Luis Jara-Palomares1, Aurora Solier-Lopez2, Teresa Elias-Hernandez2, Maribel Asensio-Cruz2, Isabel Blasco-Esquivias3, Lucia Marin-Barrera2, Maria Rodriguez de la Borbolla-Artacho4, Juan Manuel Praena-Fernandez5, Emilio Montero-Romero6, Silvia Navarro-Herrero7, Maria Pilar Serrano-Gotarredona7, José María Sánchez-Díaz8, Carlos Palacios6, Remedios Otero2. 1. Medical Surgical Unit of Respiratory Diseases, Instituto de Biomedicina de Sevilla (IBiS), Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Hospital Universitario Virgen del Rocio, Seville, Spain. Electronic address: luisoneumo@hotmail.com. 2. Medical Surgical Unit of Respiratory Diseases, Instituto de Biomedicina de Sevilla (IBiS), Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Hospital Universitario Virgen del Rocio, Seville, Spain. 3. Servicio de Urgencias, Medicina Interna, Miembro del Grupo ETV-SEMES, Hospital Virgen Macarena, Seville, Spain. 4. Oncology, Hospital Virgen de Valme, Seville, Spain. 5. Statistics, Methodology and Research Evaluation Unit, Hospital Virgen del Rocío, Seville, Spain. 6. Unidad de Urgencias Hospital General, Unidad de Gestión Clínica Cuidados Críticos y Urgencias, Hospital Universitario Virgen del Rocio, Seville, Spain. 7. Diagnostic Imaging Department, Hospital Universitario Virgen del Rocio, Sevilla, Spain. 8. Pharmaceutical, Pharmacy, Medical Surgical Unit of Respiratory Diseases, Hospital Universitario Virgen del Rocio, Seville, Spain.
Abstract
INTRODUCTION: The safety and efficacy of low-molecular-weight heparin (LMWH) treatment in patients with cancer-associated thrombosis (CAT) beyond 6months 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 6months is safe in patients with CAT.
INTRODUCTION: The safety and efficacy of low-molecular-weight heparin (LMWH) treatment in patients with cancer-associated thrombosis (CAT) beyond 6months 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 6months is safe in patients with CAT.
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Authors: Luis Jara-Palomares; Aurora Solier-Lopez; Teresa Elias-Hernandez; Maria Isabel Asensio-Cruz; Isabel Blasco-Esquivias; Veronica Sanchez-Lopez; Maria Rodriguez de la Borbolla; Elena Arellano-Orden; Lionel Suarez-Valdivia; Samira Marin-Romero; Lucia Marin-Barrera; Aranzazu Ruiz-Garcia; Emilio Montero-Romero; Silvia Navarro-Herrero; Jose Luis Lopez-Campos; Maria Pilar Serrano-Gotarredona; Juan Manuel Praena-Fernandez; Jose Maria Sanchez-Diaz; Remedios Otero-Candelera Journal: Br J Cancer Date: 2018-10-15 Impact factor: 7.640
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