Journal Article

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)

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

2025

Overview

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 ).

• Publisher: BioMed Central,BioMed Central Ltd,BMC
• Subject: Aged / Anticoagulants - administration & dosage / Anticoagulants - adverse effects / Anticoagulants - therapeutic use / Antithrombins - administration & dosage / Antithrombins - therapeutic use / Antithrombotic therapy / Aspirin - administration & dosage / Aspirin - therapeutic use / Atrial fibrillation / Atrial Fibrillation - complications / Atrial Fibrillation - drug therapy / Biomedicine / Blood clot / Cardiomyopathy and cardiac arrhythmias / Care and treatment / Clopidogrel - administration & dosage / Clopidogrel - adverse effects / Clopidogrel - therapeutic use / Comparative analysis / Complications / Complications and side effects / Dabigatran / Dabigatran - administration & dosage / Dabigatran - adverse effects / Dabigatran - therapeutic use / Dabigatran etexilate / Dosage and administration / Drug Therapy, Combination / Female / Fibrinolytic Agents - administration & dosage / Fibrinolytic Agents - adverse effects / Fibrinolytic Agents - therapeutic use / Hemorrhage - chemically induced / Humans / Male / Medicine / Medicine & Public Health / Middle Aged / Percutaneous Coronary Intervention / Prevention / Randomized controlled trials / Risk factors / Stent (Surgery) / Stents / Surgery / Testing / Thrombosis / Transluminal angioplasty / Warfarin / Warfarin - administration & dosage / Warfarin - adverse effects / Warfarin - therapeutic use