The Effect of Frailty on the Efficacy and Safety of Intensive Blood Pressure Control: A Post Hoc Analysis of the SPRINT Trial

Abstract

BACKGROUND: Frailty is associated with an increased risk of all-cause death and cardiovascular events. However, it is uncertain whether frailty modifies the efficacy and safety of intensive blood pressure control. METHODS: Data from SPRINT (Systolic Blood Pressure Intervention Trial) were used to construct a frailty index. Subgroup differences in intensive blood pressure control treatment effects and safety outcomes were measured on a relative and an absolute scale in patients with and without frailty (defined as a frailty index >0.21) using Cox proportional hazard models and generalized linear models, respectively. The primary outcome was a composite of myocardial infarction, acute coronary syndrome without myocardial infarction, stroke, heart failure, and cardiovascular death. RESULTS: A total of 9306 patients (mean age, 67.9±9.4 years), 2560 (26.7%) of whom had frailty, were included in our study. Over a median follow-up of 3.22 years, 561 primary outcomes were observed. Patients with frailty had a significantly higher risk of primary outcome in both the intensive and standard blood pressure control arms (adjusted hazard ratio, 2.10 [95% CI, 1.59–2.77] and 1.85 [95% CI, 1.46–2.35], respectively). Intensive treatment effects on primary and secondary outcomes were not significantly different on a relative scale (except for cardiovascular mortality [hazard ratio in patients with and without frailty, 0.91 (95% CI, 0.52–1.60) versus 0.30 (95% CI, 0.16–0.59), respectively; P interaction =0.01]) or absolute scale. There was no significant interaction between frailty and risks for serious adverse events with intensive treatment. CONCLUSIONS: Frailty status was a marker of high cardiovascular risk. Patients with frailty benefit similarly to other patients from intensive blood pressure control without an increased risk of serious adverse events.

Systolic and diastolic blood pressure time in target range and cardiovascular outcomes in patients with hypertension and pre‐frailty or frailty status

“… 5 However, a post hoc analysis of the SPRINT indicated that frail individuals can benefit from intensive BP control without elevated risks of SAE. 6 Hence, it is crucial to identify suitable metrics for evaluating BP control efficacy in patients with hypertension and high cardiovascular risk, which will optimize pharmacological treatment strategies and guide future clinical trials aimed at enhancing prognostic outcomes.…”

“…Model 1 remained unadjusted, while Model 2 accounted for all relevant baseline variables: age, gender, race, BMI, 19 smoking status, 20 baseline SBP, 21 baseline DBP, 22 previous CVD, 23 the number of BP‐lowering agents, 24 intensive treatment, 25 the Framingham 10‐year CVD risk score, 26 and frailty index (FI). 6 The selection of variables was determined based on their relevance to the outcomes, guided by clinical experience and a comprehensive review of the literature. Additionally, a restricted cubic spline curve (RCS) was constructed based on the principles of model 2.…”

“…5 However, the study by Wang et al showed that despite their higher susceptibility to cardiovascular events, especially acute decompensated heart failure (ADHF), patients with frailty can still derive benefits from more intensive BP management (SBP < 120 mm Hg) without an unnecessary increase in serious adverse events (SAE). 6 Historically, the emphasis in BP management has been on regulating SBP. Yet, the significance of maintaining diastolic blood pressure (DBP) has been increasingly recognized in recent times.…”

Effect of blood pressure on mortality in patients with cognitive impairment: a prospective cohort study

“…Hypertension was considered the most important independent risk factor predicting mortality in frail patients ( 48 ). The Systolic Blood Pressure Intervention Trial (SPRINT) study demonstrated that frail patients benefited from intensive blood pressure control without an increased risk of serious adverse events ( 46 ). Therefore, efforts are needed to recognize frailty in the elderly population, and interventions to limit or reverse frailty may reduce the incidence of adverse cardiovascular events and prolong survival expectations in frail older adults.…”

“…Frailty is a common geriatric syndrome among the elderly. The prevalence of frailty in the elderly population ranges from 16% to 26.7% (45)(46)(47). Frail older adults have higher rates of mortality and various diseases, especially cardiovascular diseases such as hypertension, diabetes, and heart failure.…”