OBJECTIVES

To investigate the safety and effectiveness of Factor Xa inhibitor (rivaroxaban) in real-world clinical practice in the Kingdom of Saudi Arabia (KSA).

METHODS

This was a retrospective cohort, post-marketing surveillance study. Patients with NVAF/venous thrombosis, arterial thrombosis, and stroke who began treatment with rivaroxaban enrolled in the study. Data collected from January 2015 to December 2019 patients.

RESULTS

A total of 2316 patients taking rivaroxaban recruited through several departments in king Khalid University Hospital with a mean age of 60.9 years (±17.8) were enrolled in this study. More than half (55.3%) of the patients were over 60 years of age. 58% of which were females. The prescriptions for VTE (DVT and PE) were relatively higher than NVAF. The incidence rates of recurrent thrombosis and recurrent stroke were 0.2 %. Whereas, the incidence rate was 0.04 % for MI. 50% of these patients who had recurrent thrombosis and stroke were using 15 mg/day and the other 50% using 20 mg/day of rivaroxaban. The incidence rate of major bleeding was 1.1 %. More than 50% of the patients who had major bleeding were on 20 mg daily dose of rivaroxaban. 48% of the patients who had major bleeding has a high risk for bleeding according to HAS-BLED Score (>2 score). The incidence rate of non-major bleeding was 0.6 %. Likewise, 40% of the patients who had non-major bleeding were on 20 mg daily dose of rivaroxaban. Only 6.6% of these patients had a high risk for bleeding according to HAS-BLED Score.

CONCLUSIONS

In this real-life cohort study, rivaroxaban appears to be more effective with a dose of 20 mg for patients with VTE and NVAF. Rivaroxaban was also associated with a lower risk of safety events such as recurrent thrombosis, recurrent stroke, MI, major bleeding, and non-major bleeding in patients with VTE and NVAF.