Direct Oral Anticoagulants for Venous Thromboembolism Prophylaxis Following Robot-assisted Radical Cystectomy: A Retrospective Feasibility Study at a Single Academic Medical Center

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

“…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.…”

Editorial Commentary

“…The use of DOAs for VTE prophylaxis following urological surgery is currently considered off-label; however, there is emerging evidence about their efficacy and safety after radical cystectomy in place of enoxaparin. 2 While the use of extended VTE prophylaxis after radical cystectomy is increasing, it is still only used in a minority of U.S. patients. 3 An oral medication may improve provider and patient adherence.…”

Editorial Comment

“…Standard of care involves 28 days of extended prophylaxis after major abdominal and pelvic surgery of which low molecular weight heparin (LMWH) is most often used. 1 Direct oral anticoagulants, such as apixaban, have been studied for VTE prophylaxis after cystectomy, 2,3 but not in broad use as departmental standard with other urological surgeries. Westerman et al performed a well-designed quality improvement project studying the noninferiority of apixaban vs LMWH to measure compliance and safety events (defined as symptomatic VTE or major bleed).…”