Lancet. 2025;406(10516):2244-2256.
Dual antiplatelet therapy after percutaneous coronary intervention according to bleeding risk (HOST-BR): an open-label, multicentre, randomised clinical trial.
제1저자 강지훈, 박경우 · 교신저자 김효수
소속 (20)
- Seoul National University Hospital, Seoul, South Korea; Seoul National University College of Medicine, Seoul, South Korea.
- Uijeongbu St Mary's Hospital, Seoul, South Korea.
- Chungbuk National University Hospital, Cheongju, South Korea.
- Sanggye Paik Hospital, Seoul, South Korea.
- Chungnam National University Hospital, Daejeon, South Korea.
- Gyeongsang National University Changwon Hospital, Changwon, South Korea.
- Presbyterian Medical Center, Jeonju, South Korea.
- Gangneung Asan Hospital, Gangneung, South Korea.
- Dankook University Hospital, Cheonan, South Korea.
- Gyeongsang National University Hospital, Jinju, South Korea.
- Chung-Ang University Hospital, Seoul, South Korea.
- Soonchunhyang University Seoul Hospital, Seoul, South Korea.
- Ewha Womans University Seoul Hospital, Seoul, South Korea.
- Keimyung University Dongsan Hospital, Daegu, South Korea.
- Hallym University Sacred Heart Hospital, Anyang, South Korea.
- National Health Insurance Service Ilsan Hospital, Goyang, South Korea.
- Sejong General Hospital, Bucheon, South Korea.
- Jeonbuk National University Hospital, Jeonju, South Korea.
- Hanyang University Seoul Hospital, Seoul, South Korea.
- Seoul National University Hospital, Seoul, South Korea; Seoul National University College of Medicine, Seoul, South Korea. Electronic address: hyosoo@snu.ac.kr.
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.
FUNDING Medtronic and Abbott.
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Conflict of interest statement
Declaration of interests JK reports grants or contracts from Medtronic Korea, Edwards Lifesciences Korea, and Boston Scientific Korea. KWP reports consulting fees from Shockwave Medical, Novartis, and Amgen; and payment or honoraria for lectures from Daiichi Sankyo, Novartis, Amgen, HK inno.N, Daewoong Pharmaceutical, and Sanofi-Aventis. YJC reports grants or contracts from Medtronic Korea and Edwards Lifesciences Korea; and payment or honoraria for lectures from Covidien Korea, Organon Korea, Servier Korea, Youhan, Daewoong Pharmaceutical, Hanmi Pharmaceutical, and Chong Kun Dang Pharmaceutical. H-SK reports grants or contracts from Boston Scientific; and consulting fees from Biotronik and B Braun. All other authors declare no competing interests.
그 밖의 정보
- 출판 형태
- Clinical Trial, Phase IV, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
- 저널
- Lancet (London, England) · eISSN 1474-547X
- 전자 출판
- 2025-10-23
- MeSH
- Aged · Female · Humans · Male · Middle Aged · Aspirin / administration & dosage / adverse effects · Drug-Eluting Stents · Dual Anti-Platelet Therapy* / adverse effects / methods · Hemorrhage* / chemically induced / epidemiology · Percutaneous Coronary Intervention* / adverse effects / methods · Platelet Aggregation Inhibitors* / administration & dosage / adverse effects / therapeutic use · Republic of Korea / epidemiology · Risk Factors · Treatment Outcome · Aged, 80 and over · East Asian People · Purinergic P2Y Receptor Antagonists / administration & dosage / adverse effects
- Substances
- Aspirin · Platelet Aggregation Inhibitors · Purinergic P2Y Receptor Antagonists
- 데이터
- ClinicalTrials.gov: NCT05631769