Trial design: Rivaroxaban for the prevention of major cardiovascular events after transcatheter aortic valve replacement: Rationale and design of the GALILEO study

• Published in: The American heart journal 2017-02, Vol.184, p.81-87
• Main Authors: Windecker, Stephan, Tijssen, Jan, Giustino, Gennaro, Guimarães, Ana H.C., Mehran, Roxana, Valgimigli, Marco, Vranckx, Pascal, Welsh, Robert C., Baber, Usman, van Es, Gerrit-Anne, Wildgoose, Peter, Volkl, Albert A., Zazula, Ana, Thomitzek, Karen, Hemmrich, Melanie, Dangas, George D.
• Format: Article
• Language: English
• Subjects: Acute coronary syndromes; Aortic Valve Stenosis - surgery; Aspirin - therapeutic use; Blood clots; Blood platelets; Bone surgery; Cardiac arrhythmia; Cardiovascular Diseases - epidemiology; Cardiovascular Diseases - prevention & control; Cause of Death; Drug Therapy, Combination; Embolism - epidemiology; Embolism - prevention & control; Factor Xa Inhibitors - therapeutic use; Heart Valve Diseases - epidemiology; Heart Valve Diseases - prevention & control; Humans; Mortality; Myocardial Infarction - epidemiology; Myocardial Infarction - prevention & control; Orthopedics; Patients; Platelet Aggregation Inhibitors - therapeutic use; Postoperative Care - methods; Prevention; Prostheses; Pulmonary Embolism - epidemiology; Pulmonary Embolism - prevention & control; Rivaroxaban - therapeutic use; Stroke; Stroke - epidemiology; Stroke - prevention & control; Thromboembolism; Thrombosis; Thrombosis - epidemiology; Thrombosis - prevention & control; Ticlopidine - analogs & derivatives; Ticlopidine - therapeutic use; Tomography; Transcatheter Aortic Valve Replacement; Venous Thrombosis - epidemiology; Venous Thrombosis - prevention & control
• ISSN: 0002-8703; 1097-6744
• DOI: 10.1016/j.ahj.2016.10.017

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. 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. 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.