Tinzaparin in cancer associated thrombosis beyond 6 months: TiCAT study

Identificador:  imarina:5651845

Handle: https://hdl.handle.net/20.500.11797/imarina5651845

Autors:  Jara-Palomares L; Solier-Lopez A; Elias-Hernandez T; Asensio-Cruz M; Blasco-Esquivias I; Marin-Barrera L; de la Borbolla-Artacho M; Praena-Fernandez J; Montero-Romero E; Navarro-Herrero S; Serrano-Gotarredona M; Sánchez-Díaz J; Palacios C; Otero R

Resum:
© 2017 The Author(s) 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 at months 1–6 and 7–12 was 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.