Chronic anticoagulation is recommended for patients with atrial fibrillation (AF) and additional risk factors, even during long periods of sinus rhythm. Continuous rhythm assessment with an insertable cardiac monitor (ICM) and the use of rapid onset novel oral anticoagulants (NOAC) may allow for targeted anticoagulation only around the time of an AF episode, thereby reducing bleeding complications without compromising stroke risk.
Patients on a NOAC with non-permanent AF, a CHADS2 score of 1 or 2, and a previously implanted ICM (Medtronic Reveal XT) were enrolled in a multicenter, single-arm study (REACT.COM
). After a 60-day run-in phase with no AF episodes > 1 hour, NOACs were discontinued and aspirin was prescribed. NOAC was reinitiated in response to any AF episode > 1 hour diagnosed through daily ICM transmissions and continued until the patient was AF-free for > 30 days. Major endpoints included time on NOAC, stroke, and bleeding.
Among 59 enrollees, 75% were male, mean age 67 + 8 years, 76% paroxysmal AF, 69% had prior AF ablation and 69% had CHADS2 score of 1. Over a mean follow-up period of 417 + 135 days there were 24,004 ICM transmissions with a compliance rate of 98.7%. A total of 35 AF episodes > 1 hour were observed in 18 (31%) patients, resulting in a total time on NOAC of 1472 days. This represents a 94% reduction in the time on anticoagulation compared to chronic administration of NOAC. There were three major traumatic bleeds (all on aspirin), three possible TIAs (all on aspirin with no AF episodes within the prior year), and strokes or deaths.
A personalized “pill in pocket” strategy of ICM-guided intermittent NOAC administration appears to be a feasible alternative to chronic anticoagulation in patients with non-permanent AF and moderate risk of stroke. A planned randomized trial (REACT-AF) will best define the efficacy and safety of this novel approach to stroke prevention in AF.
© 2015 Published by Elsevier Inc.