6/28/23, 12:12 AM CLOT Pathway Feedback Search Clinical Topics Home Studies CLOT CLOT Disease Disease Disease Cancer-associated thrombosis Deep vein thrombosis Pulmon Trial question Is LMWH superior to coumarin for the prevention of recurrent VTE in patients with cancer? Study design Multi-center Open label RCT Population Characteristics of study participants 51.0% female N = 676 49.0% male 676 patients (348 female, 328 male) Inclusion criteria: patients with cancer who had acute, symptomatic proximal deep vein thrombosis, PE, or both Key exclusion criteria: weight 40 kg, ECOG performance status score of 3 or 4, receipt of OAC therapy, serious bleeding within the previous two weeks, high risk of serious bleeding, contraindications to heparin therapy, or pregnancy Interventions N=338 subcutaneous dalteparin (200 IU of dalteparin per kilogram once daily for the first month and approximately 150 IU per kilogram for the remaining 5 months) N=338 oral anticoagulation (dalteparin at a dose of 200 IU per kilogram of body weight SC once daily for 5-7 days and vitamin K antagonist for 6 months) Primary outcome Recurrent venous thromboembolism at 6 months https://web.pathway.md/studies/recGqmUJW68h59km3 1/2 6/28/23, 12:12 AM CLOT Pathway 17.0 % 17 12.8 % 9 8.5 % Significant decrease 4.3 % NNT = 13 0.0 % Subcutaneous dalteparin Oral anticoagulation Significant decrease in recurrent VTE at 6 months (9% vs. 17%; HR 0.48, 95% CI 0.3 to 0.77) Secondary outcomes No significant difference in death (39% vs. 41%; RR 0.95, 95% CI -1.94 to 3.84) Safety outcomes No significant difference in rate of major bleeding (6% vs. 4%) or any bleeding (14% vs. 19%). Conclusion In patients with cancer who had acute, symptomatic proximal deep vein thrombosis, PE, or both, subcutaneous dalteparin was superior to oral anticoagulation with respect to recurrent VTE at 6 months. Reference Lee AY, Levine MN, Baker RI et al. Low-molecular-weight heparin versus a coumarin for the prevention of recurrent venous thromboembolism in patients with cancer. N Engl J Med. 2003 Jul 10;349(2):146-53. Open reference URL https://web.pathway.md/studies/recGqmUJW68h59km3 2/2