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Full Study Report of Andexanet Alfa for Bleeding Associated with Factor Xa Inhibitors.
Connolly, Stuart J; Crowther, Mark; Eikelboom, John W; Gibson, C Michael; Curnutte, John T; Lawrence, John H; Yue, Patrick; Bronson, Michele D; Lu, Genmin; Conley, Pamela B; Verhamme, Peter; Schmidt, Jeannot; Middeldorp, Saskia; Cohen, Alexander T; Beyer-Westendorf, Jan; Albaladejo, Pierre; Lopez-Sendon, Jose; Demchuk, Andrew M; Pallin, Daniel J; Concha, Mauricio; Goodman, Shelly; Leeds, Janet; Souza, Sonia; Siegal, Deborah M; Zotova, Elena; Meeks, Brandi; Ahmad, Sadia; Nakamya, Juliet; Milling, Truman J.
Afiliación
  • Connolly SJ; From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) - all in Canada; Harvard Medical School (C.M.G.) and Brigham and Women's
  • Crowther M; From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) - all in Canada; Harvard Medical School (C.M.G.) and Brigham and Women's
  • Eikelboom JW; From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) - all in Canada; Harvard Medical School (C.M.G.) and Brigham and Women's
  • Gibson CM; From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) - all in Canada; Harvard Medical School (C.M.G.) and Brigham and Women's
  • Curnutte JT; From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) - all in Canada; Harvard Medical School (C.M.G.) and Brigham and Women's
  • Lawrence JH; From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) - all in Canada; Harvard Medical School (C.M.G.) and Brigham and Women's
  • Yue P; From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) - all in Canada; Harvard Medical School (C.M.G.) and Brigham and Women's
  • Bronson MD; From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) - all in Canada; Harvard Medical School (C.M.G.) and Brigham and Women's
  • Lu G; From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) - all in Canada; Harvard Medical School (C.M.G.) and Brigham and Women's
  • Conley PB; From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) - all in Canada; Harvard Medical School (C.M.G.) and Brigham and Women's
  • Verhamme P; From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) - all in Canada; Harvard Medical School (C.M.G.) and Brigham and Women's
  • Schmidt J; From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) - all in Canada; Harvard Medical School (C.M.G.) and Brigham and Women's
  • Middeldorp S; From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) - all in Canada; Harvard Medical School (C.M.G.) and Brigham and Women's
  • Cohen AT; From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) - all in Canada; Harvard Medical School (C.M.G.) and Brigham and Women's
  • Beyer-Westendorf J; From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) - all in Canada; Harvard Medical School (C.M.G.) and Brigham and Women's
  • Albaladejo P; From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) - all in Canada; Harvard Medical School (C.M.G.) and Brigham and Women's
  • Lopez-Sendon J; From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) - all in Canada; Harvard Medical School (C.M.G.) and Brigham and Women's
  • Demchuk AM; From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) - all in Canada; Harvard Medical School (C.M.G.) and Brigham and Women's
  • Pallin DJ; From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) - all in Canada; Harvard Medical School (C.M.G.) and Brigham and Women's
  • Concha M; From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) - all in Canada; Harvard Medical School (C.M.G.) and Brigham and Women's
  • Goodman S; From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) - all in Canada; Harvard Medical School (C.M.G.) and Brigham and Women's
  • Leeds J; From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) - all in Canada; Harvard Medical School (C.M.G.) and Brigham and Women's
  • Souza S; From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) - all in Canada; Harvard Medical School (C.M.G.) and Brigham and Women's
  • Siegal DM; From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) - all in Canada; Harvard Medical School (C.M.G.) and Brigham and Women's
  • Zotova E; From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) - all in Canada; Harvard Medical School (C.M.G.) and Brigham and Women's
  • Meeks B; From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) - all in Canada; Harvard Medical School (C.M.G.) and Brigham and Women's
  • Ahmad S; From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) - all in Canada; Harvard Medical School (C.M.G.) and Brigham and Women's
  • Nakamya J; From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) - all in Canada; Harvard Medical School (C.M.G.) and Brigham and Women's
  • Milling TJ; From the Population Health Research Institute (S.J.C., J.W.E., D.M.S., E.Z., B.M., S.A., J.N.) and the Department of Medicine (M. Crowther), McMaster University, Hamilton, ON, and the University of Calgary, Calgary, AB (A.M.D.) - all in Canada; Harvard Medical School (C.M.G.) and Brigham and Women's
N Engl J Med ; 380(14): 1326-1335, 2019 04 04.
Article en En | MEDLINE | ID: mdl-30730782
ABSTRACT

BACKGROUND:

Andexanet alfa is a modified recombinant inactive form of human factor Xa developed for reversal of factor Xa inhibitors.

METHODS:

We evaluated 352 patients who had acute major bleeding within 18 hours after administration of a factor Xa inhibitor. The patients received a bolus of andexanet, followed by a 2-hour infusion. The coprimary outcomes were the percent change in anti-factor Xa activity after andexanet treatment and the percentage of patients with excellent or good hemostatic efficacy at 12 hours after the end of the infusion, with hemostatic efficacy adjudicated on the basis of prespecified criteria. Efficacy was assessed in the subgroup of patients with confirmed major bleeding and baseline anti-factor Xa activity of at least 75 ng per milliliter (or ≥0.25 IU per milliliter for those receiving enoxaparin).

RESULTS:

Patients had a mean age of 77 years, and most had substantial cardiovascular disease. Bleeding was predominantly intracranial (in 227 patients [64%]) or gastrointestinal (in 90 patients [26%]). In patients who had received apixaban, the median anti-factor Xa activity decreased from 149.7 ng per milliliter at baseline to 11.1 ng per milliliter after the andexanet bolus (92% reduction; 95% confidence interval [CI], 91 to 93); in patients who had received rivaroxaban, the median value decreased from 211.8 ng per milliliter to 14.2 ng per milliliter (92% reduction; 95% CI, 88 to 94). Excellent or good hemostasis occurred in 204 of 249 patients (82%) who could be evaluated. Within 30 days, death occurred in 49 patients (14%) and a thrombotic event in 34 (10%). Reduction in anti-factor Xa activity was not predictive of hemostatic efficacy overall but was modestly predictive in patients with intracranial hemorrhage.

CONCLUSIONS:

In patients with acute major bleeding associated with the use of a factor Xa inhibitor, treatment with andexanet markedly reduced anti-factor Xa activity, and 82% of patients had excellent or good hemostatic efficacy at 12 hours, as adjudicated according to prespecified criteria. (Funded by Portola Pharmaceuticals; ANNEXA-4 ClinicalTrials.gov number, NCT02329327.).
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Proteínas Recombinantes / Coagulantes / Factor Xa / Inhibidores del Factor Xa / Hemorragia Tipo de estudio: Prognostic_studies / Risk_factors_studies Límite: Aged / Aged80 / Female / Humans / Male Idioma: En Revista: N Engl J Med Año: 2019 Tipo del documento: Article
Texto completo
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PubMed Links
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Proteínas Recombinantes / Coagulantes / Factor Xa / Inhibidores del Factor Xa / Hemorragia Tipo de estudio: Prognostic_studies / Risk_factors_studies Límite: Aged / Aged80 / Female / Humans / Male Idioma: En Revista: N Engl J Med Año: 2019 Tipo del documento: Article