Dangas, George D., Tijssen, Jan G. P., Woehrle, Jochen, Sondergaard, Lars ORCID: 0000-0001-8961-8226, Gilard, Martine, Moellmann, Helge, Makkar, Raj R., Herrmann, Howard C., Giustino, Gennaro, Baldus, Stephan, De Backer, Ole ORCID: 0000-0002-9674-0278, Guimaraes, Ana H. C., Gullestad, Lars, Kini, Annapoorna, von Lewinski, Dirk, Mack, Michael, Moreno, Raul ORCID: 0000-0001-7179-1426, Schaefer, Ulrich, Seeger, Julia, Tchetche, Didier, Thomitzek, Karen, Valgimigli, Marco, Vranckx, Pascal, Welsh, Robert C., Wildgoose, Peter, Volkl, Albert A., Zazula, Ana, van Amsterdam, Ronald G. M., Mehran, Roxana and Windecker, Stephan (2020). A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement. N. Engl. J. Med., 382 (2). S. 120 - 130. WALTHAM: MASSACHUSETTS MEDICAL SOC. ISSN 1533-4406

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Abstract

Background Whether the direct factor Xa inhibitor rivaroxaban can prevent thromboembolic events after transcatheter aortic-valve replacement (TAVR) is unclear. Methods We randomly assigned 1644 patients without an established indication for oral anticoagulation after successful TAVR to receive rivaroxaban at a dose of 10 mg daily (with aspirin at a dose of 75 to 100 mg daily for the first 3 months) (rivaroxaban group) or aspirin at a dose of 75 to 100 mg daily (with clopidogrel at a dose of 75 mg daily for the first 3 months) (antiplatelet group). The primary efficacy outcome was the composite of death or thromboembolic events. The primary safety outcome was major, disabling, or life-threatening bleeding. The trial was terminated prematurely by the data and safety monitoring board because of safety concerns. Results After a median of 17 months, 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 (incidence rates, 9.8 and 7.2 per 100 person-years, respectively; hazard ratio with rivaroxaban, 1.35; 95% confidence interval [CI], 1.01 to 1.81; P=0.04). Major, disabling, or life-threatening bleeding (intention-to-treat analysis) had occurred in 46 and 31 patients, respectively (4.3 and 2.8 per 100 person-years; hazard ratio, 1.50; 95% CI, 0.95 to 2.37; P=0.08). A total of 64 deaths occurred in the rivaroxaban group and 38 in the antiplatelet group (5.8 and 3.4 per 100 person-years, respectively; hazard ratio, 1.69; 95% CI, 1.13 to 2.53). Conclusions In patients without an established indication for oral anticoagulation after successful TAVR, a treatment strategy including rivaroxaban at a dose of 10 mg daily was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding than an antiplatelet-based strategy. (Funded by Bayer and Janssen Pharmaceuticals; GALILEO ClinicalTrials.gov number, NCT02556203.)

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Dangas, George D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tijssen, Jan G. P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Woehrle, JochenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sondergaard, LarsUNSPECIFIEDorcid.org/0000-0001-8961-8226UNSPECIFIED
Gilard, MartineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Moellmann, HelgeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Makkar, Raj R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Herrmann, Howard C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Giustino, GennaroUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baldus, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
De Backer, OleUNSPECIFIEDorcid.org/0000-0002-9674-0278UNSPECIFIED
Guimaraes, Ana H. C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gullestad, LarsUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kini, AnnapoornaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
von Lewinski, DirkUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mack, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Moreno, RaulUNSPECIFIEDorcid.org/0000-0001-7179-1426UNSPECIFIED
Schaefer, UlrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Seeger, JuliaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tchetche, DidierUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Thomitzek, KarenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Valgimigli, MarcoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vranckx, PascalUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Welsh, Robert C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wildgoose, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Volkl, Albert A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zazula, AnaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
van Amsterdam, Ronald G. M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mehran, RoxanaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Windecker, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-349079
DOI: 10.1056/NEJMoa1911425
Journal or Publication Title: N. Engl. J. Med.
Volume: 382
Number: 2
Page Range: S. 120 - 130
Date: 2020
Publisher: MASSACHUSETTS MEDICAL SOC
Place of Publication: WALTHAM
ISSN: 1533-4406
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
SUBCLINICAL LEAFLET THROMBOSIS; IMPLANTATION; MANAGEMENTMultiple languages
Medicine, General & InternalMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/34907

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