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August 11, 2026New England Journal of Medicine6,339 citationsOpen Access

A Randomized Trial of Intensive versus Standard Blood-Pressure Control

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Key Result

Intensive blood-pressure control (target <120 mm Hg) reduced major cardiovascular events compared to standard control (<140 mm Hg) (HR 0.75; 95% CI 0.64-0.89; P<0.001).

Key Points

  • The trial aims to determine if intensive systolic blood pressure control reduces cardiovascular events more effectively than standard control in individuals without diabetes.
  • Randomly assigned 9361 individuals with systolic blood pressure ≥ 130 mm Hg and increased cardiovascular risk.
  • Intensive treatment target was <120 mm Hg, while standard treatment target was <140 mm Hg.
  • Primary outcome measured included major cardiovascular events over a median follow-up of 3.26 years.
  • Intensive treatment group experienced a significantly lower primary composite outcome rate of 1.65% per year versus 2.19% in the standard group (HR 0.75, 95% CI 0.64 to 0.89, P<0.001).
  • All-cause mortality was also reduced in the intensive group with a hazard ratio of 0.73 (95% CI 0.60 to 0.90, P=0.003).
  • Serious adverse events, particularly hypotension and electrolyte abnormalities, were higher in the intensive-treatment group.

Study Design

Type

RCT (n=9,361)

Structured PICO

Does intensive blood-pressure control (target <120 mm Hg) reduce cardiovascular events in high-risk patients without diabetes compared to standard control (target <140 mm Hg)?

P
Population
9,361 persons with systolic blood pressure ≥130 mm Hg and increased cardiovascular risk but without diabetes, followed for a median of 3.26 years.
I
Intervention
Intensive treatment to a systolic blood-pressure target of less than 120 mm Hg
C
Comparator
Standard treatment to a systolic blood-pressure target of less than 140 mm Hg
O
Outcome
Composite of myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causescomposite

In high-risk patients without diabetes, targeting a systolic blood pressure of <120 mm Hg significantly reduces major cardiovascular events and all-cause mortality compared to a target of <140 mm Hg, albeit with an increased risk of certain adverse events.

Main Result

Hazard Ratio: 0.75 (95% CI 0.64–0.89)

Absolute Event Rate: 1.65% vs 2.19%

p-value: p=<0.001

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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Cite This Study

A 2015 study conducted an RCT in Hypertension with increased cardiovascular risk (n=9,361). Intensive blood-pressure control (target <120 mm Hg) vs. Standard blood-pressure control (target <140 mm Hg) was evaluated on myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes (HR 0.75, 95% CI 0.64 to 0.89, p=<0.001). Intensive blood-pressure control (target <120 mm Hg) reduced major cardiovascular events compared to standard control (<140 mm Hg) (HR 0.75; 95% CI 0.64-0.89; P<0.001).

synapsesocial.com/papers/6a7b750964158d369a3e365ehttps://doi.org/10.1056/nejmoa1511939
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