Table 3.
Incidence of Cardiovascular, Renal, and Mortality Outcomes by Treatment Group
| Intensive Treatment
|
Standard Treatment
|
HR (95% CI)b | P Value | |||
|---|---|---|---|---|---|---|
| No. With Outcome Events (n = 1317)a | % (95% CI) With Outcome Events/y | No. With Outcome Events (n = 1319)a | % (95% CI) With Outcome Events/y | |||
| All participants | ||||||
|
| ||||||
| Cardiovascular disease primary outcomec | 102 | 2.59 (2.13–3.14) | 148 | 3.85 (3.28–4.53) | 0.66 (0.51–0.85) | .001 |
|
| ||||||
| Myocardial infarction (MI)d | 37 | 0.92 (0.67–1.27) | 53 | 1.34 (1.02–1.75) | 0.69 (0.45–1.05) | .09 |
|
| ||||||
| ACS not resulting in MId | 17 | 0.42 (0.26–0.68) | 17 | 0.42 (0.26–0.68) | 1.03 (0.52–2.04) | .94 |
|
| ||||||
| Stroked | 27 | 0.67 (0.46–0.97) | 34 | 0.85 (0.61–1.19) | 0.72 (0.43–1.21) | .22 |
|
| ||||||
| Heart failured | 35 | 0.86 (0.62–1.20) | 56 | 1.41 (1.09–1.83) | 0.62 (0.40–0.95) | .03 |
|
| ||||||
| Cardiovascular disease deathd | 18 | 0.44 (0.28–0.70) | 29 | 0.72 (0.50–1.03) | 0.60 (0.33–1.09) | .09 |
|
| ||||||
| Nonfatal MI | 37 | 0.92 (0.67–1.27) | 53 | 1.34 (1.02–1.75) | 0.69 (0.45–1.05) | .09 |
|
| ||||||
| Nonfatal stroke | 25 | 0.62 (0.42–0.91) | 33 | 0.83 (0.59–1.16) | 0.68 (0.40–1.15) | .15 |
|
| ||||||
| Nonfatal heart failure | 35 | 0.86 (0.62–1.20) | 55 | 1.39 (1.06–1.81) | 0.63 (0.40–0.96) | .03 |
|
| ||||||
| All-cause mortality | 73 | 1.78 (1.41–2.24) | 107 | 2.63 (2.17–3.18) | 0.67 (0.49–0.91) | .009 |
|
| ||||||
| Primary outcome plus all-cause mortality | 144 | 3.64 (3.09–4.29) | 205 | 5.31 (4.63–6.09) | 0.68 (0.54–0.84) | <.001 |
|
| ||||||
| CKD | ||||||
|
| ||||||
| Primary CKD outcomee | 7/584 | 0.38 (0.18–0.81) | 4/577 | 0.23 (0.08–0.60) | 1.68 (0.49–6.59) | .42 |
|
| ||||||
| Incident albuminuriaf | 26/196 | 4.43 (3.02–6.51) | 28/177 | 5.56 (3.84–8.06) | 0.96 (0.53–1.75) | .90 |
|
| ||||||
| Non-CKD | ||||||
|
| ||||||
| Secondary CKD outcomeg | 37/726 | 1.70 (1.23–2.35) | 13/732 | 0.58 (0.34–1.01) | 3.14 (1.66–6.37) | <.001 |
|
| ||||||
| Incident albuminuriaf | 29/303 | 3.31 (2.30–4.76) | 42/304 | 4.84 (3.58–6.55) | 0.80 (0.46–1.35) | .40 |
Abbreviations: ACS, acute coronary syndrome; CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; HR, hazard ratio; IQR, interquartile range.
The total No. of participants is provided if it is different from treatment group total.
Intensive treatment group vs standard treatment group.
Includes nonfatal myocardial infarction, acute coronary syndrome not resulting in a myocardial infarction, nonfatal stroke, nonfatal acute decompensated heart failure, and death from cardiovascular causes. Median follow-up time for the intensive treatment group was 3.16 years (IQR, 2.63–3.70 years), with 3938.2 person-years of follow-up. In the standard treatment group, median follow-up time was 3.12 years (IQR, 2.67–3.67 years), with 3841.0 person-years of follow-up.
These rows do not sum to the cardiovascular disease primary outcome. Only the first event contributes to the primary outcome, whereas participants with multiple events could contribute to each component outcome.
Includes a 50% reduction in eGFR (measured twice at least 90 days apart), dialysis, or a kidney transplant.
Only applies to participants with urinary albumin to creatinine ratio of less than 10 mg/g at baseline, and required a doubling of the urinary albumin to creatinine ratio from less than 10 mg/g to 10 mg/g or greater (measured twice at least 90 days apart).
Includes a 30% reduction in eGFR (measured twice at least 90 days apart) to an eGFR of less than 60 mL/min/1.73m2, dialysis, or a kidney transplant.