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
Showing posts with label Fibrinolysis. Show all posts
Showing posts with label Fibrinolysis. Show all posts
Thursday, December 20, 2007
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
Monday, September 3, 2007
ESC Congress - News - the DANAMI-2 trial - fibrinolytic therapy versus primary angioplasty in acute myocardial infarction
ESC Congress - News
The Danish multicenter randomised study of fibrinolytic therapy versus primary angioplasty in acute myocardial infarction (the DANAMI-2 trial). Outcome after three years follow-up.
Presenter report:
Nielsen, Torsten Toftegaard (Denmark)
Long-term randomized results on transfer for primary angioplasty (pPCI) versus on-site fibrinolysis for treatment of STEMI patients are sparse.The DANAMI-2 trial randomized 1572 STEMI patients to primary angioplasty (pPCI) or fibrinolysis (alteplase); 1129 of the patients were enrolled at 24 local hospitals without PCI facilities. Ninety-six percent of inter-hospital transfers for pPCI were completed within two hours. At 30 days, inter-hospital transfer for pPCI compared with fibrinolysis halved the primary composite endpoint of death, clinical reinfarction, or disabling stroke. The present study reports the long term (3 year) outcome. No patients were lost to follow-up.
The initial benefit of transfer for primary angioplasty based on the composite endpoint was sustained after three years (20.1 vs 26.7%, p=0.0007). Death occurred in 13.6 vs 16.4% (p=0.18), clinical reinfarction in 8.9% vs 12.3% (p=0.05), and disabling stroke in 3.2 vs 4.7% (p=0.23). Independent predictors of death were: clinical reinfarction, HR: 5.23 (3.63-7.54), anterior STEMI, HR.1.68 (1.26-2.23) and age, HR 1.08 (1.07-1.10).
We conclude that when inter-hospital transfer can be completed within two hours, primary angioplasty should be preferred over on-site fibrinolysis.
The Danish multicenter randomised study of fibrinolytic therapy versus primary angioplasty in acute myocardial infarction (the DANAMI-2 trial). Outcome after three years follow-up.
Presenter report:
Nielsen, Torsten Toftegaard (Denmark)
Long-term randomized results on transfer for primary angioplasty (pPCI) versus on-site fibrinolysis for treatment of STEMI patients are sparse.The DANAMI-2 trial randomized 1572 STEMI patients to primary angioplasty (pPCI) or fibrinolysis (alteplase); 1129 of the patients were enrolled at 24 local hospitals without PCI facilities. Ninety-six percent of inter-hospital transfers for pPCI were completed within two hours. At 30 days, inter-hospital transfer for pPCI compared with fibrinolysis halved the primary composite endpoint of death, clinical reinfarction, or disabling stroke. The present study reports the long term (3 year) outcome. No patients were lost to follow-up.
The initial benefit of transfer for primary angioplasty based on the composite endpoint was sustained after three years (20.1 vs 26.7%, p=0.0007). Death occurred in 13.6 vs 16.4% (p=0.18), clinical reinfarction in 8.9% vs 12.3% (p=0.05), and disabling stroke in 3.2 vs 4.7% (p=0.23). Independent predictors of death were: clinical reinfarction, HR: 5.23 (3.63-7.54), anterior STEMI, HR.1.68 (1.26-2.23) and age, HR 1.08 (1.07-1.10).
We conclude that when inter-hospital transfer can be completed within two hours, primary angioplasty should be preferred over on-site fibrinolysis.
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
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