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Intensive blood pressure lowering benefits older patients with hypertension

STEP study presented in a Hot Line Session today at ESC Congress 2021

Cardiovascular Pharmacotherapy

Sophia Antipolis, France – 30 Aug 2021:  Aggressive blood pressure treatment in older hypertensive patients lowers the incidence of cardiovascular events compared to standard therapy, without increasing adverse outcomes. That’s the finding of late breaking research presented in a Hot Line session today at ESC Congress 20211 and published in the New England Journal of Medicine2.

More than one billion people have hypertension worldwide.3 The overall prevalence in adults is around 30–45%,4 rising to more than 60% of people over 60 years of age. As populations age, adopt more sedentary lifestyles, and increase their body weight, the prevalence of hypertension worldwide will continue to rise.5 Elevated blood pressure was the leading global contributor to premature death in 2015, accounting for almost 10 million deaths.6

Trials of blood pressure lowering in older adults with hypertension have yielded mixed results7-9 and guidelines recommend different target levels.5,10,11 The STEP study was conducted to provide new evidence on the benefits of blood pressure lowering in older patients with hypertension. Specifically, it examined whether intensive treatment targeting a systolic blood pressure (SBP) below 130 mmHg could reduce the risk of cardiovascular disease compared with a SBP target below 150 mmHg.

The study enrolled 8,511 older essential hypertensive patients from 42 clinical sites in China. All participants were aged 60–80 years, with a SBP of 140–190 mmHg during three screening visits or taking antihypertensive medication. Patients with prior stroke were excluded.

Participants were randomly assigned to 1) intensive treatment (SBP target below 130 mmHg but no lower than 110 mmHg); or 2) standard treatment (SBP target 130–150 mmHg). The primary outcome was a composite of acute coronary syndrome, stroke, acute decompensated heart failure, coronary revascularisation, atrial fibrillation, or death from cardiovascular causes. Secondary outcomes included the components of the primary endpoint, major artery stiffness, and a decline in renal function or development of end-stage renal disease.

All participants were scheduled for follow-up at 1, 2, and 3 months, and every 3 months thereafter until month 48 or until the close-out visit. The same validated office blood pressure measurement device was used at all collaborating hospitals, which minimised investigator bias in determining blood pressure during the follow-up clinic visits.

One important strength of the trial was that home blood pressure was monitored as an adjunct to office measurements via a smartphone-based application (app).  At study entry, all participants were provided with the same validated automatic home blood pressure monitor. The monitor’s Bluetooth function enabled patients to upload readings to a data centre via the app. If blood pressure was not measured regularly and transmitted to the data centre, the app sent reminders via WeChat. A monthly report on home measurements was sent to doctors to improve the efficiency of blood pressure control during the trial.

During a median 3.34-year follow-up period, the average decrease in SBP from baseline was 20.4 mmHg in the intensive treatment group and 10.8 mmHg in the standard treatment group. Average SBP reached 125.6 mmHg and 135.2 mmHg in the intensive and standard groups, respectively, with an average between-group difference of 9.6 mmHg.

A total of 196 primary outcome events were documented in the standard treatment group (4.6%) compared to 147 events in the intensive treatment group (3.5%), with a relative risk reduction of 25% (hazard ratio with intensive treatment 0.75; 95% confidence interval [CI] 0.60–0.92).

Regarding secondary outcomes, intensive treatment was associated with a 34% lower relative risk of stroke (95% CI 0.46–0.95) and a 32% lower relative risk of acute coronary syndrome (95% CI 0.48–0.95). The progression of arterial stiffness evaluated by brachial-ankle pulse wave velocity was significantly slower in the intensive treatment group. Rates of serious adverse events and renal outcomes did not differ between the two groups except hypotension, which occurred in 146 (3.4%) and 113 (2.6%) patients in the intensive and standard treatment groups, respectively (p=0.03).

Principal investigator Professor Jun Cai of the Chinese Academy of Medical Sciences, Beijing, China said: “Active control of SBP to below 130 mmHg in older hypertensive patients, as compared with below 150 mmHg, resulted in a lower incidence of major cardiovascular events, with no increase in renal injuries. Home blood pressure monitoring more accurately reflected long-term fluctuations in blood pressure than office measurements.”


Notes to editor

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Funding: This work was supported by the Beijing Outstanding Young Scientist Program (BJJWZYJH01201910023029), the Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences (2016-I2M-1-006), and the National Natural Science Foundation of China (No. 81630014, 81825002).

Disclosures: The olmesartan medoxomil tablets were donated by Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd, Nanjing and the amlodipine besylate tablets were donated by China Resources Saike Pharmaceutical Co., Ltd, Beijing, China. The blood pressure monitors were donated by Omron Healthcare Co., Ltd. The companies that donated the drugs and devices had no role in the design of the study and analysis of the data. XG is an employee at Omron (Dalian) Co., LTD., China. All other authors declare no competing interests.

References and notes

1STEP Study: intensive vs. standard blood pressure control among older hypertensive patients.

2 Cai J, et Al. A Trial of Intensive Blood-Pressure Control in Older Hypertensive Patients (STEP) N Engl J Med. 10.1056/NEJMoa2111437

3NCD Risk Factor Collaboration. Worldwide trends in blood pressure from 1975 to 2015: a pooled analysis of 1479 population-based measurement studies with 19.1 million participants. Lancet. 2017;389:37–55.

4Chow CK, Teo KK, Rangarajan S, et al. Prevalence, awareness, treatment, and control of hypertension in rural and urban communities in high-, middle-, and low-income countries. JAMA.


5Williams B, Mancia G, Spiering W, et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018;39:3021-3104.

6Forouzanfar MH, Liu P, Roth GA, et al. Global burden of hypertension and systolic blood pressure of at least 110 to 115 mmHg, 1990-2015. JAMA. 2017;317:165–182.

7Williamson JD, Supiano MA, Applegate WB, et al. Intensive vs standard blood pressure control and cardiovascular disease outcomes in adults aged ³75 years: a randomized clinical trial. JAMA. 2016;315:2673-2682.

8JATOS Study Group. Principal results of the Japanese trial to assess optimal systolic blood pressure in elderly hypertensive patients (JATOS). Hypertens Res. 2008;31:2115-2127.

9Beckett NS, Peters R, Fletcher AE, et al. Treatment of hypertension in patients 80 years of age or older. N Engl J Med. 2008;358:1887-1898.

10Qaseem A, Wilt TJ, Rich R, et al. Pharmacologic treatment of hypertension in adults aged 60 years or older to higher versus lower blood pressure targets: A Clinical Practice Guideline from the American College of Physicians and the American Academy of Family Physicians. Ann Intern Med. 2017;166:430-437.

11Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the prevention, detection, evaluation, and management of high blood pressure in adults. J Am Coll Cardiol. 2018;71:e127-e248.

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