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Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation
Christopher P Cannon1, Deepak L Bhatt1, Jonas Oldgren1
1From the Baim Institute for Clinical Research (C.P.C., J.L.J.), Brigham and Women's Hospital, Heart and Vascular Center, and Harvard Medical School (C.P.C., D.L.B.), and the Cardiology Division, Massachusetts General Hospital, and Harvard Medical School (J.L.J.) - all in Boston; Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University, Uppsala, Sweden (J.O.); the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (G.Y.H.L.), Boehringer Ingelheim, Bracknell (R.H., J.M.), and Imperial College, London, London (P.G.S.) - all in the United Kingdom; Cleveland Clinic, Cleveland (S.G.E.); Kyoto University, Department of Cardiovascular Medicine, Kyoto, Japan (T.K.); Aarhus University Hospital, Skejby, Denmark (M.M.); University Heart and Vascular Center, Budapest, Hungary (B.M.); Klinikum der Stadt Ludwigshafen am Rhein, Medizinische Klinik B, Ludwigshafen (U.Z.), Boehringer Ingelheim, Ingelheim (S.G., M.N., E.K.), and Johann Wolfgang Goethe University, Department of Medicine, Division of Cardiology, Frankfurt am Main (S.H.H.) - all in Germany; St. Antonius Ziekenhuis, Nieuwegein, the Netherlands (J.M.B.); and the French Alliance for Cardiovascular Trials, F-CRIN Network, DHU FIRE, Université Paris Diderot, INSERM Unité 1148, and Hôpital Bichat Assistance Publique, Paris (P.G.S.).
Insights
Dual therapy with dabigatran and a P2Y12 inhibitor significantly reduced bleeding risk compared to triple therapy in atrial fibrillation patients post-PCI. This dual approach was also noninferior for preventing thromboembolic events.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Triple antithrombotic therapy (warfarin plus two antiplatelets) is standard post-percutaneous coronary intervention (PCI) for atrial fibrillation patients.
- This regimen carries a high risk of bleeding complications.
Purpose of the Study:
- To compare the safety and efficacy of dual antithrombotic therapy versus standard triple therapy in patients with atrial fibrillation undergoing PCI.
- To assess the primary endpoint of major or clinically relevant nonmajor bleeding and the composite efficacy endpoint of thromboembolic events.
Main Methods:
- A multicenter trial randomized 2725 patients with atrial fibrillation post-PCI into groups receiving either triple therapy (warfarin, P2Y12 inhibitor, aspirin) or dual therapy (dabigatran, P2Y12 inhibitor, no aspirin).
- Follow-up averaged 14 months, with bleeding events and thromboembolic events as primary and secondary endpoints, respectively.
Main Results:
- Dual therapy with dabigatran significantly reduced the risk of bleeding events compared to triple therapy (15.4% vs. 26.9% for 110mg dose; 20.2% vs. 25.7% for 150mg dose).
- Dual therapy was noninferior to triple therapy in preventing the composite efficacy endpoint of thromboembolic events, death, or unplanned revascularization (13.7% vs. 13.4%).
- No significant difference in the rate of serious adverse events was observed between the groups.
Conclusions:
- Dual therapy using dabigatran and a P2Y12 inhibitor offers a safer alternative to traditional triple therapy for atrial fibrillation patients post-PCI, with reduced bleeding risk.
- This dual regimen maintains comparable efficacy in preventing thromboembolic events, supporting its use as a viable treatment option.
Background:
Triple antithrombotic therapy with warfarin plus two antiplatelet agents is the standard of care after percutaneous coronary intervention (PCI) for patients with atrial fibrillation, but this therapy is associated with a high risk of bleeding.
Methods:
In this multicenter trial, we randomly assigned 2725 patients with atrial fibrillation who had undergone PCI to triple therapy with warfarin plus a P2Y12 inhibitor (clopidogrel or ticagrelor) and aspirin (for 1 to 3 months) (triple-therapy group) or dual therapy with dabigatran (110 mg or 150 mg twice daily) plus a P2Y12 inhibitor (clopidogrel or ticagrelor) and no aspirin (110-mg and 150-mg dual-therapy groups). Outside the United States, elderly patients (≥80 years of age; ≥70 years of age in Japan) were randomly assigned to the 110-mg dual-therapy group or the triple-therapy group. The primary end point was a major or clinically relevant nonmajor bleeding event during follow-up (mean follow-up, 14 months). The trial also tested for the noninferiority of dual therapy with dabigatran (both doses combined) to triple therapy with warfarin with respect to the incidence of a composite efficacy end point of thromboembolic events (myocardial infarction, stroke, or systemic embolism), death, or unplanned revascularization.
Results:
The incidence of the primary end point was 15.4% in the 110-mg dual-therapy group as compared with 26.9% in the triple-therapy group (hazard ratio, 0.52; 95% confidence interval [CI], 0.42 to 0.63; P<0.001 for noninferiority; P<0.001 for superiority) and 20.2% in the 150-mg dual-therapy group as compared with 25.7% in the corresponding triple-therapy group, which did not include elderly patients outside the United States (hazard ratio, 0.72; 95% CI, 0.58 to 0.88; P<0.001 for noninferiority). The incidence of the composite efficacy end point was 13.7% in the two dual-therapy groups combined as compared with 13.4% in the triple-therapy group (hazard ratio, 1.04; 95% CI, 0.84 to 1.29; P=0.005 for noninferiority). The rate of serious adverse events did not differ significantly among the groups.
Conclusions:
Among patients with atrial fibrillation who had undergone PCI, the risk of bleeding was lower among those who received dual therapy with dabigatran and a P2Y12 inhibitor than among those who received triple therapy with warfarin, a P2Y12 inhibitor, and aspirin. Dual therapy was noninferior to triple therapy with respect to the risk of thromboembolic events. (Funded by Boehringer Ingelheim; RE-DUAL PCI ClinicalTrials.gov number, NCT02164864 .).
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