A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement.

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

Journal

The New England journal of medicine

ISSN: 1533-4406

Titre abrégé: N Engl J Med

Pays: United States

ID NLM: 0255562

Informations de publication

Date de publication:
09 01 2020

Historique:

pubmed: 17 11 2019

medline: 31 1 2020

entrez: 17 11 2019

Statut: ppublish

Résumé

Whether the direct factor Xa inhibitor rivaroxaban can prevent thromboembolic events after transcatheter aortic-valve replacement (TAVR) is unclear. 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. 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). 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.).

Sections du résumé

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.).

Identifiants

DOI: 10.1056/NEJMoa1911425 PMID: 31733180

pubmed: 31733180

doi: 10.1056/NEJMoa1911425

doi:

Substances chimiques

Factor Xa Inhibitors 0

Platelet Aggregation Inhibitors 0

Rivaroxaban 9NDF7JZ4M3

Clopidogrel A74586SNO7

Aspirin R16CO5Y76E

Banques de données

ClinicalTrials.gov

['NCT02556203']

Types de publication

Comparative Study Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

120-129

Subventions

Organisme : Bayer

ID : Sponsor

Pays : International

Organisme : Janssen Pharmaceuticals

ID : Sponsor

Pays : International

Investigateurs

G D Dangas (GD)

S Windecker (S)

R Mehran (R)

J G P Tijssen (JGP)

R C Welsh (RC)

P Vranckx (P)

M Valgimigli (M)

R G M van Amsterdam (RGM)

K Thomitzek (K)

P Wildgoose (P)

A Colombo (A)

B Prendergast (B)

R Makkar (R)

M Mack (M)

J Webb (J)

Steven O Marx (SO)

Nicola Corvaja (N)

Newsha Ghodsi (N)

Douglas DiStefano (D)

David Kaufman (D)

Jose Meller (J)

Mark Milstein (M)

Jesse Weinberger (J)

Jin Young Cha (J)

Keith Fox (K)

Peter Block (P)

Stuart Pocock (S)

Ton de Vries (T)

Bodo Kirsch (B)

Gabriele Verspohl (G)

R van Amsterdam (R)

A Guimaraes (A)

M Alkema (M)

J Altema (J)

T Franklin-Bond (T)

R Welsh (R)

T Temple (T)

J Parrotta (J)

D von Lewinski (D)

V Legrand (V)

P Kala (P)

L Søndergaard (L)

D Tchétché (D)

H Möllmann (H)

S Baldus (S)

U Schäfer (U)

C Tamburino (C)

R de Winter (R)

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S James (S)

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