Intermittent vs. Continuous Anticoagulation theRapy in patiEnts with Atrial Fibrillation (iCARE-AF): a randomized pilot study.
OBJECTIVE
We hypothesized that intermittent anticoagulation based on daily rhythm monitoring using the novel oral anticoagulants (NOACs) is feasible and safe among patients with paroxysmal atrial fibrillation (AF).


METHODS
Patients with paroxysmal AF and ≥1 risk factors for stroke were randomized to either intermittent or continuous anticoagulation. Those in the intermittent group were instructed to transmit a daily ECG using an iPhone-based rhythm monitoring device. If AF was detected, patients received one of the NOACs for 48 h-1 week. Patients who failed to transmit an ECG for three consecutive days or more than 7 days total were crossed over to continuous anticoagulation. Patients in the continuous group received one of the NOACs.


RESULTS
Fifty-eight patients were randomized to either intermittent (n = 29) or continuous anticoagulation (n = 29). Over a median follow-up of 20 months, 20 patients in the intermittent group failed to submit a daily ECG at least once (median three failed submissions). Four patients (14 %) crossed over to continuous anticoagulation due to failure to submit an ECG for three consecutive days. One stroke (continuous group) occurred during the study. Major bleeding occurred in two patients in the continuous and one patient in the intermittent group, after crossing over to continuous anticoagulation. In a prespecified per-protocol analysis, gastrointestinal bleeding was more frequent in the continuous group (16 vs. 0 %; p = 0.047).


CONCLUSIONS
Intermittent anticoagulation based on daily rhythm monitoring is feasible and may decrease bleeding in low-risk patients with paroxysmal AF. A larger trial, adequately powered to detect clinical outcomes, is warranted.
Cardiovascular Section, Department of Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA. stavros-stavrakis@ouhsc.edu.|Heart Rhythm Institute, University of Oklahoma Health Sciences Center, 1200 Everett Drive, TCH 6E103, Oklahoma City, OK, 73104, USA. stavros-stavrakis@ouhsc.edu.
Stavros
http://orcid.org/0000-0002-4370-8135
S
Stavrakis
Department of Biostatistics and Epidemiology, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.
Julie A
JA
Stoner
Cardiovascular Section, Department of Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.
Joel
J
Kardokus
Cardiovascular Section, Department of Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.|Heart Rhythm Institute, University of Oklahoma Health Sciences Center, 1200 Everett Drive, TCH 6E103, Oklahoma City, OK, 73104, USA.
Paul J
PJ
Garabelli
Cardiovascular Section, Department of Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.|Heart Rhythm Institute, University of Oklahoma Health Sciences Center, 1200 Everett Drive, TCH 6E103, Oklahoma City, OK, 73104, USA.
Sunny S
SS
Po
Cardiovascular Section, Department of Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.|Heart Rhythm Institute, University of Oklahoma Health Sciences Center, 1200 Everett Drive, TCH 6E103, Oklahoma City, OK, 73104, USA.
Ralph
R
Lazzara
D000925:Anticoagulants / Q000008:administration & dosage*; D001281:Atrial Fibrillation / Q000150:complications / Q000188:drug therapy*; D015897:Comorbidity; D004334:Drug Administration Schedule; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000453:epidemiology* / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009825:Oklahoma / Q000453:epidemiology; D010865:Pilot Projects; D015995:Prevalence; D012307:Risk Factors; D020521:Stroke / Q000453:epidemiology* / Q000517:prevention & control*; D016896:Treatment Outcome
D000925:Anticoagulants
Anticoagulation; Atrial fibrillation; Bleeding; Remote monitoring
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