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Background <p>To assess the safety and efficacy of dabigatran-based triple antithrombotic (TAT) regimen in patients after percutaneous coronary intervention (PCI) with atrial fibrillation (AF).</p> Methods <p>A multicenter, open-label, randomized controlled trial across 50 Chinese hospitals enrolled nonvalvular AF patients after coronary stenting. Participants were randomly assigned to receive dabigatran (110&#xa0;mg twice/daily) or warfarin-based TAT regimen (dabigatran or warfarin with aspirin and clopidogrel) for 1&#xa0;month and then convert to dual antithrombotic therapy (dabigatran or warfarin with clopidogrel) for 6&#xa0;months. The primary safety endpoint was the first occurrence of clinically relevant bleeding (BARC types 2–5). Secondary endpoints included net adverse clinical events (NACEs) and major or clinically relevant non-major bleeding (CRNB). And the efficacy endpoint was the major adverse cardiac and cerebral events (MACCEs).</p> Results <p>The study was terminated early due to COVID-19 impacting recruitment. A total of 540 patients were enrolled. BARC types 2–5 bleeding occurred in 8.0% and 4.3% of patients in warfarin and dabigatran groups, respectively (HR 0.54; 95% CI 0.26–1.09; <i>P</i> = 0.0861). And total bleeding events (BARC 1–5) were 20.5% and 9.4% (HR 0.44; 95% CI 0.27–0.70; <i>P</i> = 0.0005). Dabigatran showed a lower total bleeding risk than warfarin, with similar risks for BARC types 2–5 bleeding, NACEs, CRNB, major bleeding, and MACCEs.</p> Conclusions <p>Among AF patients underwent PCI, the dabigatran-based TAT regimen did not significantly reduce the rate of BARC types 2–5 bleeding at 6&#xa0;months compared with warfarin-based regimen, although the power of the study to find a difference was low due to early termination (COACH-PCI, NCT03536611, <a href="https://clinicaltrials.gov/show/NCT03536611">https://clinicaltrials.gov/show/NCT03536611</a>).</p>

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Dabigatran-based versus warfarin-based triple antithrombotic regimen with a 1-month intensification after coronary stenting in patients with nonvalvular atrial fibrillation (COACH-AF PCI)

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  • 发表日期：

    2025年11月18日

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  • Ming Liang,
  • Jun Jin,
  • Ruiping Zhao,
  • Hui Li,
  • Shaoliang Chen,
  • Limin Liu,
  • Ping Xu,
  • Wei Wang,
  • Xiang Cheng,
  • Xuezhi Chen,
  • Ling Tao,
  • Qi Zhang,
  • Ming Yang,
  • Chunyu Zeng,
  • Li Li,
  • Yi Zheng,
  • Hong Chen,
  • Jincheng Guo,
  • Zhixiong Zhong,
  • Yayan Bi,
  • Biao Cheng,
  • Yujie Zhou,
  • Hong Wang,
  • Yujie Zhang,
  • Miaohan Qiu,
  • Qi Zhang,
  • Ping Zhang,
  • Jie Zhang,
  • ZuLu Wang,
  • Yi Li,
  • Yaling Han

摘要

Background

To assess the safety and efficacy of dabigatran-based triple antithrombotic (TAT) regimen in patients after percutaneous coronary intervention (PCI) with atrial fibrillation (AF).

Methods

A multicenter, open-label, randomized controlled trial across 50 Chinese hospitals enrolled nonvalvular AF patients after coronary stenting. Participants were randomly assigned to receive dabigatran (110 mg twice/daily) or warfarin-based TAT regimen (dabigatran or warfarin with aspirin and clopidogrel) for 1 month and then convert to dual antithrombotic therapy (dabigatran or warfarin with clopidogrel) for 6 months. The primary safety endpoint was the first occurrence of clinically relevant bleeding (BARC types 2–5). Secondary endpoints included net adverse clinical events (NACEs) and major or clinically relevant non-major bleeding (CRNB). And the efficacy endpoint was the major adverse cardiac and cerebral events (MACCEs).

Results

The study was terminated early due to COVID-19 impacting recruitment. A total of 540 patients were enrolled. BARC types 2–5 bleeding occurred in 8.0% and 4.3% of patients in warfarin and dabigatran groups, respectively (HR 0.54; 95% CI 0.26–1.09; P = 0.0861). And total bleeding events (BARC 1–5) were 20.5% and 9.4% (HR 0.44; 95% CI 0.27–0.70; P = 0.0005). Dabigatran showed a lower total bleeding risk than warfarin, with similar risks for BARC types 2–5 bleeding, NACEs, CRNB, major bleeding, and MACCEs.

Conclusions

Among AF patients underwent PCI, the dabigatran-based TAT regimen did not significantly reduce the rate of BARC types 2–5 bleeding at 6 months compared with warfarin-based regimen, although the power of the study to find a difference was low due to early termination (COACH-PCI, NCT03536611, https://clinicaltrials.gov/show/NCT03536611).