AimsAlthough non-vitamin K antagonist oral anticoagulants are recommended for stroke prevention in patients with non-valvular atrial fibrillation (NVAF) based on clinical trial results, there is a need for safety and efficacy data from unselected patients in everyday clinical practice. XANTUS investigated the safety and efficacy of the Factor Xa inhibitor rivaroxaban in routine clinical use in the NVAF setting.Methods and resultsConsecutive consenting patients with NVAF newly started on rivaroxaban were eligible and were followed up at ∼3-month intervals for 1 year, or for at least 30 days after permanent discontinuation. All adverse events (AEs) were recorded as AEs or serious AEs; major outcomes (including major bleeding, symptomatic thromboembolic events [stroke, systemic embolism, transient ischaemic attack, and myocardial infarction], and all-cause death) were centrally adjudicated. There were 6784 patients treated with rivaroxaban at 311 centres in Europe, Israel, and Canada. Mean patient age was 71.5 years (range 19–99), 41% were female, and 9.4% had documented severe or moderate renal impairment (creatinine clearance <50 mL/min). The mean CHADS2 and CHA2DS2-VASc scores were 2.0 and 3.4, respectively; 859 (12.7%) patients had a CHA2DS2-VASc score of 0 or 1. The mean treatment duration was 329 days. Treatment-emergent major bleeding occurred in 128 patients (2.1 events per 100 patient-years), 118 (1.9 events per 100 patient-years) died, and 43 (0.7 events per 100 patient-years) suffered a stroke.ConclusionXANTUS is the first international, prospective, observational study to describe the use of rivaroxaban in a broad NVAF patient population. Rates of stroke and major bleeding were low in patients receiving rivaroxaban in routine clinical practice.Trial registration numberClinicaltrials.gov: NCT01606995.

The alarms of medical devices are a matter of concern in critical and perioperative care. The frequent false alarms not only are a nuisance for patients and caregivers but can also compromise patient safety and effectiveness of care. The development of alarm systems has lagged behind the technological advances of medical devices over the last 20 years. From a clinical perspective, major improvements of alarm algorithms are urgently needed. We give an overview of the current clinical situation and the underlying problems and discuss different methods from statistics and computational science and their potential for clinical application.

This study used a new approach of off-line, video-based physician annotations, showing that even with modern monitoring systems most alarms are not clinically relevant. As the majority of alarms are simple threshold alarms, statistical methods may be suitable to help reduce the number of false-positive alarms. Our study is also intended to develop a reference database of annotated monitoring alarms for further application to alarm algorithm research.