The SPRINT trial as well as subsequent meta-analyses have yielded convincing data favoring the intensive blood pressure lowering approach. However, recent large-scale observational studies have suggested that a reduction in the systolic blood pressure to less than 130 mm Hg in older patients should be applied with caution. The results of the Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) trial, presented at the virtual European Society of Cardiology (ESC) Congress 2021, increased our confidence in the safety and efficacy of lowering systolic blood pressure (SBP) to a range of 110 to <130 mmHg in older age groups. This new Chinese study was simultaneously published online in the New England Journal of Medicine.
This multicenter, randomized, controlled trial compared two SBP targets in hypertensive patients aged 60 to 80 years of age, namely the target of 110 to less than 130 mm Hg (intensive treatment) and the target of 130 to less than 150 mm Hg (standard treatment). The primary outcome was a composite of stroke, acute coronary syndrome (acute myocardial infarction and hospitalization for unstable angina), acute decompensated heart failure, coronary revascularization, atrial fibrillation, or death from cardiovascular causes.
A total of 8511 patients were enrolled in the trial; 4243 were randomly assigned to the intensive-treatment group and 4268 to the standard-treatment group. 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. During a median follow-up period of 3.34 years, primary-outcome events occurred in 147 patients (3.5%) in the intensive-treatment group, as compared with 196 patients (4.6%) in the standard-treatment group (hazard ratio, 0.74; 95% confidence interval [CI], 0.60 to 0.92; P=0.007). The results for most of the individual components of the primary outcome also favored intensive treatment: the hazard ratio for stroke was 0.67 (95% CI, 0.47 to 0.97), acute coronary syndrome 0.67 (95% CI, 0.47 to 0.94), acute decompensated heart failure 0.27 (95% CI, 0.08 to 0.98), coronary revascularization 0.69 (95% CI, 0.40 to 1.18), atrial fibrillation 0.96 (95% CI, 0.55 to 1.68), and death from cardiovascular causes 0.72 (95% CI, 0.39 to 1.32). The results for safety and renal outcomes did not differ significantly between the two groups, except for the incidence of hypotension, which was higher in the intensive-treatment group (3.4% vs. 2.6%, P=0.03).
The main limitation of the STEP study is the inability to generalize its results to other populations. Aside from inclusion of only Han Chinese persons, population in the STEP trial was relatively low risk, with 75% below 70 years of age. Only 2% had a renal impairment, 6% had cardiovascular disease, and patients with any prior stroke were excluded.
Reference: https://www.nejm.org/doi/full/10.1056/NEJMoa2111437
