XANTUS: Low bleeding, stroke rates in patients with nonvalvular AF assigned rivaroxaban

LONDON — Rates of major bleeding events and stroke were low among patients with nonvalvular atrial fibrillation who were assigned rivaroxaban, according to results from the XANTUS study presented at the European Society of Cardiology Congress.

“Further information on the effectiveness of [non-vitamin K antagonist] oral anticoagulants is still accumulating in the form of retrospective registries and additional randomized clinical trials,” the researchers wrote. “A high volume of prospectively collected information in large patient groups is still lacking.”

A. John Camm

A. John Camm, MD, FRCP, professor of clinical cardiology in the Cardiovascular and Cell Sciences Research Institute at St. George’s University of London, and colleagues enrolled 6,784 patients treated with rivaroxaban (Xarelto, Janssen). The mean age of the patients was 71.5 years (range, 19-99), 41% were women and 9.4% had documented severe or moderate renal impairment (creatinine clearance, < 50 mL/min). Mean CHADS2 and CHA2DS2-VASc scores were 2 and 3.4, respectively; 859 (12.7%) patients had a CHA2DS2-VASc score of 0 or 1.

Study participants in this single-arm study were enrolled from 311 centers in Europe, Israel and Canada. Patients all had nonvalvular AF and had initiated treatment with rivaroxaban to diminish the risk for stroke or systemic embolism. Treatment regimens, including dose and duration of therapy, were directed by the patient’s physician.

Mean length of treatment was 329 days. Treatment-emergent major bleeding events (n = 142) occurred in 128 patients (2.1 events per 100 patient-years) and increased with age. Forty-three patients had a stroke (0.7 events per 100 patient-years); systemic embolism occurred in a further eight patients (0.1 events per 100 patient-years), according to study results. All-cause fatalities occurred in 118 patients (1.9 events per 100 patient-years), with the adjudicated cause of death predominantly related to CV causes (mainly HF), followed by cancer.

“Studies such as XANTUS complement the outcomes of pivotal trials through the use of unselected real-world populations and conditions,” the researchers write. “XANTUS is the first large, international, prospective study describing the use of rivaroxaban for stroke prevention in a broad [nonvalvular AF] patient population. The rates of major bleeding and stroke with rivaroxaban were found to be low in routine clinical practice.” – by Julia Ernst, MS

Reference:

Camm AJ, et al. Abstract 5072. Presented at: European Society of Cardiology Congress; Aug. 29-Sept. 2, 2015; London.

Camm AJ, et al. Eur Heart J. 2015;doi:10.1093/eurheartj/ehv466.

Disclosure: Camm reports serving as a consultant for AstraZeneca, Aryx, Bayer HealthCare, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Johnson & Johnson, Pfizer and Sanofi. Please see the full study for a list of all other authors’ relevant financial disclosures.