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IDARUCIZUMAB FOR REVERSAL OF THE ANTICOAGULANT EFFECTS OF DABIGATRAN IN PATIENTS IN AN EMERGENCY SETTING OF MAJOR BLEEDING, URGENT SURGERY, OR INTERVENTIONS
664 JACC April 5, 2016 Volume 67, Issue 13
Arrhythmias and Clinical EP IDARUCIZUMAB FOR REVERSAL OF THE ANTICOAGULANT EFFECTS OF DABIGATRAN IN PATIENTS IN AN EMERGENCY SETTING OF MAJOR BLEEDING, URGENT SURGERY, OR INTERVENTIONS Moderated Poster Contributions Arrhythmias and Clinical EP Moderated Poster Theater, Poster Area, South Hall A1 Saturday, April 02, 2016, 10:30 a.m.-10:40 a.m. Session Title: Anticoagulation and Stroke Prevention in AF: The Good, the Bad, and the Ugly Abstract Category: 19. Arrhythmias and Clinical EP: Other Presentation Number: 1130M-05 Authors: Charles V. Pollack, Paul Reilly, John Eikelboom, Stephan Glund, Fredrik Gruenenfelder, Richard Bernstein, Menno Huisman, Elaine Hylek, Pieter W. Kamphuisen, Jörg Kreuzer, Jerrold Levy, Frank Sellke, Joachim Stangier, Thorsten Steiner, Bushi Wang, Chak Wah Kam, Jeffrey Weitz, Thomas Jefferson University, Philadelphia, PA, USA Background: Dabigatran is a novel oral anticoagulant. Idarucizumab, a humanized Fab fragment that reverses dabigatran was approved for use in the US in Oct 2015. Methods: RE-VERSE AD is an ongoing multinational, single cohort study investigating the safety and efficacy of
5 g idarucizumab to reverse dabigatran in patients with life-threatening or uncontrolled bleeding (Group A) or who require an emergency procedure (Group B). Primary endpoint is maximum reversal of the anticoagulant effect of dabigatran, based on dTT or ECT. Clinical outcomes are also assessed.
Results: Data from 123 patients (Group A: 66, Group B: 57) are contained in this analysis. Median age was 77 years, 52.8% were male, median CrCl was 55.1 ml/min. 95% of patients were treated with dabigatran for AF. 4% had a prior major bleed. 63/66 bleeds were classified as major or life-threatening (ISTH classification) with 24 being hemodynamically unstable. 27 GI, 24 intracranial and 21 other bleeds were identified. By the end of 5 g idarucizumab infusion, complete reversal of dabigatran occurred in >89% of patients. In Group B, mean time to surgery was 1.7 hours after infusion. Normal intraoperative hemostasis was reported in 48/52 assessable patients and no major bleed occurred post-surgically. In 48 assessable patients in Group A, median time to bleeding cessation was 9.8 hours. Thrombotic events occurred in 5 patients 2 - 24 days post infusion. None were anticoagulated at the time of the event. Twenty-six of 123 patients (21%) died either due to worsening of the emergency situation or due to comorbidities. Updated results will be presented. Conclusions: Idarucizumab rapidly reverses dabigatran in emergency situations.
Arrhythmias and Clinical EP IDARUCIZUMAB FOR REVERSAL OF THE ANTICOAGULANT EFFECTS OF DABIGATRAN IN PATIENTS IN AN EMERGENCY SETTING OF MAJOR BLEEDING, URGENT SURGERY, OR INTERVENTIONS Moderated Poster Contributions Arrhythmias and Clinical EP Moderated Poster Theater, Poster Area, South Hall A1 Saturday, April 02, 2016, 10:30 a.m.-10:40 a.m. Session Title: Anticoagulation and Stroke Prevention in AF: The Good, the Bad, and the Ugly Abstract Category: 19. Arrhythmias and Clinical EP: Other Presentation Number: 1130M-05 Authors: Charles V. Pollack, Paul Reilly, John Eikelboom, Stephan Glund, Fredrik Gruenenfelder, Richard Bernstein, Menno Huisman, Elaine Hylek, Pieter W. Kamphuisen, Jörg Kreuzer, Jerrold Levy, Frank Sellke, Joachim Stangier, Thorsten Steiner, Bushi Wang, Chak Wah Kam, Jeffrey Weitz, Thomas Jefferson University, Philadelphia, PA, USA Background: Dabigatran is a novel oral anticoagulant. Idarucizumab, a humanized Fab fragment that reverses dabigatran was approved for use in the US in Oct 2015. Methods: RE-VERSE AD is an ongoing multinational, single cohort study investigating the safety and efficacy of
5 g idarucizumab to reverse dabigatran in patients with life-threatening or uncontrolled bleeding (Group A) or who require an emergency procedure (Group B). Primary endpoint is maximum reversal of the anticoagulant effect of dabigatran, based on dTT or ECT. Clinical outcomes are also assessed.
Results: Data from 123 patients (Group A: 66, Group B: 57) are contained in this analysis. Median age was 77 years, 52.8% were male, median CrCl was 55.1 ml/min. 95% of patients were treated with dabigatran for AF. 4% had a prior major bleed. 63/66 bleeds were classified as major or life-threatening (ISTH classification) with 24 being hemodynamically unstable. 27 GI, 24 intracranial and 21 other bleeds were identified. By the end of 5 g idarucizumab infusion, complete reversal of dabigatran occurred in >89% of patients. In Group B, mean time to surgery was 1.7 hours after infusion. Normal intraoperative hemostasis was reported in 48/52 assessable patients and no major bleed occurred post-surgically. In 48 assessable patients in Group A, median time to bleeding cessation was 9.8 hours. Thrombotic events occurred in 5 patients 2 - 24 days post infusion. None were anticoagulated at the time of the event. Twenty-six of 123 patients (21%) died either due to worsening of the emergency situation or due to comorbidities. Updated results will be presented. Conclusions: Idarucizumab rapidly reverses dabigatran in emergency situations.