Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes

Summary

To assess whether a rivaroxaban-based anticoagulation strategy, following successful TAVR, compared to an antiplatelet-based strategy, is superior in reducing death or first thromboembolic events (DTE). To assess the primary bleeding events (PBE) of the rivaroxaban-based strategy compared to an antiplatelet-based strategy, following TAVR.

Timeline

Start

2015-12-16

Primary completion

2018-11-27

Completion

2018-11-27

Outcome

Missed primary endpoint

Stopped: “Imbalance in the efficacy and safety endpoints between treatment arms in favor of comparator”

paper death or a first thromboembolic event (intention-to-treat analysis) had occurred in 105 patients in the rivaroxaban group and in 78 patients in the antiplatelet group PMID 31733180 ↗

registry analysis (superiority test); Rivaroxaban (Xarelto, BAY59-7939) vs Antiplatelet; p = 0.04223; Hazard Ratio (HR) 1.35 NCT02556203 ↗

Publications

• Okuno T, Dangas GD, Hengstenberg C, Sartori S, Herrmann HC, de Winter R, Gilard M, Tchetche D, Mollmann H, Makkar RR, Baldus S, De Backer O, Bendz B, Kini A, von Lewinski D, Mack M, Moreno R, Schafer U, Wohrle J, Seeger J, Snyder C, Nicolas J, Tijssen JGP, Welsh RC, Vranckx P, Valgimigli M, Mehran R, Kapadia S, Sondergaard L, Windecker S. Two-year clinical outcomes after successful transcatheter aortic valve implantation with balloon-expandable versus self-expanding valves: A subanalysis of the GALILEO trial. Catheter Cardiovasc Interv. 2022 Oct;100(4):636-645. doi: 10.1002/ccd.30370. Epub 2022 Aug 30.
• Wohrle J, Gilard M, Didier R, Kini A, Tavenier AH, Tijssen JGP, Sartori S, Snyder C, Nicolas J, Seeger J, Landmesser U, Tarantini G, Asgar A, Mollmann H, Thiele H, Capranzano P, Reimers B, Stefanini G, Moreno R, Petronio AS, Mikhail G, Kapadia S, Hildick-Smith D, Hengstenberg C, Mehran R, Windecker S, Dangas GD; GALILEO Investigator. Outcomes After Transcatheter Aortic Valve Implantation in Men Versus Women. Am J Cardiol. 2022 Oct 1;180:108-115. doi: 10.1016/j.amjcard.2022.06.035. Epub 2022 Aug 4.
• Dangas GD, Tijssen JGP, Wohrle J, Sondergaard L, Gilard M, Mollmann H, Makkar RR, Herrmann HC, Giustino G, Baldus S, De Backer O, Guimaraes AHC, Gullestad L, Kini A, von Lewinski D, Mack M, Moreno R, Schafer U, Seeger J, Tchetche D, Thomitzek K, Valgimigli M, Vranckx P, Welsh RC, Wildgoose P, Volkl AA, Zazula A, van Amsterdam RGM, Mehran R, Windecker S; GALILEO Investigators. A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement. N Engl J Med. 2020 Jan 9;382(2):120-129. doi: 10.1056/NEJMoa1911425. Epub 2019 Nov 16.
• Piayda K, Zeus T, Sievert H, Kelm M, Polzin A. Subclinical leaflet thrombosis. Lancet. 2018 Mar 10;391(10124):937-938. doi: 10.1016/S0140-6736(18)30534-8. No abstract available.
• Windecker S, Tijssen J, Giustino G, Guimaraes AH, Mehran R, Valgimigli M, Vranckx P, Welsh RC, Baber U, van Es GA, Wildgoose P, Volkl AA, Zazula A, Thomitzek K, Hemmrich M, Dangas GD. Trial design: Rivaroxaban for the prevention of major cardiovascular events after transcatheter aortic valve replacement: Rationale and design of the GALILEO study. Am Heart J. 2017 Feb;184:81-87. doi: 10.1016/j.ahj.2016.10.017. Epub 2016 Oct 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aspirin	Small molecule	75 mg	—
Subject	Aspirin	Small molecule	100 mg	—
Comparator	Clopidogrel	Small molecule	75 mg	—
Subject	Rivaroxaban	Other / unclassified	10 mg	—
Subject	Rivaroxaban	Other / unclassified	15 mg	—
Subject	Rivaroxaban	Other / unclassified	20 mg	—

Indications

No indication recorded.