A Randomized Trial of Intensive versus Standard Blood-Pressure Control
Open accessAbstract
BACKGROUND: The most appropriate targets for systolic blood pressure to reduce cardiovascular morbidity and mortality among persons without diabetes remain uncertain. METHODS: We randomly assigned 9361 persons with a systolic blood pressure of 130 mm Hg or higher and an increased cardiovascular risk, but without diabetes, to a systolic blood-pressure target of less than 120 mm Hg (intensive treatment) or a target of less than 140 mm Hg (standard treatment). The primary composite outcome was myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes. RESULTS: At 1 year, the mean systolic blood pressure was 121.4 mm Hg in the intensive-treatment group and 136.2 mm Hg in the standard-treatment group. The intervention was stopped early after a median follow-up of 3.26 years owing to a significantly lower rate of the primary composite outcome in the intensive-treatment group than in the standard-treatment group (1.65% per year vs. 2.19% per year; hazard ratio with intensive treatment, 0.75; 95% confidence interval [CI], 0.64 to 0.89; P<0.001). All-cause mortality was also significantly lower in the intensive-treatment group (hazard ratio, 0.73; 95% CI, 0.60 to 0.90; P=0.003). Rates of serious adverse events of hypotension, syncope, electrolyte abnormalities, and acute kidney injury or failure, but not of injurious falls, were higher in the intensive-treatment group than in the standard-treatment group. CONCLUSIONS: Among patients at high risk for cardiovascular events but without diabetes, targeting a systolic blood pressure of less than 120 mm Hg, as compared with less than 140 mm Hg, resulted in lower rates of fatal and nonfatal major cardiovascular events and death from any cause, although significantly higher rates of some adverse events were observed in the intensive-treatment group. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01206062.).
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In the Systolic Blood Pressure Intervention Trial, patients at high cardiovascular risk targeting a systolic BP of 120 mmHg had an approximately twofold risk of syncope compared with the control group targeting a systolic BP of 140 mmHg.
“In the Systolic Blood Pressure Intervention Trial, 261 patients at high cardiovascular risk who were already using antihypertensive drugs targeting a systolic BP of 120 mmHg had an approximately twofold risk of syncope vs. the control group targeting a systolic BP of 140 mmHg.”
From 2018 ESC Guidelines for the diagnosis and management of syncope (2018) · cites this paper as [261]
The Abstract Methods report 9,361 high-risk participants assigned to targets of less than 120 or less than 140 mm Hg. The Discussion reports syncope in 3.5% of the intensive-treatment group versus 2.4% of the standard-treatment group—higher, but not approximately twofold. The cited paper also does not support the citing sentence’s description of the trial as involving 261 patients already using antihypertensive drugs. (LLM, conf=0.90)
Experimental — accuracy not yet measuredThe results of ACCORD BP and SPRINT have been interpreted to be generally consistent, but ACCORD BP was viewed as underpowered due to the composite primary end point being less sensitive to blood pressure regulation.
“The results have been interpreted to be generally consistent between the two trials, but ACCORD BP was viewed as underpowered due to the composite primary end point being less sensitive to blood pressure regulation (38,40).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [38]
The Discussion (page unavailable in our copy) says ACCORD BP’s nonsignificant cardiovascular result was consistent with the benefit observed in SPRINT and notes that ACCORD had about half SPRINT’s sample size. It does not say ACCORD was viewed as underpowered because its composite primary end point was less sensitive to blood-pressure regulation. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn SPRINT, adverse outcomes including hypotension, syncope, electrolyte abnormality, and acute kidney injury were more common in the intensive treatment arm.
“Adverse outcomes, including hypotension, syncope, electrolyte abnormality, and acute kidney injury (AKI), were more common in the intensive treatment arm; risk of adverse outcomes needs to be weighed against the cardiovascular benefit of more intensive blood pressure lowering.”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [38]
In SPRINT, the primary composite outcome of MI, coronary syndromes, stroke, heart failure, or death from cardiovascular causes was reduced by 25% in the intensive treatment group.
“The primary composite outcome of MI, coronary syndromes, stroke, heart failure, or death from cardiovascular causes was reduced by 25% in the intensive treatment group.”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [38]
SPRINT demonstrated that treatment to a goal systolic blood pressure of <120 mmHg decreases cardiovascular event rates by 25% in high-risk individuals, although people with diabetes were excluded from this trial.
“The Systolic Blood Pressure Intervention Trial (SPRINT) demonstrated that treatment to a goal systolic blood pressure of <120 mmHg decreases cardiovascular event rates by 25% in high-risk individuals, although people with diabetes were excluded from this trial (38).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [38]
SPRINT demonstrated that treatment to a goal systolic blood pressure of <120 mmHg decreases cardiovascular event rates by 25% in high-risk individuals, although people with diabetes were excluded.
“The results of BPROAD and ESPRIT are supported by the Systolic Blood Pressure Intervention Trial (SPRINT), which demonstrated that treatment to a goal systolic blood pressure of <120 mmHg decreases cardiovascular event rates by 25% in high-risk individuals, although people with diabetes were excluded from this trial (44).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [44]
In SPRINT, adverse outcomes including hypotension, syncope, electrolyte abnormality, and acute kidney injury were more common in the intensive treatment arm.
“Adverse outcomes, including hypotension, syncope, electrolyte abnormality, and acute kidney injury (AKI), were more common in the intensive treatment arm”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [44]
In SPRINT, intensive systolic blood pressure control below 120 mm Hg versus standard below 140 mm Hg reduced yearly cardiovascular morbidity and mortality by 25% relative and 0.5% absolute in high-risk hypertensive patients.
