A controlled trial of rivaroxaban after transcatheter aortic-valve replacement
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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A controlled trial of rivaroxaban after transcatheter aortic-valve replacement. / Dangas, George D.; Tijssen, Jan G.P.; Wöhrle, Jochen; Søndergaard, Lars; Gilard, Martine; Möllmann, Helge; Makkar, Raj R.; Herrmann, Howard C.; Giustino, Gennaro; Baldus, Stephan; de Backer, Ole; Guimarães, Ana H.C.; Gullestad, Lars; Kini, Annapoorna; von Lewinski, Dirk; Mack, Michael; Moreno, Raúl; Schäfer, Ulrich; Seeger, Julia; Tchétché, Didier; Thomitzek, Karen; Valgimigli, Marco; Vranckx, Pascal; Welsh, Robert C.; Wildgoose, Peter; Volkl, Albert A.; Zazula, Ana; van Amsterdam, Ronald G.M.; Mehran, Roxana; Windecker, Stephan; GALILEO Investigators.
I: New England Journal of Medicine, Bind 382, Nr. 2, 2020, s. 120-129.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - A controlled trial of rivaroxaban after transcatheter aortic-valve replacement
AU - Dangas, George D.
AU - Tijssen, Jan G.P.
AU - Wöhrle, Jochen
AU - Søndergaard, Lars
AU - Gilard, Martine
AU - Möllmann, Helge
AU - Makkar, Raj R.
AU - Herrmann, Howard C.
AU - Giustino, Gennaro
AU - Baldus, Stephan
AU - de Backer, Ole
AU - Guimarães, Ana H.C.
AU - Gullestad, Lars
AU - Kini, Annapoorna
AU - von Lewinski, Dirk
AU - Mack, Michael
AU - Moreno, Raúl
AU - Schäfer, Ulrich
AU - Seeger, Julia
AU - Tchétché, Didier
AU - Thomitzek, Karen
AU - Valgimigli, Marco
AU - Vranckx, Pascal
AU - Welsh, Robert C.
AU - Wildgoose, Peter
AU - Volkl, Albert A.
AU - Zazula, Ana
AU - van Amsterdam, Ronald G.M.
AU - Mehran, Roxana
AU - Windecker, Stephan
AU - GALILEO Investigators
PY - 2020
Y1 - 2020
N2 - 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.
AB - 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.
U2 - 10.1056/NEJMoa1911425
DO - 10.1056/NEJMoa1911425
M3 - Journal article
C2 - 31733180
AN - SCOPUS:85075993796
VL - 382
SP - 120
EP - 129
JO - New England Journal of Medicine
JF - New England Journal of Medicine
SN - 0028-4793
IS - 2
ER -
ID: 261164862