Romain Didier1, Thibault Lhermusier2, Vincent Auffret3, Hélène Eltchaninoff4, Herve Le Breton3, Guillaume Cayla5, Philippe Commeau6, Jean Philippe Collet7, Thomas Cuisset8, Nicolas Dumonteil9, Jean Philippe Verhoye3, Sylvain Beurtheret10, Thierry Lefèvre11, Emmanuel Teiger12, Didier Carrié2, Dominique Himbert13, Bernard Albat14, Alain Cribier4, Arnaud Sudre15, Didier Blanchard16, Olivier Bar17, Gilles Rioufol18, Frederic Collet19, Remi Houel10, Louis Labrousse20, Nicolas Meneveau21, Said Ghostine22, Thibaut Manigold23, Philippe Guyon24, Stephane Delepine25, Xavier Favereau26, Geraud Souteyrand27, Patrick Ohlmann28, Vincent Doisy29, Farzin Beygui30, Antoine Gommeaux31, Jean-Philippe Claudel32, Francois Bourlon33, Bernard Bertrand34, Bernard Iung13, Martine Gilard35. 1. Department of Cardiology, Brest University Hospital, Brest, France. 2. Toulouse University Hospital, Toulouse, France. 3. Rennes University Hospital, Rennes, France. 4. Rouen University Hospital, Rouen, France. 5. Nîmes University Hospital, Nîmes, France. 6. Polyclinic des Fleurs, Ollioules, France. 7. Pitié Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France. 8. University Hospital of Marseille, La Timone, France. 9. Clinique Pasteur, Toulouse, France. 10. Saint Joseph Hospital, Marseille, France. 11. Cardiovascular Institute Paris Sud, Paris, France. 12. University Hospital Henri-Mondor, Assistance Publique-Hôpitaux de Paris, Paris, France. 13. Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Université de Paris, Paris, France. 14. University Hospital of Montpellier, Montpellier, France. 15. University Hospital of Lille, Lille, France. 16. University Hospital Paris Ouest, Assistance Publique-Hôpitaux de Paris, Paris, France. 17. Clinique Saint Gatien, Tours, France. 18. Hospital Louis Pradel, Bron, France. 19. Mediterranean Institute of Cardiology, Marseille, France. 20. University Hospital of Bordeaux, Bordeaux, France. 21. Besançon University Hospital, Besançon, France. 22. Hospital Marie Lannelongue, Le Plessis-Robinson, France. 23. University of Nantes, Department of Cardiologie, Saint-Herblain, France. 24. North Cardiological Center, Saint-Denis, France. 25. Angers University Hospital, Angers, France. 26. Private Hospital of Parly II, Le Chesnay-Rocquencourt, France. 27. University Hospital of Clermont-Ferrand, Clermont-Ferrand, France. 28. Strasbourg University Hospital, Strasbourg, France. 29. Médipôle Lyon-Villeurbanne, Villeurbanne, France. 30. Caen University Hospital, Caen, France. 31. Private Hospital of Bois-Bernard, Henin Beaumont, France. 32. Clinique de l'Infirmerie Protestante de Lyon, Lyon, France. 33. Monaco Cardiothoracic Center, Monaco, France. 34. Department of Cardiology, Grenoble Alpes University Hospital, Grenoble, France. 35. Department of Cardiology, Brest University Hospital, Brest, France. Electronic address: martine.gilard@gmail.com.
Abstract
OBJECTIVES: Using French transcatheter aortic valve replacement (TAVR) registries linked with the nationwide administrative databases, the study compared the rates of long-term mortality, bleeding, and ischemic events after TAVR in patients requiring oral anticoagulation with direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs). BACKGROUND: The choice of optimal drug for anticoagulation after TAVR remains debated. METHODS: Data from the France-TAVI and FRANCE-2 registries were linked to the French national health single-payer claims database, from 2010 to 2017. Propensity score matching was used to reduce treatment-selection bias. Two primary endpoints were death from any cause (efficacy) and major bleeding (safety). RESULTS: A total of 24,581 patients who underwent TAVR were included and 8,962 (36.4%) were treated with OAC. Among anticoagulated patients, 2,180 (24.3%) were on DOACs. After propensity matching, at 3 years, mortality (hazard ratio [HR]: 1.37; 95% confidence interval [CI]: 1.12-1.67; P < 0.005) and major bleeding including hemorrhagic stroke (HR: 1.64; 95% CI: 1.17-2.29; P < 0.005) were lower in patients on DOACs compared with those on VKAs. The rates of ischemic stroke (HR: 1.32; 95% CI: 0.81-2.15; P = 0.27) and acute coronary syndrome (HR: 1.17; 95% CI: 0.68-1.99; P = 0.57) did not differ among groups. CONCLUSIONS: In these large multicenter French TAVR registries with an exhaustive clinical follow-up, the long-term mortality and major bleeding were lower with DOACs than VKAs at discharge. The present study supports preferential use of DOACs rather than VKAs in patients requiring oral anticoagulation therapy after TAVR.
OBJECTIVES: Using French transcatheter aortic valve replacement (TAVR) registries linked with the nationwide administrative databases, the study compared the rates of long-term mortality, bleeding, and ischemic events after TAVR in patients requiring oral anticoagulation with direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs). BACKGROUND: The choice of optimal drug for anticoagulation after TAVR remains debated. METHODS: Data from the France-TAVI and FRANCE-2 registries were linked to the French national health single-payer claims database, from 2010 to 2017. Propensity score matching was used to reduce treatment-selection bias. Two primary endpoints were death from any cause (efficacy) and major bleeding (safety). RESULTS: A total of 24,581 patients who underwent TAVR were included and 8,962 (36.4%) were treated with OAC. Among anticoagulated patients, 2,180 (24.3%) were on DOACs. After propensity matching, at 3 years, mortality (hazard ratio [HR]: 1.37; 95% confidence interval [CI]: 1.12-1.67; P < 0.005) and major bleeding including hemorrhagic stroke (HR: 1.64; 95% CI: 1.17-2.29; P < 0.005) were lower in patients on DOACs compared with those on VKAs. The rates of ischemic stroke (HR: 1.32; 95% CI: 0.81-2.15; P = 0.27) and acute coronary syndrome (HR: 1.17; 95% CI: 0.68-1.99; P = 0.57) did not differ among groups. CONCLUSIONS: In these large multicenter French TAVR registries with an exhaustive clinical follow-up, the long-term mortality and major bleeding were lower with DOACs than VKAs at discharge. The present study supports preferential use of DOACs rather than VKAs in patients requiring oral anticoagulation therapy after TAVR.