Outcomes in HeartMate II Patients With No Antiplatelet Therapy: 2-Year Results From the European TRACE Study
Jazyk angličtina Země Nizozemsko Médium print-electronic
Typ dokumentu časopisecké články, multicentrická studie, pozorovací studie
PubMed
27743637
DOI
10.1016/j.athoracsur.2016.07.072
PII: S0003-4975(16)31025-6
Knihovny.cz E-zdroje
- MeSH
- antikoagulancia terapeutické užití MeSH
- časové faktory MeSH
- dospělí MeSH
- incidence MeSH
- inhibitory agregace trombocytů terapeutické užití MeSH
- kohortové studie MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- podpůrné srdeční systémy * MeSH
- pooperační krvácení epidemiologie MeSH
- senioři MeSH
- srdeční selhání mortalita terapie MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
- Geografické názvy
- Evropa MeSH
- Názvy látek
- antikoagulancia MeSH
- inhibitory agregace trombocytů MeSH
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 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
Research and Scientific Affairs St Jude Medical Inc Pleasanton California
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