Real-World Experience With Rivaroxaban for Atrial Fibrillation

Study Questions:

What are the safety and efficacy data for unselected atrial fibrillation (AF) patients treated with rivaroxaban for stroke prevention?


Consecutive consenting patients with AF initiating rivaroxaban therapy were followed every 3 months for 1 year at 311 centers in Europe, Israel, and Canada. All adverse events, including major bleeding, symptomatic thromboembolic events, and all-cause death were centrally adjudicated. Rates of adverse events were stratified based on the CHA2DS2-VASc score and renal function, as estimated by the creatinine clearance (CrCl).


A total of 6,784 patients treated with rivaroxaban were followed for a median of 366 days. About 54.5% of patients were vitamin K antagonist naive prior to initiating rivaroxaban. The mean age was 71.5 years (range 19-99 years), and 41% were female. Moderate or severe renal insufficiency was documented in 9.4% of patients (0.3% with CrCl <15 ml/min, 1.1% with CrCl ≥15 to <30 ml/min, and 8.0% with CrCl ≥30 to <50 ml/min). The mean CHADS2 and CHA2DS2-VASc scores were 2.0 and 3.4, respectively. A total of 6,522 (96.1%) patients did not experience any major adverse event during the follow-up period. Major bleeding occurred in 128 patients (2.1 events/100 patient-years), 18 (1.9 events/100 patient-years) patients died, and 43 (0.7 events/100 patient-years) patients suffered a stroke. The incidence rate of intracranial hemorrhage was 0.4 events/100 patient-years. Stroke, major bleeding, and all-cause death rates generally increased with higher CHA2DS2-VASc score. Major bleeding occurred in 3.4% of patients with a CrCl <50 ml/min. Of patients with a CrCl ≥50 ml/min, 15% received the lower dose of rivaroxaban (15 mg daily), while 36% of patients with moderate or severe renal insufficiency (CrCl <50 ml/min) received the higher dose (20 mg daily).


The authors concluded that rates of stroke and major bleeding were low in real-world patients receiving rivaroxaban.


This multicenter (multicontinent) registry provides valuable real-world data on the safety and efficacy of rivaroxaban therapy for stroke prevention in AF. Low adverse event rates in this unselected population are reassuring. However, concerns remain about frequent inappropriate dosing of patients based on renal function. It is also notable that this ‘real-world’ registry employed an every 3-month follow-up interval similar to that of the large-scale trials. As was described in a recent study from the US Veteran’s Affairs Hospital, more frequent clinical follow-up was associated with better medication adherence and possibly better outcomes (JAMA 2015;313:1443-50). Practitioners should take comfort in the real-world outcomes described here for rivaroxaban therapy, but need to carefully review renal function when dosing and consider the importance of regular follow-up.

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