Bentracimab for Ticagrelor Reversal in Patients Undergoing Urgent Surgery
نویسندگان
چکیده
BackgroundTicagrelor is a reversible oral P2Y12 platelet inhibitor used to treat patients with acute coronary syndromes, prior myocardial infarction, high-risk artery disease, transient ischemic attack, or stroke. A healthy volunteer study showed that the intravenous monoclonal antibody bentracimab rapidly reverses ticagrelor, but effect in was unknown.MethodsIn prespecified interim analysis of single-arm, prospective study, evaluated ticagrelor-treated who required urgent surgery had major hemorrhage. The extent reversal determined using VerifyNow assay. Clinical hemostasis assessed by central adjudication validated criteria. Treatment-emergent safety events were evaluated. trial ongoing and will enroll approximately 200 evaluable data.ResultsOf 150 enrolled patients, 142 8 For end-point analysis, 129 analyzable data; 122 data on adjudicated hemostasis. Bentracimab provided rapid ticagrelor’s antiplatelet effects within 5 10 minutes. sustained for more than 24 hours, as measured vasodilator-stimulated phosphoprotein phosphorylation assays (P<0.001, both all subgroups). Adjudicated achieved 90% (P<0.001); 5% thrombotic events. No allergic infusion-related reactions reported.ConclusionsBentracimab immediate ticagrelor undergoing surgical procedures. (Funded PhaseBio Pharmaceuticals, Inc.; ClinicalTrials.gov number, NCT04286438.)
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ژورنال
عنوان ژورنال: NEJM evidence
سال: 2022
ISSN: ['2766-5526']
DOI: https://doi.org/10.1056/evidoa2100047