Rivaroxaban, an anti-clotting drug, was shown to be an attractive alternative to warfarin in the prevention of stroke in patients with atrial fibrillation, revealed by researchers recently.
The full intention-to-treat analysis, which includes patients who discontinued study drug, showed that rivaroxaban was noninferior to warfarin for the prevention of stroke or blood clots. Importantly, rivaroxaban use led to less intra-cranial and fatal bleeding.
The findings, co-authored by a research team from the Duke Clinical Research Institute, were published online in the New England Journal of Medicine.
“The results of this large global trial have convincingly shown rivaroxaban to be an alternative to warfarin in treating patients with atrial fibrillation and, importantly, with no increase in bleeding.”
What is atrial fibrillation? About atrial fibrillation, it is the most common abnormal heart rhythm disorder in the U.S. and is characterized by an unusual and dangerously fast heart beat. It can cause blood to pool in the heart resulting in the formation of clots that may become lodged in the artery to the brain resulting in a stroke, or in formation of non-central nervous system blood clots.
Approximately 2.2 million Americans suffer from atrial fibrillation, which increases a person’s stroke risk by four to six times on average.
The ROCKET AF (Rivaroxaban once daily oral direct factor xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation) study included 14,264 patients with atrial fibrillation who had a history of stroke or additional independent risk factors for future stroke and were randomized to receive either rivaroxaban or warfarin. The trial included more than 1,100 centers in 45 countries.
Rates of bleeding and adverse events were similar between treatment groups. Compared to warfarin, rivaroxaban showed similar rates for the principal safety measure of major and non-major clinically relevant bleeding events (event rates = 14.9 vs. 14.5, p=0.442). Rates of major bleeding were also comparable between rivaroxaban and warfarin (event rates = 3.6 vs. 3.4, p=0.576).
Patients treated with rivaroxaban had significantly fewer intracranial hemorrhages (event rates = 0.4 vs. 0.7), critical organ bleeds (event rates = 0.8 vs. 1.2) and bleeding-related deaths (event rates = 0.2 vs. 0.5) compared with warfarin, respectively. However, patients treated with rivaroxaban did show increased rates of hemoglobin/hematocrit drop (event rates = 2.8 vs. 2.3) and transfusions (event rates = 1.7 vs. 1.3), compared to warfarin.
Atrial fibrillation is becoming increasingly prevalent and can be life-threatening if not properly managed. Stroke prevention is a key treatment goal in atrial fibrillation management.
Rivaroxaban appears to be an attractive and well-tolerated clinical alternative to warfarin for patients with atrial fibrillation.
Source: Duke University Medical Center, USA