Definitions of study outcomes are outlined in the Supplementary Appendix . A committee whose members were unaware of the study-group assignments adjudicated the clinical outcomes specified in the protocol. The primary hypothesis was that treatment to reach a systolic blood-pressure target of less than 120 mm Hg, as compared with a target of less than 140 mm Hg, would result in a lower rate of the composite outcome of myocardial infarction, acute coronary syndrome not resulting in myocardial infarction, stroke, acute decompensated heart failure, or death from cardiovascular causes. Secondary outcomes included the individual components of the primary composite outcome, death from any cause, and the composite of the primary outcome or death from any cause.
We also assessed renal outcomes, using a different definition for patients with chronic kidney disease (eGFR <60 ml per minute per 1.73 m2) at baseline and those without it. The renal outcome in participants with chronic kidney disease at baseline was a composite of a decrease in the eGFR of 50% or more (confirmed by a subsequent laboratory test) or the development of ESRD requiring long-term dialysis or kidney transplantation. In participants without chronic kidney disease at baseline, the renal outcome was defined by a decrease in the eGFR of 30% or more to a value of less than 60 ml per minute per 1.73 m2. Incident albuminuria, defined for all study participants by a doubling of the ratio of urinary albumin (in milligrams) to creatinine (in grams) from less than 10 at baseline to greater than 10 during follow-up, was also a prespecified renal outcome.
Prespecified subgroups of interest for all outcomes were defined according to status with respect to cardiovascular disease at baseline (yes vs. no), status with respect to chronic kidney disease at baseline (yes vs. no), sex, race (black vs. non-black), age (<75 vs. ≥75 years), and baseline systolic blood pressure in three levels (≤132 mm Hg, >132 to <145 mm Hg, and ≥145 mm Hg). We also planned a comparison of the effects of systolic blood-pressure targets on incident dementia, changes in cognitive function, and cerebral small-vessel ischemic disease; these results are not presented here.
We also assessed renal outcomes, using a different definition for patients with chronic kidney disease (eGFR <60 ml per minute per 1.73 m2) at baseline and those without it. The renal outcome in participants with chronic kidney disease at baseline was a composite of a decrease in the eGFR of 50% or more (confirmed by a subsequent laboratory test) or the development of ESRD requiring long-term dialysis or kidney transplantation. In participants without chronic kidney disease at baseline, the renal outcome was defined by a decrease in the eGFR of 30% or more to a value of less than 60 ml per minute per 1.73 m2. Incident albuminuria, defined for all study participants by a doubling of the ratio of urinary albumin (in milligrams) to creatinine (in grams) from less than 10 at baseline to greater than 10 during follow-up, was also a prespecified renal outcome.
Prespecified subgroups of interest for all outcomes were defined according to status with respect to cardiovascular disease at baseline (yes vs. no), status with respect to chronic kidney disease at baseline (yes vs. no), sex, race (black vs. non-black), age (<75 vs. ≥75 years), and baseline systolic blood pressure in three levels (≤132 mm Hg, >132 to <145 mm Hg, and ≥145 mm Hg). We also planned a comparison of the effects of systolic blood-pressure targets on incident dementia, changes in cognitive function, and cerebral small-vessel ischemic disease; these results are not presented here.
