XANTUS Study: Rivaroxaban Prevents Stroke in Patients With Atrial Fibrillation

Using rivaroxaban (Xarelto) in a patients with non-valvular atrial fibrillation (NVAF) can reduce rates of stroke and major bleeding, according to the result of the XANTUS study.

XANTUS is the first large, international, prospective study describing the use of rivaroxaban for stroke prevention in a broad NVAF patient population. The study results were published in European Heart Journal.

The single-arm, observational study evaluated the safety and effectiveness of rivaroxaban for stroke prevention. The researchers studied 6784 patients with NVAF across Europe and Canada in routine clinical practice. Patients were followed up for 1 year or until 30 days after premature discontinuation.

A majority of patients (96%) did not experience major bleeding, all-cause death, or stroke/systemic embolism. Stroke occurred in 0.7% of patients per year, fatal bleeding in 0.2% per year, and critical organ bleeding in 0.7% per year. Treatment and dosing was decided by the treating physician and 5336 patients received 20 mg od, 1410 received 15 mg od, and 35 received another dose.

“The findings reaffirm the positive benefit-risk profile of rivaroxaban established in the phase III clinical trial ROCKET AF, in which rivaroxaban was shown to provide effective stroke prevention with a similar overall bleeding profile and significantly lower rates of the most feared intracranial and fatal bleeds compared with vitamin K antagonists,” XANTUS principal investigator A. John Camm, MD, professor of clinical cardiology in the Cardiovascular and Cell Sciences Research Institute at St George’s University of London, UK, said in a statement.

According to the study, major bleeding, all-cause death, and thromboembolic events occurred at higher incidence rates for the 15 mg od dose compared with the 20 mg od dose.

At the end of the study, the researchers found that 5096 (75%) of patients reported to their physicians that they were “very satisfied” or “satisfied” with their treatment. Premature discontinuation only occurred among 7.9% of patients with the main reason being an adverse event.

“These real-world insights from XANTUS complement and expand on what we already know from clinical trials, and provide physicians with reassurance to prescribe rivaroxaban as an effective and well-tolerated treatment option for the broad range of patients with AF seen in their everyday clinical practice,” said Dr Camm.