If percutaneous coronary intervention ( PCI ) is required in patients taking oral anticoagulants, antiplatelet therapy with Acetylsalicylic acid ( Aspirin ) and Clopidogrel ( Plavix ) is indicated, but such triple therapy increases the risk of serious bleeding.
The safety and efficacy of Clopidogrel alone compared with Clopidogrel plus Aspirin was evaluated.
Researchers did an open-label, multicentre, randomised, controlled trial ( WOEST study ) in 15 Centres in Belgium and the Netherlands.
During the period 2008-2011, 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.
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 years and 69.5 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; p less than 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; p=0.011 ).
Use of Clopidogrel without Aspirin was associated with a significant reduction in bleeding complications and no increase in the rate of thrombotic events. ( Xagena )
Dewilde WJM et al, The Lancet 2013; 381: 1107-1115