title: Outcomes in HeartMate II Patients With No Antiplatelet Therapy: 2-Year Results From the European TRACE Study.
abstract: 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.
authors.affiliation: Department of Cardiac Surgery, Institute for Clinical and Experimental Medicine, Prague, Czech Republic; Second Department of Surgery, Department of Cardiovascular Surgery, First Faculty of Medicine, Charles University in Prague, Prague, Czech Republic. Electronic address: ivan.netuka@ikem.cz.
authors.forename: Ivan
authors.initials: I
authors.lastname: Netuka
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, Rouen University Hospital Charles Nicolle, Rouen, France.
authors.forename: Pierre-Yves
authors.initials: PY
authors.lastname: Litzler
authors.affiliation: Department of Cardiovascular Surgery, Heart Center, University of Freiburg, Freiburg, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Berchtold-Herz
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, CHU Pontchaillou, Rennes, France.
authors.forename: Erwan
authors.initials: E
authors.lastname: Flecher
authors.affiliation: Department of Cardiothoracic Surgery, University of Vienna, Vienna, Austria.
authors.forename: Daniel
authors.initials: D
authors.lastname: Zimpfer
authors.affiliation: Clinical Affairs, Research and Scientific Affairs, St. Jude Medical, Inc, Pleasanton, California.
authors.forename: Laura
authors.initials: L
authors.lastname: Damme
authors.affiliation: Research and Scientific Affairs, St. Jude Medical, Inc, Pleasanton, California.
authors.forename: Kartik S
authors.initials: KS
authors.lastname: Sundareswaran
authors.affiliation: Research and Scientific Affairs, St. Jude Medical, Inc, Pleasanton, California.
authors.forename: David J
authors.initials: DJ
authors.lastname: Farrar
authors.affiliation: Department of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany.
authors.forename: Jan D
authors.initials: JD
authors.lastname: Schmitto
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use*; D015331:Cohort Studies; D005060:Europe; D005260:Female; D006333:Heart Failure / Q000401:mortality / Q000628:therapy*; D006353:Heart-Assist Devices; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D019106:Postoperative Hemorrhage / Q000453:epidemiology*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000925:Anticoagulants; D010975:Platelet Aggregation Inhibitors