OBJECTIVE: To evaluate whether low-molecular-weight heparin (LMWH) could be equally (or more) effective than oral anti-vitamin-K agents (AVK) in the long-term treatment of deep venous thrombosis (DVT). DESIGN: A randomised, open-label trial. MATERIAL AND METHODS: In this trial, 241 patients with symptomatic proximal DVT of the lower limbs confirmed by duplex ultrasound scan were included. After initial LMWH, patients received 6 months of treatment with full therapeutic dosage of tinzaparin or acenocoumarol. The primary outcome was the 12-month incidence of symptomatic recurrent venous thrombo-embolism (VTE). Duplex scans were performed at 6 and 12 months. RESULTS: During the 12-month period, six patients (5%) of 119 who received LMWH and 13 (10.7%) of 122 who received AVK had recurrent VTE (p=0.11). In patients with cancer, recurrent VTE tended to be lower in the LMWH group (two of 36 [5.5%]) vs. seven of 33 [21.2%]; p=0.06). One major bleeding occurred in the LMWH group and three in the AVK group. Venous re-canalisation increased significantly at 6 months (73.1% vs. 47.5%) and at 12 months (91.5% vs. 69.2%) in the LMWH group. CONCLUSIONS:Tinzaparin was more effective than AVK in achieving re-canalisation of leg thrombi. Long-term tinzaparin was at least as efficacious and safe as AVK for preventing recurrent VTE, especially in patients with cancer.
RCT Entities:
OBJECTIVE: To evaluate whether low-molecular-weight heparin (LMWH) could be equally (or more) effective than oral anti-vitamin-K agents (AVK) in the long-term treatment of deep venous thrombosis (DVT). DESIGN: A randomised, open-label trial. MATERIAL AND METHODS: In this trial, 241 patients with symptomatic proximal DVT of the lower limbs confirmed by duplex ultrasound scan were included. After initial LMWH, patients received 6 months of treatment with full therapeutic dosage of tinzaparin or acenocoumarol. The primary outcome was the 12-month incidence of symptomatic recurrent venous thrombo-embolism (VTE). Duplex scans were performed at 6 and 12 months. RESULTS: During the 12-month period, six patients (5%) of 119 who received LMWH and 13 (10.7%) of 122 who received AVK had recurrent VTE (p=0.11). In patients with cancer, recurrent VTE tended to be lower in the LMWH group (two of 36 [5.5%]) vs. seven of 33 [21.2%]; p=0.06). One major bleeding occurred in the LMWH group and three in the AVK group. Venous re-canalisation increased significantly at 6 months (73.1% vs. 47.5%) and at 12 months (91.5% vs. 69.2%) in the LMWH group. CONCLUSIONS:Tinzaparin was more effective than AVK in achieving re-canalisation of leg thrombi. Long-term tinzaparin was at least as efficacious and safe as AVK for preventing recurrent VTE, especially in patients with cancer.
Authors: Clive Kearon; Elie A Akl; Anthony J Comerota; Paolo Prandoni; Henri Bounameaux; Samuel Z Goldhaber; Michael E Nelson; Philip S Wells; Michael K Gould; Francesco Dentali; Mark Crowther; Susan R Kahn Journal: Chest Date: 2012-02 Impact factor: 9.410
Authors: A Franco-Moreno; L Cabezón-Gutiérrez; M Palka-Kotlowsa; M Villamayor-Delgado; M García-Navarro Journal: J Thromb Thrombolysis Date: 2019-04 Impact factor: 2.300
Authors: Gary H Lyman; Marc Carrier; Cihan Ay; Marcello Di Nisio; Lisa K Hicks; Alok A Khorana; Andrew D Leavitt; Agnes Y Y Lee; Fergus Macbeth; Rebecca L Morgan; Simon Noble; Elizabeth A Sexton; David Stenehjem; Wojtek Wiercioch; Lara A Kahale; Pablo Alonso-Coello Journal: Blood Adv Date: 2021-02-23