Table 3.
Clinical outcomes by sex in implantable cardioverter–defibrillator (ICD) randomized controlled trial treatment arms
| Clinical outcome∗ | Total, n | Male sex, n | Female sex, n | Odds ratio (95% CI) | P |
|---|---|---|---|---|---|
| ICD arm | |||||
| All-cause death and HFH | 108/904 | 90/732 | 18/172 | 0.83 (0.49, 1.42) | 0.51 |
| All-cause death | 131/2289 | 106/1776 | 25/513 | 0.86 (0.55, 1.35) | 0.51 |
| HFH | 71/904 | 58/732 | 13/172 | 0.95 (0.51, 1.78) | 0.87 |
| CV death | 48/904 | 39/732 | 9/172 | 0.98 (0.47, 2.07) | 0.96 |
| CV death (non-arrhythmic) | 5/229 | 3/166 | 2/63 | 1.78 (0.29, 10.92) | 0.53 |
| Arrhythmic death | 2/229 | 2/166 | 0/63 | 0.52 (0.03, 10.94) | 0.67 |
| Ventricular arrhythmia | 133/904 | 111/732 | 22/172 | 0.82 (0.50, 1.34) | 0.43 |
| Comparator arm | |||||
| All-cause death and HFH | 88/894 | 80/758 | 8/136 | 0.53 (0.25, 1.12) | 0.10 |
| All-cause death | 130/2299 | 109/1801 | 21/498 | 0.68 (0.42, 1.10) | 0.12 |
| HFH | 52/894 | 48/758 | 4/136 | 0.45 (0.16, 1.26) | 0.13 |
| CV death | 39/894 | 34/758 | 5/136 | 0.81 (0.31, 2.12) | 0.67 |
| CV death (non-arrhythmic) | 6/229 | 3/160 | 3/69 | 2.38 (0.46, 12.10) | 0.30 |
| Arrhythmic death | 7/229 | 5/160 | 2/69 | 0.92 (0.17, 4.90) | 0.93 |
| Ventricular arrhythmia | 125/894 | 113/758 | 12/136 | 0.55 (0.29, 1.03) | 0.06 |
| Comparator arm 2 | |||||
| All-cause death | 50/847 | 41/655 | 9/192 | 0.75 (0.35, 1.57) | 0.44 |
CV, cardiovascular; HFH, heart failure hospitalization.
∗
Number of events per total patients in group at 1 year, unless otherwise stated.