Tuesday, March 21, 2023
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"How low is enough?" is a common question when prescribing medications to lower blood pressure, particularly among patients older than 70 years. There is concern that any benefit derived from more intensive hypertension management in this group would be offset by potential adverse effects of aggressive therapy.
SPRINT suggests otherwise. The final report of this randomized trial of adults with hypertension comparing target systolic blood pressure values of less than 120 mm Hg and less than 140 mm Hg found that more strict blood pressure targets were associated with lower risks for cardiovascular disease and overall mortality.[1] This result remained valid in a subgroup analysis of participants who were aged 75 years or older.
A more aggressive systolic blood pressure target was also associated with higher rates of hypotension, electrolyte abnormalities, syncope, and acute kidney injury. The current study again evaluates outcomes associated with tighter hypertension control among older adults, and it features measurement of blood pressure in the home.
Another large clinical trial has endorsed the approach of intensive blood pressure lowering, reinforcing the benefits of this approach seen in the previously reported SPRINT trial.
The STEP trial was conducted in China and involved patients older than 60 years who had hypertension. Intensive treatment with a systolic blood pressure target of 110 to less than 130 mm Hg produced a lower incidence of cardiovascular events than standard treatment with a target of 130 to less than 150 mm Hg.
The intensive group showed a 26% reduction in cardiovascular events, a 33% reduction in stroke, a 33% reduction in acute coronary syndrome (ACS), and a 73% reduction in acute decompensated heart failure.
The intensive group achieved a systolic pressure of 127 mm Hg with an average of 1.9 medications vs 135 mm Hg with an average of 1.5 medications in the standard group.
However, unlike in the SPRINT trial,[2] the lower pressure in the intensive group was achieved without major tolerability issues in the STEP trial, which has been attributed to a healthier population of patients included.
The STEP trial was presented August 30 at the virtual European Society of Cardiology (ESC) Congress 2021 by Jun Cai, MD, from FuWai Hospital, Beijing, China.[3] It was simultaneously published online in the New England Journal of Medicine.[4]
"Several large trials have shown a beneficial effect of intensive blood pressure control on cardiovascular outcomes in older patients, but the appropriate systolic blood pressure target remains unclear," Dr Cai said.
"Our large trial provides important evidence, showing that a reduction in the systolic blood pressure to less than 130 mm Hg resulted in cardiovascular benefits in older patients with hypertension in China," he stated.
"There is no doubt that the intensified treatment dramatically reduced cardiovascular events and was well tolerated, which is an important consideration in older patients. The levels of blood pressure were also achieved with a conventional strategy that we recommend in current guidelines," noted Dr Williams, who was the recent chair of the ESC/European Society of Hypertension guideline task force.
However, he pointed out that the population involved was relatively low risk, robust and healthy, and not all older patients would be able to achieve the blood pressure levels attained in this study.
The STEP trial enrolled 8511 Chinese patients with hypertension, aged 60 to 80 years, who were assigned to a systolic blood-pressure target of from 110 to less than 130 mm Hg (intensive treatment) or a target of from 130 to less than 150 mm Hg (standard treatment).
At 1 year of follow-up, the mean systolic blood pressure was 127.5 mm Hg in the intensive treatment group and 135.3 mm Hg in the standard treatment group.
The primary outcome was a composite of stroke, ACS (acute myocardial infarction and hospitalization for unstable angina), acute decompensated heart failure, coronary revascularization, atrial fibrillation, or death from cardiovascular causes.
During a median follow-up period of 3.34 years, primary outcome events occurred in 3.5% of patients in the intensive treatment group compared with 4.6% of patients in the standard treatment group (hazard ratio, 0.74; 95% confidence interval [CI], 0.60-0.92; P=.007).
The results for safety and renal outcomes did not differ significantly between the 2 groups, except for the incidence of hypotension, which was higher in the intensive treatment group (3.4% vs 2.6%), although there was no difference in dizziness, syncope, or fracture.
"Bespoke Medicine"In his discussion of the trial, Dr Williams noted that the issue of blood pressure targets in older people was challenging because as people age, patient heterogeneity increases dramatically as a consequence of multiple morbidities.
He pointed out that the population in the STEP trial was relatively low risk, with 75% younger than 70 years. Only 2% had a renal impairment, 6% had cardiovascular disease, and patients with prior stroke were excluded. The mean baseline blood pressure was 146/83 mm Hg. "So we're not talking about lowering an elderly person's blood pressure from a very high level down to a low target," he noted.
"This does not diminish the importance of the findings, but it puts them into context on where the patients sit on the scale of heterogeneity."
In a comparison with SPRINT, Dr Williams said the STEP data showed remarkable similarity, with big reductions in major events.
He said there would be suggestions that SPRINT went lower in terms of blood pressure levels, but he noted that SPRINT used a methodology to measure blood pressure which many thought resulted in lower than usual clinic values, and when this is taken into account, "the blood pressure levels achieved in STEP and SPRINT are probably quite similar, as are the outcomes."
What Do Current Guidelines Advise?Dr Williams explained that in terms of current recommendations for older people, US guidelines advise aiming for a blood pressure of below 130/80 mm Hg with no qualifiers. European guidelines recommend getting below 140/90 mm Hg if possible and then aim to go down to 130 mm Hg if tolerated but do not recommend going lower than 130 mm Hg.
"Perhaps as a consequence of this study, you could say that tailored targets in older patients over 65 years of age would be firstly, to try to get blood pressure below 140/90 mm Hg because many patients can't even achieve that level of control. Then we can aim to go lower down below 130 mm Hg if you can, if patients will tolerate it and accepting that this is most likely to be possible in those who are independent and active with fewer comorbidities like the patients in the STEP study."
Also commenting on the STEP results, Diederick Grobbee, MD, University Medical Center, Utrecht, the Netherlands, agreed with Dr Williams.
"This is important information showing that it is possible to lower blood pressure in older patients safely and it works," he said. "It is about generalizability. This population is clearly a healthy one who tolerated this sort of reduction well. We know that many patients can't do this, and these types of patients were not abundant in this study," he said.
European Society of Cardiology (ESC) Congress 2021. Presented August 30, 2021.
N Engl J Med. Published online August 30, 2021.
