Table 4. Primary and Secondary Outcomes.*.
Outcome | Intensive Therapy (N = 5128) | Standard Therapy (N = 5123) | Hazard Ratio (95% CI) |
P Value | ||
---|---|---|---|---|---|---|
no. of patients (%) | % per yr | no. of patients (%) | % per yr | |||
Primary outcome | 352 (6.9) | 2.11 | 371 (7.2) | 2.29 | 0.90 (0.78–1.04) | 0.16 |
Secondary outcome | ||||||
Death | ||||||
Any cause | 257 (5.0) | 1.41 | 203 (4.0) | 1.14 | 1.22 (1.01–1.46) | 0.04 |
Cardiovascular causes | 135 (2.6) | 0.79 | 94 (1.8) | 0.56 | 1.35 (1.04–1.76) | 0.02 |
Nonfatal myocardial infarction | 186 (3.6) | 1.11 | 235 (4.6) | 1.45 | 0.76 (0.62–0.92) | 0.004 |
Nonfatal stroke | 67 (1.3) | 0.39 | 61 (1.2) | 0.37 | 1.06 (0.75–1.50) | 0.74 |
Fatal or nonfatal congestive heart failure |
152 (3.0) | 0.90 | 124 (2.4) | 0.75 | 1.18 (0.93–1.49) | 0.17 |
Causes of death | ||||||
Any | 257 (5.0) | 1.41 | 203 (4.0) | 1.14 | 1.22 (1.01–1.46) | 0.04 |
Unexpected or presumed cardio- vascular disease† |
86 (1.7) | 67 (1.3) | ||||
Fatal myocardial infarction† | 19 (0.4) | 13 (0.3) | ||||
Fatal congestive heart failure† | 23 (0.4) | 16 (0.3) | ||||
Fatal procedure† | ||||||
For cardiovascular disease | 10 (0.2) | 3 (0.1) | ||||
For noncardiovascular disease | 1 (<0.1) | 3 (0.1) | ||||
Fatal arrhythmia† | 4 (0.1) | 10 (0.2) | ||||
Fatal stroke† | 9 (0.2) | 11 (0.2) | ||||
Other cardiovascular disease† | 8 (0.2) | 10 (0.2) | ||||
Cancer | 65 (1.3) | 63 (1.2) | ||||
Condition other than cancer or cardiovascular disease‡ |
50 (1.0) | 35 (0.7) | ||||
Undetermined | 7 (0.1) | 11 (0.2) |
The primary outcome was the first occurrence of nonfatal myocardial infarction or nonfatal stroke or death from cardiovascular causes. Data within categories are not mutually exclusive, and patients who were classified as having more than one possible cause of death are listed in the relevant categories. Hazard ratios are for the intensive-therapy group as compared with the standard-therapy group.
This condition was a component of the outcome of fatal cardiovascular disease.
Additional details are provided in the Supplementary Appendix.