WOEST

What is the Optimal antiplatElet & anticoagulant therapy in patients with oral anticoagulation and coronary stenTing? (2013)

Condition

Prevention of thrombotic complications with antiplatelet therapy after percutaneous coronary intervention (PCI) in patients taking oral anticoagulants

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Objective

To evaluate the safety and efficacy of clopidogrel alone compared with clopidogrel plus ASA in patients receiving oral anticoagulants and undergoing PCI

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Trial design

Randomized, open-label, controlled phase IV study
All patients were pretreated with a maintenance dose of 75 mg clopidogrel per day for at least 5 days, a loading dose of 300 mg at least 24 h before PCI, or a loading dose of 600 mg at least 4 h before PCI, and a 320 mg loading dose of ASA. During the intervention, oral anticoagulants were continued with a target INR of 2.0
Active treatment: clopidogrel 75 mg once daily (“double therapy”; n=284)
Control treatment: clopidogrel 75 mg once daily plus ASA 80–100 mg once daily (“triple therapy”; n=289)

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Endpoints

Primary efficacy endpoint: combined end point of minor, moderate or major bleeding complications during the initial hospitalization & one year followup
Secondary efficacy endpoints: combined event of death, myocardial infarction, stroke, systemic embolization & target vessel revascularisation, and the individual components of the composite primary and secondary endpoints

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Trial participants

573 patients (mean age 70.3 years) were enrolled; 1-year data were available for 279 patients assigned to double therapy and 284 assigned to triple therapy. Inclusion criteria were a long-term indication for oral anticoagulation treatment, a severe coronary lesion with indication for PCI, and 18–80 years of age

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Results

Primary outcome: At 1-year follow-up, any bleeding had occurred in 54 patients (19.4%) in the double-therapy group and in 126 patients (44.4%) in the triple-therapy group. 9 patients (3.2%) assigned to clopidogrel alone had major bleeding events, compared with 16 patients (5.6%) treated with clopidogrel + ASA. The incidence of major and minor bleeding events was significantly higher in the triple-therapy group (31.3% vs. 14.0%)
Secondary outcome: The combined secondary endpoint of death, myocardial infarction, stroke, target-vessel revascularisation, and stent thrombosis was reported in 31 patients (11.1%) in the double-therapy group and in 50 (17.6%) in the triple-therapy group. At 1 year, 7 patients (2.5%) treated with clopidogrel and 18 patients (6.3%) given clopidogrel + ASA had died from any cause. The rates for the other individual components of the secondary endpoint did not differ significantly between both groups

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Summary

Efficacy and safety: In patients taking oral anticoagulants and undergoing percutaneous coronary intervention, treatment with clopidogrel and oral anticoagulants was associated with a significantly lower risk of bleeding complications than triple therapy including ASA. There was no evidence of increased thrombotic risk without the use of ASA

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Reference

Dewilde WJ, Oirbans T, Verheugt FW, Kelder JC, De Smet BJ, Herrman JP, Adriaenssens T, Vrolix M, Heestermans AA, Vis MM, Tijsen JG, van ‚t Hof AW, ten Berg JM for the WOEST study investigators. 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;381:1107-1115

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Corresponding author

Willem JM Dewilde, MD, Sint Antonius Hospital, 1 Koekoekslaan, NL-3435-CM Nieuwegein, Netherlands, willemdewilde@yahoo.com

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