Journal Article

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

Genet, D., Tubiana-Mathieu, N., Lavau-Denes, Sandrine, Lacroix, P., Preux, P. M., Maubon, A., Slaouti, P., Labourey, J. L., Martin, J., Vénat-Bouvet, L.

2013

Overview

Purpose 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. Methods We performed a phase III prospective, open-label randomized trial. After the insertion of a central venous access device, consecutive patients with planned chemotherapy for cancer were randomized to no anticoagulant prophylaxis, low molecular weight heparin [low molecular weight heparin (LMWH); with isocoagulation doses], or warfarin 1 mg/day. Treatments were given over the first 3 months. Doppler ultrasound and venographies were performed on days 1 and 90, respectively, 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 thrombosis (DVT) occurred (10.3 %), 20 in those with no anticoagulation, 8 in those receiving warfarin, and 14 in those receiving LMWH. Nine additional non-related catheter deep vein thrombosis (CDVT) occurred. Anticoagulation significantly reduced the incidence of catheter-related DVT ( p  = 0.035) and catheter non-related DVT ( p  = 0.007), with no difference between warfarin and LMWH. Safety was good (3.4 % of attributable events) but compliance with randomized prophylaxis was lower than expected. Conclusions Prophylaxis showed a benefit regarding catheter-related and non-catheter-related DVT with no increase in serious side effects.

• Publisher: Springer-Verlag,Springer,Springer Nature B.V
• Subject: Adult / Aged / Aged, 80 and over / Anticoagulants - administration & dosage / Anticoagulants - adverse effects / Anticoagulants - therapeutic use / Antineoplastic agents / Antineoplastic Agents - administration & dosage / Antineoplastic Agents - adverse effects / Antineoplastic Agents - therapeutic use / Biological and medical sciences / Blood and lymphatic vessels / Cancer Research / Cardiology. Vascular system / Central Venous Catheters - adverse effects / Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous / Female / France - epidemiology / Heparin, Low-Molecular-Weight - adverse effects / Heparin, Low-Molecular-Weight - therapeutic use / Humans / Incidence / Intention to Treat Analysis / Lost to Follow-Up / Male / Medical sciences / Medication Adherence / Medicine / Medicine & Public Health / Middle Aged / Multiple tumors. Solid tumors. Tumors in childhood (general aspects) / Neoplasms - complications / Neoplasms - drug therapy / Oncology / Original Article / Pharmacology. Drug treatments / Pharmacology/Toxicology / Severity of Illness Index / Tumors / Upper Extremity Deep Vein Thrombosis - epidemiology / Upper Extremity Deep Vein Thrombosis - etiology / Upper Extremity Deep Vein Thrombosis - physiopathology / Upper Extremity Deep Vein Thrombosis - prevention & control / Venous Thrombosis - complications / Venous Thrombosis - epidemiology / Venous Thrombosis - physiopathology / Venous Thrombosis - prevention & control / Warfarin - administration & dosage / Warfarin - adverse effects / Warfarin - therapeutic use / Young Adult