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A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement

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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.

In: NEW ENGL J MED, Vol. 382, No. 2, 09.01.2020, p. 120-129.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Dangas, GD, Tijssen, JGP, Wöhrle, J, Søndergaard, L, Gilard, M, Möllmann, H, Makkar, RR, Herrmann, HC, Giustino, G, Baldus, S, De Backer, O, Guimarães, AHC, Gullestad, L, Kini, A, von Lewinski, D, Mack, M, Moreno, R, Schäfer, U, Seeger, J, Tchétché, D, Thomitzek, K, Valgimigli, M, Vranckx, P, Welsh, RC, Wildgoose, P, Volkl, AA, Zazula, A, van Amsterdam, RGM, Mehran, R, Windecker, S & GALILEO Investigators 2020, 'A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement', NEW ENGL J MED, vol. 382, no. 2, pp. 120-129. https://doi.org/10.1056/NEJMoa1911425

APA

Dangas, G. D., Tijssen, J. G. P., Wöhrle, J., Søndergaard, L., Gilard, M., Möllmann, H., Makkar, R. R., Herrmann, H. C., Giustino, G., Baldus, S., De Backer, O., Guimarães, A. H. C., Gullestad, L., Kini, A., von Lewinski, D., Mack, M., Moreno, R., Schäfer, U., Seeger, J., ... GALILEO Investigators (2020). A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement. NEW ENGL J MED, 382(2), 120-129. https://doi.org/10.1056/NEJMoa1911425

Vancouver

Dangas GD, Tijssen JGP, Wöhrle J, Søndergaard L, Gilard M, Möllmann H et al. A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement. NEW ENGL J MED. 2020 Jan 9;382(2):120-129. https://doi.org/10.1056/NEJMoa1911425

Bibtex

@article{5d4047e9f0b2421798d36f48889cbb45,
title = "A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement",
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.).",
keywords = "Aged, Aged, 80 and over, Aspirin/adverse effects, Atrial Fibrillation/drug therapy, Cardiovascular Diseases/mortality, Clopidogrel/adverse effects, Drug Therapy, Combination, Factor Xa Inhibitors/adverse effects, Female, Heart Valve Prosthesis, Hemorrhage/chemically induced, Humans, Intention to Treat Analysis, Kaplan-Meier Estimate, Male, Platelet Aggregation Inhibitors/adverse effects, Rivaroxaban/adverse effects, Thromboembolism/mortality, Transcatheter Aortic Valve Replacement",
author = "Dangas, {George D} and Tijssen, {Jan G P} and Jochen W{\"o}hrle and Lars S{\o}ndergaard and Martine Gilard and Helge M{\"o}llmann and Makkar, {Raj R} and Herrmann, {Howard C} and Gennaro Giustino and Stephan Baldus and {De Backer}, Ole and Guimar{\~a}es, {Ana H C} and Lars Gullestad and Annapoorna Kini and {von Lewinski}, Dirk and Michael Mack and Ra{\'u}l Moreno and Ulrich Sch{\"a}fer and Julia Seeger and Didier Tch{\'e}tch{\'e} and Karen Thomitzek and Marco Valgimigli and Pascal Vranckx and Welsh, {Robert C} and Peter Wildgoose and Volkl, {Albert A} and Ana Zazula and {van Amsterdam}, {Ronald G M} and Roxana Mehran and Stephan Windecker and {GALILEO Investigators}",
note = "Copyright {\textcopyright} 2019 Massachusetts Medical Society.",
year = "2020",
month = jan,
day = "9",
doi = "10.1056/NEJMoa1911425",
language = "English",
volume = "382",
pages = "120--129",
journal = "NEW ENGL J MED",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "2",

}

RIS

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

N1 - Copyright © 2019 Massachusetts Medical Society.

PY - 2020/1/9

Y1 - 2020/1/9

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. (Funded by Bayer and Janssen Pharmaceuticals; GALILEO ClinicalTrials.gov number, NCT02556203.).

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. (Funded by Bayer and Janssen Pharmaceuticals; GALILEO ClinicalTrials.gov number, NCT02556203.).

KW - Aged

KW - Aged, 80 and over

KW - Aspirin/adverse effects

KW - Atrial Fibrillation/drug therapy

KW - Cardiovascular Diseases/mortality

KW - Clopidogrel/adverse effects

KW - Drug Therapy, Combination

KW - Factor Xa Inhibitors/adverse effects

KW - Female

KW - Heart Valve Prosthesis

KW - Hemorrhage/chemically induced

KW - Humans

KW - Intention to Treat Analysis

KW - Kaplan-Meier Estimate

KW - Male

KW - Platelet Aggregation Inhibitors/adverse effects

KW - Rivaroxaban/adverse effects

KW - Thromboembolism/mortality

KW - Transcatheter Aortic Valve Replacement

U2 - 10.1056/NEJMoa1911425

DO - 10.1056/NEJMoa1911425

M3 - SCORING: Journal article

C2 - 31733180

VL - 382

SP - 120

EP - 129

JO - NEW ENGL J MED

JF - NEW ENGL J MED

SN - 0028-4793

IS - 2

ER -