Summary: REVERSE-IT Trial – ACC.25 (Reversal if Ticagrelor’s Antiplatelet Effects in Urgent Surgery or Major Bleeding) Source: ACC.25 Scientific Session, presented by Dr. Deepak Bhatt (New York, NY, USA) Date: March 2025
Summary: REVERSE-IT Trial – ACC.25
(Reversal if Ticagrelor’s Antiplatelet Effects in Urgent Surgery or Major Bleeding)
Source: ACC.25 Scientific Session, presented by Dr. Deepak Bhatt (New York, NY, USA)
Date: March 2025
Bentracimab Rapidly Reverses Ticagrelor’s Antiplatelet Effects in Urgent Surgery or Major Bleeding
1. Background:
• Ticagrelor is a potent oral P2Y₁₂ inhibitor with no available reversal agent via platelet transfusion.
• Bentracimab is a recombinant human monoclonal antibody designed to reverse ticagrelor’s antiplatelet activity.
2. Study Design:
• Phase 3, prospective, open-label, single-arm, multicenter REVERSE-IT trial.
• Included 226 ticagrelor-treated patients needing urgent surgery (n=141) or experiencing major bleeding (n=71).
• Bentracimab was administered via IV infusion.
3. Primary Endpoint:
• Reversal of ticagrelor effect within 4 hours measured by VerifyNow P2Y₁₂ assay.
• Achieved in all groups with statistical significance (P<0.0001).
4. Secondary Endpoint (Effective Hemostasis):
• Achieved in:
• 94.3% of total patients
• 100% of surgery patients
• 83.1% of bleeding patients
• All results were statistically significant (P<0.0001).
5. Safety:
• Drug-related adverse events:
• 2.2% overall
• No serious drug-related adverse events or treatment discontinuations.
6. Regulatory Note:
• Bentracimab recently received orphan drug designation from the FDA.
Conclusion:
Bentracimab provided rapid and sustained reversal of ticagrelor’s antiplatelet effects with high rates of effective hemostasis and a strong safety profile, offering a critical breakthrough for managing urgent surgery or bleeding in ticagrelor-treated patients.