近日，首尔国立大学医院Hyo-Soo Kim团队研究了根据出血风险进行经皮冠状动脉介入治疗后的双重抗血小板治疗（HOST-BR）的效果。2025年10月23日出版的《柳叶刀》杂志发表了这项成果。

根据出血风险，冠状动脉支架植入术后双重抗血小板治疗（DAPT）的最佳持续时间尚不明确。该研究旨在根据出血风险评估冠状动脉支架植入术后DAPT的最佳持续时间。

在这项开放标签、多中心、随机临床试验中，根据高出血风险标准学术研究联盟，研究组在韩国50个大容量心脏病中心接受经皮冠状动脉药物洗脱支架介入治疗的19岁及以上患者被分为高出血风险（HBR）和非HBR层。HBR层患者随机分配（1:1）至1个月或3个月DAPT，非HBR层患者随机分配（1:1）至3个月或12个月DAPT。三个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、中风或大出血）、重大心脏或大脑不良事件（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），以及随机分组后1年的任何可操作的非手术性出血。在意向治疗人群中按等级顺序评估主要终点。

2020年7月24日至2023年9月25日，研究组共纳入4897例患者（HBR组1598例，非HBR组3299例）。在HBR层，与3个月的DAPT相比，1个月的净不良临床事件未达到非劣效性（798例患者中144例[18.4%]vs 800例患者中110例[14.0%]；风险比[HR] 1.337；非劣效性p= 0.82）。DAPT治疗1个月组有74例（9.8%）发生严重的心脏或大脑不良事件，3个月组有44例（5.8%）发生严重的心脏或大脑不良事件；1个月组出血105例（13.8%），3个月组出血122例（15.8%）。在非HBR层中，3个月的净不良临床事件不低于12个月的DAPT（1649例患者中47例[2.9%]对1650例患者中72例[4.4%]；HR为0.657 [0.455 - 0.949];p= 0.0001；非劣效性）和重大心脏或大脑不良事件（36例[2.2%]对37例[2.3%]；HR为0.984[0.622 - 0.558]；非劣效性患者p= 0.0082），出血优于DAPT（120例[7.4%]对190例[11.7%]；HR为0.631 [0.502 - 0.793];p= 0.0001）。

研究结果表明，在东亚HBR患者中，1个月DAPT与3个月DAPT相比，净不良临床事件没有达到非劣效性。在没有HBR的患者中，3个月DAPT在净不良临床事件和重大心脏或脑不良事件方面不低于12个月DAPT，在出血方面优于12个月DAPT。

附：英文原文

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

Author: Jeehoon Kang, Kyung Woo Park, Jung-Kyu Han, Doyeon Hwang, Han-Mo Yang, Sungjoon Park, Hyo-Suk Ahn, Kyung-Kuk Hwang, Byung Gyu Kim, Jin-Ok Jeong, Jong-Hwa Ahn, Jay Young Rhew, Hanbit Park, Tae Soo Kang, Jin-Sin Koh, Kyung-Taek Park, Duk Won Bang, Choong-Won Goh, Hyuck-Jun Yoon, Sang-Ho Jo, Ji Yong Jang, Young Jin Choi, Sang Rok Lee, Young-Hyo Lim, Hyo-Soo Kim, Hyo-Soo Kim, Jeehoon Kang, Young-Hyo Lim, Sang Rok Lee, Young Jin Choi, Hyo-Suk Ahn, Kyung-Kuk Hwang, Byung Gyu Kim, Jin-Ok Jeong, Jong-Hwa Ahn, Jay Young Rhew, Ji Yong Jang, Hanbit Park, Tae-Soo Kang, Jin Sin Koh, Kyung-Taek Park, Duk-Won Bang, Choong-Won Goh, Hyuk Joon Yoon, Sang-Ho Jo, You-Jeong Ki, Yong Hoon Kim, Man-Won Park, Tae-Hyun Yang, Soon Jun Hong, Sang-Hyun Park, Sung-Wook Kwon, Gyu-Rok Han, In-Ho Chae, Seung Hwan Han, Namho Lee, Jin-Man Cho, Sung-Kyun Ahn, Song-Yi Kim, Han-Cheol Lee, Seung-Jin Lee, Seok-Min Seo, Joo-Hyun Oh, Se Hun Kang, Jung Ho Heo, Seung-Woon Rha, Jong Shin Woo, Sanghyun Kim, Soo-Han Kim, Eun-Seok Shin, Chee-Hae Kim, Woo Jung Park, Cheol-Ho Lee, Seong-Ho Her, Doo-Soo Jeon, Kyu-Sun Lee, Seung-Uk Lee, Ung Kim

Issue&Volume: 2025-10-23

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.

DOI: 10.1016/S0140-6736(25)01571-5

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01571-5/abstract