Use of clopidogrel with or without aspirin in patients taking oral anticoagulant therapy and undergoing percutaneous coronary intervention: an open-label, randomised, controlled trial
作者： Willem JM Dewilde , Tom Oirbans , Freek WA Verheugt , Johannes C Kelder , Bart JGL De Smet
DOI: 10.1016/S0140-6736(12)62177-1
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摘要: Methods We did an open-label, multicentre, randomised, controlled trial in 15 centres Belgium and the Netherlands. From November, 2008, to N ovember, 2011, adults receiving oral anticoagulants undergoing PCI were assigned clopidogrel alone (double therapy) or plus aspirin (triple therapy). The primary outcome was any bleeding episode within 1 year of PCI, assessed by intention treat. This study is registered with ClinicalTrials.gov, number NCT00769938. Findings 573 patients enrolled 1-year data available for 279 (98·2%) double therapy 284 (98·3%) triple therapy. Mean ages 70·3 (SD 7·0) years 69·5 (8·0) years, respectively. B leeding episodes seen 54 (19·4%) 126 (44·4%) (hazard ratio [HR] 0·36, 95% CI 0·26–0·50, p<0·0001). In double-therapy group, six (2·2%) had multiple events, compared 34 (12·0%) triple-therapy group. 11 (3·9%) required at least one blood transfusion, 27 (9·5%) group (odds from Kaplan-Meier curve 0·39, 0·17–0·84, p=0·011). Interpretation Use clopiogrel without associated a signifi cant reduction complications no increase rate thrombotic events.
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