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

Abstract

AimThis open-label, randomized, and multicentre trial tested the hypothesis that, on a background of aspirin, continuing clopidogrel would be superior to stopping clopidogrel at 12 months following drug-eluting stent (DES) implantation. Methods and resultsPatients (N ¼ 1799) who had undergone placement of ≥1 DES for stable coronary artery disease or acute coronary syndrome were included in 58 French sites (January 2009-January 2013. Patients (N ¼ 1385) free of major cardiovascular/cerebrovascular events or major bleeding and on aspirin and clopidogrel 12 months after stenting were eligible for randomization (1:1) between continuing clopidogrel 75 mg daily (extended-dual antiplatelet therapy, DAPT, group) or discontinuing clopidogrel (aspirin group). The primary outcome was net adverse clinical events defined as the composite of death, myocardial infarction, stroke, or major bleeding. 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 patients. Median follow-up after stenting was 33.4 months. The primary outcome occurred in 40 patients (5.8%) in the extended-DAPT group and 52 in the aspirin group (7.5%; hazard ratio 0.75, 95% confidence interval 0.50 -1.28; P ¼ 0.17). Rates of death were 2.3% in the extended-DAPT group and 3.5% in the aspirin group (HR 0.65, 95% CI 0.34 -1.22; P ¼ 0.18). Rates of major bleeding were identical (2.0%, P ¼ 0.95). ... .... ..... ..... ..... .... ..... ..... ..... ..... .... ..... ..... ..... .... ..... ..... ..... .... ..... ..... ..... .... ..... ..... ..... .... ..... ..... ..... ..... .... ..... ..... ..... .... ..... .. ConclusionsExtended 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. ClinicalTrials.gov number

Duration of dual antiplatelet therapy following drug‐eluting stent implantation: A systemic review and meta‐analysis of randomized controlled trials with longer follow up

“…2692 publications were found at initial search and after abstract and manuscript evaluation eleven studies are selected for final analysis ( Figure 1) [3][4][5][6][7][8][9][10][11][12][13]. In selected eleven RCTs, 33, 520 patients were randomized to S-DAPT (N=16, 687) and L-DAPT (n=16,833), respectively.…”

“…duration of DAPT have reported conflicting results [3][4][5][6][7][8][9][10][11][12][13]. Previous meta-analyses of RCTs comparing S-DAPT versus L-DAPT have shown inconsistent results [14][15][16][17].…”

“…Previous meta-analyses of RCTs comparing S-DAPT versus L-DAPT have shown inconsistent results [14][15][16][17]. Furthermore, results of most recent RCT comparing L-DAPT and S-DAPT-Optimal Duration of Dual Antiplatelet Therapy After Drug-eluting Stent Implantation (OPTIDUAL)-showed non superiority of L-DAPT (48 months) over standard (12 months) DAPT, after extended median follow up of 33 months [13]. However, the power of the OPTIDUAL was low as this study was prematurely terminated due to slow enrollment [13].…”

“…Furthermore, results of most recent RCT comparing L-DAPT and S-DAPT-Optimal Duration of Dual Antiplatelet Therapy After Drug-eluting Stent Implantation (OPTIDUAL)-showed non superiority of L-DAPT (48 months) over standard (12 months) DAPT, after extended median follow up of 33 months [13]. However, the power of the OPTIDUAL was low as this study was prematurely terminated due to slow enrollment [13]. In this context, we conducted this updated meta-analysis of RCTs to investigate cumulative evidence for efficacy and safety of S-DAPT versus L-DAPT strategy after DES implantation.…”

New guidelines on duration of dual antiplatelet therapy in patients with coronary artery disease: what's the novelty?

“…Undoubtedly, the answer is yes for several reasons. First, because some very recent trials have been published after the formulation of the latest recommendations for duration of DAPT in prior guidelines (2). Secondly, because after the extensive reading of these new guidelines, the reader will probably have a better understanding of the current knowledge according to the different situations he will have to deal with.…”