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. Author manuscript; available in PMC: 2015 Aug 28.
Published in final edited form as: N Engl J Med. 2008 Jun 6;358(24):2545–2559. doi: 10.1056/NEJMoa0802743

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.