AIM: This open-label, randomized, and multicentre trial tested the hypothesis that, on a background of @entity117 , continuing @entity1397 would be superior to stopping @entity1397 at 12 months following drug-eluting stent (DES) implantation. METHODS AND RESULTS: @entity1 (N = 1799) who had undergone placement of >= 1 DES for stable @entity453 or @entity1187 were included in 58 French sites (January 2009-January 2013). @entity1 (N = 1385) free of major cardiovascular/cerebrovascular events or major @entity548 and on @entity117 and @entity1397 12 months after stenting were eligible for randomization (1:1) between continuing @entity1397 75 mg daily (extended-dual antiplatelet therapy, DAPT, group) or discontinuing @entity1397 ( @entity117 group). The primary outcome was net adverse clinical events defined as the composite of @entity204 , @entity583 , @entity64 , or major @entity548 . Follow-up was planned from a minimum of 6 to a maximum of 36 months after randomization. Owing to slow recruitment, the study was stopped after enrolment of 1385 of a planned 1966 @entity1 . Median follow-up after stenting was 33.4 months. The primary outcome occurred in 40 @entity1 (5.8%) in the extended-DAPT group and 52 in the @entity117 group (7.5%; hazard ratio 0.75, 95% confidence interval 0.50-1.28; P = 0.17). Rates of @entity204 were 2.3% in the extended-DAPT group and 3.5% in the @entity117 group (HR 0.65, 95% CI 0.34-1.22; P = 0.18). Rates of major @entity548 were identical (2.0%, P = 0.95). CONCLUSIONS: Extended DAPT did not achieve superiority in reducing net adverse clinical events compared to 12 months of DAPT after DES placement. The power of the OPTIDUAL trial was however low and reduced by premature termination of enrolment. CLINICALTRIALSGOV NUMBER: NCT00822536.

Stopping or continuing XXXX 12 months after drug-eluting stent placement: the OPTIDUAL randomized trial.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity1187 :: ('MESH:D054058', 'Disease') :: ['acute coronary syndrome'] @entity64 :: ('MESH:D020521', 'Disease') :: ['stroke'] @entity583 :: ('MESH:D009203', 'Disease') :: ['myocardial infarction'] @entity548 :: ('MESH:D006470', 'Disease') :: ['bleeding'] @entity1397 :: ('MESH:C055162', 'Chemical') :: ['clopidogrel'] @entity117 :: ('MESH:D001241', 'Chemical') :: ['aspirin'] @entity453 :: ('MESH:D003324', 'Disease') :: ['coronary artery disease'] @entity204 :: ('MESH:D003643', 'Disease') :: ['death']
@entity1397 :: (MESH:C055162,Chemical) :: ['clopidogrel']
