1546O_PR - Prophylaxis of catheter-related deep vein thrombosis in cancer patients with low-dose warfarin, low molecular weight heparin, or control: a randomiz...
|Date||01 October 2012|
|Event||ESMO Congress 2012|
|Session||Is thromboprophylaxis mandatory in the management of patients with advanced cancer?|
|Topics|| Supportive Care
N. Tubiana-Mathieu1, S. Lavau-Denes2, P. Lacroix3, A. Maubon4, P. Preux5, D. Genet6, L. Venat-Bouvet6, J. Labourey6, J. Martin6, P. Slaouti6
AbstractBackground: 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 < 0.0001), mainly with LMWH (P = 0.002). Statistically, there was no increase in bleeding in those who received anticoagulants compared with those who received no anticoagulants (P = 0.33). However, the
compliance with randomized prophylaxis was lower than expected, as in all arms, one third of patients did not follow their allocated treatment until D90. 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.