Systolic Blood Pressure Intervention Trial - SPRINT
- goal of the trial was to compare the safety and efficacy of intensive lowering of systolic blood pressure (SBP) to <120 mm Hg versus routine management to <140 mm Hg
Study Design
Patients were randomized to intensive SBP lowering (target <120 mm Hg) or routine SBP management (target <140 mm Hg)
- total number of enrollees: 9,361
- duration of follow-up: 5 years (median 3.26 years)
Inclusion criteria:
- age >=50 years
- hypertension with SBP >=130 mm Hg
At least one risk factor for heart disease:
- presence of clinical or subclinical cardiovascular disease other than stroke
- chronic kidney disease, defined as estimated glomerular filtration rate (eGFR) 20-59 ml/min/1.73 m2
- a Framingham Risk Score for 10-year cardiovascular disease risk> =15%
- age >75 years
Exclusion criteria:
- indication for a specific BP-lowering medication that the person is not taking and the person has not been documented to be intolerant of the medication class
- known secondary cause of hypertension
- one-minute standing SBP <110 mm Hg
- proteinuria
- arm circumference too large or small to allow accurate BP measurement with available devices
- diabetes mellitus
- history of stroke
- polycystic kidney disease
- glomerulonephritis treated with or likely to be treated with immunosuppressive therapy
- eGFR <20 ml/min/1.73 m2 or end-stage renal disease
- cardiovascular event or procedure or hospitalization for unstable angina within last 3 months
- symptomatic heart failure within the past 6 months or left ventricular ejection fraction <35%
- medical condition likely to limit survival to <3 years or a malignancy other than nonmelanoma skin cancer within the last 2 years
- organ transplant
Principal Findings:
- trial was terminated early due to overwhelming evidence of benefit. The primary outcome, myocardial infarction (MI), acute coronary syndrome (ACS), stroke, congestive heart failure (CHF), or cardiovascular (CV) death, was significantly lowered in the intensive BP management arm compared with the routine management arm (5.2% vs. 6.8%, hazard ratio 0.75, 95% confidence interval 0.64–0.89; p < 0.0001).
Individual components (event rates for intensive vs. routine management, absolute event rates):
- MI: 2.1% vs. 2.5%, p = 0.19
- ACS: 0.9% vs. 0.9%, p = 0.99
- Stroke: 1.3% vs. 1.5%, p = 0.5
- CHF: 1.3% vs. 2.1%, p = 0.002
- CV death: 0.8% vs. 1.4%, p = 0.0005
Interpretation:
- results of this landmark trial indicate that intensive BP lowering to a target <120 mm Hg is superior to routine management with a target of <140 mm Hg in high-risk nondiabetic patients with hypertension, including in elderly patients. There were also reductions noted in CV and all-cause mortality, accompanied by a reduction in CHF. An intensive strategy carried a higher risk of hypotension, syncope, and accelerated reductions in GFR (only in patients without CKD at baseline)
Further analysis of SPRINT study (2):
- primary results of the Systolic Blood Pressure Intervention Trial (SPRINT) trial were previously reported using data through August 2015 when the trial was stopped due to benefit in the intensive treatment group (1).In the SPRINT trial the effect of a systolic blood pressure (SBP) target <120 mmHg on clinical outcomes was compared to that of SBP target <140 mmHg
- data have been collected during an observational postintervention period. An updated analysis of all data through August 2015, as well as an analysis of data through July 2016 has been reported
- updated results from the SPRINT trial showed that intensive-treatment regime with SBP target <120 mmHg resulted in reduction of the primary composite outcome, the primary outcome minus HF events, the components of the primary outcome, and all-cause mortality when compared to standard treatment regime with target goal <140 mmHg in patients with increased CV risk
- intensive-treatment group, all-cause mortality was 1.06% per year and 1.41% in the standard-treatment group (HR 0.75, 95%CI: 0.61-0.92, P=0.006), similar to previous findings (HR 0.73)
- rates of individual endpoints of MI, HF, and death from CV causes were lower in the intensive-treatment group than in the standard-treatment group.
- no significant between-group difference in the renal composite endpoint between the two groups in those with CKD at baseline.
- no differential effect of treatment group on the primary outcome or all-cause mortality between the intervention and post-intervention periods, but there were differences for acute decompensated HF and the renal outcome between the two periods (higher rate of acute decompensated HF in the intensive-treatment group in the post-intervention period and lower rate of the renal outcome in the intensive-treatment group in the post-intervention period)
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