A Study on the Efficacy and Safety of Rivaroxaban in Urologic Cancer-Associated Venous Thromboembolism

Abstract

Purpose: Although direct oral anticoagulants (DOACs) are recommended as an alternative to low-molecular weighted heparin for cancer-associated venous thromboembolism (VTE), there is no firm evidence on the efficacy and safety of DOACs in patients with urologic cancer. Therefore, we compared the efficacy and safety of rivaroxaban and dalteparin for treating cancer-associated VTE in urologic cancer. Materials and Methods: We reviewed the medical records of 124 eligible VTE patients with urologic cancers who were treated with dalteparin or rivaroxaban. The primary outcome was the composite event of clinically relevant bleeding or VTE recurrence. The secondary outcomes were VTE recurrence, clinically relevant bleeding events, and all-cause mortality. Results: During anticoagulation period, there was no significant difference in primary and secondary outcomes between the groups. In Cox proportional hazards model for composite events, although there was no statistical significance, rivaroxaban presented lower hazard ratio (HR) than dalteparin (HR, 0.472; 95% confidence interval [CI], 0.210-1.060; p=0.069 in univariate analysis; HR, 0.505; 95% CI, 0.206-1.234; p=0.134 in multivariate analysis). In clinically relevant bleeding events, there was no significance difference between rivaroxaban and dalteparin (HR, 0.568; 95% CI, 0.238-1.358; p=0.203 in univariate analysis; HR, 0.617; 95% CI, 0.232-1.636; p=0.331 in multivariate analysis). Conclusions: Rivaroxaban can be regarded as a valuable option for VTE in urologic cancer. Further prospective studies are warranted to prove the safety or efficacy of rivaroxaban for treating VTE in patients with urologic cancer.

Hematuria in anticoagulated patients with atrial fibrillation and urologic cancer

“… 11 , 22 , 23 However, only little evidence supports the treatment choice for patients initiating anticoagulant therapy in patients with urologic cancer. 14 Our study demonstrated similar risk of bleeding after initiation of DOACs or warfarin for patients with AF and history of urologic cancer as well as in those with active urologic cancer. In our sensitivity analysis that only considered patients initiating standard‐dose DOAC by excluding patients at potentially high bleeding risk initiating reduced‐dose DOAC, the HR estimates were essentially similar to the overall analysis.…”

“…It has previously been demonstrated that DOACs may be a safe choice compared with vitamin K antagonists in patients with cancer in general, also for those with active cancer 11,22,23 . However, only little evidence supports the treatment choice for patients initiating anticoagulant therapy in patients with urologic cancer 14 . Our study demonstrated similar risk of bleeding after initiation of DOACs or warfarin for patients with AF and history of urologic cancer as well as in those with active urologic cancer.…”

“… 12 Few studies have assessed bleeding outcomes in patients treated with oral anticoagulants with urologic cancer, and none of these specifically included a population of patients with AF. 13 , 14 …”

“…Indeed, DOACs in the presence of urologic cancer may particularly increase the risk of hematuria because these drugs are partly cleared renally and may exert a direct effect in the urinary system 12 . Few studies have assessed bleeding outcomes in patients treated with oral anticoagulants with urologic cancer, and none of these specifically included a population of patients with AF 13,14 …”

The Net Clinical Benefit of Rivaroxaban Compared to Low-Molecular-Weight Heparin in the Treatment of Cancer-Associated Thrombosis: Systematic Review and Meta-Analysis

“…Our initial database search has retrieved 1432 potentially relevant articles, of which 17 studies were included in the metaanalysis (Figure 1). The included studies were comprised of 1 recent RCT, 9 16 observational studies, [17][18][19][20][21][22][23][24][25][26][27][28][29][30] and 12 real-world data. 31 The total number of patients was 12 318 patients distributed between the intervention and the control arms (Tables 1 and 2).…”