Effectiveness and safety of rivaroxaban vs warfarin in patients with pulmonary embolism and right ventricular dysfunction: a retrospective cohort study

Abstract

Background

Limited data exist comparing the effectiveness and safety of rivaroxaban and warfarin in patients with right ventricular dysfunction (RVD), a common acute pulmonary embolism (PE) complication.

Objectives

To assess the effectiveness and safety of rivaroxaban compared with warfarin among patients with PE and RVD.

Methods

Adult patients newly prescribed rivaroxaban or warfarin during PE-related hospitalization with evidence of RVD were identified from Mass General Brigham’s Research Patient Data Registry database (January 2013-May 2023). Outcomes included time-to-first recurrent venous thromboembolism (VTE) and time-to-first major bleeding event. The proportion of international normalized ratio (INR) measurements within therapeutic range (INR: 2-3) while on warfarin was described. Kaplan–Meier analysis described event rates at 6-month intervals up to 36 months, which were compared using hazard ratios, 95% CIs, and P values from Cox proportional hazards models.

Results

Overall, 246 rivaroxaban and 315 warfarin users were included (mean age, 63 years; female: 53%). Median time of treatment was 270 and 235 days for rivaroxaban and warfarin users, respectively; 50.9% of INR measurements among warfarin users were within therapeutic range. Rivaroxaban was associated with significantly lower risk of VTE recurrence than warfarin at all-time points, including 41% lower risk at 36 months (20.4% vs 30.3%; hazard ratio [95% CI], 0.59 [0.38, 0.92]). There was no significant difference in risk of major bleeding between cohorts up to 36 months of treatment (8.2% vs 13.6%).

Conclusion

Rivaroxaban was associated with lower risk of recurrent VTE compared with warfarin, without a significant difference in risk of major bleeding.