Initial Experience with Apixaban for Extended Venous Thromboembolism Prophylaxis After Radical Cystectomy

Apixaban vs Enoxaparin for Post-Surgical Extended-Duration Venous Thromboembolic Event Prophylaxis: A Prospective Quality Improvement Study

“…This is consistent with a recently published retrospective series of 72 patients given apixaban for EP after radical cystectomy which also reported zero major bleeding events or VTEs. 14 Our baseline and intervention groups were very well matched in terms of procedure performed, approach, and demographic factors, therefore it is unlikely that the difference in complication events are due to confounding variables. However, it may be beneficial to test superiority in a randomized clinical trial.…”

“…24 Based on the existing literature demonstrating lower rates of VTE in oncologic patients, improved efficacy in orthopedic surgery patients (without a concomitant increase in bleeding), retrospective urological studies safely utilizing DOACs, as well as 1 randomized controlled trial in gynecologic oncology, we felt the evidence base supported a practice change from enoxaparin to apixaban. 8,11–14 Some reluctance to accept DOACs as a safe EP agent have emanated from unfamiliarity with these newer agents and a fear of life threatening bleeding in the setting of medications with prolonged half-life without reversal options; however, andexanet alfa (Adnexxa®) was approved by the U.S. Food and Drug Administration in 2018 as the first and only antidote for anticoagulation reversal in patients treated with apixaban (and rivaroxaban); this was available in our formulary prior to initiation of the trial but was not needed as there were no major bleeding events in the apixaban group. Nonetheless, to ensure that we were providing a benefit to patients without increasing their risk of harm, we designed a quality improvement project to evaluate our practice change using the Institute for Healthcare Improvement Model for Improvement framework.…”

“…Following in-depth review and discussion of the existing literature, our clinical group unanimously decided that the favorable safety profile of DOACs supported their utilization as the new standard of care for patients needing EP after major abdominopelvic surgery for urological malignancy. 8,11–14 Deming’s plan-do-study-act model was used to test the effect of our practice change on compliance events (see supplementary Figure, https://www.jurology.com). 18 A secondary noninferiority analysis was planned to test the safety of apixaban compared to enoxaparin.…”

“…8 Likewise, retrospective case series evaluating the use of apixaban in patients who have undergone cystectomy have shown no increase in complications, although sample sizes are small. 13,14 We sought to improve patient compliance with EP. While a randomized clinical trial would be best to evaluate safety and efficacy of DOACs, we used the Institute for Healthcare Improvement Model for Improvement as the framework to design a department-wide practice change from injectable to oral EP.…”

Extended Anticoagulation after Radical Cystectomy Using Direct Acting Oral Anticoagulants: A Single-Institutional Experience

“…21 Some studies have also suggested better efficacy of DOA vs enoxaparin in reducing the risk of VTE-related events. 22 In the setting of RC, the only study to evaluate the application of oral anticoagulation postoperatively was a descriptive correspondence by Rosen et al 23 The study included 72 patients who received apixaban (2.5 mg twice daily), and the authors reported no events of thromboembolism in this cohort. 23 Our study is the first comparison study that evaluates patients who undergo RC who receive VTE thromboprophylaxis that includes oral anticoagulation options vs those who receive no form of extended prophylaxis.…”