Abstract 14809: Comparison Of The Effectiveness And Safety Of Dabigatran Etexilate Versus Acenocoumarol In Patients With Left Ventricular Assist Device
Administration of anticoagulation is mandatory in patients with LVAD. Vitamin K antagonists require regular monitoring and dosage adjustment. Dabigatran administered at a standard dose twice daily is more convenient, achieves stable anticoagulant effect but its effectiveness and safety in patients with LVADs has not been investigated
Objective: To evaluate whether dabigatran is safe and non inferior to adjusted acenocoumarol dose in the prevention of stroke, non-CNS systematic embolism (SE) or device thrombosis (DT) in patients with LVAD-HeartMate II (HMII) type
Methods: Study population consisted of 7 patients with end-stage heart failure who underwent HMII implantation and sequentially received acenocoumarol and dabigatran. Occurrence of stroke, SE, DE and major or life-threatening bleeding were the primary end-points. Acute decrease in plasma haemoglobin > 2gr/dL or need of transfusion of at least 2 units of packed red blood cells (PRBC) were defined as major bleeding, while acute decrease in plasma haemoglobin > 5 gr/dL, fatal, symptomatic intracranial bleed, need of transfusion of at least 4 units PRBC or association with hypotension requiring the use of intravenous inotropic agents or surgical intervention was defined as life-threatening bleeding
Results: Duration of patients’ follow-up was 1376 ± 271 days. Patients received acenocoumarol for 855 ± 246 days followed by dabigatran for 520 ± 247 days. Dabigatran was not inferior to acenocoumarol in preventing thromboembolic events [Stroke (0.128 vs 0 strokes/patient-year, p= 0.35), SE (no event in both groups) and DT (0.059 vs 0.258 events/ patient-year, p=0.18), for dabigatran and acenocoumarol, respectively]. Compared to adjusted acenocumarol dose, the standard dabigatran dose resulted in similar rates of life-threatening bleeding, but significantly lower rates of major bleeding (0.26 vs 0.27 bleeds /patient-years, p= 0.98 and 0.128 vs 0.547, p=0.001 for dabigatran and acenocoumarol, respectively)
Conclusion: The use of dabigatran as anticoagulation therapy in patients with HM II is non inferior in terms of effectiveness when compared to acenocoumarol. Dabigatran is associated with significantly lower rate of major bleeding. These data must be confirmed in a randomized study.
- © 2011 by American Heart Association, Inc.