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• W2195488531 abstract "Non-vitamin K antagonist oral anticoagulants are recommended in the CCS guidelines for stroke prevention in patients with non-valvular AF. There is a need for safety data on these drugs from everyday practice. XANTUS is a prospective, single-arm, non-interventional study on the safety of rivaroxaban for stroke prevention in patients with non-valvular AF in routine clinical use. All patients with non-valvular AF who were newly started on rivaroxaban were eligible. The attending physician determined the dosing regimen. Patients were followed for 1 year, at approximately 3-month intervals, or for at least 30 days after permanent discontinuation. All adverse events (AEs) were recorded as AEs or serious AEs (SAEs). Major bleeding (ISTH definition), symptomatic thromboembolic events (stroke, systemic embolism [SE], TIA), myocardial infarction, and all-cause death were adjudicated centrally. In total, 6785 patients were enrolled from June 2012 to December 2013. One patient did not take rivaroxaban; therefore, the analysis was based on 6784 patients from 311 centres in Europe and Canada. 78.7% of patients received rivaroxaban 20 mg once daily (od), 20.8% received 15 mg od, and 0.5% received another dose. The mean treatment duration was 329 days. The mean age of patients was 71.5 years (range 19–99 years; 37% aged >75 years); 41% were female. At baseline, 19% of patients had first diagnosed AF; 41% had paroxysmal AF; 19% of patients had a prior stroke, SE, or TIA; 19% had heart failure; 75% had hypertension; and 20% had diabetes. Mean CHADS2 score was 2.0 (median=2.0); mean CHA2DS2-VASc score was 3.4 (median=3.0); 13% of patients had CHA2DS2-VASc score of 0 or 1. The discontinuation rate at the end of the observation period was 20%. Overall, 2709 (40%) patients experienced an AE and 1200 (18%) an SAE. The on-treatment all-cause mortality rate was 1.7%, and 1.9% of patients experienced a treatment-emergent major bleeding event (0.2% fatal bleeding). Stroke occurred in 0.6% of patients and stroke/SE in 0.8%. Clinical outcomes are shown in the Table. Data on patients receiving rivaroxaban 20 mg od and 15 mg od will be presented. XANTUS is the first international prospective study that describes the use of rivaroxaban for stroke prevention in a broad patient population with non-valvular AF. Patients in XANTUS were at lower overall risk than those in ROCKET AF. The rates of major bleeding and stroke with rivaroxaban were low in routine clinical practice." @default.
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• W2195488531 date "2015-10-01" @default.
• W2195488531 modified "2023-09-25" @default.
• W2195488531 title "NON-INTERVENTIONAL STUDY ON THE SAFETY OF RIVAROXABAN FOR STROKE PREVENTION IN NON-VALVULAR ATRIAL FIBRILLATION IN ROUTINE CLINICAL PRACTICE: XANTUS" @default.
• W2195488531 doi "https://doi.org/10.1016/j.cjca.2015.07.178" @default.
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