BACKGROUND: Current recommendations of antithrombotic therapy for HeartMate II (HMII) patients include the use of both an anticoagulant and an antiplatelet agent. Because bleeding is still the most frequent adverse event, the TRACE (STudy of Reduced Anti-Coagulation/Anti-platelet Therapy in Patients with the HeartMatE II) study was initiated to evaluate the incidence of adverse events in HMII patients on reduced antithrombotic (RT) therapy. METHODS: HMII patients (n = 101) from nine centers were enrolled in the European arm of TRACE and were managed on a single anticoagulant (vitamin K antagonist) with no antiplatelet agents. An analysis of bleeding and thrombotic adverse events from all 101 patients with 2-year follow-up after initiation of RT therapy is reported here. RESULTS: Median age was 56 years (range, 18 to 72 years), 93% were men, 70% had an Interagency Registry for Mechanically Assisted Circulatory Support profile 1 to 3, and 82% received the HMII as a bridge to transplantation. Ninety-two percent were placed on RT therapy as a center standard of care or due to physician preference and 6% as a response to bleeding. Median HMII support duration on RT therapy was 25 months (range, 1 to 93 months). Median international normalized ratio was 2.31 [quartile 1 to quartile 3: 2.07 to 2.60]. At 2 years, freedom from bleeding, ischemic stroke, hemorrhagic stroke, and pump thrombosis after initiation of RT therapy was 81% ± 6%, 96% ± 2%, 94% ± 3%, and 94% ± 3%, respectively. CONCLUSIONS: The 2-year analysis of the observational European TRACE study suggests that managing HMII patients with a vitamin K antagonist with a target international normalized ratio of 2.3 without antiplatelet therapy may help to reduce the incidence of major bleeding without increasing the risk of thromboembolic events, including ischemic stroke and pump thrombosis.

Clinical Affairs Research and Scientific Affairs St Jude Medical Inc Pleasanton California

Department of Cardiac Surgery Institute for Clinical and Experimental Medicine Prague Czech Republic; 2nd Department of Surgery Department of Cardiovascular Surgery 1st Faculty of Medicine Charles University Prague Prague Czech Republic

Department of Cardiac Thoracic Transplantation and Vascular Surgery Hannover Medical School Hannover Germany

Department of Cardiothoracic Surgery University of Vienna Vienna Austria

Department of Cardiovascular Surgery Heart Center University of Freiburg Freiburg Germany

Department of Thoracic and Cardiovascular Surgery CHU Pontchaillou Rennes France

Department of Thoracic and Cardiovascular Surgery Rouen University Hospital Charles Nicolle Rouen France

Research and Scientific Affairs St Jude Medical Inc Pleasanton California

Ann Thorac Surg. 2017 Apr;103(4):1268-1269. doi: 10.1016/j.athoracsur.2016.08.017. PubMed

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Aspirin and left ventricular assist devices: rationale and design for the international randomized, placebo-controlled, non-inferiority ARIES HM3 trial