6/28/23, 11:09 PM Hokusai VTE Cancer Pathway Feedback Search Clinical Topics Home Studies Hokusai VTE Cancer Hokusai VTE Cancer Disease Disease Disease Cancer-associated thrombosis Deep vein thrombosis Pulmon Trial question Is edoxaban noninferior to dalteparin for the management of VTE in patients with cancer? Study design Multi-center Open label RCT Population Characteristics of study participants 48.5% female N = 1050 51.5% male 1050 patients (506 female, 540 male) Inclusion criteria: patients with cancer who had acute symptomatic or incidental VTE Key exclusion criteria: basal cell or squamous cell skin cancer, a history of VTE, previous treatment dose of anticoagulant or > 75 mg aspirin per day, clinically significant liver disease, active bleeding or high risk of bleeding, or uncontrolled hypertension Interventions N=522 edoxaban (LMWH for at least 5 days followed by oral edoxaban at a dose of 60 mg once daily) N=524 dalteparin (subcutaneous dose of 200 IU/kg of body weight once daily for 1 month followed by a dose of 150 IU/kg once daily) Primary outcome Recurrent venous thromboembolism or major bleeding 13.5 13 5 % 12 8 https://web.pathway.md/studies/recmIlnWz7o5W9ffl 1/2 6/28/23, 11:09 PM 13.5 % Hokusai VTE Cancer Pathway 12.8 10.1 % 6.8 % Difference not exceeding nonferiority margin 3.4 % 0.0 % Edoxaban Dalteparin Difference not exceeding nonferiority margin in recurrent VTE or major bleeding (12.8% vs. 13.5%; HR 0.97, 95% CI 0.7 to 1.36) Secondary outcomes No significant difference in recurrent VTE (7.9% vs. 11.3%; HR 0.71, 95% CI 0.48 to 1.06) Significant increase in major bleeding (6.9% vs. 4%; HR 1.77, 95% CI 1.03 to 3.04) No significant difference in death from any cause (39.5% vs. 36.6%; HR 1.12, 95% CI 0.92 to 1.37) Safety outcomes No significant differences in adverse events, including progression of neoplasm and pneumonia. Conclusion In patients with cancer who had acute symptomatic or incidental VTE, edoxaban was noninferior to dalteparin with respect to recurrent VTE or major bleeding. Reference Raskob GE, van Es N, Verhamme P et al. Edoxaban for the Treatment of Cancer-Associated Venous Thromboembolism. N Engl J Med. 2018 Feb 15;378(7):615-624. Open reference URL https://web.pathway.md/studies/recmIlnWz7o5W9ffl 2/2