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Warfarin and Aspirin Versus Warfarin Alone for Prevention of Embolic Events in Patients with a HeartMate II(R) Left Ventricular Assist Device.

Van Tuyl, Joseph S. PharmD; Hollis, Ian B. PharmD; Alburikan, Khalid A. PharmD; Tran, Richard PharmD; Murray, Brian P. PharmD; Rodgers, Jo E. PharmD; Katz, Jason N. MD, MHS; Sheridan, Brett C. MD
doi: 10.1097/MAT.0000000000000561
Original Article: PDF Only

Acquired von Willebrand disease increases bleeding risk in patients implanted with a continuous-flow left ventricular assist device. Lower aspirin doses decrease the risk of bleeding without an increased risk of embolic events. No published studies in the U.S. have compared the incidence of bleeding and thrombotic events between antithrombotic regimens with and without aspirin. A single-center, retrospective analysis was conducted of adult patients implanted with a HM II. Patients received warfarin and aspirin 81 mg daily or warfarin alone. The primary endpoint was a composite of death, bleeding events, and thrombotic events from the date of HM II implantation to first event or 18 months. Secondary endpoints included the individual components of the primary endpoint and the proportion of patients alive with HM II or transplanted. The Wilcoxon rank-sum test and Fisher's exact test were utilized for statistical analysis. Of the seventy-six patients meeting inclusion criteria, 44 received warfarin and aspirin and 32 received warfarin alone. Baseline characteristics were similar between groups. Warfarin alone was not associated with an increased risk of the primary composite outcome (53% versus 59%, respectively, p=0.64). No significant difference was observed in any bleeding event (34% versus 43%, respectively, p=0.48) nor any thrombotic event (9% versus 11%, respectively, p=1.00) with warfarin alone compared to warfarin and aspirin. Elimination of antiplatelet therapy from the HM II antithrombotic regimen was associated with no significant difference in the composite outcome of bleeding events, thrombotic events, or death, nor the individual components of each endpoint.

Copyright (C) 2017 by the American Society for Artificial Internal Organs