Noncentral Nervous System Systemic Embolism in Patients With Atrial Fibrillation
Results From ROCKET AF (Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation)
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Atrial fibrillation (AF) is common and occurs in 2% to 4% of adults 60 years of age or older.1 Thromboembolic events, including stroke and noncentral nervous system (CNS) systemic embolism (SE), are common complications. Non-CNS SE accounts for ≈10% of all thromboembolic events2 and is important to identify because they are associated with high morbidity and mortality. Using data from ROCKET AF (Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation; NCT00403767), we describe the incidence, location, diagnosis, treatment, and outcomes in patients with non-CNS SE. Baseline characteristics of patients with non-CNS SE are presented and discussed to identify those at increased risk of such an event.
Methods and Results
The design and methods of ROCKET AF have been described.3,4 In brief, it was a multicenter, randomized, double-blind, event-driven trial conducted at 1178 participating sites in 45 countries.3 Included patients had AF and were at moderate-to-high risk for stroke as defined by a CHADS2 score (Congestive Heart Failure, Hypertension, Age, Diabetes Mellitus, Stroke 2 Score) ≥2. A total of 14 264 patients were randomly assigned to receive fixed-dose rivaroxaban 20 mg daily (15 mg daily in patients with creatinine clearance 30–49 mL/min) or dose-adjusted warfarin (target international normalized ratio 2.0–3.0). Patients were intended to continue study drug throughout the trial unless discontinuation was clinically indicated (eg, safety concern, pregnancy, stroke or non-CNS SE, HIV diagnosis, abnormal liver function, creatinine clearance <25 mL/min on 2 consecutive measurements, or need for excluded medication).4
Non-CNS SE was defined as abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms. In the presence of atherosclerotic peripheral artery disease (PAD), diagnosis of embolism to the lower extremities required …