Rivaroxaban versus Apixaban for Treatment of Cancer-Associated Venous Thromboembolism in Patients at Lower Risk of Bleeding

Abstract

This retrospective study, utilizing U.S. electronic health record (EHR) data from January 2013 to December 2020, sought to assess whether rivaroxaban and apixaban had similar effectiveness and safety in the treatment of cancer-associated venous thromboembolism (VTE) in patients with a cancer type not associated with a high risk of bleeding. We included adults diagnosed with active cancer, excluding esophageal, gastric, unresected colorectal, bladder, noncerebral central nervous system cancers and leukemia, who experienced VTE and received a therapeutic VTE dose of rivaroxaban or apixaban on day 7 post-VTE, and were active in the EHR ≥12 months prior to the VTE. Primary outcome was the composite of recurrent VTE or any bleed resulting in hospitalization at 3 months. Secondary outcomes included recurrent VTE, any bleed resulting in hospitalization, any critical organ bleed, and composites of these outcomes at 3 and 6 months. Inverse probability of treatment-weighted Cox regression was used to calculate hazard ratios (HRs) with 95% confidence intervals (CIs). We included 1,344 apixaban and 1,093 rivaroxaban patients. At 3 months, rivaroxaban was found to have similar hazard to apixaban for developing recurrent VTE or any bleed resulting in hospitalization (HR: 0.87; 95% CI: 0.60–1.27). No differences were observed between cohorts for this outcome at 6 months (HR: 1.00; 95% CI: 0.71–1.40) or for any other outcome at 3 or 6 months. In conclusion, patients receiving rivaroxaban or apixaban showed similar risks of the composite of recurrent VTE or any bleed resulting in hospitalization in patients with cancer-associated VTE. This study was registered at www.clinicaltrials.gov as #NCT05461807. Key Points

Pulmonary embolism in cancer patients. Effectiveness of vitamin K antagonists and direct oral anticoagulants in long-term therapy

“…It included adults diagnosed with active cancer, excluding esophageal, gastric, unresected colorectal, bladder, noncerebral central nervous system cancers and leukemia, who experienced VTE and received a therapeutic VTE dose of rivaroxaban or apixaban. Similar effectiveness and safety were reported for treatment of cancer-associated VTE through 6 months with both drugs [ 38 ]. Rivaroxaban and apixaban were the only anticoagulants from the DOAC group that were compared in cancer-associated VTE.…”

Rivaroxaban Versus Apixaban: A Comparison Without a Simple Solution

“…A large retrospective cohort study of patients with cancer-associated VTE and low risk of bleeding (OSCAR-US) compared 1093 patients on rivaroxaban and 1344 patients on apixaban with the outcome of developing recurrent VTE or any bleed resulting in hospitalization at 3 and 6 months. 28 The authors used inverse probability of treatment-weighted Cox regression to calculate hazard ratios (HRs) and 95% CIs. Rivaroxaban was found to have similar hazard to apixaban for the composite outcome at 3 months (HR, 0.87; 95% CI, 0.60-1.27) and 6 months (HR, 1.00; 95% CI, 0.71-1.40) and for any other outcome at 3 or 6 months.…”

“…Rivaroxaban was found to have similar hazard to apixaban for the composite outcome at 3 months (HR, 0.87; 95% CI, 0.60-1.27) and 6 months (HR, 1.00; 95% CI, 0.71-1.40) and for any other outcome at 3 or 6 months. 28 …”

“…It is of concern that the basis of any therapeutic decision be dependent solely on a safety end point GI bleeding, without focusing on the balance between primary efficacy relative to the safety outcomes, that is, “net clinical benefit.” A perspective published by the US FDA entitled, “Weighing Benefits and Risks – The US FDA’s Review of Prasugrel” 30 highlighted the need for balance stating “the components of the primary end point represented irreversible tissue damage and concluded that the benefits of preventing such events is generally worth the risk of bleeding events that have no irreversible consequences.” In references to older adults, the US FDA further stated, “However, older patients… particularly high risk patients… The US FDA made sure that prasugrel’s label clearly articulates the balance between efficacy and risk – a balance that physicians will need to assess carefully when choosing treatment for individual patients.” 28 Adverse effects need to be highlighted and their frequency minimized, but in the end, it is the balance that should dictate therapeutic decision making. Two published reports quantified benefit vs risk in NVAF 29 and long-term DVT/VTE prophylaxis.…”