Introduction:

Venous thromboembolism (VTE) after radical cystectomy (RC) and pelvic lymph node dissection (PLND) represents a significant problem in terms of morbidity, mortality, and cost. Much work has already been done studying the use of extended prophylaxis (EP) to lower VTE rates, and the use of 28 days of EP with enoxaparin is considered standard of care in many surgical guidelines. Unfortunately there are still significant barriers to adoption of this practice after RC, including patient pain, dissatisfaction, lack of insurance coverage, and costs. Apixaban has emerged as a possible alternative that may alleviate some of the issues with enoxaparin, however data comparing enoxaparin to apixaban in the RC population is limited. We have designed a pragmatic, multi-site, randomized, controlled trial of discharge on EP with apixaban vs enoxaparin to compare patient adherence, patient satisfaction, drug costs, and rates of VTE and bleeding.

Methods:

Inclusion criteria are patients undergoing RC with PLND for urothelial bladder cancer (any T, N0-1, M0) at the University of Pennsylvania and Vanderbilt University Medical Center. Exclusion criteria include medical contraindication to prophylactic anticoagulation, failure to undergo RC with PLND, failure to be discharged by post-op day (POD) 14, and inability to communicate via telephone in English. Patients will be screened and enrolled pre-op, randomized prior to discharge, and contacted by phone at POD 30 and 90 for study assessments.

The primary outcome is adherence, measured as the proportion of days covered (PDC). Secondary outcomes include barriers to adherence, satisfaction, cost, and VTE rates. The trial is designed as a non-inferiority study (H_A: PDC of apixaban is non-inferior to that of enoxaparin) with plans to analyze for superiority (H_A: PDC of apixaban is superior to that of enoxaparin) if non-inferiority is found. Target sample size is 220 participants.

Results:

Conclusion:

Funding: N/A