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Andexanet for Factor Xa Inhibitor-Associated Acute Intracerebral Hemorrhage.
Connolly, Stuart J; Sharma, Mukul; Cohen, Alexander T; Demchuk, Andrew M; Czlonkowska, Anna; Lindgren, Arne G; Molina, Carlos A; Bereczki, Daniel; Toni, Danilo; Seiffge, David J; Tanne, David; Sandset, Else Charlotte; Tsivgoulis, Georgios; Christensen, Hanne; Beyer-Westendorf, Jan; Coutinho, Jonathan M; Crowther, Mark; Verhamme, Peter; Amarenco, Pierre; Roine, Risto O; Mikulik, Robert; Lemmens, Robin; Veltkamp, Roland; Middeldorp, Saskia; Robinson, Thompson G; Milling, Truman John; Tedim-Cruz, Vitor; Lang, Wilfried; Himmelmann, Anders; Ladenvall, Per; Knutsson, Mikael; Ekholm, Ella; Law, Andrew; Taylor, Amanda; Karyakina, Tetyana; Xu, Lizhen; Tsiplova, Kate; Poli, Sven; Kallmünzer, Bernd; Gumbinger, Christoph; Shoamanesh, Ashkan.
Afiliación
  • Connolly SJ; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Sharma M; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Cohen AT; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Demchuk AM; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Czlonkowska A; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Lindgren AG; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Molina CA; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Bereczki D; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Toni D; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Seiffge DJ; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Tanne D; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Sandset EC; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Tsivgoulis G; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Christensen H; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Beyer-Westendorf J; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Coutinho JM; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Crowther M; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Verhamme P; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Amarenco P; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Roine RO; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Mikulik R; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Lemmens R; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Veltkamp R; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Middeldorp S; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Robinson TG; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Milling TJ; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Tedim-Cruz V; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Lang W; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Himmelmann A; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Ladenvall P; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Knutsson M; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Ekholm E; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Law A; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Taylor A; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Karyakina T; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Xu L; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Tsiplova K; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Poli S; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Kallmünzer B; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Gumbinger C; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
  • Shoamanesh A; From the Population Health Research Institute, McMaster University, Hamilton, ON (S.J.C., M.S., M.C., A.T., T.K., L.X., K.T., A.S.), and the Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB (A.M.D.) - both
N Engl J Med ; 390(19): 1745-1755, 2024 May 16.
Article en En | MEDLINE | ID: mdl-38749032
ABSTRACT

BACKGROUND:

Patients with acute intracerebral hemorrhage who are receiving factor Xa inhibitors have a risk of hematoma expansion. The effect of andexanet alfa, an agent that reverses the effects of factor Xa inhibitors, on hematoma volume expansion has not been well studied.

METHODS:

We randomly assigned, in a 11 ratio, patients who had taken factor Xa inhibitors within 15 hours before having an acute intracerebral hemorrhage to receive andexanet or usual care. The primary end point was hemostatic efficacy, defined by expansion of the hematoma volume by 35% or less at 12 hours after baseline, an increase in the score on the National Institutes of Health Stroke Scale of less than 7 points (scores range from 0 to 42, with higher scores indicating worse neurologic deficit) at 12 hours, and no receipt of rescue therapy between 3 hours and 12 hours. Safety end points were thrombotic events and death.

RESULTS:

A total of 263 patients were assigned to receive andexanet, and 267 to receive usual care. Efficacy was assessed in an interim analysis that included 452 patients, and safety was analyzed in all 530 enrolled patients. Atrial fibrillation was the most common indication for factor Xa inhibitors. Of the patients receiving usual care, 85.5% received prothrombin complex concentrate. Hemostatic efficacy was achieved in 150 of 224 patients (67.0%) receiving andexanet and in 121 of 228 (53.1%) receiving usual care (adjusted difference, 13.4 percentage points; 95% confidence interval [CI], 4.6 to 22.2; P = 0.003). The median reduction from baseline to the 1-to-2-hour nadir in anti-factor Xa activity was 94.5% with andexanet and 26.9% with usual care (P<0.001). Thrombotic events occurred in 27 of 263 patients (10.3%) receiving andexanet and in 15 of 267 (5.6%) receiving usual care (difference, 4.6 percentage points; 95% CI, 0.1 to 9.2; P = 0.048); ischemic stroke occurred in 17 patients (6.5%) and 4 patients (1.5%), respectively. There were no appreciable differences between the groups in the score on the modified Rankin scale or in death within 30 days.

CONCLUSIONS:

Among patients with intracerebral hemorrhage who were receiving factor Xa inhibitors, andexanet resulted in better control of hematoma expansion than usual care but was associated with thrombotic events, including ischemic stroke. (Funded by Alexion AstraZeneca Rare Disease and others; ANNEXA-I ClinicalTrials.gov number, NCT03661528.).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Proteínas Recombinantes / Factor Xa / Hemorragia Cerebral / Inhibidores del Factor Xa / Hematoma Límite: Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: N Engl J Med Año: 2024 Tipo del documento: Article
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Proteínas Recombinantes / Factor Xa / Hemorragia Cerebral / Inhibidores del Factor Xa / Hematoma Límite: Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: N Engl J Med Año: 2024 Tipo del documento: Article