Final report of a trial of intensive versus standard blood-pressure control

Academic Article


  • BACKGROUND In a previously reported randomized trial of standard and intensive systolic bloodpressure control, data on some outcome events had yet to be adjudicated and posttrial follow-up data had not yet been collected. METHODS We randomly assigned 9361 participants who were at increased risk for cardiovascular disease but did not have diabetes or previous stroke to adhere to an intensive treatment target (systolic blood pressure, <120 mm Hg) or a standard treatment target (systolic blood pressure, <140 mm Hg). The primary outcome was a composite of myocardial infarction, other acute coronary syndromes, stroke, acute decompensated heart failure, or death from cardiovascular causes. Additional primary outcome events occurring through the end of the intervention period (August 20, 2015) were adjudicated after data lock for the primary analysis. We also analyzed post-trial observational follow-up data through July 29, 2016. RESULTS At a median of 3.33 years of follow-up, the rate of the primary outcome and allcause mortality during the trial were significantly lower in the intensive-treatment group than in the standard-treatment group (rate of the primary outcome, 1.77% per year vs. 2.40% per year; hazard ratio, 0.73; 95% confidence interval [CI], 0.63 to 0.86; all-cause mortality, 1.06% per year vs. 1.41% per year; hazard ratio, 0.75; 95% CI, 0.61 to 0.92). Serious adverse events of hypotension, electrolyte abnormalities, acute kidney injury or failure, and syncope were significantly more frequent in the intensive-treatment group. When trial and post-trial follow-up data were combined (3.88 years in total), similar patterns were found for treatment benefit and adverse events; however, rates of heart failure no longer differed between the groups. CONCLUSIONS Among patients who were at increased cardiovascular risk, targeting a systolic blood pressure of less than 120 mm Hg resulted in lower rates of major adverse cardiovascular events and lower all-cause mortality than targeting a systolic blood pressure of less than 140 mm Hg, both during receipt of the randomly assigned therapy and after the trial. Rates of some adverse events were higher in the intensivetreatment group. (Funded by the National Institutes of Health; SPRINT ClinicalTrials .gov number, NCT01206062.).
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    Author List

  • Lewis CE; Fine LJ; Beddhu S; Cheung AK; Cushman WC; Cutler JA; Evans GW; Johnson KC; Kitzman DW; Oparil S
  • Start Page

  • 1921
  • End Page

  • 1930
  • Volume

  • 384
  • Issue

  • 20