Reviewer : Dr. Kerim Esenboğa

Name of the Study: STEP Study: intensive vs. standard blood pressure control among older hypertensive patients

Published Congress: ESC 2021

Link: https://www.nejm.org/doi/full/10.1056/NEJMoa2111437

Background:

In elderly persons, achieving the appropriate systolic blood pressure (SBP) treatment target is challenging. Furthermore, blood pressure lowering trials in older persons with hypertension have had inconsistent findings, and different target values are recommended by guidelines.

Objective:

The STEP trial was performed to produce new evidence on the benefits of blood pressure lowering in older hypertensive patients. A SBP target of less than 130 mmHg was compared to a target of less than 150 mmHg in order to determine if intensive therapy could lower the risk of cardiovascular disease.

Methods:

A total of 8,511 elderly essential hypertensive patients were enrolled in the trial from 42 clinical sites across China. All patients were between the ages of 60 and 80 and had an SBP of 140–190 mmHg during three screening visits or were on antihypertensive medication. Patients who have previously suffered a stroke were eliminated. Subjects were randomized to one of two groups: 1) intensive treatment (blood pressure target below 130 mmHg but not below 110 mmHg); or 2) standard treatment (blood pressure 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 individual components of the primary endpoint, death from any cause, major adverse cardiac events and renal outcomes.

Results:

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 throughout a median 3.34-year follow-up period. The average SBP in the intensive and standard groups was 125.6 mmHg and 135.2 mmHg, respectively, with an average difference of 9.6 mmHg between groups. The standard treatment group had 196 primary endpoint events (4.6%) compared to 147 events in the intensive therapy group (3.5%), resulting in a 26% relative risk reduction (hazard ratio with intensive treatment 0.74; 95% confidence interval [CI] 0.60–0.92, p=0.007). Additionally, intensive treatment was related with a 33% reduction in the relative risk of stroke (95% CI 0.47 to 0.97) and a 33% reduction in the relative risk of ACS (95% CI 0.47 to 0.94). Except for hypotension, which occurred in 3.4% of patients in the intensive group and 2.6% in the standard group (p=0.03), the incidence of safety and renal outcomes did not differ between the groups.

Conclusion:

In older hypertensive patients, intensive treatment with a SBP goal of 110 to less than 130 mm Hg was associated with a reduced incidence of cardiovascular events than standard treatment with a target of 130 to less than 150 mm Hg.

Interpretations:

The results of the study significantly support intensive blood pressure control in the elderly population in terms of cardiovascular endpoints. However, considering the fact that 75% of the participants in the study were between the ages of 60-69, the frailty characteristics of the patients were not known at the beginning of the treatment, and the possibility of poor compliance with polypharmacy in the elderly population, it may be a reasonable approach to personalize the antihypertensive treatment to be given to elderly individuals according to patient characteristics.