The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

Dual antithrombotic therapy with dabigatran in patients with atrial fibrillation after percutaneous coronary intervention for ST elevation myocardial infarction: results from the randomised RE-DUAL PCI trial

DOI: 10.4244/EIJ-D-20-00799

1. Klinikum Ludwigshafen and Institut für Herzinfarktforschung, Ludwigshafen, Germany, Germany
2. Brigham and Women’s Hospital and Heart and Vascular Center, and Harvard Medical School Boston MA USA
3. Johann Wolfgang Goethe University Frankfurt am Main Germany
4. Université Paris Diderot, Paris, France
5.INSERM U_1148, Paris, France
6.Hôpital Bichat Assistance Publique-Hôpitaux de Paris, Paris, France
7. Uppsala Clinical Research Center and Department of Medical Sciences Uppsala University Uppsala Sweden
8. University of Bonn Bonn Germany
9. Medical Centre Hungarian Defence Forces Budapest Hungary
10. Istanbul University-Cerrahpasa Istanbul Turkey
11. Hospital Italiano de Buenos Aires Buenos Aires Argentina
12. Canisius-Wilhelmina Hospital Nijmegen the Netherlands
13. Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom; AND Aalborg Thrombosis Research Unit Department of Clinical Medicine, Aalborg University Aalborg, Denmark
14. Boehringer Ingelheim GmbH, Ingelheim, Germany
15. Mainanalytics ma GmbH, Sulzbach (Taunus), Germany
16. St Antonius Ziekenhuis Nieuwegein the Netherlands
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Aims: To investigate the safety and efficacy of dabigatran dual therapy (110 or 150 mg twice daily, plus clopidogrel or ticagrelor) vs warfarin triple therapy in patients with atrial fibrillation undergoing PCI for ST elevation myocardial infarction (STEMI).

Methods and results: In RE-DUAL PCI, 305 patients with STEMI were randomised to dabigatran 110 mg (n=113 versus 106 warfarin) or 150 mg (n=86 versus 84 warfarin).  Primary endpoint was time to first major/clinically relevant non-major bleeding event (MBE/CRNMBE). Thrombotic endpoint was a composite of death, thromboembolic events, or unplanned revascularisation.

In STEMI patients, dabigatran 110 mg (HR 0.39, 95% CI 0.20-0.74) and 150 mg (0.43, 0.21-0.89) dual therapy reduced the risk of MBE/CRNMBE versus warfarin triple therapy (p interaction vs all other patients = 0.31 and 0.16). Risk of thrombotic events, for dabigatran 110 mg (HR 1.61, 95% CI: 0.85-3.08) and 150 mg (0.56, 0.20-1.51) had p interactions of 0.20 and 0.33, respectively. For net clinical benefit, HRs were 0.74 (95% CI 0.46-1.17) and 0.49 (0.27-0.91) for dabigatran 110 and 150 mg (p interaction = 0.80 and 0.12).

Conclusions: After PCI for STEMI in patients with atrial fibrillation, dabigatran dual therapy had lower risks of bleeding events versus warfarin triple therapy with similar risks of thromboembolic events, supporting dabigatran dual therapy even in patients with high thrombotic risk.

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