Table 2. Primary and Secondary Outcomes by Intention-to-Treat Analysis.

Outcome	Participants, No. (%)		Rate difference, % (95% CI)
	Continuous monitoring (n = 163)	Usual care (n = 173)
Primary outcome: patients with a cumulative duration of AF or AFL lasting ≥6 min or 12-lead ECG demonstrating AF or AFL detected in first 30 d	32 (19.6)	3 (1.7)	17.9 (11.5 to 24.3)a
Components of the primary outcome
Patients with a cumulative duration of AF or AFL lasting ≥6 min in first 30 d	30 (18.4)	0	18.4 (12.5 to 24.4)a
Patients with at least 1 episode of 12-lead ECG detected AF or AFL in first 30 d	6 (3.7)	3 (1.7)	1.9 (–1.5 to 5.4)
Secondary outcomes
Patients with cumulative duration of AF or AFL lasting ≥6 h in first 30 d	14 (8.6)	0	8.6 (4.3 to 12.9)a
Patients with cumulative duration of AF or AFL lasting ≥24 h in first 30 d	5 (3.1)	0	3.1 (0.4 to 5.7)
Patients with non–protocol-mandated Holter or event recorder in first 30 d	5 (3.1)	4 (2.3)	0.8 (–2.7 to 4.2)
Patients with prescription of oral anticoagulation in first 45 d	7 (4.3)	4 (2.3)	2.0 (–1.9 to 5.8)
Patients with prescription of oral anticoagulation after 45 d	6 (3.7)	5 (2.9)	0.8 (–3.0 to 4.6)
Patients with major bleeding in first 45 d	0	1 (0.6)	–0.6 (–1.7 to 0.6)
Patients with major bleeding after 45 d	1 (0.6)	3 (1.7)	–1.1 (–3.4 to 1.2)
Patients who experienced death, myocardial infarction, ischemic stroke, or non-CNS thromboembolism in first 45 d	1 (0.6)	1 (0.6)	0.0 (–1.6 to 1.7)
Patients who experienced death, myocardial infarction, ischemic stroke, or non-CNS thromboembolism after 45 d	1 (0.6)	3 (1.7)	–1.1 (–3.4 to 1.2)
Patients who experienced adverse events associated with the use of protocol-mandated monitoring within 30 d after randomization	17 (10.4)	0	10.4 (5.7 to 15.1)a

Abbreviations: AF, atrial fibrillation; AFL, atrial flutter; CNS, central nervous system; ECG, electrocardiogram.

^aP < .001.