Table 2.
Study Outcomes in the Global Sample: Analysis by Sex and Device Interaction
| Unadjusted Analysis | ||||
|---|---|---|---|---|
| Outcome | Event Rate, % (n) | P Value | ||
| Global Sample (n=5539) | Male Sex (n=4702) | Female Sex (n=837) | ||
| Appropriate therapies | 8.2 per 100 patient years (95% CI 7.8–8.7) | 8.6 per 100 patient years (95% CI 8.1–9.1) | 6.0 per 100 patient years (95% CI 5.1–7.1) | <0.001 |
| Early complications | 710 (12.8%) | 599 (12.7%) | 111 (13.3%) | 0.785 |
| Inappropriate shocks | 355 (6.7%) | 302 (6.7%) | 53 (6.7%) | 0.997 |
| Mortality | 4.9 per 100 patient years (95% CI 4.6–5.3) | 5.0 per 100 patient years (95% CI 4.7–5.4) | 4.2 per 100 patient years (95% CI 3.5–5.1) | 0.01 |
|
Multivariate‐Adjusted Analysisa
Odds Ratio/Hazard Ratio (95% CI)—All Patients | ||
|---|---|---|
| Appropriate therapies | HR=0.59 (0.45–0.76) | <0.001 |
| Early complications | OR=1.00 (0.75–1.32) | 0.992 |
| Inappropriate shocks | OR=0.84 (0.50–1.39) | 0.492 |
| Mortality | HR=0.87 (0.66–1.15) | 0.324 |
| VVI and DDD‐ICD patients | ||
| Appropriate therapies | HR=0.76 (0.52–1.11) | 0.159 |
| Early complications | OR=0.83 (0.48–1.43) | 0.498 |
| Inappropriate shocks | OR=0.61 (0.28–1.31) | 0.609 |
| Mortality | HR=1.50 (0.96–2.34) | 0.072 |
| CRT‐D patients | ||
| Appropriate therapies | HR=0.49 (0.34–0.70) | <0.001 |
| Early complications | OR=1.10 (0.78–1.55) | 0.574 |
| Inappropriate shocks | OR=1.08 (0.54–2.18) | 0.828 |
| Mortality | HR=0.68 (0.47–0.97) | 0.034 |
CRT‐D indicates cardiac resynchronization therapy with defibrillator; DDD‐ICD, dual chamber device‐implantable cardioverter defibrillators; HR, hazard ratio; OR, odds ratio; VVI, single chamber device.
a
Adjusted for baseline differences in New York Heart Association class, atrial fibrillation, ischemic cardiomyopathy, QRS width, use of CRT‐D, treatment with β‐blockers, amiodarone, spironolactone, calcium channel blockers, antiplatelet agents, and vitamin K antagonists.