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

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. (2016). Trial design: Rivaroxaban for the prevention of major cardiovascular events after transcatheter aortic valve replacement: Rationale and design of the GALILEO study. American Heart Journal, 184, pp. 81-87. Elsevier 10.1016/j.ahj.2016.10.017

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Windecker, Stephan and Valgimigli, Marco

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0002-8703

Publisher:

Elsevier

Language:

English

Submitter:

Judith Liniger

Date Deposited:

23 Dec 2016 14:12

Last Modified:

12 Jan 2017 01:32

Publisher DOI:

10.1016/j.ahj.2016.10.017

PubMed ID:

27892890

BORIS DOI:

10.7892/boris.91064

URI:

https://boris.unibe.ch/id/eprint/91064

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