Dual antiplatelet therapy after percutaneous coronary intervention according to bleeding risk (HOST-BR): an open-label, multicentre, randomised clinical trial

Abstract

Background The optimal duration of dual antiplatelet therapy (DAPT) after coronary stenting according to bleeding risk is not well established. We aimed to evaluate the optimal duration of DAPT after coronary stenting according to bleeding risk. Methods In this open-label, multicentre, randomised clinical trial, patients aged 19 years and older who received percutaneous coronary intervention with a drug-eluting stent at 50 high-volume cardiology centres in South Korea were stratified into high bleeding risk (HBR) or non-HBR strata, according to Academic Research Consortium for High Bleeding Risk criteria. Patients in the HBR stratum were randomly assigned (1:1) to 1-month or 3-month DAPT, and those in the non-HBR stratum were randomly assigned (1:1) to 3-month or 12-month DAPT. The three coprimary endpoints were net adverse clinical events (all-cause death, myocardial infarction, stent thrombosis, stroke, or major bleeding), major adverse cardiac or cerebral events (cardiovascular death, myocardial infarction, definite or probable stent thrombosis, or ischaemic stroke), and any actionable non-surgical bleeding at 1 year after randomisation. Primary endpoints were assessed in hierarchical order in the intention-to-treat population. This study is registered with cris.nih.go.kr, KCT0005356, and ClinicalTrials.gov, NCT05631769, and is complete. Findings From July 24, 2020, to Sept 25, 2023, 4897 patients were enrolled (1598 in the HBR stratum and 3299 in the non-HBR stratum). In the HBR stratum, 1-month compared with 3-month DAPT did not reach non-inferiority for net adverse clinical events (144 [18<middle dot>4%] of 798 vs 110 [14<middle dot>0%] of 800 patients; hazard ratio [HR] 1<middle dot>337 [95% CI 1<middle dot>043-1<middle dot>713]; p=0<middle dot>82 for non-inferiority). Major adverse cardiac or cerebral events occurred in 74 (9<middle dot>8%) patients in the 1-month DAPT group and 44 (5<middle dot>8%) in the 3-month group; bleeding occurred in 105 (13<middle dot>8%) patients in the 1-month group and 122 (15<middle dot>8%) in the 3-month group. In the non-HBR stratum, 3-month was non-inferior to 12-month DAPT regarding net adverse clinical events (47 [2<middle dot>9%] of 1649 vs 72 [4<middle dot>4%] of 1650 patients; HR 0<middle dot>657 [0<middle dot>455-0<middle dot>949]; p<0<middle dot>0001 for non-inferiority) and major adverse cardiac or cerebral events (36 [2<middle dot>2%] vs 37 [2<middle dot>3%]; HR 0<middle dot>984 [0<middle dot>622-1<middle dot>558]; p=0<middle dot>0082 for non-inferiority), and superior for bleeding (120 [7<middle dot>4%] vs 190 [11<middle dot>7%]; HR 0<middle dot>631 [0<middle dot>502-0<middle dot>793]; p<0<middle dot>0001). Interpretation In east Asian patients with HBR, 1-month DAPT did not reach non-inferiority to 3-month DAPT for net adverse clinical events. In patients without HBR, 3-month DAPT was non-inferior to 12-month DAPT regarding net adverse clinical events and major adverse cardiac or cerebral events, and superior for bleeding. Copyright (c) 2025 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.