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Deepak Bhatt, MD, MPH, discusses the results of the interim analysis of the REVERSE-IT trial presented at AHA 2021, which indicates bentracimab provided immediate and sustained reversal of ticagrelor's antiplatelet effects in patients requiring urgent surgery or experiencing major bleeding.
Bentracimab has the ability to provide patients with immediate and sustained reversal of ticagrelor’s antiplatelet effects, according to results of the REVERSE-IT trial.
Presented by Deepak Bhatt, MD, MPH, at the American Heart Association (AHA) 2021 Scientific Sessions, results of the interim analysis of the trial also suggest rates of effective hemostasis were adjusted as good or excellent in more than 90% of cases and benefits observed with bentracimab were consistent in all prespecified subgroups, including patients undergoing surgery and with major bleeding.
“Overall, I would say bentracimab is a very promising option for ticagrelor reversal,” said Bhatt, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital, in an interview with Practical Cardiology. “Of course, we have to see what the FDA say to the data. Of course, we have to still finish the trial and enroll several more bleeding patients, but I think in this prespecified interim analysis the data look really, really promising.”
A global single-arm, open-label, FDA and EMA registrational study, REVERSE-IT was designed to evaluate the safety and efficacy of bentracimab in patients using ticagrelor who need urgent surgery or other invasive procedures or with uncontrolled major or life-threatening bleeding. The trial was designed to include a prespecified interim analysis of the first 140 enrolled patients, which was the data presented at AHA 2021.
The trial had pair of co-primary end points, which were the achievement of ticagrelor reversal within 4 hours and achievement of effective hemostasis. Achievement of ticagrelor reversal was assessed with a point-of-care platelet-function assay. Safety outcomes were assessed by an independent data safety monitoring board and the overall safety profile included adverse events, serious adverse events, laboratory, and thrombotic events.
Results of the interim analysis indicated bentracimab provided immediate and sustained reversal of ticagrelor’s antiplatelet effects. No drug-related serious adverse events or allergic or infusion-related reactions were observed in the trial and rates of effective hemostasis were adjudicated as good or excellent in more than 90% of cases. Further analysis revealed the apparent benefits observed in the trial were consistent in all prespecified subgroups.
For more perspective into the results of the trial, Practical Cardiology reached out to Bhatt for his insight and that conversation is the subject of the following AHA 2021 House Call.
This study, “Effect of Bentracimab on Platelet Inhibition and Hemostasis in Ticagrelor Patients with Uncontrolled Hemorrhage or Requiring Urgent Surgery in the REVERSE-IT trial,” was presented at AHA 2021.