Outcomes from a prospectively implemented protocol using apixaban after robot‐assisted radical cystectomy

Abstract

ObjectivesTo compare the safety and efficacy of oral apixaban with that of injectable enoxaparin after robot‐assisted radical cystectomy (RARC) for venous thromboembolism (VTE) thromboprophylaxis.Materials and MethodsWe conducted a retrospective review of prospectively collected data for all RARC patients treated at our tertiary care centre between 2018 and 2022. The study included two groups: patients who were subject to a prospectively implemented protocol from October 2021 to the present, comprising a 21‐day postoperative course of apixaban 2.5 mg twice daily after discharge, and patients treated prior to October 2021 who received enoxaparin 40 mg daily. Baseline demographics and clinical characteristics, such as VTE (defined as deep vein thrombosis and pulmonary embolism), were analysed. The primary outcome was incidence of symptomatic VTE confirmed with definitive imaging within 90 days of RARC. Secondary outcomes included major bleeding, complications, readmission, and mortality within 30 days postoperatively. Descriptive statistics included baseline patient characteristics, operative information and complications. Differences in baseline characteristics and postoperative data were compared between groups. Multivariate logistic regression was used to determine associations between variables and the primary outcome.ResultsA total of 124 patients received apixaban and 250 patients received enoxaparin prophylaxis. Ten patients (2.7%) experienced a VTE within 90 days postoperatively (two [1.6%] apixaban group vs eight [3.2%] enoxaparin group; P = 0.5). After patient stratification into European Association of Urology risk groups, no statistically significant difference in VTE rates was seen between groups in the apixaban (2.7% high‐ + intermediate‐risk group vs 1.1% low‐risk group; P = 0.5) and enoxaparin cohorts (4.3% high‐ + intermediate‐risk group vs 2.5% low‐risk group; P = 0.5). On multivariate logistic regression, no variables were associated with the development of the primary outcome.ConclusionProphylaxis with apixaban and enoxaparin showed no statistically significant differences in VTE rates among RARC patients. Apixaban appears to be safe and effective for VTE prophylaxis after RARC.

Efficacy and safety of direct oral anticoagulants versus low-molecular-weight heparin for thromboprophylaxis after cancer surgery: a systematic review and meta-analysis

“…A total of 10 studies (three RCTs [ 21 , 22 , 32 ] and 7observational studies [ 33 – 39 ]), encompassing 3054patients, were included in the systematic review. Of the 10 studies, eight (three RCTs [ 21 , 22 , 32 ] and five observational studies [ 34 , 36 – 39 ]) were included in the pooled analysis comparing the efficacy and safety of thromboprophylaxis after cancer surgery within 30 days. The types of cancer included gynecological malignancies ( n = 5), urological malignancies ( n = 3), Pancreatic adenocarcinoma ( n = 1) and lung cancer ( n = 1).…”

“…All seven observational studies had at least a moderate risk of bias due to confounding of the effect of intervention in this study, such as the type and duration of surgery, age and the presence of other VTE risks. 3 observational studies [ 33 , 36 , 37 ] were adjudicated to a moderate risk of confounding bias by using a multivariate logistic regression analysis method that controlled for the confounding domain (Fig. 2 B).…”

“…2 B). Most observational studies had a bias of missing data [ 33 , 34 , 36 – 39 ]; however, one study that used a modified intention-to-treat analysis for compliance was adjudicated to a low risk of bias due to missing data [ 39 ] (Fig. 2 B).Risk-of-bias plots were created by the tool [ 40 ].…”

“…Of the 10 studies, 30-day clinical VTE was assessed in 8 studies (3 RCTs [ 21 , 22 , 32 ] and 5 observational studies [ 34 , 36 – 39 ]). We pooled the outcome by 30 days postoperative comparisons between DOAC and LMWH.…”

“…30-day major bleeding was reported in 8 studies (3 RCTs [ 21 , 22 , 32 ] and 5 observational studies [ 34 , 36 – 39 ]). There was no statistically significant difference in the incidence of major bleeding with DOAC (24/1019) compared with LMWH (18/1338) (2.4% vs. 1.3%, RR: 1.55 [95% CI: 0.82–2.93], Cochran Q = 0.4, I 2 = 2%; Fig.…”