A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement

GALILEO Investigators

doi:10.1056/NEJMoa1911425

A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement

GALILEO Investigators

Afdeling for Hjertesygdomme

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.).

Originalsprog	Engelsk
Tidsskrift	The New England journal of medicine
Vol/bind	382
Udgave nummer	2
Sider (fra-til)	120-129
Antal sider	10
ISSN	0028-4793
DOI	https://doi.org/10.1056/NEJMoa1911425
Status	Udgivet - 9 jan. 2020

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10.1056/NEJMoa1911425

Citationsformater

@article{29fd8d8a4c514eecae55f98bd4567cff,

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 = "The New England journal of medicine",

issn = "0028-4793",

publisher = "Massachusetts Medical Society",

number = "2",

}

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 - 2020/1/9

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 - Journal article

C2 - 31733180

SN - 0028-4793

VL - 382

SP - 120

EP - 129

JO - The New England journal of medicine

JF - The New England journal of medicine

IS - 2

ER -

A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement

Abstract

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