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)

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 ).