Rivaroxaban versus Low-Molecular-Weight Heparin for Venous Thromboembolism in Gastrointestinal and Pancreatobiliary Cancer

Abstract

Background Low-molecular-weight heparin (LMWH) is the standard treatment for venous thromboembolism (VTE) in patients with active cancer. However, use of factor Xa inhibitors, such as rivaroxaban, is increasing on the basis of limited clinical evidence. The present single-center study compared the incidence of bleeding and other treatment outcomes in gastrointestinal and pancreatobiliary cancer (GI tract cancer) patients administered rivaroxaban or LMWH for the treatment of VTE. Methods Retrospective data from 281 GI tract cancer patients who were treated for VTE with rivaroxaban (n = 78) or LMWH (n = 203) between 1 January 2012 and 31 December 2016, were analyzed. Primary end-point was the incidence of major and clinically relevant bleeding. Secondary outcomes included the incidence of recurrent VTE and mortality. Results Clinically relevant bleeding occurred in 19 patients (24.4%) in the rivaroxaban group and 31 (15.3%) in the LMWH group ( P = 0.074). No inter-group difference was observed for rate of VTE recurrence (3.8% with rivaroxaban vs. 3.9% with LMWH; P > 0.999) or incidence of major bleeding (5.1% with rivaroxaban vs. 8.9% with LMWH; P = 0.296). Multivariate Cox proportional hazards analysis for age, cancer type, metastasis, history of chemotherapy or recent surgery, and Eastern Cooperative Oncology Group performance status revealed a 1.904-fold higher risk of bleeding with rivaroxaban than LMWH (1.031–3.516; P = 0.040). No significant inter-group difference was found in terms of hazard ratio for all-cause mortality. Conclusion Compared to LMWH, rivaroxaban was associated with a higher incidence of clinically relevant bleeding in GI tract cancer patients presenting with VTE.

Treatment of venous thromboembolism in cancer patients: a systematic review and meta-analysis on the efficacy and safety of different direct oral anticoagulants (DOACs)

“…In terms of DOACs, 10 studies (including 1 RCT) compared the efficacy and safety of rivaroxaban and LMWH in the treatment of VTE (11)(12)(13)(14)(15)(16)(17)(18)(19), apixaban was used in 3 studies (including 2 RCTs) (19-21), edoxaban was given in 1 RCT (22), and 5 studies did not specify the oral anticoagulant used in the trials (23)(24)(25)(26)(27). The duration of follow-up these studies ranged from 6 months to 24 months.…”

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

“…In addition, urinary tract and gastrointestinal bleeding have been observed in other cancer types. 18,23,24 Thus, it possible that DOACs have more effect on the gastrointestinal and urinary tract than LMWH in inducing bleeding, and other sites are less affected by DOACs than LMWH. Although we performed subgroup analysis to prove this hypothesis, there was no statistical difference.…”

Use of New Oral Anticoagulants/ Direct Oral Anticoagulants in Malignant Patients

“…Still, the NOACs cannot be compared directly with LMWH in malignant patients but it is considered that these drugs will prove even better than the previously used LMWH [30]. In the use of NOACs, there is less occurrence of bleeding and mortality rate, yet the quality of life is compromised and leads to lifelong medication [38].…”