Windecker, StephanStephanWindeckerTijssen, JanJanTijssenGiustino, GennaroGennaroGiustinoGuimarães, Ana H CAna H CGuimarãesMehran, RoxanaRoxanaMehranValgimigli, MarcoMarcoValgimigliVranckx, PascalPascalVranckxWelsh, Robert C.Robert C.WelshBaber, UsmanUsmanBabervan Es, Gerrit-AnneGerrit-Annevan EsWildgoose, PeterPeterWildgooseVolkl, Albert A.Albert A.VolklZazula, AnaAnaZazulaThomitzek, KarenKarenThomitzekHemmrich, MelanieMelanieHemmrichDangas, George D.George D.Dangas2024-10-242024-10-242016-10-31https://boris-portal.unibe.ch/handle/20.500.12422/146904BACKGROUND 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.en600 - Technology::610 - Medicine & healtharticle10.7892/boris.910642789289010.1016/j.ahj.2016.10.017