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Lowering Systolic BP to <120 mm Hg vs <140 mm Hg in Patients at High Cardiovascular Risk With and Without Diabetes or Previous Stroke
abstract
This abstract is available on the publisher's site.
Access this abstract now Full Text Available for ClinicalKey SubscribersBACKGROUND
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.
Additional Info
Disclosure statements are available on the authors' profiles:
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;[EPub Ahead of Print], J Liu, Y Li, J Ge, X Yan, H Zhang, X Zheng, J Lu, X Li, Y Gao, L Lei, J Liu, J LiFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
High systolic blood pressure (BP), an important feature of hypertension, is the leading contributor to global death and disability from heart disease and stroke.1 Among the estimated 1.3 billion adults with hypertension worldwide, only about 1 in 5 have their hypertension controlled to a systolic BP of less than 140 mm Hg. The reason for this poor hypertension control rate is complex and includes factors at multiple levels; among these factors is the lack of treatment intensification to achieve ideal BP targets. For many physicians, there remains substantial uncertainty about the benefits and risks of lowering systolic BP to less than 120 mm Hg, despite compelling evidence from the SPRINT study, which showed that an intensive BP target of less than 120 mm Hg significantly reduced the risks of cardiovascular events and mortality compared with a target of less than 140 mm Hg.2
To further address this uncertainty, the present study randomized 11,255 adults (mean age, 64.6 years) with high cardiovascular risk (4359 with diabetes and 3022 with previous stroke) to intensive treatment (target systolic BP, <120 mm Hg) or standard treatment (target systolic BP, <140 mm Hg). The primary outcome was a composite of myocardial infarction, revascularization, hospitalization for heart failure, stroke, and death from cardiovascular causes. During a median follow-up period of 3.4 years, the incidences of the primary outcome in the intensive and standard treatment groups were 9.7% and 11.1%, respectively. Syncope occurred more frequently in the intensive treatment group (0.4% vs 0.1%), with a hazard ratio of 3.00 (95% CI, 1.35–6.68); however, there were no significant between-group differences in other serious adverse events.
The major take-home message from this study is that, for patients with hypertension who are at high cardiovascular risk (with or without diabetes or a history of previous stroke), treatment to a systolic BP target of less than 120 mm Hg is superior to treatment to a target of less than 140 mm Hg for the prevention of major cardiovascular events. However, patients who do not tolerate a systolic BP of less than 120 mm Hg should be maintained at their lowest tolerable systolic BP level. The observed increase in the incidence of syncope during the intensive treatment strategy calls for increasing patient awareness of and education on strategies to mitigate symptoms of low systolic BP during intensive treatment of hypertension.
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