Mount Sinai Med-Lit Review
Clinical question: What is the optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) placement in patients according to bleeding risk (high bleeding risk versus non-high bleeding risk)?
Background: Previous studies evaluating DAPT duration in patients post PCI with DES were limited by the inclusion of both high bleeding risk (HBR) patients and non-HBR patients. HBR patients tend to have increased thrombotic risk, which must be accounted for when determining optimal DAPT duration. In HBR patients, current guidelines recommend one to three months of DAPT. Still, prior studies did not use the Academic Research Consortium for High Bleeding Risk’s (ARC-HBR) standardized criteria and were not based on randomized controlled trials. This study aims to identify ideal DAPT duration after DES in patients stratified by a standardized definition of bleeding risk.
Study design: Open-label, multicentre, randomized, clinical trial
Setting: A total of 50 high-volume cardiology centers in South Korea
Synopsis: The study enrolled 4,897 East Asian patients aged 19 or older post-DES placement. Using the ARC-HBC criteria, patients were classified as HBR or non-HBR and randomized to a DAPT duration of one versus three months in the HBR group and three versus 12 months in the non-HBR group. In HBR patients, one-month DAPT was inferior to three months for net adverse clinical events (hazard ratio [HR], 1.337; 95% confidence interval [CI], 1.043 to 1.713; P=0.82 for non-inferiority), although major bleeding events were comparable. In non-HBR patients, DAPT duration of three months was non-inferior to 12 months for net adverse clinical events (HR, 0.657; CI, 0.455 to 0.949; P <0.0001 for non-inferiority), with a reduction in bleeding risk (HR, 0.631; CI, 0.502 to 0.793; P <0.0001) and no significant increase in thrombotic events.
The study was limited by its failure to standardize P2Y12 inhibitors across patients and the lack of patient stratification based on ischemic risk. An individualized approach to DAPT duration is still recommended, but utilization of bleeding risk stratification can be helpful when considering shortening DAPT duration.
Bottom line: Optimal DAPT duration to minimize both bleeding risk and net adverse clinical events post PCI and DES varies in HBR versus non-HBR patients, and shorter DAPT courses of three months in non-HBR patients improved outcomes.
Citation: Kang J, et al. Dual antiplatelet therapy after percutaneous coronary intervention according to bleeding risk (HOST-BR): an open-label, multicentre, randomised clinical trial. Lancet. 2025;406(10516):2244-2256. doi: 10.1016/S0140-6736(25)01571-5.
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Dr. Sooklal
Dr. Sooklal is a hospitalist in the department of hospital medicine at Mount Sinai Hospital and an assistant professor of medicine at the Icahn School of Medicine at Mount Sinai, both in New York.