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A Randomized Trial of Intensive versus Standard Blood-Pressure Control

Why this mattered

SPRINT mattered because it changed hypertension treatment from a debate over population-level “reasonable control” to a randomized demonstration that, for many high-risk adults without diabetes, pushing systolic blood pressure substantially lower could prevent major cardiovascular events and deaths. Earlier practice often treated <140 mm Hg as the main therapeutic threshold, partly because the marginal benefit and safety of lower targets were uncertain. SPRINT showed that targeting <120 mm Hg, compared with <140 mm Hg, produced fewer myocardial infarctions, acute coronary syndromes, strokes, heart-failure events, cardiovascular deaths, and deaths from any cause, with the trial stopped early after a median 3.26 years because of benefit.

Its paradigm-shifting force came from making intensive blood-pressure control clinically actionable rather than merely epidemiologically plausible. The trial did not say “lower is always better” for every patient: it excluded people with diabetes, prior stroke, and some other groups, and intensive treatment increased serious adverse events such as hypotension, syncope, electrolyte abnormalities, and acute kidney injury or failure. But it gave clinicians and guideline writers strong randomized evidence that a lower systolic target could be worth pursuing in selected high-risk patients, provided harms were monitored carefully.

After SPRINT, hypertension care increasingly centered on individualized cardiovascular-risk reduction rather than a single universal threshold. The trial helped motivate lower treatment targets in subsequent blood-pressure guidelines and shaped later work on implementation, medication intensification, home and automated blood-pressure measurement, kidney safety, frailty, and older-adult hypertension management. Its legacy is not simply the number “120,” but the proof that aggressive risk-factor modification, tested in a large pragmatic randomized trial, could measurably reduce mortality in a common chronic condition.

Abstract

BACKGROUND: The most appropriate targets for systolic blood pressure to reduce cardiovascular morbidity and mortality among persons without diabetes remain uncertain. METHODS: We randomly assigned 9361 persons with a systolic blood pressure of 130 mm Hg or higher and an increased cardiovascular risk, but without diabetes, to a systolic blood-pressure target of less than 120 mm Hg (intensive treatment) or a target of less than 140 mm Hg (standard treatment). The primary composite outcome was myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes. RESULTS: At 1 year, the mean systolic blood pressure was 121.4 mm Hg in the intensive-treatment group and 136.2 mm Hg in the standard-treatment group. The intervention was stopped early after a median follow-up of 3.26 years owing to a significantly lower rate of the primary composite outcome in the intensive-treatment group than in the standard-treatment group (1.65% per year vs. 2.19% per year; hazard ratio with intensive treatment, 0.75; 95% confidence interval [CI], 0.64 to 0.89; P<0.001). All-cause mortality was also significantly lower in the intensive-treatment group (hazard ratio, 0.73; 95% CI, 0.60 to 0.90; P=0.003). Rates of serious adverse events of hypotension, syncope, electrolyte abnormalities, and acute kidney injury or failure, but not of injurious falls, were higher in the intensive-treatment group than in the standard-treatment group. CONCLUSIONS: Among patients at high risk for cardiovascular events but without diabetes, targeting a systolic blood pressure of less than 120 mm Hg, as compared with less than 140 mm Hg, resulted in lower rates of fatal and nonfatal major cardiovascular events and death from any cause, although significantly higher rates of some adverse events were observed in the intensive-treatment group. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01206062.).

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