"Apixaban for the Treatment of Venous Thromboembolism in Patients with Cancer". The New England Journal of Medicine.
Links to original sources: Wiki Journal Post Full Journal Article
Does treatment with oral apixaban offer noninferior efficacy and safety for the treatment of cancer-associated venous thromboembolism compared to subcutaneous dalteparin?
Oral apixaban was noninferior to subcutaneous dalteparin in treating cancer-associated venous thromboembolism without an increased risk of major bleeding.
Patients with cancer are at increased risk of venous thromboembolism (VTE), and the treatment with anticoagulants is complex due to a higher risk of both recurrent VTE and bleeding. Direct oral anticoagulants (DOACs) like edoxaban, and rivaroxaban have recently been integrated into treatment recommendations, although concerns about bleeding risks persist. In the Caravaggio trial, apixaban, an oral factor Xa inhibitor, was shown to be noninferior to dalteparin for preventing VTE recurrence in patients with cancer, without increasing the risk of major bleeding, including gastrointestinal bleeding.
Recent guidelines recommend considering the DOACs edoxaban or rivaroxaban for treating VTE in patients with cancer, taking into account the potential increased risk of bleeding.
Multinational, randomized, investigator-initiated, open-label, noninferiority trial with blinded central outcome adjudication.
Inclusion Criteria: Adults with cancer diagnosed with a symptomatic or incidental acute proximal deep-vein thrombosis (DVT) or pulmonary embolism (PE)
Exclusion Criteria: Patients with primary brain tumors, intracerebral metastases, acute leukemia, or other significant bleeding risks.
Baseline Characteristics: Similar across treatment groups, predominantly advanced active cancer and acute symptomatic VTE.
Patients were assigned to oral apixaban (10 mg BID for 7 days, then 5 mg BID) or subcutaneous dalteparin (200 IU/kg daily for 1 month, then 150 IU/kg daily) for 6 months.
Primary Outcomes: Objectively confirmed recurrent VTE.
Secondary Outcome: Major bleeding events and clinically relevant nonmajor bleeding.
Additional Analyses: Subgroup analyses by age and cancer type, and sensitivity analyses for protocol adherence and per-protocol population.
Adverse Events: Progression of cancer was the most common adverse event. Other adverse events were consistent with previous studies.
The trial was open-label and excluded patients with brain tumors, cerebral metastases, or acute leukemia. The sample size was calculated for the primary outcome and not powered to definitively assess bleeding risk.
The Bristol-Myers Squibb–Pfizer Alliance provided an unrestricted grant for the study.
A complete list of the investigators in the Caravaggio trial is provided in the Supplementary Appendix of the original publication.