Table 3.
All-Cause Mortality in the Matched Groups
Kaplan-Meier Mortality Rate, % (95% CI)
|
ICD Registry vs Trial Patients With ICDs
|
ICD Registry vs Trial Patients Receiving Medical Therapy
|
|||||
---|---|---|---|---|---|---|---|
Trial-like Registry Patients | ICD-Randomized Trial Patients | Medical Therapy–Randomized Trial Patients | Adjusted HR (95% CI) | P Value | Adjusted HR (95% CI) | P Value | |
All Patients | |||||||
MADIT-II | |||||||
Year 1 | 7.3 (6.2–8.3) | 8.9 (6.7–11.1) | 10.2 (7.4–13.1) | 1.06 (0.85–1.31) | .62 | 0.73 (0.59–0.92) | .007 |
| |||||||
Year 2 | 13.9 (12.6–15.3) | 15.6 (12.4–18.7) | 22.0 (17.6–26.4) | ||||
| |||||||
Total deaths, No. | 507 | 105 | 97 | ||||
| |||||||
Patients, No. | 2464 | 742 | 490 | ||||
| |||||||
SCD-HeFT | |||||||
Year 1 | 5.6 (4.8–6.4) | 6.2 (4.5–7.8) | 5.9 (4.3–7.5) | 1.16 (0.97–1.38) | .11 | 0.82 (0.70–0.96) | .01 |
| |||||||
Year 2 | 11.3 (10.3–12.4) | 11.7 (9.5–13.9) | 14.5 (12.1–16.9) | ||||
| |||||||
Year 3 | 17.3 (16.0–18.7) | 17.4 (14.7–20.0) | 22.4 (19.5–25.2) | ||||
| |||||||
Total deaths, No. | 588 | 182 | 244 | ||||
| |||||||
Patients, No. | 3352 | 829 | 847 | ||||
| |||||||
Patients ≥65 y | |||||||
MADIT-II | |||||||
Year 1 | 9.2 (7.6–10.8) | 10.8 (7.5–14.1) | 14.1 (9.6–18.7) | 1.02 (0.78–1.33) | .88 | 0.65 (0.49–0.85) | .002 |
| |||||||
Year 2 | 16.5 (14.5–18.5) | 19.8 (14.9–24.7) | 31.5 (24.6–38.5) | ||||
| |||||||
Total deaths, No. | 333 | 70 | 70 | ||||
| |||||||
Patients, No. | 1306 | 397 | 262 | ||||
| |||||||
SCD-HeFT | |||||||
Year 1 | 7.1 (5.6–8.6) | 8.8 (5.6–12.1) | 7.7 (4.6–10.9) | 1.05 (0.81–1.36) | .73 | 0.76 (0.60–0.96) | .02 |
| |||||||
Year 2 | 14.8 (12.7–16.8) | 16.0 (11.8–20.2) | 18.7 (14.1–23.2) | ||||
| |||||||
Year 3 | 21.8 (19.2–24.4) | 24.8 (19.7–29.9) | 30.2 (24.8–35.7) | ||||
| |||||||
Total deaths, No. | 255 | 94 | 107 | ||||
| |||||||
Patients, No. | 1132 | 294 | 284 |
Abbreviations: HR, hazard ratio; ICD, implantable cardioverter-defibrillator; MADIT-II, Multicenter Automatic Defibrillator Implantation Trial II; SCD-HeFT, Sudden Cardiac Death in Heart Failure Trial.