INTRODUCTION: The appropriate targets for managing systolic blood pressure to lower cardiovascular morbidity and mortality among individuals with diabetes is still unambiguous. In a clinical trial among patients at high risk for cardiovascular events but without diabetes, focusing on systolic blood pressure below 120 mm Hg compared with less than 140 mm Hg led to reduced rates of fatal and nonfatal significant cardiovascular event and death due to any reason, even though the considerably higher frequency of some adverse events was seen in the intensive treatment group. However, data on certain outcome events should be adjudicated and post-trial was not collected in this study. 

METHOD: An adjudication of the additional primary outcome events occurring through the end of the intervention period following data lock underwent primary analysis. A post-trial observational analysis of the follow-up data was also conducted. In this, 9361 patients at increased risk for cardiovascular disease but did not have diabetes or prior stroke included in the study were randomly assigned to adhere to an intensive treatment target (systolic blood pressure, <120 mm Hg; 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. 

RESULTS: After the median 3.33 years of follow-up, the rate of the primary outcome and all-cause mortality during the trial were considerably reduced in the intensive-treatment group compared with 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 side effects reported were hypotension, electrolyte abnormalities, acute kidney injury or failure, and syncope were significantly more frequent in the intensive treatment group. Following the combination of trial and post-trial follow-up data were combined (3.88 years in total), similar trends were identified for treatment benefit and adverse events; however, rates of heart failure did not differ between the groups. 

CONCLUSION: The results concluded that among patients at an increased cardiovascular risk, a target of achieving a systolic blood pressure below 120 mm Hg led to a reduction in major adverse cardiovascular events and reduced all-cause mortality compared with systolic blood pressure under 140 mm Hg. Besides, rates of specific adverse events were more in the intensive-treatment group. 

Reference: 

1. The SPRINT Research Group. A randomized trial of intensive versus standard blood-pressure control. N Engl J Med. 2015; 373: 2103-2116.
2. The SPRINT Research Group. Final report of a trial of intensive versus standard blood-pressure control. N Engl J Med. 2021; 384:1921-1930.