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Background <p>Early discontinuation of dual antiplatelet therapy (DAPT) within 3 months after implantation of drug-eluting stents may reduce bleeding risk without increasing ischaemic events. This study aimed to assess whether 3-month DAPT is as safe as the conventional 12-month regimen in patients treated with Firehawk stents, which have demonstrated 99.9% reendothelialisation at 3 months by optical coherence tomography.</p> Methods <p>From January 1, 2019, to April 30, 2022, 2445 patients were randomly assigned to a 3-month (<i>n</i> = 1222) or 12-month DAPT regimen (<i>n</i> = 1223) in this randomised, open-label, non-inferiority trial, patients from 36 centres in China who underwent percutaneous coronary intervention with Firehawk stents. The primary endpoint was a composite of all-cause death, myocardial infarction, cerebrovascular accident, and major bleeding (Bleeding Academic Research Consortium type 2, 3, or 5) at 18 months. The co-equal secondary endpoints were major adverse cardiovascular events, defined as a composite of all-cause death, myocardial infarction and ischaemia-driven target lesion revascularisation, and major bleeding.</p> Results <p>From January 1, 2019, to April 30, 2022, 2445 patients were randomly assigned to 3-month (<i>N</i> = 1222) or 12-month DAPT regimen (<i>N</i> = 1223). Adherence to the protocol-defined DAPT duration was 71.0% and 95.5%, respectively. Rates of the primary endpoint were comparable between both groups (10.1% vs 10.9%). Non-inferiority of 3-month DAPT was established (absolute rate difference, − 0.76%; upper limit of 1-sided 97.5% CI, 1.70%; <i>p</i> non-inferiority = 0.0003, with a predefined non-inferiority margin of 3.5%). Rates of co-secondary endpoints showed no significant difference (both <i>p</i> &gt; 0.05). Landmark analysis (3–18 months) showed significant lower rate of major bleeding (2.7% vs 4.4%; <i>p</i> = 0.03) with 3-month DAPT.</p> Conclusions <p>In patients treated with Firehawk stents, 3-month DAPT was non-inferior to 12-month DAPT for the primary composite endpoint of all-cause death, myocardial infarction, cerebrovascular accident, and major bleeding at 18 months.</p> Trial registration <p>NCT03008083 (clinicaltrials.gov).</p>

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Three vs 12-month DAPT after implantation of biodegradable-polymer sirolimus-eluting coronary stent: a randomised clinical trial

  • 期刊论文

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  • 发表日期：

    2025年12月24日

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  • Hongbo Yang,
  • Feng Zhang,
  • Xiwen Zhang,
  • Yanqing Wu,
  • Zhixiong Zhong,
  • Jian’an Wang,
  • Yujie Zhou,
  • Lang Hong,
  • Wei Yang,
  • Tingbo Jiang,
  • Jianjie Zou,
  • Zheng Zhang,
  • Yitong Ma,
  • Shangyu Wen,
  • Zhongcai Fan,
  • Dawen Xu,
  • Hong Jiang,
  • Jianhong Tao,
  • Haojin Ren,
  • Yong Xia,
  • Yijie Huang,
  • Guidong Xu,
  • Ruifen Cao,
  • Ming Zheng,
  • Juying Qian,
  • Dominic P. Francese,
  • Alexandra J. Lansky,
  • Junbo Ge,
  • Biao Xu,
  • Haibing Jiang,
  • Yaojun Zhang,
  • Yan Li,
  • Yansong Li,
  • Dajun Liu,
  • Min Fan,
  • Jingang Zheng,
  • Zeqi Zheng,
  • Chunyu Zeng,
  • Jincheng Guo,
  • Zhaofen Zheng,
  • Likun Ma,
  • Zuyi Yuan,
  • Xi Su

摘要

Background

Early discontinuation of dual antiplatelet therapy (DAPT) within 3 months after implantation of drug-eluting stents may reduce bleeding risk without increasing ischaemic events. This study aimed to assess whether 3-month DAPT is as safe as the conventional 12-month regimen in patients treated with Firehawk stents, which have demonstrated 99.9% reendothelialisation at 3 months by optical coherence tomography.

Methods

From January 1, 2019, to April 30, 2022, 2445 patients were randomly assigned to a 3-month (n = 1222) or 12-month DAPT regimen (n = 1223) in this randomised, open-label, non-inferiority trial, patients from 36 centres in China who underwent percutaneous coronary intervention with Firehawk stents. The primary endpoint was a composite of all-cause death, myocardial infarction, cerebrovascular accident, and major bleeding (Bleeding Academic Research Consortium type 2, 3, or 5) at 18 months. The co-equal secondary endpoints were major adverse cardiovascular events, defined as a composite of all-cause death, myocardial infarction and ischaemia-driven target lesion revascularisation, and major bleeding.

Results

From January 1, 2019, to April 30, 2022, 2445 patients were randomly assigned to 3-month (N = 1222) or 12-month DAPT regimen (N = 1223). Adherence to the protocol-defined DAPT duration was 71.0% and 95.5%, respectively. Rates of the primary endpoint were comparable between both groups (10.1% vs 10.9%). Non-inferiority of 3-month DAPT was established (absolute rate difference, − 0.76%; upper limit of 1-sided 97.5% CI, 1.70%; p non-inferiority = 0.0003, with a predefined non-inferiority margin of 3.5%). Rates of co-secondary endpoints showed no significant difference (both p > 0.05). Landmark analysis (3–18 months) showed significant lower rate of major bleeding (2.7% vs 4.4%; p = 0.03) with 3-month DAPT.

Conclusions

In patients treated with Firehawk stents, 3-month DAPT was non-inferior to 12-month DAPT for the primary composite endpoint of all-cause death, myocardial infarction, cerebrovascular accident, and major bleeding at 18 months.

Trial registration

NCT03008083 (clinicaltrials.gov).