“in which there was a notable 25% relative/0.5% absolute reduced risk per year of cardiovascular morbidity and mortality with intensive (<120 mm Hg) as compared with standard (<140 mm Hg) systolic blood pressure control in patients with hypertension and high cardiovascular risk.71”
From Clinical management of stable coronary artery disease in patients with type 2 diabetes mellitus: a scientific statement from the American Heart Association (2020) · cites this paper as [71]
This graded approach is based on evidence from multiple meta-analyses and individual RCTs, which show a consistent and graded reduction in CVD risk in response to reductions in TC and LDL-C levels.
“This graded approach is based on evidence from multiple meta-analyses and individual RCTs, which show a consistent and graded reduction in CVD risk in response to reductions in TC and LDL-C levels. 61-71”
From 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias (2016) · cites this paper as [70]
These trials are consistent in showing that the higher the initial LDL-C level, the greater the absolute reduction in risk, while the relative risk reduction remains constant at any given baseline LDL-C level.
“These trials are consistent in showing that the higher the initial LDL-C level, the greater the absolute reduction in risk, while the relative risk reduction remains constant at any given baseline LDL-C level.”
From 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias (2016) · cites this paper as [70]
In SPRINT, the primary composite outcome of myocardial infarction, coronary syndromes, stroke, heart failure, or death from cardiovascular causes was reduced by 25% in the intensive treatment group.
“The primary composite outcome of myocardial infarction (MI), coronary syndromes, stroke, heart failure, or death from cardiovascular causes was reduced by 25% in the intensive treatment group.”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [33]
SPRINT demonstrated that treatment to a target systolic blood pressure below 120 mmHg decreases cardiovascular event rates by 25% in high-risk patients, although people with diabetes were excluded.
“The Systolic Blood Pressure Intervention Trial (SPRINT) demonstrated that treatment to a target systolic blood pressure of < 120 mmHg decreases cardiovascular event rates by 25% in high-risk patients, although people with diabetes were excluded from this trial (33).”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [33]
ACCORD BP and SPRINT targeted a similar systolic blood pressure below 120 mmHg, but the primary composite cardiovascular end point was nonsignificantly reduced in ACCORD BP.
“Of note, the ACCORD BP and SPRINT trials targeted a similar systolic blood pressure < 120 mmHg, but in contrast to SPRINT, the primary composite cardiovascular end point was nonsigni fi cantly reduced in ACCORD BP.”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [33]
In SPRINT, achieved systolic blood pressures were 121 mmHg and 136 mmHg in the intensive versus standard treatment groups, respectively.
“The achieved systolic blood pressures in the trial were 121 mmHg and 136 mmHg in the intensive versus standard treatment group, respectively.”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [33]
In SPRINT, adverse outcomes including hypotension, syncope, electrolyte abnormality, and acute kidney injury were more common in the intensive treatment arm.
“Adverse outcomes, including hypotension, syncope, electrolyte abnormality, and acute kidney injury were more common in the intensive treatment arm; risk of adverse outcomes needs to be weighed against the cardiovascular bene fi t of more intensive blood pressure lowering.”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [33]
The results of ACCORD BP and SPRINT have been interpreted as generally consistent, but ACCORD BP was viewed as underpowered because the composite primary end point was less sensitive to blood pressure regulation.
“The results have been interpreted to be generally consistent between both trials, but ACCORD BP was viewed as underpowered due to the composite primary end point being less sensitive to blood pressure regulation (33).”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [33]
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Nocturnal Hypertension: New Technology and Evidence
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9. Cardiovascular Disease and Risk Management
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- Authors
- The SPRINT Research Group
- Affiliations
- University Hospitals Cleveland Medical Center (US)
- Corresponding author
- The SPRINT Research Group
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2015-11-26
- Volume
- 373
- Issue
- 22
- Pages
- 2103-2116
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC4689591
- OpenAlex
- W3150595609
- Cited by
- 6,325
- References
- 27
- Citations by year
- 2026: 390 · 2025: 449 · 2024: 437 · 2023: 498 · 2022: 523 · 2021: 602 · 2020: 570 · 2019: 694 · 2018: 734 · 2017: 767 · 2016: 613 · 2015: 40 · 2014: 3
- FWCI
- 522.60
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (UL1TR000093, UL1TR000050, UL1TR001427, UL1TR000073, UL1TR001064, UL1TR001085, UL1TR000002, UL1TR000075, UL1TR000064, UL1TR000005, UL1TR000433, UL1TR000003, UL1TR000445, UL1TR000439, UL1TR000105)
- National Institute on Aging (P30AG021332)
- National Heart, Lung, and Blood Institute (HHSN268200900040C, A-HL-13-002-001, HHSN268200900049C, HHSN268200900048C, HHSN268200900047C, HHSN268200900046C)
- National Institute of General Medical Sciences (P30GM103337)
- National Center for Research Resources (UL1RR025755, UL1RR024134, UL1RR025752, UL1RR025771)
- National Center for Advancing Translational Sciences (9U54TR000017‐06)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Health Sciences › Nursing › Nutrition and Dietetics › Sodium Intake and Health
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Health and Disease Prevention
- Keywords
- intensive blood pressure control, systolic blood pressure target, antihypertensive therapy, cardiovascular risk, cardiovascular events, all-cause mortality, adverse events, hypotension, acute kidney injury, non-diabetic patients
- MeSH terms
- Age Factors, Aged, Antihypertensive Agents, Blood Pressure, Cardiovascular Diseases, Cause of Death, Female, Goals, Humans, Hypertension, Male, Middle Aged, Risk Factors, Practice Guidelines as Topic
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