title: Use of clopidogrel with or without aspirin in patients taking oral anticoagulant therapy and undergoing percutaneous coronary intervention: an open-label, randomised, controlled trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  Use of clopiogrel without aspirin was associated with a significant reduction in bleeding complications and no increase in the rate of thrombotic events.
  
  
  BACKGROUND
  Antonius Ziekenhuis Foundation, Strect Foundation.
authors: Department of Cardiology, Twee Steden Hospital, Tilburg, Netherlands. willemdewilde@yahoo.com
authors: Willem J M
authors: WJ
authors: Dewilde
authors: Tom
authors: T
authors: Oirbans
authors: Freek W A
authors: FW
authors: Verheugt
authors: Johannes C
authors: JC
authors: Kelder
authors: Bart J G L
authors: BJ
authors: De Smet
authors: Jean-Paul
authors: JP
authors: Herrman
authors: Tom
authors: T
authors: Adriaenssens
authors: Mathias
authors: M
authors: Vrolix
authors: Antonius A C M
authors: AA
authors: Heestermans
authors: Marije M
authors: MM
authors: Vis
authors: Jan G P
authors: JG
authors: Tijsen
authors: Arnoud W
authors: AW
authors: van 't Hof
authors: Jurriën M
authors: JM
authors: ten Berg
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000925:Anticoagulants / Q000009:adverse effects*; D001241:Aspirin / Q000009:adverse effects*; D000077144:Clopidogrel; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D013988:Ticlopidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: D000925:Anticoagulants; D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin