The New England Journal of Medicine November 26, 2015

A Randomized Trial of Intensive versus Standard Blood-Pressure Control (SPRINT)

The SPRINT Research Group (Jackson T. Wright Jr., Jeff D. Williamson, Paul K. Whelton, et al.)

Bottom Line

In high-risk adults without diabetes or a history of stroke, intensive blood pressure control targeting a systolic pressure of less than 120 mm Hg significantly reduced the rates of major cardiovascular events and death from any cause compared to a standard target of less than 140 mm Hg.

Key Findings

1. The primary composite outcome (myocardial infarction, acute coronary syndrome, stroke, heart failure, or cardiovascular death) occurred at a significantly lower rate in the intensive-treatment group (1.65% vs. 2.19% per year; HR 0.75, 95% CI 0.64-0.89, P<0.001), yielding a number needed to treat (NNT) of 61.
2. All-cause mortality was significantly lower in the intensive-treatment group (HR 0.73, 95% CI 0.60-0.90, P=0.003), corresponding to an NNT of 90 to prevent one death.
3. Intensive treatment specifically reduced the risk of death from cardiovascular causes by 43% (HR 0.57, P=0.005) and heart failure by 38% (HR 0.62, P=0.002).
4. During the trial, the mean achieved systolic blood pressure was 121.5 mm Hg in the intensive group versus 134.6 mm Hg in the standard group, requiring a mean of 2.8 and 1.8 antihypertensive medications, respectively.
5. Serious adverse events were overall similar between the two groups, but the intensive group had significantly higher rates of hypotension (2.4% vs. 1.4%), syncope (2.3% vs. 1.7%), electrolyte abnormalities (3.1% vs. 2.3%), and acute kidney injury or failure (4.1% vs. 2.5%).

Study Design

Design
RCT
Open-Label
Sample
9,361
Patients
Duration
3.26 yr
Median
Setting
Multicenter, US
Population Adults aged 50 years or older with a systolic blood pressure of 130 to 180 mm Hg and an increased risk of cardiovascular events (clinical/subclinical CVD, CKD, Framingham 10-year risk ≥15%, or age ≥75), excluding those with diabetes, prior stroke, or symptomatic heart failure.
Intervention Intensive blood-pressure control targeting a systolic blood pressure of less than 120 mm Hg.
Comparator Standard blood-pressure control targeting a systolic blood pressure of less than 140 mm Hg.
Outcome A composite of myocardial infarction, acute coronary syndrome not resulting in MI, stroke, acute decompensated heart failure, or death from cardiovascular causes.

Study Limitations

The trial excluded patients with diabetes mellitus and prior stroke, limiting the direct applicability of these findings to two large and highly relevant populations.
Blood pressure was measured using unattended, automated office blood pressure (AOBP) monitors. This technique eliminates 'white coat' effect and generally yields readings 5-15 mm Hg lower than conventional clinic measurements, complicating the translation of SPRINT targets to routine clinical practice.
The trial was terminated early (after a median follow-up of 3.26 years instead of the planned 5 years) due to unequivocal benefit, which can sometimes lead to an overestimation of the treatment effect size.
Due to the nature of blood pressure titration, the trial utilized an open-label design, although clinical endpoints were blindly adjudicated.

Clinical Significance

SPRINT represents a landmark paradigm shift in cardiovascular medicine. By demonstrating a clear mortality and morbidity benefit to aggressive blood pressure lowering in high-risk patients, it directly catalyzed the 2017 ACC/AHA guidelines, which formally redefined hypertension as a blood pressure of ≥130/80 mm Hg and lowered the treatment targets for most adults. It also highlighted the necessary clinical trade-off between preventing macrovascular events and managing increased risks of hypotensive and renal adverse effects.

Historical Context

Prior to SPRINT, the optimal systolic blood pressure target was intensely debated. Previous trials, notably the ACCORD BP trial in diabetic patients, failed to show a significant primary cardiovascular benefit for targeting a systolic pressure <120 mm Hg. Additionally, recent guidelines preceding SPRINT (such as JNC 8 in 2014) had actually relaxed blood pressure targets to <150/90 mm Hg for adults over 60, largely due to fears of the 'J-curve' phenomenon (where excessively low blood pressure might precipitate cardiovascular events). SPRINT decisively countered this trend for high-risk non-diabetic populations, proving that 'lower is better' when monitored carefully.

Guided Discussion

High-yield insights from every perspective

Med Student
Medical Student

How does intensive systolic blood pressure lowering conceptually reduce the risk of heart failure, which was one of the primary drivers of the composite cardiovascular outcome reduction in the SPRINT trial?

Key Response

High systolic blood pressure increases left ventricular afterload, leading to concentric left ventricular hypertrophy, impaired relaxation (diastolic dysfunction), and eventually decompensated heart failure. Lowering the target to less than 120 mm Hg reduces this afterload, preventing pathological remodeling and preserving myocardial function. This highlights the direct pathophysiological link between hemodynamics and end-organ damage.

Resident
Resident

The SPRINT trial specifically excluded patients with diabetes mellitus and prior stroke. Given this exclusion, how should we approach blood pressure management for a 65-year-old patient with a history of type 2 diabetes and a current systolic BP of 135 mm Hg?

Key Response

Residents must recognize study exclusion criteria to avoid inappropriate generalization of evidence. The ACCORD-BP trial investigated intensive BP control in diabetics and did not show the same primary composite cardiovascular benefit as SPRINT, although it did reduce stroke risk. Current ACC/AHA guidelines recommend a target of less than 130/80 mm Hg for patients with diabetes, requiring a nuanced, patient-specific approach rather than blindly applying the SPRINT less than 120 mm Hg target.

Fellow
Fellow

SPRINT demonstrated a significant reduction in cardiovascular events but also an increased incidence of acute kidney injury (AKI) and electrolyte abnormalities in the intensive arm. How do we differentiate between hemodynamically mediated eGFR decline and true intrinsic renal injury in these aggressively treated patients?

Key Response

Fellows must balance the trade-offs of aggressive therapies. The AKI observed in SPRINT was often a reversible decline in eGFR due to reduced renal perfusion pressure secondary to RAAS blockade and aggressive diuresis, rather than structural tubular damage. Understanding this distinction is crucial for deciding whether to safely continue, adjust, or completely hold life-saving antihypertensive regimens when serum creatinine predictably rises.

Attending
Attending

The SPRINT trial utilized automated office blood pressure (AOBP) measurements, where patients were seated alone in a quiet room and multiple automated readings were averaged. How does this methodological nuance impact the safety and feasibility of translating the less than 120 mm Hg target into a busy primary care setting?

Key Response

Attendings must contextualize trial methods into real-world workflows. AOBP minimizes the white-coat effect and generally yields readings 5 to 10 mm Hg lower than traditional, often rushed, triage-nurse measurements. Attempting to achieve a less than 120 mm Hg target using standard clinical measurements might inadvertently push the patient's true resting systolic BP dangerously low, increasing the risk of iatrogenic hypotension, syncope, and falls.

Scholarly Review

Critical appraisal through the lens of expert reviewers and guideline development

PhD
PhD

The SPRINT trial was terminated early for benefit after a median follow-up of 3.26 years due to a significant reduction in mortality. What are the statistical and epidemiological risks associated with early trial termination, and how might this affect the estimated magnitude of the treatment effect?

Key Response

Trials stopped early for benefit are highly susceptible to overestimating the true treatment effect, a phenomenon known as random high bias or the winner's curse. While early stoppage was ethically justified by the data safety monitoring board, researchers must critically evaluate whether the absolute risk reduction would have regressed toward the mean with longer follow-up, and whether the truncated timeline prevented the detection of late-emerging adverse effects.

Journal Editor
Journal Editor

SPRINT utilized a PROBE (Prospective Randomized Open, Blinded End-point) design, meaning the intervention was open-label while end-point adjudication remained blinded. What specific threats to internal validity does this design introduce, particularly regarding the reporting of adverse events?

Key Response

In a PROBE design, both patients and treating clinicians are aware of the treatment allocation. This introduces significant detection and reporting bias. Clinicians might be more vigilant in checking for and documenting hypotensive episodes, syncope, or AKI in the intensive arm, while patients may be more likely to report side effects. A critical reviewer must scrutinize whether the safety profile was artificially skewed by this lack of blinding during the clinical encounter.

Guideline Committee
Guideline Committee

Following SPRINT, the 2017 ACC/AHA guidelines redefined hypertension and lowered the general blood pressure target to less than 130/80 mm Hg, a departure from JNC 8 recommendations. Based strictly on SPRINT, should future guidelines explicitly assign a Class I recommendation for a less than 120 mm Hg target for non-diabetic high-risk patients, or do implementation barriers preclude this?

Key Response

Guideline committees must weigh raw trial efficacy against real-world harms and measurement practicalities. While SPRINT proved less than 120 mm Hg is superior in a highly controlled environment with AOBP, assigning it a Class I recommendation universally is controversial. Committees must decide if guidelines should mandate the specific measurement technique (AOBP) alongside the aggressive target, and whether the number needed to harm regarding polypharmacy and syncope outweighs the benefits when applied broadly outside of an academic trial setting.

Clinical Landscape

Noteworthy Related Trials

2010

ACCORD BP Trial

n = 4,733 · NEJM

Tested

Intensive BP control (target systolic <120 mm Hg)

Population

Patients with type 2 diabetes at high risk for cardiovascular events

Comparator

Standard BP control (target systolic <140 mm Hg)

Endpoint

Composite of nonfatal MI, nonfatal stroke, or cardiovascular death

Key result: Intensive BP control did not significantly reduce the primary composite cardiovascular outcome compared to standard therapy, though it did reduce the risk of stroke.
2013

SPS3 Trial

n = 3,020 · Lancet

Tested

Intensive BP control (target systolic <130 mm Hg)

Population

Patients with a recent symptomatic lacunar stroke

Comparator

Standard BP control (target systolic 130-149 mm Hg)

Endpoint

Recurrent stroke (ischemic or hemorrhagic)

Key result: Targeting a systolic blood pressure of less than 130 mm Hg did not significantly reduce the overall rate of recurrent stroke, but it significantly reduced the rate of intracerebral hemorrhage.
2021

STEP Trial

n = 8,511 · NEJM

Tested

Intensive BP control (target systolic 110-130 mm Hg)

Population

Older adults (aged 60-80 years) with hypertension

Comparator

Standard BP control (target systolic 130-150 mm Hg)

Endpoint

Composite of stroke, acute coronary syndrome, decompensated heart failure, revascularization, atrial fibrillation, or CV death

Key result: Intensive treatment significantly lowered the incidence of cardiovascular events compared to standard treatment without increasing adverse renal outcomes.

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