ESPRIT: intensieve bloeddrukcontrole bij fragiele patiënten — post-hoc analyse

BACKGROUND: Evidence regarding the benefits and harms of intensive blood pressure (BP) control in patients with higher degrees of frailty is limited. OBJECTIVES: We aimed to characterize the benefit-harm profile of intensive BP control by frailty status in the ESPRIT trial. METHODS: In this post hoc analysis of the ESPRIT trial, we categorized participants into nonfrail, moderately frail, and severely frail according to their baseline frailty index (FI), which was calculated by the Rockwood cumulative deficit approach. We examined heterogeneity in the effect of intensive BP-lowering treatment on major adverse cardiovascular events (MACE) (a composite of myocardial infarction, hospitalization for heart failure, stroke, or death from cardiovascular diseases), all-cause death, and safety outcomes (kidney outcomes, and other serious adverse events of special interest [hypotension, syncope, electrolyte abnormality, injurious fall, or acute kidney injury]). RESULTS: We included 11,255 participants whose average age was 64.6 ± 7.1 years. Of the total participants, 4,366 (38.8%) were nonfrail (FI ≤0.210), 5,257 (46.7%) were moderately frail (FI 0.211-0.310), and 1,632 (14.5%) were severely frail (FI ≥0.311). Compared with nonfrail, moderately frail (HR: 1.32; 95% CI: 1.24-1.41) and severely frail (HR: 1.68; 95% CI: 1.54-1.84) participants were associated with a higher risk of serious adverse events. The effects of intensive treatment on MACE did not vary significantly by level of frailty (nonfrail: risk ratio [RR]: 0.84; 95% CI: 0.65-1.08; moderately frail: RR: 0.83; 95% CI: 0.70-0.99; severely frail: RR: 0.86; 95% CI: 0.69-1.08; Pinteraction = 0.67). Effects on all-cause death showed a similar pattern. Greater absolute risk reductions in MACE, cardiovascular death, and all-cause death were observed with increasing frailty, but the interactions were not significant. The effects of intensive treatment were also consistent across the spectrum of continuous FI. None of the safety outcomes differed by frailty status. CONCLUSIONS: Hypertensive patients with high cardiovascular risk benefit from the treatment strategy of targeting systolic BP <120 mm Hg, regardless of their frailty status. In addition, the effects of intensive treatment on experiencing adverse events did not differ by frailty status. (The Effects of intensive Systolic blood Pressure lowering treatment in reducing RIsk of vascular evenTs [ESPRIT]; NCT04030234).