Abstract 16418: Reinitiation of Antithrombotic Therapy After Emergency Procedures or After an Uncontrolled or Life Threatening Bleeding Event. Initial Experience From the Re-verse Ad Trial
Background: In AF patients, oral anticoagulation is effective for stroke risk reduction, but there is uncertainty on how to manage re-initiation of anticoagulation after a bleeding complication. Ideally, therapy would be stopped immediately and reinitiated as soon as possible after the bleeding has resolved. In clinical trials comparing dabigatran to warfarin, urgent interventions were linked to higher rates of both bleeding and thromboembolic events than elective interventions. Idarucizumab immediately reverses the anticoagulant effects of dabigatran without prothrombotic effect. Due to idarucizumab’s specificity to dabigatran, other drug-drug interaction is not expected, allowing the clinician flexibility in managing antithrombotic therapy during and after the event.
Methods: In the ongoing phase III RE-VERSE AD study, dabigatran-treated patients with uncontrolled bleeding (Group A) or who require emergency surgery (Group B) are given 5 g of idarucizumab IV. The primary endpoint was median maximum reversal of the anticoagulant effect of dabigatran, based on dilute thrombin time (dTT) or ecarin clotting time (ECT) within 4 h of study drug infusion. Data collection on re-initiation of antithrombotic therapy was studied as a secondary endpoint.
Results: In the interim analysis of 90 patients, median maximum reversal of the anticoagulant effect of dabigatran was 100%. For antithrombotic re-initiation data, see Table.
Conclusions: Idarucizumab is an immediate-acting, specific reversal agent for dabigatran. Preliminary results from RE-VERSE AD suggest that idarucizumab facilitates the periprocedural management of dabigatran-treated patients. Of note is that after an acute event, alternative antithrombotic therapy can be initiated at any time after idarucizumab application. Reintroduction of dabigatran was possible as early as 24 h after idarucizumab treatment. This is desirable to protect patients from their underlying thromboembolic risk.
Author Disclosures: C.V. Pollack, Jr.: None. P.A. Reilly: None. J. Eikelboom: None. S. Glund: None. P. Verhamme: None. R.A. Bernstein: None. R. Dubiel: None. M.V. Huisman: None. E. Hylek: None. P.W. Kamphuisen: None. J. Kreuzer: None. J.H. Levy: None. F. Sellke: Consultant/Advisory Board; Modest; medicines company, advisory committee, boehringer ingleheim, DSMB. J. Stangier: None. T. Steiner: None. B. Wang: None. C. Kam: None. J.I. Weitz: None.
- © 2015 by American Heart Association, Inc.