A Randomized Trial of Intensive versus Standard Blood-Pressure Control.
Level 2 - randomized trial
Large multicenter randomized controlled trial
PubMed 26551272 · doi:10.1056/NEJMoa1511939
What was done
A multicenter randomized controlled trial evaluated 9,361 individuals with systolic blood pressure of 130 mm Hg or higher and increased cardiovascular risk, but without diabetes. Participants were randomly assigned to an intensive systolic blood-pressure target of less than 120 mm Hg or a standard target of less than 140 mm Hg. The primary composite outcome was myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes.
What was found
At 1 year, mean systolic blood pressure was 121.4 mm Hg in the intensive-treatment group versus 136.2 mm Hg in the standard-treatment group. The trial was stopped early after a median follow-up of 3.26 years due to efficacy. The intensive-treatment group showed a significantly lower annual rate of the primary composite outcome (1.65% vs. 2.19% per year; HR 0.75, 95% CI 0.64 to 0.89, P<0.001) and lower all-cause mortality (HR 0.73, 95% CI 0.60 to 0.90, P=0.003). Rates of serious adverse events including hypotension, syncope, electrolyte abnormalities, and acute kidney injury or failure were higher in the intensive group, while injurious falls showed no significant difference.
Why it matters
This study provides definitive evidence that lowering systolic blood pressure to below 120 mm Hg improves cardiovascular and mortality outcomes in high-risk patients without diabetes.
Limits
The trial excluded individuals with diabetes, limiting applicability to that population. Early trial termination may overestimate treatment benefits, and intensive therapy carried a higher risk of adverse events including acute kidney injury and hypotension.
Cited by
- supports The SPRINT trial demonstrated that maintaining blood pressure at 120/80 mmHg or lower provides superior cardiovascular outcomes compared to higher targets.