC NEWS:
http://news.bbc.co.uk/go/pr/fr/-/1/hi/health/6719075.stm
Published: 2007/06/05 07:31:17 GMT
Thursday, May 17, 2007
Stent implants in U.S. declined in April - Wall Street Journal
Stent implants in U.S. declined in April-WSJ
Thu May 17, 2007 4:41am ET
NEW YORK, May 17 (Reuters) - The number of coronary stents implanted in the United States dropped in April, the Wall Street Journal reported on its Web site on Thursday, citing a market research firm.
Stents are tiny wire mesh tubes used to prop open diseased heart arteries. Stent makers include Boston Scientific Corp. (BSX.N: Quote, Profile , Research), Abbott Laboratories (ABT.N: Quote, Profile , Research) and Johnson & Johnson (JNJ.N: Quote, Profile , Research).
Doctors performed about 71,200 stentings in April, the Journal reported, citing estimates from Millennium Research Group, a Toronto firm that surveys about 140 U.S. hospitals. The number was down more than 10 percent from March and more than 15 percent from a year earlier, it said.
The Journal cited doctors as saying that the drop was an unusually quick response to a study showing the devices provided little advantage over drug therapy in some patients.
Wall Street Journal - FREE PREVIEW
Stent Implants Declined in April
By Keith J. Winstein
Companies Featured in This Article: Boston Scientific, Abbott Laboratories, Johnson & Johnson
The number of coronary stents implanted in the U.S. dropped sharply in April, according to a leading market researcher, in what doctors said was an unusually quick response to a study showing the devices provided little advantage over drug therapy in some patients.
The new figures are the latest evidence that the tiny scaffolds used to prop open arteries are no longer a powerful growth engine for the medical industry. Americans spent at least $14 billion on coronary-stent procedures last year, including surgical and hospital fees. World-wide sales of the devices totaled about $6 billion.
Doctors performed about 71,200 stentings ...
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Thu May 17, 2007 4:41am ET
NEW YORK, May 17 (Reuters) - The number of coronary stents implanted in the United States dropped in April, the Wall Street Journal reported on its Web site on Thursday, citing a market research firm.
Stents are tiny wire mesh tubes used to prop open diseased heart arteries. Stent makers include Boston Scientific Corp. (BSX.N: Quote, Profile , Research), Abbott Laboratories (ABT.N: Quote, Profile , Research) and Johnson & Johnson (JNJ.N: Quote, Profile , Research).
Doctors performed about 71,200 stentings in April, the Journal reported, citing estimates from Millennium Research Group, a Toronto firm that surveys about 140 U.S. hospitals. The number was down more than 10 percent from March and more than 15 percent from a year earlier, it said.
The Journal cited doctors as saying that the drop was an unusually quick response to a study showing the devices provided little advantage over drug therapy in some patients.
Wall Street Journal - FREE PREVIEW
Stent Implants Declined in April
By Keith J. Winstein
Companies Featured in This Article: Boston Scientific, Abbott Laboratories, Johnson & Johnson
The number of coronary stents implanted in the U.S. dropped sharply in April, according to a leading market researcher, in what doctors said was an unusually quick response to a study showing the devices provided little advantage over drug therapy in some patients.
The new figures are the latest evidence that the tiny scaffolds used to prop open arteries are no longer a powerful growth engine for the medical industry. Americans spent at least $14 billion on coronary-stent procedures last year, including surgical and hospital fees. World-wide sales of the devices totaled about $6 billion.
Doctors performed about 71,200 stentings ...
THE FULL WSJ.com ARTICLE IS ONLY AVAILABLE TO SUBSCRIBERS.
IF YOU ARE ALREADY A SUBSCRIBER, PLEASE LOG IN AT THE TOP RIGHT OF THE PAGE.
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