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Asundexian versus Apixaban in Patients with Atrial Fibrillation.
Piccini, Jonathan P; Patel, Manesh R; Steffel, Jan; Ferdinand, Keith; Van Gelder, Isabelle C; Russo, Andrea M; Ma, Chang-Sheng; Goodman, Shaun G; Oldgren, Jonas; Hammett, Christopher; Lopes, Renato D; Akao, Masaharu; De Caterina, Raffaele; Kirchhof, Paulus; Gorog, Diana A; Hemels, Martin; Rienstra, Michiel; Jones, W Schuyler; Harrington, Josephine; Lip, Gregory Y H; Ellis, Stephen J; Rockhold, Frank W; Neumann, Christoph; Alexander, John H; Viethen, Thomas; Hung, James; Coppolecchia, Rosa; Mundl, Hardi; Caso, Valeria.
Afiliación
  • Piccini JP; From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich
  • Patel MR; From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich
  • Steffel J; From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich
  • Ferdinand K; From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich
  • Van Gelder IC; From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich
  • Russo AM; From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich
  • Ma CS; From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich
  • Goodman SG; From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich
  • Oldgren J; From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich
  • Hammett C; From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich
  • Lopes RD; From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich
  • Akao M; From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich
  • De Caterina R; From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich
  • Kirchhof P; From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich
  • Gorog DA; From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich
  • Hemels M; From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich
  • Rienstra M; From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich
  • Jones WS; From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich
  • Harrington J; From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich
  • Lip GYH; From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich
  • Ellis SJ; From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich
  • Rockhold FW; From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich
  • Neumann C; From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich
  • Alexander JH; From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich
  • Viethen T; From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich
  • Hung J; From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich
  • Coppolecchia R; From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich
  • Mundl H; From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich
  • Caso V; From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich
N Engl J Med ; 2024 Sep 01.
Article en En | MEDLINE | ID: mdl-39225267
ABSTRACT

BACKGROUND:

Stroke prevention with direct-acting oral anticoagulant agents in patients with atrial fibrillation confers a risk of bleeding and limits their use. Asundexian, an activated factor XI (XIa) inhibitor, is an oral anticoagulant that may prevent strokes with less bleeding.

METHODS:

In a phase 3, international, double-blind trial, we randomly assigned high-risk patients with atrial fibrillation in a 11 ratio to receive asundexian at a dose of 50 mg once daily or standard-dose apixaban. The primary efficacy objective was to determine whether asundexian is at least noninferior to apixaban for the prevention of stroke or systemic embolism. The primary safety objective was to determine whether asundexian is superior to apixaban with respect to major bleeding events.

RESULTS:

A total of 14,810 randomly assigned patients were included in the intention-to-treat population. The mean (±SD) age of the patients was 73.9±7.7 years, 35.2% were women, 18.6% had chronic kidney disease, 18.2% had a previous stroke or transient ischemic attack, 16.8% had received oral anticoagulants for no more than 6 weeks, and the mean CHA2DS2-VASc score (range, 0 to 9, with higher scores indicating a greater risk of stroke) was 4.3±1.3. The trial was stopped prematurely at the recommendation of the independent data monitoring committee. Stroke or systemic embolism occurred in 98 patients (1.3%) assigned to receive asundexian and in 26 (0.4%) assigned to receive apixaban (hazard ratio, 3.79; 95% confidence interval [CI], 2.46 to 5.83). Major bleeding occurred in 17 patients (0.2%) who received asundexian and in 53 (0.7%) who received apixaban (hazard ratio, 0.32; 95% CI, 0.18 to 0.55). The incidence of any adverse event appeared to be similar in the two groups.

CONCLUSIONS:

Among patients with atrial fibrillation at risk for stroke, treatment with asundexian at a dose of 50 mg once daily was associated with a higher incidence of stroke or systemic embolism than treatment with apixaban in the period before the trial was stopped prematurely. There were fewer major bleeding events with asundexian than with apixaban during this time. (Funded by Bayer; OCEANIC-AF ClinicalTrials.gov number, NCT05643573; EudraCT number, 2022-000758-28.).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: N Engl J Med Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: N Engl J Med Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos