WOEST
Trial question
What is the role of double therapy with clopidogrel in patients receiving OACs and undergoing PCI?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
20.4% female
79.6% male
N = 573
573 patients (115 female, 448 male)
Inclusion criteria: adult patients receiving OACs and undergoing PCI
Key exclusion criteria: history of intracranial bleeding; cardiogenic shock; contraindication to use of aspirin, clopidogrel, or both; peptic ulcer in the previous 6 months; thrombocytopenia; major bleeding in the past 12 months; and pregnancy.
Interventions
N=279 double antithrombotic therapy (anticoagulation plus clopidogrel)
N=284 triple antithrombotic therapy (anticoagulation plus aspirin and clopidogrel)
Primary outcome
Bleeding complications at 1 year
19.4
44.4
44.4 %
33.3 %
22.2 %
11.1 %
0.0 %
Double antithrombotic
therapy
Triple antithrombotic
therapy
Significant
decrease ▼
NNT = 4
Significant decrease in bleeding complications at 1 year (19.4% vs. 44.4%; HR 0.36, 95% CI 0.26 to 0.5)
Secondary outcomes
Significant decrease in death, myocardial infarction, stroke, target-vessel revascularisation, or stent thrombosis (11.1% vs. 17.6%; HR 0.6, 95% CI 0.38 to 0.94)
No significant difference in myocardial infarction (3.2% vs. 4.6%; HR 0.69, 95% CI 0.29 to 1.6)
No significant difference in stroke (1.1% vs. 2.8%; HR 0.37, 95% CI 0.1 to 1.4)
Conclusion
In adult patients receiving OACs and undergoing PCI, double antithrombotic therapy was superior to triple antithrombotic therapy with respect to bleeding complications at 1 year.
Reference
Dewilde WJ, Oirbans T, Verheugt FW et al. Use of clopidogrel with or without aspirin in patients taking oral anticoagulant therapy and undergoing percutaneous coronary intervention: an open-label, randomised, controlled trial. Lancet. 2013 Mar 30;381(9872):1107-15.
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