Medizinische Universität Graz - Research portal
Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Andreas, M; Moayedifar, R; Wieselthaler, G; Wolzt, M; Riebandt, J; Haberl, T; Angleitner, P; Schlöglhofer, T; Wiedemann, D; Schima, H; Laufer, G; Zimpfer, D.
Increased Thromboembolic Events With Dabigatran Compared With Vitamin K Antagonism in Left Ventricular Assist Device Patients: A Randomized Controlled Pilot Trial.
Circ Heart Fail. 2017; 10(5):
Doi: 10.1161/CIRCHEARTFAILURE.116.003709
[OPEN ACCESS]
Web of Science
PubMed
FullText
FullText_MUG
- Leading authors Med Uni Graz
- Andreas Martin
- Co-authors Med Uni Graz
- Zimpfer Daniel
- Altmetrics:
- Dimensions Citations:
- Plum Analytics:
- Scite (citation analytics):
- Abstract:
- BACKGROUND: Left ventricular assist device-supported patients are usually anticoagulated with a combination of aspirin and vitamin K antagonists. Long-term vitamin K antagonist therapy can be complicated by unstable international normalized ratio values and patient-related compliance problems. Therefore, direct thrombin inhibitors may represent an alternative to vitamin K antagonists. METHODS AND RESULTS: Thirty HeartWare ventricular assist device patients with stable renal function were planned for this prospective, randomized, open-label, single-center study. Patients were randomized to receive either phenprocoumon or dabigatran in addition to aspirin for long-term anticoagulation. Treatment duration was scheduled for 1 year and stopped after observation of a primary end point. Dabigatran dose was 110 and 75 mg BID in patients with normal or impaired renal function (glomerular filtration rate >80 mL/min or between 80 and 30 mL/min, respectively). The study was stopped prematurely for safety reasons after 16 patients (61±8 years, 1 female) were randomized. Thromboembolic events occurred in 4 subjects receiving dabigatran (50%) and in 1 receiving phenprocoumon (13%; P=0.28). No major bleeding was recorded, and no patient died during the study. Median time to treatment termination was significantly shorter in dabigatran patients (8.5 versus 12.0 months; P=0.015). CONCLUSIONS: Thromboembolic events on dabigatran led to early termination of a randomized controlled trial of dabigatran versus phenprocoumon in left ventricular assist device patients. CLINICAL TRIAL REGISTRATION: https://www.clinicaltrials.gov. Unique identifier: NCT02872649.
- Find related publications in this database (using NLM MeSH Indexing)
- Antithrombins - administration & dosage
- Dabigatran - administration & dosage
- Dose-Response Relationship, Drug - administration & dosage
- Equipment Failure - administration & dosage
- Female - administration & dosage
- Follow-Up Studies - administration & dosage
- Heart Ventricles - surgery
- Heart-Assist Devices - adverse effects
- Humans - administration & dosage
- Male - administration & dosage
- Middle Aged - administration & dosage
- Phenprocoumon - administration & dosage
- Pilot Projects - administration & dosage
- Prospective Studies - administration & dosage
- Thromboembolism - epidemiology, etiology, prevention & control
- Time Factors - administration & dosage
- United States - epidemiology
- Vitamin K - antagonists & inhibitors
- Find related publications in this database (Keywords)
- anticoagulants
- aspirin
- dabigatran
- glomerular filtration rate
- hemorrhage