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A Non-Inferiority Comparison between Generic Clopidogrel and Original Clopidogrel in Terms of Clinical Efficacy and Safety in the Era of Drug-Eluting Stents
가천의대 길병원 심장내과
박예민, 이경훈, 안태훈, 정을식, 신동수, 김명건, 신권철, 강웅철, 한승환, 최인석, 신익균
Background: Dual antiplatelet therapy with clopidogrel and aspirin has been shown to reduce ischemic events in patients underwent percutaneous coronary intervention (PCI) with drug-eluting stent (DES). Even though generic clopidogrels (GC) are used a lot in these days, there are not enough data evaluating the clinical equivalence to original clopidogrel (OC). This study was aimed to investigate the clinical efficacy and safety of GC compared to OC following PCI. Methods: From July 2006 to February 2009, a cohort of 450 patients who had been performed PCI at Gil Hospital and completed follow-up more than twelve months were enrolled. Patients were divided into two groups according to OC or GC treatment and analyzed. A total of 266 were OC group and 224 patients were GC group and. Primary end point was major adverse cardio-cerebro-vascular event (MACCE) at 12 month. MACCE was a composite of cardiac death (CD), myocardial infarction (MI), cerebral vascular accident (CVA) and target vessel revascularization (TVR). Also stent thromboses (ST) by ARC definition were evaluated. Results: Baseline demographic and procedural characteristics were not different between GC group and OC group. MACCE at 12 month were 5.3% (0 CD, 1 MI, 2 CVA, 9 TVR) in OC group and 8.0 % (2 CD, 4 MI, 2 CVA, 11 TVR) in GC group (p=0.25). Although the incidence of CD and MI seemed to be high in GC group but there was no significant difference to OC group (P=0.25, P=0.22) (Figure 1). Stent thrombosis was 0% in OC group and 0.4% (1 definite and subacute ST) in GC group at 12-month follow-up (p=0.50). Conclusions: Generic clopidogrels showed non-inferiority compare to original clopidogrel in terms of cardiac death, MI, CVA, TVR and stent thrombosis in patients who underwent DES implantation.
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