BACKGROUND AND PURPOSE:

• Previous data from the SPRINT trial showed that intensive blood pressure therapy (systolic blood-pressure [SBP] target <120 mm Hg) was associated with fewer clinical events than standard treatment (target <140 mm Hg)
• The SPRINT research group (NEJM, 2021) updated the analysis of all events through 2016 and included data from post-trial close out visits

METHODS:

• 2-arm, multicenter, randomized clinical trial
  • The Systolic Blood Pressure Intervention Trial (SPRINT)
• Participants
  • SBP: 130 to 180 mm Hg
  • With or without antihypertensive medications   
  • ≥1 additional CVD risk factor
  • No diabetes, dementia, or previous stroke
• Interventions
  • Intensive treatment target: SBP <120 mm Hg
  • Standard treatment target: SBP <140 mm Hg
• Study design
  • Additional primary outcome events occurring through the end of the intervention period (August 20, 2015) were adjudicated after data lock for the primary analysis
• Primary outcome
  • Composite of: MI | Other acute coronary syndromes | Stroke | Acute decompensated heart failure | Death from cardiovascular causes

RESULTS:

• 9361 participants | Median 3.3 years follow-up
• Rate of the primary outcome and all-cause mortality were significantly lower in the intensive-treatment group
  • Rate of primary composite outcome
    • Intensive: 1.77% per year
    • Standard: 2.40% per year
    • Hazard ratio (HR) 0.73 (95% CI, 0.63 to 0.86)
  • All-cause mortality
    • Intensive: 1.06% per year
    • Standard: 1.41% per year
    • HR 0.75 (95% CI, 0.61 to 0.92)
• Serious adverse events
  • Significantly more frequent in the intensive-treatment group
  • Hypotension | Electrolyte abnormalities | Acute kidney injury or failure | Syncope
  • Majority of kidney events were solitary and generally mild
  • Hypotension and syncope more likely among those with chronic kidney disease, frailty, or older age
• Combined trial and post-trial follow-up data (3.88 years total)
  • Similar patterns found for treatment benefit and adverse events
  • Rates of heart failure no longer differed between the groups

CONCLUSION:

• For people at an increased risk of cardiovascular events, an intensive treatment target (systolic BP <120 mm Hg) led to fewer cardiovascular events and lower all-cause mortality
• Rates of adverse events were higher in the intensive treatment group
• The authors conclude

When data from the intervention and postintervention periods were combined, the benefits of intensive treatment with respect to the primary outcome and all-cause mortality remained highly significant and similar in magnitude to effects seen during the trial

Learn More – Primary Sources:

Final Report of a Trial of Intensive versus Standard Blood-Pressure Control

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