Drug-eluting stents versus bare-metal stents with a single month of dual antiplatelet therapy: a trial sequential analysis

Excerpt

Despite the superiority of drug-eluting stents (DES) over bare-metal stents (BMS) in coronary interventions, a segment of patients are deemed inappropriate for DES implantation due to high bleeding risk associated with the prolonged use of guideline-recommended dual anti-platelet therapy (DAPT) (6 to 12 months) [1, 2]. However, in a recent trial-level meta-analysis, Shah et al. reported significantly reduced 1-year major adverse cardiac events (MACE) (odds ratio [OR] 0.687; 95% confidence interval [CI] 0.573–0.824; P < 0.001) without increased risk of stent thrombosis (OR 0.566; 95% CI 0.273–1.175, P = 0.13) in DES-treated patients with only 1 month of DAPT compared with BMS [3]. Nevertheless, their meta-analysis included a limited sample size from a few clinical trials, and the observed promising results might potentially be attributed to ‘random errors’ due to repetitive significance testing and lack of power. In a single randomized clinical trial, advanced sequential hypothesis testing is used to predict whether a trial could be terminated early because of sufficient statistical evidence (interim analysis) [4, 5]. Similar rigorous sequential monitoring boundaries could be applied to a meta-analysis by calculating a priori information (sample) size, adjusted for the included trials’ heterogeneity, in order to obtain more reliable results (i.e., trial sequential analysis [TSA]) [4, 5]. Therefore, we aimed to evaluate their meta-analysis in a manner that accounts for the small sample size to minimize any overestimates of treatment effects. …