Rapid and Sustained Reversal of Ticagrelor–Intervention Trial called REVERSE-IT

In this trial, the safety and efficacy of bentracimab was assessed in reversing the antiplatelet effect of ticagrelor among patients needing urgent surgery or a procedure, or with major bleeding. 150 patients with a mean age of 65 years who either needed urgent surgery or a procedure or with major bleeding were enrolled in an open-label single-arm study. On day 1, patients received an intravenous (IV) infusion of an initial IV bolus of 6 g infused over 10 minutes for rapid reversal, followed immediately by a 6 g IV loading infusion over 4 hours and then a 6 g IV maintenance infusion over 12 hours (total 18 g). After 48 hours of follow-up, the primary reversal endpoint - minimum % inhibition of VerifyNow P2Y12 Response Unit or PRU within 4 hours of bentracimab initiation, was successfully met (p-value of significant was < 0.001). PRUs increased from a baseline of <100 to >200 within 5-10 minutes with a steady increase by 4 hours and appeared to be sustained for 24 hours (with p-value of significance < 0.001 for all time points studied). The results of this phase III trial indicate that bentracimab, a recombinant IgG1 monoclonal antibody antigen-binding fragment that binds with high affinity to ticagrelor and its active metabolite, is safe and effective in reversing the antiplatelet effect of ticagrelor. This drug is not expected to work against clopidogrel and prasugrel, which are irreversible P2Y12 receptor inhibitors. Reversal was noted within 5 minutes, and the duration of reversal was infusion-time dependent. Effective haemostasis was achieved in most cases and no rebound increase in platelet activity was noted. Disclaimer: Lupin makes no representation or warranty of any kind, expressed or implied, regarding the accuracy, adequacy, validity, reliability, availability, or completeness of any scientific information shared by the HCP on the ­­­STAR UPDATE podcast. You should not allow the contents of this to substitute for your own medical judgment, which you should exercise in evaluating the information on this website.