Article (Scientific journals)
A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement.
Dangas, George D; Tijssen, Jan G P; Wöhrle, Jochen et al.
2020In New England Journal of Medicine, 382 (2), p. 120-129
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Keywords :
Factor Xa Inhibitors; Platelet Aggregation Inhibitors; 9NDF7JZ4M3 (Rivaroxaban); A74586SNO7 (Clopidogrel); R16CO5Y76E (Aspirin); Aged; Aged, 80 and over; Aspirin/adverse effects/therapeutic use; Atrial Fibrillation/drug therapy; Cardiovascular Diseases/mortality; Clopidogrel/adverse effects/therapeutic use; Drug Therapy, Combination; Factor Xa Inhibitors/adverse effects/therapeutic use; Female; Heart Valve Prosthesis; Hemorrhage/chemically induced; Humans; Intention to Treat Analysis; Kaplan-Meier Estimate; Male; Platelet Aggregation Inhibitors/adverse effects/therapeutic use; Rivaroxaban/adverse effects/therapeutic use; Thromboembolism/mortality; Transcatheter Aortic Valve Replacement
Abstract :
[en] 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.).
Disciplines :
Cardiovascular & respiratory systems
Author, co-author :
Dangas, George D;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
Tijssen, Jan G P;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
Wöhrle, Jochen;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
Søndergaard, Lars;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
Gilard, Martine;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
Möllmann, Helge;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
Makkar, Raj R;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
Herrmann, Howard C;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
Giustino, Gennaro;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
Baldus, Stephan;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
De Backer, Ole;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
Guimarães, Ana H C;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
Gullestad, Lars;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
Kini, Annapoorna;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
von Lewinski, Dirk;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
Mack, Michael;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
Moreno, Raúl;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
Schäfer, Ulrich;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
Seeger, Julia;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
Tchétché, Didier;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
Thomitzek, Karen;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
Valgimigli, Marco;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
Vranckx, Pascal;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
Welsh, Robert C;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
Wildgoose, Peter;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
Volkl, Albert A;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
Zazula, Ana;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
van Amsterdam, Ronald G M;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
Mehran, Roxana;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
Windecker, Stephan;  From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of
GALILEO, Investigators
More authors (21 more) Less
Other collaborator :
Dangas, G D
Windecker, S
Mehran, R
Tijssen, J G P
Welsh, R C
Vranckx, P
Valgimigli, M
van Amsterdam, R G M
Thomitzek, K
Wildgoose, P
Colombo, A
Dumonteil, N
Sauguet, A
St Etienne, C
Ivanes, F
Angoulvant, D
Genet, T
Delepine, S
Pinaud, F
Caussin, C
Kaufman, David
Cantor, W
Veugeois, A
Van Belle, E
Juthier, F
Mugnier, A
Rousse, N
Himbert, D
Urena, M
Abtan, T
Kim, W K
Fischer-Rasokat, U
Peniston, C
Meller, Jose
Renker, M
Osman, N
Liebetrau, C
Walther, T
Doss, M
Baumgarten, H
Schmidt, S
Wagner, A
Lauer, B
Prabhakar, M
Richter, S
Milstein, Mark
Reents, W
Zacher, M
Barth, S
Lenos, A
Toelg, R
Abdel-Wahab, M
Richardt, G
Schwarz, B
Hussain, F
