Prophylaxis of catheter-related deep vein thrombosis in cancer patients with low-dose warfarin, low molecular weight heparin, or control: a randomized, controlled, phase III study

Autor: Pierre-Marie Preux, Antoine Maubon, J. Martin, Nicole Tubiana-Mathieu, D Genet, J L Labourey, L. Venat-Bouvet, Philippe Lacroix, Sandrine Lavau-Denes, P. Slaouti
Rok vydání: 2013
Předmět:
Male
Cancer Research
Deep vein
medicine.medical_treatment
Toxicology
Severity of Illness Index
law.invention
Randomized controlled trial
law
Neoplasms
Upper Extremity Deep Vein Thrombosis
Central Venous Catheters
Pharmacology (medical)
Aged
80 and over
Venous Thrombosis
Incidence
Hematology
Heparin
Middle Aged
Thrombosis
Intention to Treat Analysis
Catheter
medicine.anatomical_structure
Oncology
Anesthesia
Female
France
medicine.symptom
Central venous catheter
medicine.drug
Adult
medicine.medical_specialty
medicine.drug_class
Low molecular weight heparin
Antineoplastic Agents
Asymptomatic
Medication Adherence
Young Adult
medicine
Humans
cardiovascular diseases
Aged
Pharmacology
business.industry
Warfarin
Anticoagulants
Heparin
Low-Molecular-Weight
medicine.disease
Surgery
Lost to Follow-Up
business
Zdroj: Cancer Chemotherapy and Pharmacology. 72:65-73
ISSN: 1432-0843
0344-5704
DOI: 10.1007/s00280-013-2169-y
Popis: Background Whether an anticoagulant prophylaxis is needed for patients with cancer with a central venous catheter is a highly controversial subject. We designed a study to compare different prophylactic strategies over 3 months of treatment. Patients and methods: We performed a phase III prospective, randomized trial. After the insertion of a central venous access device, consecutive outpatients with local nodes or metastatic invasion, and planned chemotherapy were randomized to no anticoagulant prophylaxis, low molecular weight heparin (LMWH : dalteparine 2500 IU, nadroparine 2850 IU, or enoxaparine 4000 IU, once daily), or warfarin 1 mg/day. Treatments were given over the first 3 months. Doppler ultrasound and venographies were performed on days 1 and 90 or sooner in case of clinical presumption of thrombosis. Results A total of 420 patients were randomized and 407 were evaluable. Forty-two catheter-related deep-vein thromboses (DVT) occurred (10.3%), 20 in those with no anticoagulation, 8 in those receiving warfarin, and 14 in those receiving LMWH. Anticoagulation significantly reduced the incidence of catheter-related DVT (P = 0.035), with no difference between warfarin and LMWH. The most frequent DVT localization was at the distal extremity of the catheter in the superior vena cava (50%). The mean delay of occurrence was 30 days, and 30 were asymptomatic (71%). Anticoagulation use also had an impact on unrelated-cathter DVT (P = 0.007 by Fisher's test on the 9 events) with no difference between warfarin and LMWH use (0.75 versus 0.72%, P = 1). Safety was good. One hundred forty six patients experienced thrombopenia, but only 24 were grade 3 or 4, chemotherapy-induced, increased by anticoagulant use (p Conclusions Prophylaxis showed a benefit regarding catheter-related and non catheter-related DVT with no increase in serious side effects. Disclosure All authors have declared no conflicts of interest.
Databáze: OpenAIRE
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