Journal Article

Use of clopidogrel with or without aspirin in patients taking oral anticoagulant therapy and undergoing percutaneous coronary intervention: an open-label, randomised, controlled trial

Vrolix, Mathias, Vis, Marije M, Adriaenssens, Tom, Heestermans, Antonius ACM, Kelder, Johannes C, van 't Hof, Arnoud W, ten Berg, Jurriën M, Herrman, Jean-Paul, Dewilde, Willem JM, Tijsen, Jan GP, De Smet, Bart JGL, Verheugt, Freek WA, Oirbans, Tom

2013

Overview

If percutaneous coronary intervention (PCI) is required in patients taking oral anticoagulants, antiplatelet therapy with aspirin and clopidogrel is indicated, but such triple therapy increases the risk of serious bleeding. We investigated the safety and efficacy of clopidogrel alone compared with clopidogrel plus aspirin. We did an open-label, multicentre, randomised, controlled trial in 15 centres in Belgium and the Netherlands. From November, 2008, to November, 2011, adults receiving oral anticoagulants and undergoing PCI were assigned clopidogrel alone (double therapy) or clopidogrel plus aspirin (triple therapy). The primary outcome was any bleeding episode within 1 year of PCI, assessed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00769938. 573 patients were enrolled and 1-year data were available for 279 (98·2%) patients assigned double therapy and 284 (98·3%) assigned triple therapy. Mean ages were 70·3 (SD 7·0) years and 69·5 (8·0) years, respectively. Bleeding episodes were seen in 54 (19·4%) patients receiving double therapy and in 126 (44·4%) receiving triple therapy (hazard ratio [HR] 0·36, 95% CI 0·26–0·50, p<0·0001). In the double-therapy group, six (2·2%) patients had multiple bleeding events, compared with 34 (12·0%) in the triple-therapy group. 11 (3·9%) patients receiving double therapy required at least one blood transfusion, compared with 27 (9·5%) patients in the triple-therapy group (odds ratio from Kaplan-Meier curve 0·39, 95% CI 0·17–0·84, p=0·011). Use of clopiogrel without aspirin was associated with a significant reduction in bleeding complications and no increase in the rate of thrombotic events. Antonius Ziekenhuis Foundation, Strect Foundation.

• Publisher: Elsevier Ltd,Elsevier,Elsevier Limited
• Subject: Administration, Oral / adults / Aged / Angina pectoris / Anticoagulants / Anticoagulants - adverse effects / aspirin / Aspirin - adverse effects / Belgium / Biological and medical sciences / blood transfusion / Cardiology. Vascular system / Cardiovascular disease / Coronary heart disease / Coronary vessels / Diseases of the cardiovascular system / Dose-Response Relationship, Drug / Drug Administration Schedule / Drug therapy / Drug Therapy, Combination / Female / Follow-Up Studies / General aspects / Heart / Heart attacks / hemorrhage / Hemorrhage - chemically induced / Humans / Internal Medicine / Male / Medical sciences / Middle Aged / Netherlands / odds ratio / patients / Percutaneous Coronary Intervention / Platelet Aggregation Inhibitors - administration & dosage / Platelet Aggregation Inhibitors - adverse effects / Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) / risk / Ticlopidine - administration & dosage / Ticlopidine - adverse effects / Ticlopidine - analogs & derivatives