The risk of cancer related recurrent venous thromboembolism (VTE) will drop over time, while bleeding risk will persist. At present, it is recommended we continue anticoagulation therapy while cancer remains active or under treatment.
The authors hypothesis is that the use of a reduced dose of anticoagulants might offer similar benefits in terms of efficacy and better safety vs. standard doses when treating cancer related VTE.
To assess this hypothesis, a double blind and non-inferiority randomized study was carried out, for the prevention of recurrent VTE, as well as a superiority analysis to assess clinically relevant bleeding. Patients were randomized to receiving apixaban reduce dose (2.5 mg twice a day) vs standard (5 mg twice a day), and were stratified according to cancer type and venous thromboembolic compromise (PE with or without DVT or isolated DVT).
Primary end points at 12 months were:
- Efficacy primary end point: VTE recurrence (symptomatic recurrence, incidental VTE or VTE related death).
- Bleeding related secondary end points: major bleeding and clinically relevant non-major bleeding.
1,766 patients from 121 centers in 11 countries were included. Mean patient age was 67.4; 43.4% were men, 43.4% had a history of VTE, and 75.5% presented proximal PE±DVT. Breast cancer was the most frequent (22.7%), followed by colorectal (15.3%), with 65.8% of cases presenting metastasis.
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The efficacy primary end point showed non-inferiority for reduced vs standard dose (HR 0.76 [0.41-1.41]; p for non-inferiority = 0.001). As regards the safety secondary end point, reduced dose patients saw a significant reduction of 25% in hemorrhagic event incidence (HR 0.75; CI 95% 0.58-0.97; p = 0.03). There were no significant differences in mortality (HR 0.96; CI 95% 0.86-1.06; p = 0.42).
Conclusions
Cancer patients completing six months of anticoagulation therapy with apixaban reduced dose did not show non-inferiority vs standard dose in the prevention of recurrent thromboembolic events and presented a better safety profile.
Presented by Isabelle Mahé in Late-Breaking Clinical Trials ACC 25, march 29, Chicago, EE.UU.
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