Rivaroxaban for Stroke Prevention in Patients With Nonvalvular Atrial Fibrillation and Active Cancer

Abstract

Rivaroxaban is broadly used for the primary prevention of stroke and systemic embolism in the general population with non-valvular atrial fibrillation (AF). However, there is little published evidence on the safety and efficacy of rivaroxaban for AF in patients with active cancer. The aim of this study was to assess the safety and efficacy of rivaroxaban in patients with active cancer and AF. Use of rivaroxaban in cancer patients at Memorial Sloan Kettering Cancer Center (MSKCC) is monitored in the setting of a Quality Assessment Initiative. Patients with active cancer and AF, treated with rivaroxaban from 1/1/2014 through 3/31/2016 are included in this analysis. Clinical endpoints were defined a priori and assessed through text searches of medical records. A total of 163 evaluable patients were identified. After adjusting for competing risks, the estimated 1 year cumulative incidence of ischemic stroke was 1.4% (95% CI=0–3.4%) and major bleeding was 1.2% (95% CI=0–2.9%). The risk of clinically-relevant non-major bleeding leading to discontinuation of anticoagulation at 1 year was 14.0% (95% CI=4.2–22.7%). The cumulative incidence of mortality was 22.6% (95% CI=12.2–31.7%) at one year, reflecting an active cancer population. One patient died after developing an acute ischemic cerebrovascular insult. In conclusion, the safety and efficacy of rivaroxaban treatment for non-valvular AF in patients with active cancer is comparable to the results of the ROCKET-AF study in the general population.

Use of Direct Oral Anticoagulants in Patients with Cancer: Practical Considerations for the Management of Patients with Nausea or Vomiting

“…A recent small observational study addressed the safety and efficacy of rivaroxaban in patients with active cancer and AF. The estimated cumulative incidence of ischemic stroke, major bleeding, and clinically relevant nonmajor bleeding was 1.4% (95% confidence interval [CI], 0%–3.4%) and 1.2% (95% CI, 0%–2.9%) in the acute (first 90 days of anticoagulation) and subsequent chronic phases of anticoagulation, respectively . Although the authors noted that these safety and efficacy findings were similar to those from the ROCKET‐AF study, further large prospective studies are needed to comprehensively address the question of whether DOACs are suitable for use in patients with AF and concomitant cancer.…”

Atrial Fibrillation and Malignancy: The Clinical Performance of Non–Vitamin K Oral Anticoagulants—A Systematic Review

“…We identified five cohort studies as eligible, of which one was a retrospective population-based cohort study, 13 two post hoc analyses from two RCTs, 14,15 and two retrospective singlecenter-based cohort studies, 16,17 and one eligible case-control study. 18 The quality assessment shows low comparability between exposed and nonexposed patients in two out of three cohort studies using a control group, 13,14 as no adjustments for major confounders were made in the analysis.…”

“…Low comparability was also found between cases and controls in the study by Ianotto et al 18 because matching for major confounders was not detailed. Two out of six papers 16,17 did not use a control group so that results are not comparable with the general population of AF patients with cancer using the currently recommended anticoagulation therapy. One study 16 did not reach good quality in the item "adequacy of follow-up" because more than 40% of the patients were lost to followup before reaching 365 days (time of follow-up).…”

“…Two out of six papers 16,17 did not use a control group so that results are not comparable with the general population of AF patients with cancer using the currently recommended anticoagulation therapy. One study 16 did not reach good quality in the item "adequacy of follow-up" because more than 40% of the patients were lost to followup before reaching 365 days (time of follow-up). Details on quality assessment are provided in ►Table 1.…”

Clinical use and laboratory testing of oral anticoagulation therapy: experience from Finland

“…DOACs are gaining new indications, rivaroxaban for prevention of atherothrombosis in coronary artery disease, and several DOACs are being considered in cancer patients as well (5)(6)(7). While the use of DOACs is increasing, clinicians will encounter many patients switching from traditional vitamin K antagonists (VKAs) to DOACs, and broad education is required (8).…”