Journal
THROMBOSIS RESEARCH
Volume 157, Issue -, Pages 90-96Publisher
PERGAMON-ELSEVIER SCIENCE LTD
DOI: 10.1016/j.thromres.2017.07.004
Keywords
Cancer; Tinzaparin; Low-molecular-weight heparin; Pulmonary embolism; Venous thromboembolism
Categories
Funding
- FEDER (Federacion Espanola de Enfermedades Raras)
- Plan Nacional de Investigacion Cientifica, Desarrollo e Innovacion Tecnologica [Instituto de Salud Carlos III, Fondo de Investigacion Sanitaria] [PI11/02308]
- SEPAR (Sociedad Espanola de Neumologia y Cirugia Toracica) [140/2013]
- NEUMOSUR [5/2013]
- LEO Pharma Research Foundation
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Introduction: The safety and efficacy of low-molecular-weight heparin (LMWH) treatment in patients with cancer-associated thrombosis (CAT) beyond 6 months are unknown. Our aim was to determine the safety of long-term tinzaparin use in patients with CAT. Methods: We performed a prospective, open, single arm, multicentre study in patients with CAT receiving treatment with tinzaparin. We evaluated the rate of clinically relevant bleeding events (major and non-major clinically relevant bleeding) and venous thromboembolism (VTE) recurrence. Results: A total of 247 patients were recruited, with a crude incidence of major bleeding of 4.9% (12/247). The rate of clinically relevant bleeding during months 1-6 and 7-12, was 0.9% [95% confidence interval (95% CI) 0.5 to 1.6%] and 0.6% (95% CI 0.2 to 1.4%) (p = 0.5) per patient and month, respectively. Male gender showed greater risk for clinically relevant bleeding with a hazard ratio (HR) of 2.97 (95% CI 1.01 to 8.1; p=0.02). The incidence of VTE recurrence atmonths 1-6 and7-12was 4.5% (95% CI 2.2 to 7.8%) and 1.1% (95% CI 0.1 to 3.9%), respectively. One patient died due to VTE recurrence and two because of severe bleeding. Conclusions: Treatment with tinzaparin beyond 6 months is safe in patients with CAT. (C) 2017 The Author(s). Published by Elsevier Ltd.
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