El Marwardy, M
Sulimov, D
Weinberger, Jesse
Kebernik, J
Kaur, J
Landt, M
Arnold, M
Achenbach, S
Lang, S
Bal, Z
Teng, C
Marwan, M
Gruber, M
Roether, J
Young Cha, Jin
Lengerer, S
Stangl, V
Baldenhofer, G
Dreger, H
Schoebel, C
Taubert, T
Tyrrell, B
Meissler, S
Herold, J
Braun-Dullaeus, R
Wiegand, C
Fox, Keith
Wagner, M
Nowak, S
Gori, T
Schulz, E
Münzel, T
Meyer, S
Siedel, P
Hollmann, S
Ruff, B
Debl, K
Fischer, M
Block, Peter
Endemann, D
Resch, M
Ergresits, J J
Strack, C
Shanks, M
Werner, N
Nickenig, G
Twelker, K
Adam, M
Stundl, A
Fuchs, A
Pocock, Stuart
Halbach, M
Von Hodenberg, E
Grunebaum, J P
Butler, C
König, W
Hengstenberg, C
Husser, O
Braun, S
Pellegrini, C
Lanig, C
Santer, D
de Vries, Ton
Ates, S
Schacher, N
Horlick, E
Joner, M
Abt, B
Wegehenkel, E
Mootz, R
Kohler, H
Geisler, T
Borst, O
Müller, K
Kirsch, Bodo
Droppa, M
Prendergast, B
Landmesser, U
Fröhlich, G
Lauten, A
Heuberger, A
Steinbeck, L
Wewetzer, W
Friebel, J
Hoting, M
Girker, G
Verspohl, Gabriele
Osten, M
Kempfert, J
Meyer, A
Unbehaun, A
Polzin, A
Dannenberg, L
Kleinebrecht, L
Zeus, T
Sotemann, D
Afzal, S S
Piayda, K D
Wood, D
van Amsterdam, R
Zako, S
Mohring, A M
Schäfer, S
Schmitt, S
Deuschl, F
Karakas, M
Sydow, K
Conradi, L
Schofer, N
Ramanathan, K
Moser, A
Guimaraes, A
Widder, J
Tillmanns, J
Zwadlo, C
Kempf, T
Zimmermann, A
Abou Moulig, V
Haenselmann, A
Tongers, J
Htun, N M
Knoll, V
Haude, M
Alkema, M
Degen, H
Rottländer, D
Niethammer, M
Schächinger, V
Boes, C
Bufe, A
Guelker, J
Attinger, A
Bansemir, L
Ilousis, D
Jansen, R
Altema, J
von Zur Muhlen, C
Reinoehl, J
Ahrens, I
Rilinger, J
Stachon, P
Wennekes Neagu, V
Della Siega, A
Bugger, H
Diehl, P
Thiele, H
Haußig, S
Franklin-Bond, T
Linke, A
Hoellriegel, R
Holzhey, D
Winzer, E
Woitek, F
Pelzer, E
Kiefer, P
Desch, S
Binner, C
Mangner, N
Frey, N
Welsh, R
Frank, D
Lambers, M
Kuhn, C
Deichstetter, M
Robinson, S
Brück, B
Nagel, B
Schlichting, A
Eggebrecht, H
Lindhoff-Last, E
Schulze-Waltrup, N
Temple, T
Blumenstein, J
Froemke, J
Marks, M
Nadra, I
Sahin, D
Bourhaial, H
Lohmann, M
Schroeder, J
Brandenburg, V
Wöhrle, J
Rottbauer, W
Parrotta, J
Seeger, J
Gonska, B
Lounsbury, N
Markovic, S
Bothner, C
Scharnbeck, D
Awad, B
Baumhardt, M
Hartveg, P
Rodewald, C
Hoffmeister, U
von Lewinski, D
Dragomir, S
Makkar, R
Scheller, B
Schirmer, S
Millenaar, D
Lavall, D
Kratz, M
Tiroch, K
Gunzenhausen, P
Bleiziffer, S
Ruge, H
LEGRAND, Victor ;  Centre Hospitalier Universitaire de Liège - CHU > > Service de cardiologie
Sorenson, S
Kreuzpointner, R
Goppel, G
Erlebach, M
Firschke, C
Hambrecht, R
Fiehn, E
Kuehl, M
Osteresch, R
Pader, P
Grunwald, S
Martin, E
Kala, P
Ben Ammar, A
Wienbergen, F
Fach, A
Kudaibergenov, H
Martel-Coll, A
Capranzano, P
Di Simone, E
Picci, A
Bruschi, G
Munoz, A
Canova, P
Søndergaard, L
Nava, S
Soriano, F
Colombo, P
Valsecchi, O
Fiocca, L
Serino, F
Vassileva, A
Collaku, E
Iqbal, M B
Musumeci, G
Reimers, B
Tchétché, D
Malanchini, G
Pagnotta, P
Pisaniello, M
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Ferrante, G
Gasparini, G
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Stefanini, G
Panico, C
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Möllmann, H
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Napodana, M
Fraccaro, C
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Matteo, M
Giannini, F
Nadeem, S N
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Giannini, C
Spontoni, P
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Tijssen, R
Kalkman, D
Nassif, M
Van Mieghem, N
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Schäfer, U
Kroon, H
van Gils, L
El Faquir, N
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Meuwissen, M
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Schaap, J
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Jenssen, K
Bendz, B
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Kovac, J
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Manoharan, G
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Bonan, R
