Atrial fibrillation (AFib) patients treated with rivaroxaban for stroke prevention have low rates of bleeding and stroke, according to data from the XANTUS study presented Sept. 1 during ESC Congress 2015 in London and simultaneously published in European Heart Journal. According to investigators, the findings confirm clinical trial data and demonstrate that oral anticoagulation with rivaroxaban is safe and effective for stroke prevention in AFib patients at both high- and low-risk of thromboembolic events.

XANTUS evaluated the safety and effectiveness of rivaroxaban for stroke prevention in 6,784 non-valvular AFib patients from 311 centers across Europe and Canada in routine clinical practice. All treatment and dosing decisions were at the discretion of the treating physicians and patients were followed up for one year or until 30 days after premature discontinuation. Bleeding events and major thromboembolic events were centrally adjudicated by an independent committee.

Overall results found that by the end of the observation period, the majority (96.1 percent) of patients had not experienced treatment-emergent major bleeding, all-cause death or stroke / systemic embolism. The rate of on-treatment all-cause mortality was 1.9 percent per year. Researchers noted that 2.1 percent of patients per year experienced treatment-emergent major bleeding, with most of these cases treated using standard clinical measures. Additionally, the rate of fatal bleeding was 0.2 percent per year; stroke was 0.7 percent per year; critical organ bleeding was 0.7 percent per year; and intracranial haemorrhage was 0.4 percent per year.

XANTUS also showed that the majority of patients (80 percent) adhered to their treatment with rivaroxaban throughout the one year study period. "Treatment persistence is especially important as discontinuation of anticoagulation leaves patients with AFib unprotected from the risk of stroke," said lead investigator A. John Camm, MD, FACC, professor of clinical cardiology in the Cardiovascular and Cell Sciences Research Institute at St George's University of London, UK.

Camm also noted that the overall findings from XANTUS 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."

Keywords: ESC Congress, Atrial Fibrillation, Embolism, Hemorrhage, Intracranial Hemorrhages, Morpholines, Stroke, Thiophenes, Vitamin K

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