Table. Baseline Characteristics of Participants in a Study of Long-term Continuous Cardiac Monitoring vs Usual Care on Detection of Atrial Fibrillation in Patients With Stroke Attributed to Large- or Small-Vessel Disease.
| Characteristic | No. (%) | |
|---|---|---|
| Insertable cardiac monitor (n = 242)a | Usual care (n = 250) | |
| Age, mean (SD), y | 66.6 (9.3) [n = 240] | 67.5 (9.5) |
| Age <65 y | 107/240 (44.2) | 108 (43.2) |
| Age 65-74 y | 81/240 (33.5) | 77 (30.8) |
| Age ≥75 y | 52/240 (21.5) | 65 (26.0) |
| Men | 144/240 (60.0) | 161 (64.4) |
| Women | 96/240 (40.0) | 89 (35.6) |
| CHA2DS2-VASc score, median (IQR)b | 5.0 (4.0-5.0) | 5.0 (4.0-6.0) |
| Comorbidities/risk factors | ||
| Stroke | 242 (100.0) | 250 (100.0) |
| Hypertension | 197 (81.4) | 200 (80.0) |
| Smoking tobacco | 130 (53.7) | 133 (53.2) |
| Diabetes | 87 (36.0) | 100 (40.0) |
| Vascular disease | 45 (18.6) | 47 (18.8) |
| Congestive heart failure | 28 (11.6) | 23 (9.2) |
| TOAST classificationc | ||
| Large-vessel disease | 140 (57.9) | 142 (56.8) |
| Small-vessel disease | 100 (41.3) | 108 (43.2) |
| CT only | 13 (5.4) | 11 (4.4) |
| MRI only | 11 (4.5) | 20 (8.0) |
| Both CT and MRI | 211 (87.2) | 219 (87.6) |
| Neither CT nor MRI | 7 (2.9) | 0 |
| NIHSS score, median (IQR)d | 2.0 (1.0-4.0) | 2.0 (1.0-5.0) |
Abbreviations: CT, computed tomography; IQR, interquartile range; MRI, magnetic resonance imaging; TIA, transient ischemic attack.
Unless otherwise noted. Two patients in the ICM group for whom age and sex are not known exited the study early. One patient exited the same day of randomization and the other patient exited a day after being randomized. Both patients met the inclusion criterion stating that the patient had an ischemic stroke believed to be due to small-vessel disease or large-vessel cervical or intracranial atherosclerosis within the past 10 days of enrollment. This information was used to calculate a CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke or TIA, vascular disease, age 65 to 74 years, sex category) score of 2. Type of qualifying stroke event was provided at the enrollment case report form and was used as the TOAST (Trial of Org 10172 in Acute Stroke Treatment) classification of subtypes of acute ischemic stroke.
Scores on the CHA2DS2-VASc risk assessment range from 0 to 9, with higher scores indicating a greater risk of stroke. A score of 5 corresponds to an estimated stroke risk of 7.2% per year.14
The TOAST classification categorizes subtypes of ischemic stroke based on etiology into (1) large-artery atherosclerosis (or large-vessel disease), (2) cardioembolism, (3) small-vessel occlusion (or small-vessel disease), (4) stroke of other determined etiology, and (5) stroke of undetermined etiology.
Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits. An NIHSS score of 2 corresponds to a relatively mild stroke.