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Search: WFRF:(Connolly David) > (2020-2024) > Andexanet for Facto...

  • Connolly, Stuart J.Population Health Research Institute, Ontario (author)

Andexanet for Factor Xa Inhibitor-Associated Acute Intracerebral Hemorrhage

  • Article/chapterEnglish2024

Publisher, publication year, extent ...

  • 2024
  • 11 s.

Numbers

  • LIBRIS-ID:oai:lup.lub.lu.se:b0ad56ea-51ad-40d3-9086-f5e3f75d7521
  • https://lup.lub.lu.se/record/b0ad56ea-51ad-40d3-9086-f5e3f75d7521URI
  • https://doi.org/10.1056/NEJMoa2313040DOI

Supplementary language notes

  • Language:English
  • Summary in:English

Part of subdatabase

Classification

  • Subject category:art swepub-publicationtype
  • Subject category:ref swepub-contenttype

Notes

  • 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 1:1 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.).

Subject headings and genre

Added entries (persons, corporate bodies, meetings, titles ...)

  • Sharma, MukulPopulation Health Research Institute, Ontario (author)
  • Cohen, Alexander T.Guy's and St Thomas' NHS Foundation Trust (author)
  • Demchuk, Andrew M. (author)
  • Członkowska, AnnaInstitute of Psychiatry and Neurology, Warszawa (author)
  • Lindgren, Arne G.Lund University,Lunds universitet,Neurologi, Lund,Sektion IV,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Klinisk strokeforskning,Forskargrupper vid Lunds universitet,Neurology, Lund,Section IV,Department of Clinical Sciences, Lund,Faculty of Medicine,Clinical Stroke Research Group,Lund University Research Groups,Skåne University Hospital(Swepub:lu)neur-ali (author)
  • Molina, Carlos A.Vall d'Hebron University Hospital (author)
  • Bereczki, DanielSemmelweis University (author)
  • Toni, DaniloSapienza University of Rome (author)
  • Seiffge, David J.Bern University Hospital (author)
  • Tanne, DavidTechnion - Israel Institute of Technology (author)
  • Sandset, Else CharlotteOslo university hospital (author)
  • Tsivgoulis, GeorgiosNational and Kapodistrian University of Athens (author)
  • Christensen, HanneBispebjerg Hospital (author)
  • Beyer-Westendorf, JanUniversity Hospitals Leuven (author)
  • Coutinho, Jonathan M.Academic Medical Center of University of Amsterdam (AMC) (author)
  • Crowther, MarkUniversity Hospitals Leuven (author)
  • Verhamme, PeterUniversity Hospitals Leuven (author)
  • Amarenco, PierreHopital Bichat-Claude-Bernard AP-HP (author)
  • Roine, Risto O.Turku University Hospital (author)
  • Mikulik, Robert (author)
  • Lemmens, RobinUniversity Hospitals Leuven,Catholic University of Leuven (author)
  • Veltkamp, RolandImperial College London,Alfried Krupp Krankenhaus (author)
  • Middeldorp, SaskiaRadboud University Medical Center (author)
  • Robinson, Thompson G.University of Leicester (author)
  • Milling, Truman JohnDell Medical School,University of Houston (author)
  • Tedim-Cruz, VitorUniversity of Porto (author)
  • Lang, WilfriedSigmund Freud Private University (author)
  • Himmelmann, AndersUniversity Clinic Carl Gustav Carus at the TU Dresden,AstraZeneca, UK (author)
  • Ladenvall, PerAstraZeneca, UK (author)
  • Knutsson, MikaelAstraZeneca, UK (author)
  • Ekholm, EllaAstraZeneca, UK (author)
  • Law, AndrewSemmelweis University (author)
  • Taylor, AmandaBispebjerg Hospital (author)
  • Karyakina, TetyanaAlfried Krupp Krankenhaus (author)
  • Xu, LizhenUniversity of Tübingen (author)
  • Tsiplova, KateRadboud University Medical Center (author)
  • Poli, SvenUniversity of Tübingen (author)
  • Kallmünzer, BerndUniversity Hospital Erlangen (author)
  • Gumbinger, ChristophUniversity Hospital Heidelberg (author)
  • Shoamanesh, AshkanAcademic Medical Center of University of Amsterdam (AMC) (author)
  • Population Health Research Institute, OntarioGuy's and St Thomas' NHS Foundation Trust (creator_code:org_t)
  • ANNEXA-I Investigators

Related titles

  • In:New England Journal of Medicine390:19, s. 1745-17550028-4793

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