Background: Real-world data on the safety and effectiveness of factor Xa inhibitor (rivaroxaban) among patients with non-valvular atrial fibrillation and venous thromboembolism is scares.

Aims: Examine the safety and effectiveness of rivaroxaban in the largest academic center in the Kingdom of Saudi Arabia.

Methods: A retrospective observational study designed to examine the prescribing pattern, safety, and real world effectiveness of rivaroxaban in patients with ‎NVAF/ and VTE Data on rivaroxaban prescriptions were collected analyzed. Bleeding outcomes were defined as per the ISTH definition

Results: A total of 2316 patients. The mean age is 61 years (±17.8) with 55% above the age of 60. .58% were females. The most common indication was VTE followed by NVAF. 23% of the patients were discharged on a 15 mg total daily dose. The incidence rate of recurrent thrombosis and recurrent stroke was 0.2%. . The incidence rate of major bleeding was 1.1%. More than 50% of the patients who had major bleeding were on a 20 mg daily dose of rivaroxaban. 48% of the patients who had major bleeding have a high risk for bleeding according to HAS-BLED Score (>2 scores).

Conclusion(s): In this real-life cohort study, rivaroxaban prescribing is not consistent with the prescrining label or phase 3 randomized clinical trial data. However, it appears that the efficacy of the 20 mg dose is better than pivotal trial data for patients with VTE and NVAF. Moreover, in real world setting, rivaroxaban was 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.

Key words: real-world, rivaroxaban, VTE, stroke, major bleeding, non-major bleeding

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ISTH Congress Abstracts - https://abstracts.isth.org/abstract/real-world-effectiveness-and-safety-of-rivaroxaban-in-patients-with-non-valvular-atrial-fibrillation-and-venous-thromboembolism-in-saudi-arabia/