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Am Heart J. 2017 Feb;184:81-87. doi: 10.1016/j.ahj.2016.10.017. Epub 2016 Oct 31.

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

Author information

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.

PMID:
27892890
DOI:
10.1016/j.ahj.2016.10.017
[Indexed for MEDLINE]
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