Safety Of Rivaroxaban Therapy Research Articles

Characteristics and Effect of Rivaroxaban on Venous Thromboembolism in Korean Patients Compared to Western Population: A Subgroup Analysis from XALIA(-LEA) Study.

This study aimed to compare the characteristics of venous thromboembolic disease (VTE) in Korean to Caucasian population. XALIA-LEA and XALIA were phase IV non-interventional prospective studies with identical designs that investigated the effect of rivaroxaban versus standard anticoagulation for VTE. Koreans accounted for the largest proportion of the overall enrolled population of XALIA-LEA. However, in the XALIA study, most patients were Caucasian. Therefore, Korean data from XALIA-LEA and Caucasian data from XALIA were used in this study. This study compared the clinical characteristics and primary outcomes of the XALIA program, including major bleeding, recurrent VTE, and all-cause mortality. The Korean population was older, was less obese, and had more active cancer at baseline than the Caucasian population. Provoked VTE was more common in the Korean population. Interestingly, Koreans showed less accompanying thrombophilia than Caucasians, and factor V Leiden mutations were not detected. Korean analyses comparing the effects of rivaroxaban and standard anticoagulation with primary outcomes showed a lower incidence of major bleeding, recurrent VTE, and all-cause mortality with rivaroxaban. Similar results were obtained in the propensity score matching analysis. Characteristic differences were found between Korean and Caucasian VTE patients. Despite these ethnic differences, the effectiveness and safety of rivaroxaban therapy in these patients were consistent.

Rivaroxaban in patients with atrial fibrillation: from research to real practice (based on REGistry of Long-term AnTithrombotic TherApy-2 (REGATA))

Introduction. Despite the large evidence base for the use of rivaroxaban, cohort studies are interesting because shows the possibility of anticoagulant therapy in patients with high thromboembolic and bleeding risk and a burden of comorbidity in practice.Aim: to evaluate the efficacy and safety of rivaroxaban therapy in patients with atrial fibrillation in prospective REGATTA registry.Materials and methods. This study is a fragment of a single-center prospective REGATA registry (Registry of Long-term Antithrombotic Therapy (NCT043447187), conducted on the basis of the National Research Center of Cardiology of the Ministry of Health of the Russian Federation. 152 patients with high thromboembolic risk (median CHA2DS2-VASc = 4) received rivaroxaban therapy (median follow-up 1.5 years). The efficacy endpoint was the sum of cardiovascular complications (including cardiovascular death, ischemic stroke, and acute coronary syndrome). The safety endpoint bleedinds BARC types 2-5.Results. The frequency of cardiovascular events (combining cardiovascular death, ischemic stroke and acute coronary syndrome) was 5.8/100 patient-years. The use of a “reduced” dose of rivaroxaban was an independent predictor of the development of fatal cardiovascular complications. The rate of major bleeding was 3.7/100 patient-years, and the rate of clinical relevant bleedings was 19.4 /100 patientyears. The predictors of major/ clinical relevant bleedings were chronic kidney disease with a decrease in creatinine clearance of less than 50 ml/min and the anamneses of major/ clinical relevant bleedings.Conclusion. The main requirement for improving the safety of anticoagulants is follow up, focused in all changes in the cardiovascular and somatic status of the patient during treatment.

Treatment of cancer-related thrombosis: from recommendations to real clinical practice

Aim. To highlight the modern treatment and secondary prevention of recurrent thrombotic complications in patients with cancer. Materials and methods. We studied 40 scientific sources published in the Russian and foreign press in the period of 1997 to 2018. Results. Oncology patients are at higher risk of thrombotic complications which can worse outcomes of antitumor treatment and occupy one of the leading places among causes of death. Low molecular weight heparins (LMWHs) are the drugs of first choice for the treatment of cancer-associated thrombosis. Taking into account the complexity of LMWH application, many patients stop receiving the recommended therapy and are switching to oral anticoagulants. For instance, according to the GARFIELD-AF prospective registry direct oral anticoagulants (DOACs) are used in 25% of cancer patients. The most promising drug in this group is rivaroxaban (Xarelto). Multiple studies are currently undergoing in the framework of CALLISTO Program, designed to study various issues of managing patients with cancer-associated thrombosis: primary and secondary prevention of thrombosis using rivaroxaban, to study quality of life and the treatment adherence. In the Mayo Clinic Thrombophilia database retrospective study was demonstrated comparable efficacy of rivaroxaban and LMWH and in the studies US claims analysis and US Humana database were noted the reduction of recurrences of thromboembolic complications on using rivaroxaban treatment in comparison with LMWH on the same frequency of severe bleeding. In subanalysis of the prospective XALIA study was showed a favorable profile of efficacy and safety of rivaroxaban therapy in cancer patients, so the results proved the results of real practice. Conclusion. In 2018 the results of submitted studies helped several international societies, such as International Society on Thrombosis and Hemostasis and The National Comprehensive Cancer Network, to recommend rivaroxaban as one of the treatment options for patients with cancer-associated thrombosis with low risk of bleeding and no drug-drug interactions with current systemic therapy. Rivaroxaban can be considered as an alternative to low molecular weight

Effectiveness and safety of rivaroxaban therapy in daily-care patients with atrial fibrillation. Results from the Dresden NOAC Registry.

The effectiveness and safety of rivaroxaban for stroke prevention in atrial fibrillation (SPAF) demonstrated in ROCKET AF needs to be confirmed in daily care. To evaluate effectiveness and safety of rivaroxaban therapy in SPAF patients in daily care, we used data from an ongoing, prospective, non-interventional registry of more than 2700 patients on novel oral anticoagulants in daily care. Between October 1, 2011 and February 28, 2013, a total of 1204 SPAF patients receiving rivaroxaban were enrolled. During a mean follow-up of 796.2 ± 207.3 days, the combined endpoint of stroke/transient ischaemic attack/systemic embolism occurred at a rate of 2.03/100 patient-years in the intention-to-treat analysis (95 % confidence interval [CI] 1.5-2.7) and at 1.7/100 patient-years in the on-treatment analysis (events within 3 days after last intake). On-treatment rates were higher in patients selected for 15 mg rivaroxaban (n=384) once daily [OD] compared with the 820 patients selected for 20 mg OD (2.7 [95 % CI 1.6-4.2] vs 1.25/100 patient-years [95 % CI 0.8-1.9]). On treatment, major bleeding occurred at a rate of 3.0/100 patient-years and significantly more often in patients receiving the 15 mg OD dose compared with the 20 mg OD dose (4.5 vs 2.4/100 patient-years). Rivaroxaban treatment discontinuation occurred in a total of 277 patients during follow-up (12.0/100 patient-years in Kaplan-Meier analysis). Our data contribute to the confirmation of effectiveness and relative safety of rivaroxaban in daily-care patients. Furthermore, rivaroxaban discontinuation rates were considerably lower than those reported for vitamin K antagonists.