Oral anticoagulation with rivaroxaban for stroke prevention in atrial fibrillation (AF) patients resulted in low rates of bleeding and stroke, supporting the ROCKET AF study data that rivaroxaban is safe and effective for these patients at both high- and low-risk of thromboembolic events, researchers presented at the European Society of Cardiology Congress 2015.
The XANTUS study was a single-arm, observational study that assessed the safety and effectiveness of rivaroxaban for stroke prevention (n=6,784) in patients with non-valvular AF. This study was the first international, prospective real-world non-vitamin K antagonist oral anticoagulant (NOAC) study conducted in patients with AF. Treatment and dosing decisions were at the discretion of the physician. Patients were followed up for one year or until 30 days after premature discontinuation.
At the end of the observation period, 96.1% of patients did not experience treatment-emergent major bleeding, all-cause mortality, or stroke/systemic embolism. In general, treatment-emergent major bleeding was seen in 2.1% of patients per year and most cases were treated with standard measures. Researchers also reported that the rate of on-treatment all-cause mortality was 1.9% per year, rate of fatal bleeding was 0.2% per year, while stroke and critical organ bleeding occurred in 0.7% patients per year. Treatment persistence was seen in 80% of patients compared to 62% seen with vitamin k antagonists (VKAs) in other studies.
These findings confirm the positive benefit-risk profile of rivaroxaban as demonstrated in the Phase 3 ROCKET AF trial where it showed effective stroke prevention with a similar overall bleeding profile and significantly lower rates compared with VKAs, concluded John A. Camm, professor of clinical cardiology from St. George’s University of London, U.K.
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