Format

Send to

Choose Destination
Circ Heart Fail. 2017 May;10(5). pii: e003709. doi: 10.1161/CIRCHEARTFAILURE.116.003709.

Increased Thromboembolic Events With Dabigatran Compared With Vitamin K Antagonism in Left Ventricular Assist Device Patients: A Randomized Controlled Pilot Trial.

Author information

1
From the Division of Cardiac Surgery (M.A., R.M., J.R., T.H., P.A., D.W., H.S., G.L., D.Z.), Department of Clinical Pharmacology (M.W.), and Center for Medical Physics and Biomedical Engineering and Ludwig-Boltzmann-Cluster for Cardiovascular Research (T.S., H.S.), Medical University of Vienna, Austria; and Division of Adult Cardiothoracic Surgery, University of California, San Francisco School of Medicine (G.W.). martin.andreas@meduniwien.ac.at.
2
From the Division of Cardiac Surgery (M.A., R.M., J.R., T.H., P.A., D.W., H.S., G.L., D.Z.), Department of Clinical Pharmacology (M.W.), and Center for Medical Physics and Biomedical Engineering and Ludwig-Boltzmann-Cluster for Cardiovascular Research (T.S., H.S.), Medical University of Vienna, Austria; and Division of Adult Cardiothoracic Surgery, University of California, San Francisco School of Medicine (G.W.).

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.

KEYWORDS:

anticoagulants; aspirin; dabigatran; glomerular filtration rate; hemorrhage

[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Atypon Icon for PubMed Central
Loading ...
Support Center