Drug-eluting stents versus bare-metal stents with a single month of dual antiplatelet therapy: a trial sequential analysis
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 . 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...
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Conflicts of interest
DLB discloses the following relationships—Advisory Board: Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, PhaseBio, Regado Biosciences; Board of Directors: Boston VA Research Institute, Society of Cardiovascular Patient Care, TobeSoft; Chair: American Heart Association Quality Oversight Committee; Data Monitoring Committees: Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Cleveland Clinic, Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo), Population Health Research Institute; Honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Vice-Chair, ACC Accreditation Committee), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national co-leader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees); Other: Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); Research Funding: Abbott, Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi, Eisai, Ethicon, Forest Laboratories, Idorsia, Ironwood, Ischemix, Lilly, Medtronic, PhaseBio, Pfizer, Regeneron, Roche, Sanofi Aventis, Synaptic, The Medicines Company; Royalties: Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease); Site Co-Investigator: Biotronik, Boston Scientific, St. Jude Medical (now Abbott), Svelte; Trustee: American College of Cardiology; Unfunded Research: FlowCo, Merck, Novo Nordisk, PLx Pharma, Takeda. The remaining authors report no relationships that could be construed as a conflict of interest.