6/29/23, 12:43 AM RE-DUAL PCI (dabigatran 110 mg BID) Pathway Feedback Search Clinical Topics Home Studies RE DUAL PCI (dabigatran 110 mg BID RE DUAL PCI (dabigatran 110 mg BID Disease Atrial fibrillation Trial question Is dual antithrombotic therapy with dabigatran superior to triple antithrombotic therapy with warfarin in AF? Study design Multi-center Open label RCT Population Characteristics of study participants 25.0% female N = 1962 75.0% male 1962 patients (484 female, 1478 male) Inclusion criteria: patients with AF who had undergone PCI Key exclusion criteria: bioprosthetic or mechanical heart valves; severe renal insufficiency or other major coexisting conditions Interventions N=981 dual therapy with dabigatran (dabigatran at a dose of 110 mg BID plus a P2Y12 inhibitor and no aspirin) N=981 triple therapy with warfarin (warfarin plus a P2Y12 inhibitor and aspirin for 1 to 3 months) Primary outcome https://web.pathway.md/studies/recuLNmhvkx7nUeF8 1/2 6/29/23, 12:43 AM RE-DUAL PCI (dabigatran 110 mg BID) Pathway Major or clinically relevant nonmajor bleeding event during follow-up 26.9 % 26.9 20.2 % 15.4 13.4 % Significant decrease 6.7 % NNT = 9 0.0 % Dual therapy with dabigatran Triple therapy with warfarin Significant decrease in major or clinically relevant nonmajor bleeding event during follow-up (15.4% vs. 26.9%; HR 0.52, 95% CI 0.42 to 0.63) Secondary outcomes No significant difference in composite of thromboembolic events, death, or unplanned revascularization (15.2% vs. 13.4%; HR 1.13, 95% CI 0.9 to 1.43) No significant difference in thromboembolic events or death (11% vs. 8.5%; HR 1.3, 95% CI 0.98 to 1.73) No significant difference in death from any cause (5.6% vs. 4.9%; HR 1.12, 95% CI 0.76 to 1.65) Safety outcomes No significant difference in intracranial hemorrhage. Significant differences in major bleeding (5.0% vs. 9.2%), total bleeding (27.1% vs. 42.9%). Conclusion In patients with AF who had undergone PCI, dual therapy with dabigatran was superior to triple therapy with warfarin with respect to major or clinically relevant nonmajor bleeding event during follow-up. Reference Christopher P Cannon, Deepak L Bhatt, Jonas Oldgren et al. Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation. N Engl J Med. 2017 Oct 19;377(16):1513-1524. Open reference URL https://web.pathway.md/studies/recuLNmhvkx7nUeF8 2/2