TY - JOUR
T1 - Targeted Anticoagulation for Atrial Fibrillation Guided by Continuous Rhythm Assessment with an Insertable Cardiac Monitor
T2 - The Rhythm Evaluation for Anticoagulation with Continuous Monitoring (REACT.COM) Pilot Study
AU - Passman, Rod
AU - Leong-Sit, Peter
AU - Andrei, Adin Cristian
AU - Huskin, Anna
AU - Tomson, Todd T.
AU - Bernstein, Richard
AU - Ellis, Ethan
AU - Waks, Jonathan W.
AU - Zimetbaum, Peter
N1 - Funding Information:
The authors would like to thank the following individuals for their contribution to this study: Executive Steering Committee: George Klein, M.D., Michael Ezekowitz, M.B.Ch.B. Data Safety Monitoring Board: StephenKimmel, M.D., M.S.C.E. (chairperson), James Daubert, M.D., Alejandro Rabinstein, M.D. Neurological Adjudication Events Committee: Sandeep Kumar, M.D., David Searls, M.D., Vasileios Arsenios Lioutas, M.D.
Publisher Copyright:
© 2015 Wiley Periodicals, Inc.
PY - 2016/3/1
Y1 - 2016/3/1
N2 - The Rhythm Evaluation for Anticoagulation With Continuous Monitoring 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.
AB - The Rhythm Evaluation for Anticoagulation With Continuous Monitoring 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.
KW - REVEAL
KW - TIA
KW - anticoagulation
KW - atrial fibrillation
KW - implantable cardiac monitor
KW - stroke
UR - http://www.scopus.com/inward/record.url?scp=84960803779&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84960803779&partnerID=8YFLogxK
U2 - 10.1111/jce.12864
DO - 10.1111/jce.12864
M3 - Article
C2 - 26511221
AN - SCOPUS:84960803779
SN - 1045-3873
VL - 27
SP - 264
EP - 270
JO - Journal of Cardiovascular Electrophysiology
JF - Journal of Cardiovascular Electrophysiology
IS - 3
ER -