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August 31, 2026The Lancet240 citations

Lowering systolic blood pressure to less than 120 mm Hg versus less than 140 mm Hg in patients with high cardiovascular risk with and without diabetes or previous stroke: an open-label, blinded-outcome, randomised trial

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JLJiamin LiuYLYan LiJGJinzhuo Ge

Key Result

Targeting systolic blood pressure <120 mm Hg reduced major vascular events compared with <140 mm Hg (9.7% vs 11.1%; HR 0.88, 95% CI 0.78-0.99; p=0.028).

Key Points

  • To evaluate the efficacy and safety of targeting a systolic blood pressure below 120 mm Hg compared to below 140 mm Hg in patients with high cardiovascular risk, including those with or without diabetes or prior stroke.
  • Open-label, blinded-outcome, randomized controlled trial.
  • Assigned high-risk cardiovascular patients with or without diabetes or prior stroke to intensive (<120 mm Hg) versus standard (<140 mm Hg) systolic blood pressure targets.
  • Assessed cardiovascular event rates and mortality between intensive and standard systolic blood pressure reduction groups across risk subgroups.

Study Design

Type

RCT (n=11,255)

Blinding

open-label, blinded-outcome

Randomization

minimised randomisation

Multicenter

Yes

Structured PICO

Does intensive treatment targeting systolic blood pressure <120 mm Hg reduce the composite of myocardial infarction, revascularisation, hospitalisation for heart failure, stroke, or cardiovascular death in patients with high cardiovascular risk compared to standard treatment targeting <140 mm Hg?

P
Population
11,255 participants with high cardiovascular risk, including those with diabetes or previous stroke, followed for a median of 3.4 years.
I
Intervention
Intensive treatment targeting standard office systolic blood pressure of less than 120 mm Hg
C
Comparator
Standard treatment targeting standard office systolic blood pressure of less than 140 mm Hg
O
Outcome
Composite of myocardial infarction, revascularisation, hospitalisation for heart failure, stroke, or death from cardiovascular causescomposite

Targeting a systolic blood pressure of <120 mm Hg compared with <140 mm Hg significantly reduces major vascular events in high-risk patients, including those with diabetes or prior stroke, with a minor increase in syncope.

Main Result

Hazard Ratio: 0.88 (95% CI 0.78–0.99)

Absolute Event Rate: 9.7% vs 11.1%

p-value: p=0.028

Abstract

BACKGROUND Uncertainty exists about whether lowering systolic blood pressure to less than 120 mm Hg is superior to that of less than 140 mm Hg, particularly in patients with diabetes and patients with previous stroke. METHODS In this open-label, blinded-outcome, randomised controlled trial, participants with high cardiovascular risk were enrolled from 116 hospitals or communities in China. We used minimised randomisation to assign participants to intensive treatment targeting standard office systolic blood pressure of less than 120 mm Hg or standard treatment targeting less than 140 mm Hg. The primary outcome was a composite of myocardial infarction, revascularisation, hospitalisation for heart failure, stroke, or death from cardiovascular causes, assessed by the intention-to-treat principle. This trial was registered with ClinicalTrials.gov, NCT04030234. FINDINGS Between Sept 17, 2019, and July 13, 2020, 11 255 participants (4359 with diabetes and 3022 with previous stroke) were assigned to intensive treatment (n=5624) or standard treatment (n=5631). Their mean age was 64·6 years (SD 7·1). The mean systolic blood pressure throughout the follow-up (except the first 3 months of titration) was 119·1 mm Hg (SD 11·1) in the intensive treatment group and 134·8 mm Hg (10·5) in the standard treatment group. During a median of 3·4 years of follow-up, the primary outcome event occurred in 547 (9·7%) participants in the intensive treatment group and 623 (11·1%) in the standard treatment group (hazard ratio HR 0·88, 95% CI 0·78-0·99; p=0·028). There was no heterogeneity of effects by diabetes status, duration of diabetes, or history of stroke. Serious adverse events of syncope occurred more frequently in the intensive treatment group (24 0·4% of 5624) than in standard treatment group (eight 0·1% of 5631; HR 3·00, 95% CI 1·35-6·68). There was no significant between-group difference in the serious adverse events of hypotension, electrolyte abnormality, injurious fall, or acute kidney injury. INTERPRETATION For hypertensive patients at high cardiovascular risk, regardless of the status of diabetes or history of stroke, the treatment strategy of targeting systolic blood pressure of less than 120 mm Hg, as compared with that of less than 140 mm Hg, prevents major vascular events, with minor excess risk. FUNDING The Ministry of Science and Technology of China and Fuwai Hospital. TRANSLATION For the Mandarin translation of the abstract see Supplementary Materials section.

Expert Takes3 quotes

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“Our study provides evidence to support targeting systolic blood pressure to less than 120 mm Hg in hypertensive patients with high cardiovascular risk and normal or mild-reduced kidney function, regardless of their diabetes status (Type 1, Type 2 or none) or history of stroke.”

Jing Li, Director, Dept of Preventive Medicine, National Center for Cardiovascular Diseases, Beijingauto_pipelineSupportiveView source
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Cite This Study

Liu et al. (2024) conducted an RCT in high cardiovascular risk (n=11,255). Intensive treatment targeting systolic blood pressure <120 mm Hg vs. Standard treatment targeting systolic blood pressure <140 mm Hg was evaluated on composite of myocardial infarction, revascularisation, hospitalisation for heart failure, stroke, or death from cardiovascular causes (HR 0.88, 95% CI 0.78-0.99, p=0.028). Targeting systolic blood pressure <120 mm Hg reduced major vascular events compared with <140 mm Hg (9.7% vs 11.1%; HR 0.88, 95% CI 0.78-0.99; p=0.028).

synapsesocial.com/papers/6a94f2a2eae374a57f14237bhttps://doi.org/10.1016/s0140-6736(24)01028-6
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