Rationale and design of the Apixaban for the reduction of thrombo-embolism in patients with Device-Detected Sub-Clinical Atrial Fibrillation (ARTESiA) trial

Publication date: Available online 24 April 2017 Source:American Heart Journal Author(s): Renato D. Lopes, Marco Alings, Stuart J. Connolly, Heather Beresh, Christopher B. Granger, Juan Benezet Mazuecos, Giuseppe Boriani, Jens C. Nielsen, David Conen, Stefan H. Hohnloser, Georges H. Mairesse, Philippe Mabo, A. John Camm, Jeffrey S. Healey Device-detected subclinical atrial fibrillation (AF) refers to infrequent, short-lasting, asymptomatic AF that is detected only with long-term continuous monitoring. Subclinical AF is common and associated with an increased risk of stroke; however, the risk of stroke with subclinical AF is lower than for clinical AF, and very few patients with subclinical AF alone have been included in large AF anticoagulation trials. The net benefit of anticoagulation in patients with subclinical AF is unknown. Design ARTESiA is a prospective, multicenter, double-blind, randomized controlled trial, recruiting patients with subclinical AF detected by an implanted pacemaker, defibrillator, or cardiac monitor, and who have additional risk factors for stroke. Patients with clinical AF documented by surface electrocardiogram will be excluded from the study. Participants will be randomized to receive either apixaban (according to standard AF dosing) or aspirin 81mg daily. The primary outcome is the composite of stroke, transient ischemic attack with diffusion-weighted magnetic resonance imaging evidence of cerebral infarction, and systemic emboli...
Source: American Heart Journal - Category: Cardiology Source Type: research