Liu J, Li Y, Ge J, et al. 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. Lancet. 2024 Jun 27:S0140-6736(24)01028-6. doi: 10.1016/S0140-6736(24)01028-6. (Original study)

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.

Discipline Area Score
Internal Medicine 6 / 7
Endocrine 6 / 7
Cardiology 6 / 7
Family Medicine (FM)/General Practice (GP) 6 / 7
General Internal Medicine-Primary Care(US) 6 / 7
Comments from MORE raters

Cardiology rater

For patients at high CV risk, targeting SBP to below 120 is superior to <140 in preventing CV events, with a modest increase in syncope but not other adverse effects.

Endocrine rater

Asian populations differ in their response to antihypertensives. This needs to be repeated in a population of Europeans.

Endocrine rater

The data about target BPs is confusing with 2 studies (ACCORD and RESPECT) showing no advantages with systolics <120, and SPRINT showing an advantage. This large randomized study favored the lower target necessitating more meds, of course, and a slight increase in side effects. It will be more difficult to treat patients but probably worth it.
Comments from EvidenceAlerts subscribers

Dr. Zsolt Nagykaldi (7/9/2024 2:53 PM)

Number needed to treat to prevent one adverse outcome is around 50.