Table 2.
Treatment Received during the Trial Period.*
| Treatment | Device Group (N = 1524) |
Control Group (N = 778) |
P Value |
|---|---|---|---|
| Wearable cardioverter-defibrillator | |||
| Patients with device — no. (%)† | 1481 (97.2) | 20 (2.6) | <0.001 |
| Hours per day that device was worn during follow-up‡ | |||
| Median (IQR) | 18.0 (3.8–22.7) | 0.0 (0.0–0.0) | <0.001 |
| Mean | 14.0±9.3 | 0.4±2.7 | <0.001 |
| Implantable cardioverter-defibrillator | |||
| Patients with device — no. (%)§ | 67 (4.4) | 44 (5.7) | 0.18 |
| Median no. of days from randomization to implantation (IQR) | 62 (24–81) | 58 (25–77) | 0.33 |
| Medication use — no. (%)¶ | |||
| Aspirin | 1329 (87.2) | 678 (87.1) | 0.97 |
| Other antiplatelet agent | 1379 (90.5) | 680 (87.4) | 0.02 |
| Statin | 1386 (90.9) | 696 (89.5) | 0.25 |
| Beta-blocker, including carvedilol | 1411 (92.6) | 720 (92.5) | 0.97 |
| ACE inhibitor or ARB | 1334 (87.5) | 667 (85.7) | 0.23 |
| Eplerenone or spironolactone | 662 (43.4) | 343 (44.1) | 0.77 |
| Other diuretic agent | 736 (48.3) | 385 (49.5) | 0.59 |
| Amiodarone | 106 (7.0) | 55 (7.1) | 0.92 |
| Other antiarrhythmic agent of class IA, IC, or III | 5 (0.3) | 4 (0.5) | 0.50 |
| Digoxin | 86 (5.6) | 44 (5.7) | 0.99 |
P values were not corrected for multiple comparisons. ACE denotes angiotensin-converting enzyme, and ARB angio- tensin-receptor blocker
The use of any wearable cardioverter-defibrillator by participants in the control group was a protocol violation
The number of hours per day that the wearable cardioverter-defibrillator was worn included follow-up days after discharge from the hospital and before death or implantable cardioverter-defibrillator (ICD) implantation and also included participants who did not wear it at all (0 hours per day on those days) in the two groups in order to describe the difference in the device coverage according to group. A total of 11 participants (4 in the device group and 7 in the control group) who died before discharge from the hospital were excluded from this analysis
The implantation of an ICD in a participant in either group before 90 days of follow-up, unless for acceptable clinical indications for secondary prevention (e.g., cardiac arrest or sustained ventricular tachycardia during follow-up), was a protocol violation (Table S6 in the Supplementary Appendix)
Participants provided details regarding medication use at follow-up visits