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

• Published in: Cancer chemotherapy and pharmacology Vol. 72; no. 1; pp. 65 - 73
• Main Authors: Lavau-Denes, Sandrine, Lacroix, P., Maubon, A., Preux, P. M., Genet, D., Vénat-Bouvet, L., Labourey, J. L., Martin, J., Slaouti, P., Tubiana-Mathieu, N.
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer-Verlag 01.07.2013; Springer; Springer Nature B.V
• Subjects: 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; France; LMWH; Catheter-related thromboembolism; Prophylaxis; Cancer; Phase III trial; Human; Warfarin; Coumarine derivatives; Low dose; Catheter; Deep vein thrombosis; Cardiovascular disease; Low molecular weight heparin; Malignant tumor; Embolism; Venous disease; Vascular disease; Prevention; Antivitamin K; Randomization; Treatment; Medical device; Venous thrombosis; Thromboembolism
• ISSN: 0344-5704; 1432-0843
• DOI: 10.1007/s00280-013-2169-y

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.