Assessing the effectiveness of primary angioplasty compared with thrombolysis and its relationship to time delay: a Bayesian evidence synthesis
Heart 2007;93:1244-1250
Christian Asseburg, Yolanda Bravo Vergel, Stephen Palmer, Elisabeth Fenwick, Mark de Belder, Keith R Abrams, Mark Sculpher
ABSTRACT
Background: Meta-analyses of trials have shown greater benefits from angioplasty than thrombolysis after an acute myocardial infarction, but the time delay in initiating angioplasty needs to be considered.
Objective: To extend earlier meta-analyses by considering 1- and 6-month outcome data for both forms of reperfusion. To use Bayesian statistical methods to quantify the uncertainty associated with the estimated relationships.
Methods: A systematic review and meta-analysis published in 2003 was updated. Data on key clinical outcomes and the difference between time-to-balloon and time-to-needle were independently extracted by two researchers. Bayesian statistical methods were used to synthesise evidence despite differences between reported follow-up times and outcomes. Outcomes are presented as absolute probabilities of specific events and odds ratios (ORs; with 95% credible intervals (CrI)) as a function of the additional time delay associated with angioplasty.
Results: 22 studies were included in the meta-analysis, with 3760 and 3758 patients randomised to primary angioplasty and thrombolysis, respectively. The mean (SE) angioplasty-related time delay (over and above time to thrombolysis) was 54.3 (2.2) minutes. For this delay, mean event probabilities were lower for primary angioplasty for all outcomes. Mortality within 1 month was 4.5% after angioplasty and 6.4% after thrombolysis (OR = 0.68 (95% CrI 0.46 to 1.01)). For non-fatal reinfarction, OR = 0.32 (95% CrI 0.20 to 0.51); for non-fatal stroke OR = 0.24 (95% CrI 0.11 to 0.50). For all outcomes, the benefit of angioplasty decreased with longer delay from initiation.
Conclusions: The benefit of primary angioplasty, over thrombolysis, depends on the former’s additional time delay. For delays of 30–90 minutes, angioplasty is superior for 1-month fatal and non-fatal outcomes. For delays of around 90 minutes thrombolysis may be the preferred option as assessed by 6-month mortality; there is considerable uncertainty for longer time delays.
Showing posts with label Thrombolytics. Show all posts
Showing posts with label Thrombolytics. Show all posts
Monday, September 24, 2007
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.
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