A recent subanalysis of the CARAVAGGIO trial showed that in patients with cancer-related venous thromboembolism (VTE), treatment with oral apixaban did not show differences in outcomes compared with subcutaneous dalteparin at any time point. These data were presented at the 2022 ASH Annual Meeting by Katherine J. Creeper, MBBS, BPharm, of Guy’s and St Thomas’ NHS Foundation Trust in Floreat, Australia, and colleagues.
The trial (ClinicalTrials.gov Identifier: NCT03045406) had enrolled patients with active cancer and newly diagnosed VTE, including confirmed deep-vein thrombosis (DVT) or pulmonary embolism (PE). Patients in this study were treated with either apixaban or dalteparin as monotherapy for 6 months. The study had a primary efficacy outcome of incidence of objectively confirmed VTE and a primary safety outcome of major and clinically relevant nonmajor (CRNM) bleeding, with both measured at 7, 30, and 90 days after treatment.
The study had a modified intention-to-treat population of 1155 patients, with 576 in the apixaban group and 579 in the dalteparin group. Patients reportedly showed similar demographic and clinical features and had mean ages of 67.2 years in each group.
A total of 11 recurrent VTE events were reported across the study population within the first 7 days. In the first 30 days, 35 events occurred, and by day 90, there were 63 events. Between treatment arms, in the first 7 days recurrent VTE events were reported in 1.0% of patients in the apixaban group and in 0.9% of the dalteparin group (relative risk [RR], 1.206; 95% CI, 0.370-3.930). Rates were also similar at other time points. By 90 days, these rates were 4.7% in the apixaban group and 6.2% in the dalteparin group (RR, 0.754; 95% CI, 0.464-1.225).
Rates of major and CRNM bleeding by 90 days were 8.0% in the apixaban group and 7.4% in the dalteparin group (RR, 1.075; 95% CI, 0.721-1.603). Rates of these events were also similar between the treatment groups across other time points.
In this subanalysis, patients did not show differences between apixaban and dalteparin treatment groups in rates of recurrent VTE events or bleeding events at all time points that were examined. The study investigators considered the results to support the early use of oral anticoagulation. They also noted that oral anticoagulation has benefits over subcutaneous anticoagulation in terms of ease of administration and availability for outpatient administration, potentially improving patient quality of life.
Disclosures: Some authors have declared affiliations with or received grant support from the pharmaceutical industry. Please refer to the original study for a full list of disclosures.
Creeper KJ, Cohen AT, Alikhan R, et al. Early time courses of recurrent thromboembolism and bleeding during apixaban or dalteparin therapy for patients with cancer. Presented at ASH 2022. December 10-13, 2022. Abstract 3819.