Final Report of a Trial of Intensive versus Standard Blood-Pressure Control.
Level 2 - randomized trial
Individual randomized controlled trial
PubMed 34010531 · doi:10.1056/NEJMoa1901281
What was done
In this multicenter randomized controlled trial (SPRINT), 9,361 participants at increased cardiovascular risk without diabetes or prior stroke were assigned to an intensive systolic blood pressure target (<120 mm Hg) or a standard target (<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. The study evaluated adjudicated events through the end of the intervention (median follow-up 3.33 years) and combined trial and post-trial observational follow-up (3.88 years total).
What was found
During the trial period, the primary composite outcome rate was 1.77% per year in the intensive group versus 2.40% per year in the standard group (HR 0.73; 95% CI, 0.63 to 0.86). All-cause mortality was 1.06% per year versus 1.41% per year (HR 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 with intensive treatment. In combined trial and post-trial follow-up, benefits and adverse event patterns persisted, though heart failure rates no longer differed significantly.
Why it matters
This final report confirms that intensive systolic blood pressure lowering below 120 mm Hg yields sustained reductions in major cardiovascular events and total mortality among high-risk patients without diabetes.
Limits
The trial excluded individuals with diabetes or prior stroke, limiting generalizability to those groups. Intensive lowering increased serious adverse events including acute kidney injury, hypotension, and syncope, and open-label treatment assignment may introduce performance bias.
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.