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ESPRIT - Intensive Blood Pressure Control on Stroke

Q: What were the key findings of the ESPRIT - Intensive Blood Pressure Control on Stroke trial?

Intensive SBP control halved the risk of hemorrhagic stroke and did not increase ischemic stroke risk. The stroke prevention benefit emerged after 1 year of intervention.

Effect of Intensive Blood Pressure Control on Stroke: A Prespecified Secondary Analysis of the ESPRIT Trial

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Year of Publication: 2025

Authors: Jingkuo Li, Lubi Lei, Yan Li, ..., the ESPRIT Collaborative Group

Journal: Journal of the American College of Cardiology

Citation: JACC. 2025;86:1405-1417

Link: https://doi.org/10.1016/j.jacc.2025.07.055

Clinical Question

Does intensive systolic blood pressure lowering to <120 mmHg reduce stroke risk compared to standard treatment targeting <140 mmHg in hypertensive patients with high cardiovascular risk?

Bottom Line

Intensive SBP control halved the risk of hemorrhagic stroke and did not increase ischemic stroke risk. The stroke prevention benefit emerged after 1 year of intervention.

        Major Points
        Intensive SBP control (<120 mmHg) reduced hemorrhagic stroke by 49% (HR 0.51, 95% CI 0.31-0.85, P=0.009)
Overall stroke reduction was 14% but not statistically significant (HR 0.86, 95% CI 0.73-1.02, P=0.083)
Landmark analysis showed significant stroke reduction after 1 year (HR 0.75, 95% CI 0.60-0.94, P=0.011)
No increase in ischemic stroke with intensive treatment (HR 0.93, 95% CI 0.78-1.11, P=0.423)
Benefits consistent across all subgroups including patients with previous stroke

      

Design

Study Type: Multicenter open-label randomized controlled trial

Randomization: 1

Blinding: Open-label with blinded outcome adjudication

Follow-up Duration: Median 3.4 years (Q1-Q3: 3.0-3.4 years)

Centers: 116

Countries: China

Sample Size: 11255

Analysis: Intention-to-treat

Inclusion Criteria

Age ≥50 years
SBP 130-180 mmHg
Increased cardiovascular disease risk (established CVD or ≥2 major CV risk factors)
Major CV risk factors: age ≥60 years (men) or ≥65 years (women), diabetes, dyslipidemia, current smoking

Exclusion Criteria

Incident atherosclerotic cardiovascular events during past 3 months
Scheduled revascularization within next 6 months
Secondary cause of hypertension
1-minute standing SBP <110 mmHg
Left ventricular ejection fraction <35%
eGFR <45 mL/min per 1.73 m²

Arms

Field	Control	Intensive treatment
Intervention	Target SBP <140 mmHg using unified treatment algorithms with antihypertensive medications	Target SBP <120 mmHg using unified treatment algorithms with antihypertensive medications
Duration	Median 3.37 years	Median 3.34 years

Outcomes

Outcome	Type	Control	Intervention	HR / OR / RR	P-value
Stroke (composite of ischemic and hemorrhagic)	Primary	303/5,631 (5.4%)	262/5,624 (4.7%)	0.86	0.083
Ischemic stroke \| Effect Size: 0.93; 95% CI: 0.78-1.11	Secondary	261/5,631 (4.6%)	243/5,624 (4.3%)		0.423
Hemorrhagic stroke \| Effect Size: 0.51; 95% CI: 0.31-0.85	Secondary	45/5,631 (0.8%)	23/5,624 (0.4%)		0.009
Stroke after 1 year (landmark analysis) \| Effect Size: 0.75; 95% CI: 0.60-0.94	Secondary	182/5,487 (3.32%)	137/5,477 (2.50%)		0.011
Study intervention discontinuation	Adverse	35 (0.6%)	127 (2.3%)

Subgroup Analysis

No significant interactions were found across all prespecified subgroups including age, sex, region, smoking status, alcohol consumption, BMI, baseline SBP, baseline DBP, orthostatic hypotension, diabetes, previous stroke, ASCVD, atrial fibrillation, and eGFR (all P for interaction >0.05). The treatment effect was consistent in patients with and without previous stroke.

