Chest. 2021 Oct 7:S0012-3692(21)04079-4. doi: 10.1016/j.chest.2021.09.037. Online ahead of print.
ABSTRACT
BACKGROUND: Direct oral anticoagulants (DOACs) are an alternative to low-molecular-weight heparin for treating cancer-associated venous thromboembolism (VTE).
RESEARCH QUESTION: Is rivaroxaban as efficient and safe as dalteparin to treat patients with cancer-associated VTE?
STUDY DESIGN AND METHODS: In a randomized open-label non-inferiority trial, patients with active cancer who had proximal deep-vein thrombosis (DVT) and/or pulmonary embolism (PE) were randomly assigned to therapeutic doses of rivaroxaban or dalteparin for 3 months. The primary outcome was the cumulative incidence of recurrent VTE, a composite of symptomatic or incidental DVT or PE, and worsening of pulmonary vascular or venous obstruction at 3 months.
RESULTS: Of 158 randomized patients, 74 and 84 patients were assigned to receive rivaroxaban and dalteparin, respectively. Mean age was 69.4 years, 115 patients (76.2%) had metastatic disease. The primary outcome occurred in 4 and 6 patients in the rivaroxaban and dalteparin groups, respectively (cumulative incidence 6.4% vs 10.1%, subdistribution hazard ratio [SHR] 0.75, 95% confidence interval [CI] 0.21-2.66, in both the intention-to-treat and per-protocol populations). Major bleeding occurred in 1 and 3 patients in the rivaroxaban and dalteparin groups, respectively (cumulative incidence 1.4% vs 3.7%, SHR 0.36, 95%CI 0.04-3.43). Major or clinically relevant non-major bleeding occurred in 9 and 8 patients in the rivaroxaban and dalteparin groups, respectively (cumulative incidence 12.2% vs 9.8%, SHR 1.27, 95%CI 0.49-3.26). Overall, 19 (25.7%) and 20 (23.8%) patients died in the rivaroxaban and dalteparin groups, respectively (HR 1.05, 95% CI, 0.56-1.97).
INTERPRETATION: In this trial comparing rivaroxaban and dalteparin in the treatment of cancer-associated VTE, the number of patients was insufficient to reach the predefined criteria for non-inferiority, but efficacy and safety results were consistent with those previously reported with DOACs. An updated meta-analysis of randomized trials comparing DOACs with low-molecular-weight heparin in patients with cancer-associated VTE is provided.
TRIAL REGISTRATION: NCT02746185.
PMID:34627853 | DOI:10.1016/j.chest.2021.09.037