Stephan Windecker1, Jan Tijssen2, Gennaro Giustino3, Ana H C Guimarães4, Roxana Mehran3, Marco Valgimigli5, Pascal Vranckx6, Robert C Welsh7, Usman Baber3, Gerrit-Anne van Es8, Peter Wildgoose9, Albert A Volkl9, Ana Zazula10, Karen Thomitzek11, Melanie Hemmrich11, George D Dangas3. 1. Bern University Hospital, Bern, Switzerland; European Cardiovascular Research Institute (ECRI), Rotterdam, the Netherlands. Electronic address: stephan.windecker@insel.ch. 2. European Cardiovascular Research Institute (ECRI), Rotterdam, the Netherlands; Academic Medical Center-University of Amsterdam, Amsterdam, the Netherlands. 3. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City. 4. Cardialysis, Clinical Research Organization, Rotterdam, the Netherlands. 5. Bern University Hospital, Bern, Switzerland; European Cardiovascular Research Institute (ECRI), Rotterdam, the Netherlands. 6. Hartcentrum Hasselt, Hasselt, Belgium; European Cardiovascular Research Institute (ECRI), Rotterdam, the Netherlands. 7. Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada. 8. European Cardiovascular Research Institute (ECRI), Rotterdam, the Netherlands; Cardialysis, Clinical Research Organization, Rotterdam, the Netherlands. 9. Janssen Pharmaceuticals Inc., Raritan, NJ. 10. Bayer, São Paulo, Brazil. 11. Bayer Pharma AG, Berlin, Germany.
Abstract
BACKGROUND: Optimal antithrombotic treatment after transcatheter aortic valve replacement (TAVR) is unknown and determined empirically. The direct factor Xa inhibitor rivaroxaban may potentially reduce TAVR-related thrombotic complications and premature valve failure. DESIGN: GALILEO is an international, randomized, open-label, event-driven, phase III trial in more than 1,520 patients without an indication for oral anticoagulation who underwent a successful TAVR (ClinicalTrials.govNCT02556203). Patients are randomized (1:1 ratio), 1 to 7days after a successful TAVR, to either a rivaroxaban-based strategy or an antiplatelet-based strategy. In the experimental arm, subjects receive rivaroxaban (10mg once daily [OD]) plus acetylsalicylic acid (ASA, 75-100mg OD) for 90days followed by rivaroxaban alone. In the control arm, subjects receive clopidogrel (75mg OD) plus ASA (as above) for 90days followed by ASA alone. In case new-onset atrial fibrillation occurs after randomization, full oral anticoagulation will be implemented with maintenance of the original treatment assignment. The primary efficacy end point is the composite of all-cause death, stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep venous thrombosis, and systemic embolism. The primary safety end point is the composite of life-threatening, disabling, and major bleeding, according to the Valve Academic Research Consortium definitions. CONCLUSIONS: GALILEO will test the hypothesis that a rivaroxaban-based antithrombotic strategy reduces the risk of thromboembolic complications post-TAVR with an acceptable risk of bleeding compared with the currently recommended antiplatelet therapy-based strategy in subjects without need of chronic oral anticoagulation.
RCT Entities:
BACKGROUND: Optimal antithrombotic treatment after transcatheter aortic valve replacement (TAVR) is unknown and determined empirically. The direct factor Xa inhibitor rivaroxaban may potentially reduce TAVR-related thrombotic complications and premature valve failure. DESIGN: GALILEO is an international, randomized, open-label, event-driven, phase III trial in more than 1,520 patients without an indication for oral anticoagulation who underwent a successful TAVR (ClinicalTrials.govNCT02556203). Patients are randomized (1:1 ratio), 1 to 7days after a successful TAVR, to either a rivaroxaban-based strategy or an antiplatelet-based strategy. In the experimental arm, subjects receive rivaroxaban (10mg once daily [OD]) plus acetylsalicylic acid (ASA, 75-100mg OD) for 90days followed by rivaroxaban alone. In the control arm, subjects receive clopidogrel (75mg OD) plus ASA (as above) for 90days followed by ASA alone. In case new-onset atrial fibrillation occurs after randomization, full oral anticoagulation will be implemented with maintenance of the original treatment assignment. The primary efficacy end point is the composite of all-cause death, stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep venous thrombosis, and systemic embolism. The primary safety end point is the composite of life-threatening, disabling, and major bleeding, according to the Valve Academic Research Consortium definitions. CONCLUSIONS: GALILEO will test the hypothesis that a rivaroxaban-based antithrombotic strategy reduces the risk of thromboembolic complications post-TAVR with an acceptable risk of bleeding compared with the currently recommended antiplatelet therapy-based strategy in subjects without need of chronic oral anticoagulation.
Authors: Ted E Feldman; Michael J Reardon; Vivek Rajagopal; Raj R Makkar; Tanvir K Bajwa; Neal S Kleiman; Axel Linke; Dean J Kereiakes; Ron Waksman; Vinod H Thourani; Robert C Stoler; Gregory J Mishkel; David G Rizik; Vijay S Iyer; Thomas G Gleason; Didier Tchétché; Joshua D Rovin; Maurice Buchbinder; Ian T Meredith; Matthias Götberg; Henrik Bjursten; Christopher Meduri; Michael H Salinger; Dominic J Allocco; Keith D Dawkins Journal: JAMA Date: 2018-01-02 Impact factor: 56.272
Authors: Davide Capodanno; Deepak L Bhatt; John W Eikelboom; Keith A A Fox; Tobias Geisler; C Michael Gibson; Jose Ramon Gonzalez-Juanatey; Stefan James; Renato D Lopes; Roxana Mehran; Gilles Montalescot; Manesh Patel; P Gabriel Steg; Robert F Storey; Pascal Vranckx; Jeffrey I Weitz; Robert Welsh; Uwe Zeymer; Dominick J Angiolillo Journal: Nat Rev Cardiol Date: 2020-01-17 Impact factor: 32.419