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.

Background Frailty and cognitive impairment are common in the elderly, with various shared risk factors like hypertension. Frailty is a marker for future cognitive function. Moreover, whether intensive blood pressure interacted with frailty and cognitive impairment is unknown. Methods and Results We performed a post hoc analysis of data from SPRINT (Systolic Blood Pressure Intervention Trial). The relationship between frailty and a composite of probable dementia (PD) and mild cognitive impairment (MCI) was analyzed. Also, we evaluated the interaction of intensive blood pressure lowering in the relationship between frailty and cognitive impairment. A total of 8537 patients were included in our study, and 35.1% were women. The mean age of these participants was 67.9±9.3 years. According to the baseline frailty index, 1670, 4637, and 2230 patients were in fit, less fit, and frail statuses, respectively. During a mean follow‐up of 4.61 years, 871 cases of PD or MCI occurred. Compared with those in fit status, those with less fit (hazard ratio [HR], 2.14 [95% CI, 1.65–2.77]) and frailty (HR, 4.28 [95% CI, 3.26–5.61]) status had a higher incidence of a composite of PD and MCI. Blood pressure control strategy interacted with the correlation between frailty and cognitive impairment. Intensive blood pressure control (HR, 2.4 [95% CI, 2.0–2.8]) accelerated the relationship between frailty and incidence of PD and MCI compared with the standard treatment group (HR, 1.8 [95% CI, 1.5–2.1]; P for interaction=0.009). Conclusions This study found that the baseline frailty status was a possible marker for the incidence of a composite of PD and MCI. Intensive blood pressure control may strengthen this correlation. Registration URL: https://clinicaltrials.gov/ ; Unique identifier: NCT01206062.