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Roberts, D
Chua, Y
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Miskolczi, S
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Tzalamouras, V
Roy, J
Kini, A
Sharma, S
Kovacic, J
Khan, A
Kastner, J
Ragosta, M
Webb, J
Ailawadi, G
Ghanta, R
Kern, J
Lim, D S
Yarboro, L
Anwaruddin, S
Chang, G
Desai, N
Giri, J
Schrutka, L
Cartier, R
Li, R
Vallabhajosyula, P
Pitts, J
Szeto, W
Szerlip, M
Brinkman, W
Brown, D
Gopal, A
Gunukula, S
Harrington, K
Demers, P
Stojkovic, S
Ryan, W
Potluri, S
Holper, E
Kindsvater, S
Davidson, C
Flaherty, J
Malaisrie, S C
Thinh Pham, D
Ricciardi, M
Lamarche, Y
Sweis, R
Scherzer, S
Churyla, A
Gupta, A
Griffith, B P
Gottlieb, S
Terrien, E
Moossavi, S
Chava, S
El-Haddad, M
Basmadjian, A
Worgan, B
Abernethy, A
Koller, L
Rambod, M
Lahoud, R
Alkhalil, I
Azarbal, A
Chhatriwalla, A
Cohen, D
Baron, S
Cademartiri, F
Hart, A
Allen, K
Applegate, R
Lang, I
Zhao, D
Gandhi, S
Feldman, T
Salinger, M
Levisay, J
Guerrero, M
Pham, M
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Petrossian, G
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Kreiner, G
Dhoble, A
Loyalka, P
Smalling, R
Kleiman, N
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Robillard, J
Little, S
Ramchandani, M
Reardon, M
Reyes, M
Sarker, K
Pichler, P
Gray, T
Reul, S
Ben-Dor, I
Satler, L
Henri, C
Kereiakes, D
Bailey, K
Bruce, J
Sarembock, I
Choo, J
O'Neill, W
Weidenauer, D
Greenbaum, A
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Terrone, D
Cohen, M
De Marchena, E
Alfonso, C
Dyal, M
MARTINEZ, Christophe ;  Centre Hospitalier Universitaire de Liège - CHU > > Service de cardiologie
Spriggs, S
Navas, J
Adlbrecht, C
Barry, M
Babaliaros, V
Toleva, O
Thourani, V
Devireddy, C
Harjai, K
Young, B
Hopkins, E
Manganiello, M
Agarwal, S
Meraj, P
Strouhal, A
Rutkin, B
Marx, Steven O
Jauhar, R
Boutis, L
Cheng, W
Nakamura, M
Chakravarty, T
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Sorajja, P
Poulose, A
Pedersen, W
Delle Karth, G
Kass, M
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Kapadia, S
Kirshnaswamy, A
Mick, S
Bakaeen, F
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Kipperman, R
Cohen, B
Brown, J
Slater, J
Šebo, M
Fiegl, N
Xydas, S
Magovern, C
Polomsky, M
Genereux, P
Popma, J
Pinto, D
Laham, R
Cutlip, D
Guibone, K
Třetina, M
Papazian, S
Huber, M
Soffer, D
Angiolillo, D
Bass, T
Antoun, P
Pirris, J
Zenni, M
Suryadevera, S
Mooney, J
Kočka, V
Luber, J
Reiter, R
Secky, L
Mixon, T
Lawrence, M
Chawla, A
McAllister, D
Yazdani, S
Sherwood, M
Geloo, N
Linková, H
Schober, A
Eber, B
Lassnig, E
Porodko, M
Maurer, E
Hoppe, U
Hammerer, M
Prinz, E
Wintersteller, W
Lichtenhauer, M
Sulženko, J
Wernly, B
Steinwender, C
Grund, M
Lambert, T
Nahler, A
Huber, K
Wessely, E
Egger, F
Smetana, P
Jager, B
Bednář, F
Geppert, A
Andric, T
LANCELLOTTI, Patrizio  ;  Centre Hospitalier Universitaire de Liège - CHU > > Service de cardiologie
Gach, O
Benit, E
Ferdinande, B
Dens, J
Toušek, P
Zelίzko, M
Bronislav, J
Corvaja, Nicola
Zelizko, M
Vymetalova, J
Barciakova, L
Kotrč, M
de Backer, O
Jørgensen, T
Dagnegard, H
Østergaard, L
Veien, K T
Christensen, N L
Ghodsi, Newsha
Nissen, H
Fallesen, C
Terkelsen, C J
Christiansen, E
Mathiassen, O N
Noergaard, B
Gilard, M
Didier, R
Nicol, P
Picart, M
DiStefano, Douglas
Castellant, P
More authors (717 more) Less
Language :
English
Title :
A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement.
Publication date :
09 January 2020
Journal title :
New England Journal of Medicine
ISSN :
0028-4793
eISSN :
1533-4406
Publisher :
Massachusetts Medical Society, Us ma
Volume :
382
Issue :
2
Pages :
120-129
Peer reviewed :
Peer Reviewed verified by ORBi
Funding number :
Sponsor/Bayer/International; Sponsor/Janssen Pharmaceuticals/International
Commentary :
Copyright © 2019 Massachusetts Medical Society.
Available on ORBi :
since 18 May 2022

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