Trial design: Rivaroxaban for the prevention of major cardiovascular events after transcatheter aortic valve replacement: Rationale and design of the GALILEO study
Stephan Windecker, Jan Tijssen, Gennaro Giustino, Ana H C Guimarães, Roxana Mehran, Marco Valgimigli, Pascal Vranckx, Robert C Welsh, Usman Baber, Gerrit-Anne van Es, Peter Wildgoose, Albert A Volkl, Ana Zazula, Karen Thomitzek, Melanie Hemmrich, George D Dangas, Stephan Windecker, Jan Tijssen, Gennaro Giustino, Ana H C Guimarães, Roxana Mehran, Marco Valgimigli, Pascal Vranckx, Robert C Welsh, Usman Baber, Gerrit-Anne van Es, Peter Wildgoose, Albert A Volkl, Ana Zazula, Karen Thomitzek, Melanie Hemmrich, George D Dangas
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.
Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.
Source: PubMed