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Presentation Details
Reduced dose compared to standard dose apixaban for VTE secondary prevention in patients with active cancer

Claire E.Burbridge, Tenley E.Ryan, Amanda R.Gillion.

Lt.Col.Luke Weathers Jr.Veterans Affairs Medical Center, Memphis, TN, USA

Abstract


Background: The duration of treatment for patients receiving apixaban for venous thromboembolism (VTE) secondary prevention must weigh risk of VTE recurrence versus bleeding. Patients are at high risk of VTE recurrence if the VTE was unprovoked or provoked by major or minor persistent risk factors as described by the CHEST guidelines. In patients with cancer, the ASH guidelines suggest long-term anticoagulation for secondary prophylaxis in patients with active cancer and VTE. The optimal dose of anticoagulation in this population is unknown and must balance the risk of VTE with the risk of bleeding. Bleeding risk may be increased in certain cancer sites such as head and neck cancer, while certain populations such as those receiving targeted cancer treatments like thalidomide, patients with metastatic disease, and advanced age may be at higher risk for VTE. Current guidelines recommend that patients who require indefinite anticoagulation receive reduced-dose apixaban. Recommendations for reduced-dose apixaban specifically are based primarily on the AMPLIFY-EXT trial, whose findings supported apixaban 2.5mg BID to reduce risk of recurrent VTE without increasing rate of major bleeding. However in the AMPLIFY-EXT trial, subjects with cancer treated indefinitely with anticoagulation were excluded. Approximately 2% of patients in both treatment groups and the placebo group did have active cancer. Furthermore, in the RENOVE trial, subjects with active cancer within the previous six months were excluded. About 10% of patients in both treatment groups had previous cancer greater than six months before the index event. Though the RENOVE trial did not meet non-inferiority criteria, the findings that reduced-dose apixaban reduced clinically relevant bleeding also supports current guideline recommendations. The API-CAT trial intentionally enrolled patients with active cancer to determine if reduced-dose apixaban was noninferior to full-dose apixaban for prevention of recurrent VTE. Though this trial did find that reduced-dose apixaban was noninferior with a lower incidence of clinically relevant bleeding complications, certain questions remain. Rates of recurrent VTE remained low and the trial only looked at patients through a 12-month period. Additionally, it is unclear whether these recommendations apply to patients with line or port-related VTE events, as well as patients at higher bleed and/or VTE risk. Objectives: The primary objective is VTE recurrence within 24 months. Secondary objectives include major bleeding, minor bleeding, and death (due to bleeding, malignancy, or other causes). Methods: An SQL query was used to identify adult patients with hematology/oncology appointments from December 2021 through July 2023 prescribed apixaban for secondary prevention of VTE. Patients were categorized based on which dose of apixaban they are receiving after 6 months of initial treatment. Patients were followed for 24 months after the initial prescription. Additional data collection points include demographic data (including BMI and age), renal and hepatic function, cancer type (including site of cancer), if patients had a port or an IVC, time since cancer diagnosis, if patients were receiving immunomodulatory medications such as thalidomide or lenalidomide, and other risk factors for VTE including immobilization, and previous DVT and/or PE. Results: Data collection is ongoing. Conclusions: Data collection is ongoing.

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