Trial reportBMC medicine2025
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).
Trial report in BMC medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03536611 (A Randomized Study Comparing Dabigatran Etexilate Versus Warfarin in Chinese Patients With Nonvalvular Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention With Stenting), which is not on this map. Not yet cited in PubMed.
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A Randomized Study Comparing Dabigatran Etexilate Versus Warfarin in Chinese Patients With Nonvalvular Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention With Stenting (DES)
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31 authors.
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Abstract
backgroundTo assess the safety and efficacy of dabigatran-based triple antithrombotic (TAT) regimen in patients after percutaneous coronary intervention (PCI) with atrial fibrillation (AF).
methodsA 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).
resultsThe 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.
conclusionsAmong 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 ).
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