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Author(s):
Deepak L. Bhatt, MD, MPH, reviews the latest phase 2b trial data supporting the fast-acting monoclonal antibody infusion for bleeding risk reversal.
Novel investigative ticagrelor-reversal agent bentracimab provided “immediate and significant” counteractively to the antiplatelet’s bleeding effect in previous data, and has now shown sustained reversal in treated patients over 48 hours.
In phase 2b data presented at the American College of Cardiology (ACC) 2022 Scientific Sessions in Washington, DC, this weekend, Deepak L. Bhatt, MD, MPH, executive director of interventional cardiovascular programs, highlighted the newest supporting efficacy and safety data for the monoclonal antibody designed to reverse antiplatelet effect caused by ticagrelor.
Per both PRU and PRI analyses conducted in the randomized, double-blind, placebo-controlled trial, bentracimab provided immediate antiplatelet reversal—observed before the first hour post-dose—and sustained benefit through 48 hours post-dose (P <.0001).
“Platelet function was restored to essentially baseline immediately after the bolus, with an effect that was sustained throughout the period of infusion,” investigators wrote. “There was no evidence of platelet rebound as assessed by p selectin levels or mean platelet volume.”
In an interview with HCPLIve at ACC 2022, Bhatt discussed the potential utility of an agent like bentracimab—as dictated by prescriber concern over bleeding risk with viable therapies including ticagrelor.
“The issue of bleeding is one that’s at the forefront of clinician’s minds when prescribing antiplatelet therapy—understandably so,” Bhatt said. “Nobody wants to cause a bleeding complication, or any complication.”
Though much available data is supportive of the efficacy of dual-antiplatelet therapy (DAPT), Bhatt said fear of bleeding remains a prominent hurdle to greater use, or sustained prescribing, among his colleagues.
“One thing I think would make physicians feels more confident about prescribing antiplatelet therapy—in patients where their indications would be appropriate to do it, whether it’s high ischemic risk—is if a reversal were available,” Bhatt said.
Bhatt additionally explained the components of ticagrelor that make it an eligible antiplatelet therapy to pair with bentracimab—an agent designed to bind to the active metabolite of ticagrelor that thus far has provided reversal benefit in as soon as 5 minutes post-infusion.
The investigator additionally reviewed the REVERSE-IT trial for bentracimab, before sharing perspective on his team’s newest data leading into the ongoing phase 3 study.
“Now we’ve got a really large body—at least large in terms of platelet assay data—showing that bentracimab is highly effective at reversing ticagrelor’s effect,” Bhatt said.