Criticisms

Open-label design may introduce ascertainment bias
Overall stroke reduction did not reach statistical significance
Limited power to detect differences between subgroups
Study conducted entirely in China, limiting generalizability to other populations
Prolonged antihypertensive treatment titration during COVID-19 delayed BP difference establishment
8 stroke events were of undetermined subtype and classified as ischemic

Funding

China Academy of Chinese Medical Sciences Innovation Fund for Medical Science (2021-I2M-1-009), National Key Research and Development Program (2018YFC1312400), Independent Project of National Cardiovascular Disease Clinical Research Center

Based on: ESPRIT - Intensive Blood Pressure Control on Stroke (Journal of the American College of Cardiology, 2025)

Authors: Jingkuo Li, Lubi Lei, Yan Li, ..., the ESPRIT Collaborative Group

Citation: JACC. 2025;86:1405-1417

Content summarized and formatted by NeuroTrials.ai.

ESPRIT - Intensive Blood Pressure Control on Stroke

(2025)

Objective

To assess the effects of intensive treatment targeting SBP <120 mm Hg on stroke compared with standard treatment targeting SBP <140 mm Hg

Study Summary

• Intensive SBP control (<120 mmHg) halved hemorrhagic stroke risk (HR 0.51, 95% CI 0.31-0.85, P=0.009) vs standard control (<140 mmHg)
• Overall stroke reduction was nonsignificant (4.7% vs 5.4%, HR 0.86, 95% CI 0.73-1.02, P=0.083)
• Stroke prevention benefit emerged after 1 year of treatment (HR 0.75, 95% CI 0.60-0.94, P=0.011)

Intervention

Intensive arm: SBP target <120 mmHg with attended office BP measurement; Standard arm: SBP target <140 mmHg. Both arms used unified treatment algorithms with antihypertensive medication adjustment every 3 months

Inclusion Criteria

Age ≥50 years, SBP 130-180 mmHg, established cardiovascular disease or ≥2 major CV risk factors (age ≥60 men/≥65 women, diabetes, dyslipidemia, current smoking)

Study Design

Arms: Intensive treatment (target SBP <120 mmHg) vs Standard treatment (target SBP <140 mmHg)

Patients per Arm: Intensive: 5,624; Standard: 5,631

Outcome

• Primary (stroke): 262/5,624 (4.7%) intensive vs 303/5,631 (5.4%) standard, HR 0.86 (95% CI 0.73-1.02), P=0.083
• Hemorrhagic stroke: 23 (0.4%) vs 45 (0.8%), HR 0.51 (95% CI 0.31-0.85), P=0.009
• Ischemic stroke: 243 (4.3%) vs 261 (4.6%), HR 0.93 (95% CI 0.78-1.11), P=0.423

Bottom Line

Intensive SBP control halved the risk of hemorrhagic stroke and did not increase ischemic stroke risk. The stroke prevention benefit emerged after 1 year of intervention.

Major Points

Intensive SBP control (<120 mmHg) reduced hemorrhagic stroke by 49% (HR 0.51, 95% CI 0.31-0.85, P=0.009)
Overall stroke reduction was 14% but not statistically significant (HR 0.86, 95% CI 0.73-1.02, P=0.083)
Landmark analysis showed significant stroke reduction after 1 year (HR 0.75, 95% CI 0.60-0.94, P=0.011)
No increase in ischemic stroke with intensive treatment (HR 0.93, 95% CI 0.78-1.11, P=0.423)
Benefits consistent across all subgroups including patients with previous stroke

Study Design

Study Type: Multicenter open-label randomized controlled trial
Randomization: Yes
Blinding: Open-label with blinded outcome adjudication
Sample Size: 11255
Follow-up: Median 3.4 years (Q1-Q3: 3.0-3.4 years)
Centers: 116
Countries: China

Primary Outcome

Definition: Stroke (composite of ischemic and hemorrhagic)

Control	Intervention	HR/OR	P-value
303/5,631 (5.4%)	262/5,624 (4.7%)	0.86 (0.73-1.02)	0.083

Limitations & Criticisms

Open-label design may introduce ascertainment bias
Overall stroke reduction did not reach statistical significance
Limited power to detect differences between subgroups
Study conducted entirely in China, limiting generalizability to other populations
Prolonged antihypertensive treatment titration during COVID-19 delayed BP difference establishment
8 stroke events were of undetermined subtype and classified as ischemic

Citation

JACC. 2025;86:1405-1417

View Original Publication →

ESPRIT - Intensive Blood Pressure Control on Stroke

Effect of Intensive Blood Pressure Control on Stroke: A Prespecified Secondary Analysis of the ESPRIT Trial

Clinical Question

Bottom Line

Major Points

Design

Inclusion Criteria

Exclusion Criteria

Arms

Outcomes

Subgroup Analysis

Criticisms

Funding

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