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

We aimed to evaluate the optimal duration of DAPT after coronary stenting according to bleeding risk.

我们旨在根据出血风险评估冠状动脉支架植入后双抗血小板治疗（DAPT）的最佳持续时间。

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.

在这项开放标签、多中心、随机临床试验中，年龄在19岁及以上的患者在韩国50个高容量心脏病中心接受了药物洗脱支架的经皮冠状动脉介入治疗，根据学术研究联盟高出血风险标准被分为高出血风险(HBR)或非HBR组。

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.

HBR组的患者被随机分配（1:1）接受1个月或3个月的双联抗血小板治疗(DAPT)，而非HBR组的患者被随机分配（1:1）接受3个月或12个月的双联抗血小板治疗(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.

三个共同主要终点是净不良临床事件（全因死亡、心肌梗死、支架血栓形成、中风或重大出血）、主要不良心脏或脑血管事件（心血管死亡、心肌梗死、确定或可能的支架血栓形成或缺血性中风）以及随机化后1年内任何可采取行动的非手术性出血。

Primary endpoints were assessed in hierarchical order in the intention-to-treatpopulation.

主要终点在意向治疗人群中按层次顺序进行评估。

This study is registered with cris.nih.go.kr, KCT0005356, and ClinicalTrials.gov, NCT05631769, and is complete.

该研究已在cris.nih.go.kr上注册，编号为KCT0005356，在ClinicalTrials.gov上注册，编号为NCT05631769，并已完成。

Results

From July 24, 2020, to Sept 25, 2023, 4897 patients were enrolled (1598 in the HBR stratum and 3299 in the non-HBR stratum).

从2020年7月24日至2023年9月25日，共有4897名患者被纳入研究（高风险人群1598名，非高风险人群3299名）。

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).

在高血小板反应性（HBR）患者中，1个月与3个月的双联抗血小板治疗（DAPT）在净不良临床事件方面未达到非劣效性（1个月组144例[18.4%]，3个月组110例[14.0%]；风险比[HR] 1.337，95%置信区间[CI] 1.043-1.713；非劣效性检验p=0.82）。

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.

主要不良心脏或脑血管事件在1个月DAPT组中发生在74名（9.8%）患者中，而在3个月组中发生在44名（5.8%）患者中；出血事件在1个月组中发生在105名（13.8%）患者中，而在3个月组中发生在122名（15.8%）患者中。

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).

在非高出血风险（non-HBR）人群中，3个月的双联抗血小板治疗（DAPT）在净不良临床事件（47 [2·9%] vs 72 [4·4%]；风险比HR 0·657 [0·455-0·949]；p<0·0001 表明非劣效性）和主要不良心脏或脑血管事件（36 [2·2%] vs 37 [2·3%]；HR 0·984 [0·622-1·558]；p=0·0082 表明非劣效性）方面不劣于12个月的DAPT，并且在出血事件方面更优（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.

在具有高出血风险（HBR）的东亚患者中，1个月的DAPT在净不良临床事件方面未能达到与3个月DAPT的非劣效性。

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.

在没有高出血风险（HBR）的患者中，3个月的双联抗血小板治疗（DAPT）在净不良临床事件和主要不良心脏或脑血管事件方面与12个月的DAPT相比非劣效，并且在出血方面更优。

funding

Medtronic and Abbott.

美敦力和雅培。