SPRINT: Intensive BP lowering Superior in Terms of Lowering CV Events & Death vs. Standard BP lowering in High-Risk Patients without Diabetes

Introduction

There is uncertainty over the most appropriate targets for systolic blood pressure (SBP) to reduce cardiovascular (CV) morbidity and mortality in individuals without diabetes.

Aim

To compare the clinical benefits of treating SBP to a target of <120 mm Hg vs. a target of <140 mm Hg

Patient Profile

• Adult patients (age; ≥50 years) with SBP in the range of 130-180 mm Hg, having an increased risk of CV events, but without diabetes (n=9361)

Method

Study Design

Randomized, controlled, open-label trial

Duration of Follow-up

5 years (Median 3.26 years)

Treatment Strategy

Treatment Groups

• Intensive Treatment Group: Therapy adjusted to achieve and maintain a target SBP <120 mm Hg
• Standard Treatment Group: Therapy adjusted to achieve and maintain SBP of 135 to 139 mm Hg

Primary Outcome

• The composite outcome of myocardial infarction (MI), acute coronary syndrome (ACS) not resulting in MI, stroke, acute decompensated heart failure (HF), or death from CV causes

Secondary Outcomes

• The individual components of the primary composite outcome, death from any cause, and the composite of the primary outcome or death from any cause

Renal outcomes

• In patients with chronic kidney disease (CKD): Composite of a decrease in the (eGFR) of ≥50% or the development of end stage renal disease (ESRD) requiring long-term dialysis or kidney transplantation
•  In patients without CKD: A decrease in the estimated glomerular filtration rate (eGFR) of ≥30% to a value of less than 60 ml/min/1.73 m2, or incident albuminuria

Results

• The intervention was stopped early after a median follow-up of 3.26 years owing to a significant reduction of the primary composite outcome in the intensive-treatment group vs. the standard-treatment group (1.65% per year vs. 2.19% per year; hazard ratio [HR]; 0.75, p<0.001) (Figure 1)
• All-cause mortality was lower in the intensive vs. the standard treatment arm (155 vs. 210; HR, 0.73; p=0.003) (Figure 1)
• There was a 43% relative risk reduction (p=0.005) for death due to CV causes in patients treated intensively (Figure 1)

• Amongst patients with CKD, the composite of renal outcomes did not differ significantly for the two treatment arms
• Amongst patients without CKD, those treated intensively had a higher incidence of renal outcomes (1.21% per year vs. 0.35% per year, HR; 3.49, p<0.0001)
• Incidence of hypotension (2.4% vs. 1.4%; p=0.001) and acute kidney injury or acute renal failure (4.1% vs. 2.5%; p<0.001) was higher in intensive treatment arm vs. standard treatment arm

Conclusion

• An SBP target of <120 mm Hg vs. <140 mm Hg offers a greater reduction in rates of fatal and nonfatal major CV events and death from any cause in nondiabetic patients at high risk of CV events. Intensive treatment is however, associated with higher rates of some adverse events

N Engl J Med 2015; 373: 2103-16