Targeted Anticoagulation for Atrial Fibrillation Guided by Continuous Rhythm Assessment With an Insertable Cardiac Monitor: The Rhythm Evaluation for Anticoagulation With Continuous Monitoring (REACT.COM) Pilot Study

Abstract

Introduction: Chronic anticoagulation is recommended for patients with AF and additional stroke risk factors, even during long periods of sinus rhythm. Continuous rhythm assessment with an insertable cardiac monitor (ICM) and use of rapid onset novel oral anticoagulants (NOACs) allow for targeted anticoagulation only around an AF episode, potentially reducing bleeding complications without compromising stroke risk.

Methods: This multicenter, single-arm study enrolled patients on NOAC with nonpermanent AF and CHADS2 score 1 or 2. After a 60-day run-in with no AF episodes ≥ 1 hour, NOACs were discontinued but reinitiated for 30 days following any AF episode ≥ 1 hour diagnosed through daily ICM transmissions. Major endpoints included time on NOAC, stroke, and bleeding.

Results: Among 59 enrollees, 75% were male, age 67 ± 8 years, 76% paroxysmal AF, 69% had prior AF ablation, and mean CHADS2 score 1.3 ± 0.5. Over 466 ± 131 mean days of follow-up there were 24,004 ICM transmissions with a compliance rate of 98.7%. A total of 35 AF episodes ≥ 1 hour occurred in 18 (31%) patients, resulting in a total time on NOAC of 1,472 days. This represents a 94% reduction in the time on NOAC compared to chronic anticoagulation. There were three traumatic bleeds (all on aspirin), three potential transient ischemic attacks (all on aspirin with CHADS2 score of 1), and no strokes or deaths.

Conclusions: A targeted strategy of ICM-guided intermittent NOAC administration is feasible. A large-scale trial is necessary to evaluate the safety of this approach.

Trial registration: ClinicalTrials.gov NCT01706146.

Keywords: REVEAL; TIA; anticoagulation; atrial fibrillation; implantable cardiac monitor; stroke.

Figure 1

Study Schema

Figure 2

Representative samples of patient data (A) AF burden over 14-month enrollment period in a 58-year-old male with hypertension (CHADS₂ = 1) with paroxysmal AF on an antiarrhythmic drug. The AF burden trend (A) shows a single episode of atrial fibrillation lasting 5 hours and 14 minutes with corresponding R-R interval plot (Figure 2B) and ECG (Figure 2C) supporting the diagnosis. This patient received one month of NOAC in response to the single AF episode. (B) R-R interval plot of AF episode shown in Figure 2A (C) ECG recorded from ICM demonstrating AF episode

Figure 2

Representative samples of patient data (A) AF burden over 14-month enrollment period in a 58-year-old male with hypertension (CHADS₂ = 1) with paroxysmal AF on an antiarrhythmic drug. The AF burden trend (A) shows a single episode of atrial fibrillation lasting 5 hours and 14 minutes with corresponding R-R interval plot (Figure 2B) and ECG (Figure 2C) supporting the diagnosis. This patient received one month of NOAC in response to the single AF episode. (B) R-R interval plot of AF episode shown in Figure 2A (C) ECG recorded from ICM demonstrating AF episode

Figure 2

Representative samples of patient data (A) AF burden over 14-month enrollment period in a 58-year-old male with hypertension (CHADS₂ = 1) with paroxysmal AF on an antiarrhythmic drug. The AF burden trend (A) shows a single episode of atrial fibrillation lasting 5 hours and 14 minutes with corresponding R-R interval plot (Figure 2B) and ECG (Figure 2C) supporting the diagnosis. This patient received one month of NOAC in response to the single AF episode. (B) R-R interval plot of AF episode shown in Figure 2A (C) ECG recorded from ICM demonstrating AF episode

Figure 3

AF burden histogram of a 68-year-old female with hypertension (CHADS₂ = 1) treated with pulmonary vein isolation. The patient had no recurrences of AF over a 14-month enrollment period and received 0 days of NOAC.