Aggressive BP lowering reduces CV events in older adults with hypertension
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Intensive treatment to a systolic BP target of 110 mm Hg to less than 130 mm Hg was associated with a 26% reduced risk for CV events in older adults with hypertension compared with standard BP management.
Moreover, the strategy of intensive BP lowering did not increase risk for adverse outcomes, according to new data from the STEP study presented at the European Society of Cardiology Congress.
Results of most components of the primary outcome — stroke, acute coronary syndrome and acute decompensated HF — also favored intensive BP treatment, Jun Cai, MD, PhD, director of the Hypertension Center at FuWai Hospital and professor at Peking Union Medical College and the Chinese Academy of Medical Sciences, China, said during a press conference.
“Our study results support, for older patients, [the] systolic BP target should be set lower than 130 mm Hg for [the] best CV benefits,” Cai said.
Trials of BP lowering in older adults with hypertension have yielded mixed results and guidelines recommend different target levels, Cai said. The target is less than 150 mm Hg in the American College of Physicians/American Academy of Family Physicians guideline, 130 to 139 mm Hg in the European guideline, and less than 130 mm Hg in the American College of Cardiology/American Heart Association guideline.
Study design
The study enrolled 8,511 adults in China aged 60 to 80 years with hypertension (systolic BP 140-190 mm Hg during three screening visits) who were treated to a systolic BP target of 110 mm Hg to less than 130 mm Hg (intensive treatment; n = 4,243) or a target of 130 mm Hg to less than 150 mm Hg (standard treatment; n = 4,268). The mean age was 66 years, 46.5% were men and 19.1% had diabetes.
Patients were provided with antihypertensive drugs, including olmesartan, amlodipine and hydrochlorothiazide. Office BP was measured by trained clinicians using the same validated electric sphygmomanometer (Omron); home BP was assessed via a home monitor connected to a smartphone app.
“In our study, we found that home BP was very similar to office BP — the difference was just 3 mm Hg,” Cai said during the press conference.
The findings were simultaneously published in The New England Journal of Medicine.
A ‘rapid and sustained’ difference
The two treatment strategies led to a rapid and sustained between-group difference in systolic BP. At 1-year follow-up, mean systolic BP was 127.5 mm Hg in the intensive-treatment group and 135.3 mm Hg in the standard-treatment group.
During the median follow-up of 3.34 years, the mean decrease in systolic BP from baseline was 19.4 mm Hg in the intensive-treatment group and 10.1 mm Hg in the standard-treatment group. Throughout follow-up, mean systolic BP was 126.7 mm Hg in the intensive-treatment group and 135.9 mm Hg in the standard-treatment group; mean diastolic BP was 76.4 mm Hg and 79.2 mm Hg, respectively.
The primary outcome — a composite of stroke, acute coronary syndrome (acute MI and hospitalization for unstable angina), acute decompensated HF, coronary revascularization, atrial fibrillation or CV death — occurred in 3.5% of the intensive-treatment group and 4.6% of the standard-treatment group during follow-up (HR = 0.74; 95% CI, 0.6-0.92; P = .007).
When the researchers evaluated individual components of the primary outcome, intensive treatment was associated with a 33% reduction in stroke (HR = 0.67; 95% CI, 0.47-0.97), 33% reduction in ACS (HR = 0.67; 95% CI, 0.47-0.94) and 73% reduction in acute decompensated HF (HR = 0.27; 95% CI, 0.08-0.98).
Rates of coronary revascularization, AF and all-cause mortality were not significant between the two groups, Cai said.
In addition, “the beneficial effects of intensive treatment were consistent across our prespecified subgroup analyses, with variables including age below or above 70 years, sex, prior diabetes, and 10-year Framingham risk score.”
Safety and renal outcomes did not differ between groups; however, hypotension incidence was higher in the intensive-treatment group.
Treating to an ‘arbitrary number’
In a related editorial published in NEJM, Mark R. Nelson, MBBS, MFM, PhD, of the Menzies Institute for Medical Research at the University of Tasmania in Hobart, Australia, noted that only a modest number of medications were needed to reach BP targets in STEP — a mean of 1.9 vs. 1.5 medications in the intensive and standard groups, respectively — which is “crucial for real-world implementation of these findings,” he said.
“We continue to manage blood pressure as an isolated risk factor rather than as an integrated part of a patient’s risk profile because we adhere to the rusted-on clinical concept of hypertension,” Nelson wrote. “According to this concept, there is an arbitrary number above which disease is present and below which it is absent. The STEP trial and
SPRINT tell us that now is an opportune time to return elevated blood pressure to its status as a continuous-variable risk factor, instead of treating it as a dichotomous disease.”
References:
- Nelson MR. N Engl J Med. 2021; doi:10.1056/NEJMe2112992.
- Zhang W, et al. N Engl J Med. 2021; doi:10.1056/NEJMoa2111437.
Perspective
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When one looks at the totality of the data — the STEP study and a post hoc analysis of SPRINT, put together with the older trials — the following can be said: For people who do not have diabetes and a greater than 15% 10-year CV risk, there is no question that a lower systolic BP, less than 130 mm Hg, gets you where you want to be. The data are clear on this.
There are, however, exceptions. If a patient has significant vascular stiffness, with a pulse pressure greater than 70, a BP that low will cause a person to be symptomatic —lightheaded, memory problems, falls, which some participants in STEP experienced. If a person has diabetes, you probably want to level off at 125 mm Hg, as there are a lot of things one may not appreciate clinically that can increase risk if going too low. There are good epidemiologic data support that. You must use your judgement.
The STEP cohort is Chinese, so there was a focus on stroke, which is understandable. However, if you look at SPRINT, what drove the positivity was not stroke. It was HF. Looking at the STEP HF data, it was not as positive as the SPRINT data; I am not sure why. Additionally, looking at the STEP stroke data, the risk reduction they saw in the group with lower BP was comparable with SPRINT; yet, in SPRINT, they did not see a significant difference in stroke. Additionally, this trial, unlike SPRINT, had virtually no kidney disease. The data for kidney patients are different, so that should be considered.
I do not want to say lower is better, because that is misleading. Less than 130 mm Hg is where you should be if you are older, do not have a high pulse pressure and can tolerate it. Otherwise, we must follow the edict of the SHEP trial in 1991 (JAMA. 1991; doi:10.1001/JAMA.1991.03460240051027), which showed that if you reduce BP to less than 140 mm Hg, you see significant CV benefits. If you cannot lower BP to less than 140 mm Hg, at least get it to well below 160 mm Hg. That is practical advice.
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Cai J, et al. Hot Line: STEP. Presented at: European Society of Cardiology Congress; Aug. 27-30, 2021 (virtual meeting).
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