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Lancet, Nov 08 2025, 406 (10516) S0140-6736(25)01571-5 | https://doi.org/10.1016/S0140-6736(25)01571-5 Dual antiplatelet therapy after percutaneous coronary intervention according to bleeding risk (HOST-BR): an open-label, multicentre, randomised clinical trial

Jeehoon Kang MD ^a,b†, Kyung Woo Park MD ^a,b†, Jung-Kyu Han MD ^a,b, Doyeon Hwang MD ^a,b, Han-Mo Yang MD ^a,b, Sungjoon Park MD ^a,b, Hyo-Suk Ahn MD ^c, Kyung-Kuk Hwang MD ^d, Byung Gyu Kim MD ^e, Jin-Ok Jeong MD^f, Jong-Hwa Ahn MD ^g, Jay Young Rhew MD ^h, Hanbit Park MD ⁱ, Tae Soo Kang MD ^j, Jin-Sin Koh MD ^k, Kyung-Taek Park MD ^l, Duk Won Bang MD ^m, Choong-Won Goh MD ⁿ, Hyuck-Jun Yoon MD ^o, Sang-Ho Jo MD ^p, Ji Yong Jang MD ^q, Young Jin Choi MD ^r, Sang Rok Lee MD ^s, Young-Hyo Lim MD ^t, Hyo-Soo Kim MD^a,b on behalf of the HOST-BR investigators

^aSeoul National University Hospital, Seoul, South Korea
^bSeoul National University College of Medicine, Seoul, South Korea
^cUijeongbu St Mary's Hospital, Seoul, South Korea
^dChungbuk National University Hospital, Cheongju, South Korea
^eSanggye Paik Hospital, Seoul, South Korea
^fChungnam National University Hospital, Daejeon, South Korea
^gGyeongsang National University Changwon Hospital, Changwon, South Korea
^hPresbyterian Medical Center, Jeonju, South Korea
ⁱGangneung Asan Hospital, Gangneung, South Korea
^jDankook University Hospital, Cheonan, South Korea
^kGyeongsang National University Hospital, Jinju, South Korea
^lChung-Ang University Hospital, Seoul, South Korea
^mSoonchunhyang University Seoul Hospital, Seoul, South Korea
ⁿEwha Womans University Seoul Hospital, Seoul, South Korea
^oKeimyung University Dongsan Hospital, Daegu, South Korea
^pHallym University Sacred Heart Hospital, Anyang, South Korea
^qNational Health Insurance Service Ilsan Hospital, Goyang, South Korea
^rSejong General Hospital, Bucheon, South Korea
^sJeonbuk National University Hospital, Jeonju, South Korea
^tHanyang University Seoul Hospital, Seoul, South Korea

^†Contributed equally
Correspondence to: Prof Hyo-Soo Kim

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 [18·4%] of 798 vs 110 [14·0%] of 800 patients; hazard ratio [HR] 1·337 [95% CI 1·043-1·713]; p=0·82 for non-inferiority). Major adverse cardiac or cerebral events occurred in 74 (9·8%) patients in the 1-month DAPT group and 44 (5·8%) in the 3-month group; bleeding occurred in 105 (13·8%) patients in the 1-month group and 122 (15·8%) 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 [2·9%] of 1649 vs 72 [4·4%] of 1650 patients; HR 0·657 [0·455-0·949]; p<0·0001 for non-inferiority) and major adverse cardiac or cerebral events (36 [2·2%] vs 37 [2·3%]; HR 0·984 [0·622-1·558]; p=0·0082 for non-inferiority), and superior for bleeding (120 [7·4%] vs 190 [11·7%]; HR 0·631 [0·502-0·793]; p<0·0001).

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.

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