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Clopidogrel as Adjunctive Reperfusion Therapy for Thrombosis in Myocardial Infarction: Presented at ESC By Chris Berrie STOCKHOLM, SWEDEN -- September 8, 2005 -- Pretreatment with the P2Y12 adenosine diphosphate receptor blocker clopidogrel significantly appears to reduce the incidence of cardiovascular death (CVD) and ischaemic complications both before and after percutaneous coronary intervention (PCI) without significant increasing the risk of major and minor bleeding in patients with ST-segment elevation myocardial infarction (STEMI) treated with fibrinolytic therapy. The results, from an international, multicentre, double-blind, randomised, placebo-controlled study, were presented here September 4th at the European Society of Cardiology (ESC) Congress 2005. Gilles Montalescot, MD, PhD, Substudy Coordinator and Professor of Cardiology, Department of Cardiology, Institut de Cardiologie, Hôpital Pitié-Salpêtrière, Paris, France, presented the study on behalf of the Clopidogrel as Adjunctive Reperfusion Therapy (CLARITY) -- Thrombosis in Myocardial Infarction (TIMI) 28 investigators. Although it has already been seen that clopidogrel treatment following PCI can reduce thrombotic and ischaemic complications, the potential benefits of clopidogrel pre-treatment before PCI until now remained uncertain. "We therefore hypothesised that in patients undergoing PCI after initial pharmacological therapy for STEMI, clopidogrel pre-treatment hours to days before PCI is superior to clopidogrel treatment initiated at the time of PCI in preventing major adverse cardiovascular events," Dr Montalescot said. Of the 3941 patients who were randomised into the main CLARITY-TIMI 28 study, 1752 were assigned to a 300-mg loading dose of clopidogrel that was followed by 75 mg/day clopidogrel maintenance, while the remaining 1739 patients were assigned to placebo. Following angiography, approximately 50% from each group (at the discretion of the treating physician) followed an immediate open-label clopidogrel 30-day follow-up. The primary results demonstrated a 36% reduction in the odds of closed artery or death or MI before angiography (P < .001), a 20% decrease in the odds of CVD, MI or urgent revascularisation by 30 days (P = .026), and no excess major bleeding. As part of the newly-named PCI-CLARITY-TIMI 28, the remaining patients underwent PCI during index hospitalisation (with open-label clopidogrel loading dose recommended) as the clopidogrel-pretreated group (n = 933) and the placebo-pretreated group (n = 930), followed by a 30-day clinical follow-up. Patients' baseline characteristics were well matched, with no significant differences between the clopidogrel and placebo groups. Dr. Montalescot indicated that the PCI characteristics themselves did show two significant differences: time from randomisation to PCI (3.2, 2.9 days; P = .003) and pre-PCI infarct-related artery patency (87%, 81%; P < .001). There were no further significant differences in the PCI characteristics (glycoprotein IIa/IIIb use during PCI, 31%, 34%; stenting, 95% for each; loading dose of open-label clopidogrel at time of PCI, 78% for each). For the primary combined endpoint of CVD, MI or stroke following PCI, there was a 46% reduction at the 30-day post-PCI follow-up in the clopidogrel-pretreated group, with the 6.2% seen in the placebo-pretreated group reduced to 3.6% (P = .008). This benefit of clopidogrel was also directionally consistent across all the subgroups of the primary endpoints. "The benefit from clopidogrel was also consistent whether the PCI was urgent or elective, for the times from randomisation to PCI, whether or not a glycoprotein IIb/IIIa inhibitor was used during PCI, and whether or not the patients got an open-label loading dose of clopidogrel at the time of PCI, although all of these subgroup P values were not significant," added Dr Montalescot. Dr. Montalescot then detailed that when considering MI or stroke before PCI, the clopidogrel-pretreated group showed a significant 38% reduced outcome over the placebo-treated group (P = .028). Furthermore, the combined CVD, MI or stroke endpoint from randomisation to the end of the 30-day follow-up showed a 41% decrease from the placebo- to the clopidogrel-pretreated group (from 12.0% to 7.5%, respectively; P = .001). Of note, when considered from PCI to follow-up, there were no significant differences in the TIMI major or TIMI minor bleeding between the clopidogrel- and placebo-pretreated groups (major, 0.5% vs. 1.1%; minor, 1.4% vs. 0.8%; respectively). Thus, this use of clopidogrel pre-treatment significantly reduces the incidence of CVD and ischaemic complications both before and after PCI in these patients. Bristol-Myers Squibb and Sanofi-Aventis provided financial support for this study. [Study title: CLARITY-TIMI 28: Clopidogrel as Adjunctive Reperfusion Therapy -- Thrombosis in Myocardial Infarction. Abstract 755] E-mail this page to a friend or colleague! To print, use this version