STrategy of blood pressure intervention in the Elderly hypertensive Patients - STEP

Contribution To Literature:

The STEP study showed that intensive blood pressure management was effective at reducing cardiovascular outcomes among elderly patients with hypertension.

Description:

The goal of the trial was to evaluate intensive blood pressure management compared with standard blood pressure management among elderly patients with hypertension.

Study Design

  • Randomization
  • Parallel

Elderly participants with hypertension were randomized to intensive blood pressure management (n = 4,243) versus standard blood pressure management (n = 4,268).

In the intensive blood pressure group, the target blood pressure was 110 to <130 mm Hg.

In the standard blood pressure group, the target blood pressure was 130 to <150 mm Hg.

Patients were treated with olmesartan, amlodipine, and hydrochlorothiazide, as needed, to reach their blood pressure target.

  • Total number of enrollees: 8,511
  • Duration of follow-up: median 3.3 years
  • Mean patient age: 66 years
  • Percentage female: 53%
  • Percentage with diabetes: 19%

Inclusion criteria:

  • Participants 60-80 years of age with hypertension
  • Systolic blood pressure 140-190 mm Hg during three screening visits or taking antihypertensive medication

Exclusion criteria:

  • Systolic blood pressure ≥190 mm Hg or diastolic blood pressure <60 mm Hg
  • Uncontrolled diabetes (glycated hemoglobin >8%)
  • Secondary hypertension
  • Ischemic or hemorrhagic stroke
  • Myocardial infarction within the last 6 months
  • Coronary revascularization within the last 12 months or planned within the next 12 months
  • History of atrial fibrillation or ventricular arrhythmia
  • New York Heart Association class III-IV
  • Severe valvular heart disease
  • Hypertrophic cardiomyopathy
  • Severe liver or kidney disease
  • Cognitive impairment

Other salient features/characteristics:

  • Mean blood pressure in the intensive blood pressure group at 1 year: 127.5 mm Hg
  • Mean blood pressure in the standard blood pressure group at 1 year: 135.3 mm Hg

Principal Findings:

The primary outcome, composite of cardiovascular mortality, stroke, acute coronary syndrome, hospitalization for unstable angina, acute decompensated heart failure, coronary revascularization, or atrial fibrillation, was 3.5% in the intensive blood pressure group compared with 4.6% in the standard blood pressure group (p = 0.007).

Secondary outcomes:

  • ≥50% reduction in estimated glomerular filtration rate among patients with chronic kidney disease: 1.0% in the intensive blood pressure group compared with 1.0% in the standard blood pressure group (p = 0.99)
  • Dizziness: 1.1% in the intensive blood pressure group compared with 1.1% in the standard blood pressure group (p = 0.70)
  • Cardiovascular mortality: hazard ratio (HR) 0.72 (95% confidence interval [CI] 0.39-1.32)
  • Stroke: HR 0.67 (95% CI, 0.47-0.97)
  • Acute coronary syndrome: HR 0.67 (95% CI, 0.47-0.94)
  • Acute decompensated heart failure: HR 0.27 (95% CI, 0.08-0.98)
  • Coronary revascularization: HR 0.69 (95% CI, 0.40-1.18)
  • Atrial fibrillation: HR 0.96 (95% CI, 0.55-1.68)

Interpretation:

Among elderly patients with hypertension, intensive blood pressure management compared with standard blood pressure management was beneficial. Intensive blood pressure management to a target blood pressure of 110 to <130 mm Hg (mean 127.5 mm Hg) was associated with a reduction in major adverse clinical events. All components of the primary composite outcome were nominally reduced with intensive blood pressure management. Dizziness and worsening of renal function were the same between treatment groups.

The SPRINT trial excluded participants with diabetes, while the STEP trial did not. The SPRINT trial documented reduction in cardiovascular events with a systolic blood pressure target <120 mm Hg; however, this occurred at a cost of increased kidney injury.

References:

Zhang W, Zhang S, Deng Y, et al., on behalf of the STEP Study Group. Trial of Intensive Blood-Pressure Control in Older Patients With Hypertension. N Engl J Med 2021;385:1286-79.

Editorial: Nelson MR. Moving the Goalposts for Blood Pressure — Time to Act. N Engl J Med 2021;385:1328-9.

Presented by Dr. Jun Cai at the European Society of Cardiology Virtual Congress, August 30, 2021.

Clinical Topics: Acute Coronary Syndromes, Arrhythmias and Clinical EP, Cardiac Surgery, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Prevention, Atrial Fibrillation/Supraventricular Arrhythmias, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Acute Heart Failure, Interventions and ACS, Hypertension

Keywords: ESC Congress, ESC21, Acute Coronary Syndrome, Angina, Unstable, Antihypertensive Agents, Atrial Fibrillation, Blood Pressure, Blood Pressure Determination, Dizziness, Geriatrics, Glomerular Filtration Rate, Heart Failure, Hypertension, Kidney Diseases, Myocardial Revascularization, Primary Prevention, Renal Insufficiency, Chronic, Stroke


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