Two-year results show rivaroxaban was associated with reduced stroke and systemic embolism versus warfarin, without altering risk of major bleeding. The study evaluated efficacy and safety of rivaroxaban, apixaban and dabigatran each versus warfarin.
The Janssen Pharmaceutical Companies of Johnson & Johnson has announced new real-world data that showed frail patients with non-valvular atrial fibrillation (NVAF) experienced significantly fewer strokes and systemic emboli when treated with rivaroxaban (brand name Xarelto) over a two-year period compared to those taking warfarin. Specifically, long-term rivaroxaban use reduced the risk of stroke and systemic embolism by 32% and ischaemic stroke alone by 31% compared to warfarin, with no significant increase in major bleeding. Results from the study, which also assessed the efficacy and safety of apixaban and dabigatran each versus warfarin, were recently published in the Journal of the American Heart Association.
“There is not widespread consensus on the best way to manage frail patients with NVAF in clinical practice, which is why some patients are not treated at all and remain at high risk of having a stroke,” said Craig Coleman, PharmD, professor of Pharmacy Practice, University of Connecticut, USA. “These results show long-term rivaroxaban use reduced stroke and systemic embolism in a vulnerable patient group, without increasing the risk of major bleeding. They also give physicians important insights into a well-tolerated, effective approach to treat their frail patients with NVAF.”
In the study, researchers used US Truven MarketScan claims data and identified frail patients with NVAF taking rivaroxaban, apixaban, or dabigatran. Each treatment group was matched separately with warfarin users in a 1:1 ratio and followed for up to two years or until an event, insurance disenrollment or end of follow-up occurred. The primary efficacy outcome was stroke (ischaemic or haemorrhagic) or systemic embolism. Major bleeding was the primary safety outcome.
Researchers made the following two-year observations:
- Rivaroxaban was associated with a 32% reduction in stroke or systemic embolism (HR=0.68; 95% CI=0.49-0.95) and 3% reduction in ischaemic stroke alone (HR=0.69; 95% CI=0.48-0.99) compared to warfarin.
- Rivaroxaban had similar rates of major bleeding compared to warfarin (HR=1.07; 95% CI=0.81-1.32).
- Though both apixaban and dabigatran treatment were associated with numerically fewer strokes, neither statistically significantly reduced the risk of stroke or systemic embolism at two years compared to warfarin (HR=0.78; 95% CI=0.46-1.35 and HR=0.94; 95% CI=0.60-1.45).
- Rates of major bleeding were also evaluated for apixaban versus warfarin (HR=0.72; 95% CI=0.49-1.06) and dabigatran versus warfarin (HR=0.87; 95% CI=0.63-1.19).