Effect of Frailty on Intensive Blood Pressure Lowering in Hypertensive Patients at High Cardiovascular Risk – Post-hoc Analysis of the ESPRIT Trial
Effect of Frailty on Intensive Blood Pressure Lowering in Hypertensive Patients at High Cardiovascular Risk – Post-hoc Analysis of the ESPRIT Trial
Source: Shitian Li, MD, presented at ACC.25 Scientific Session (March 2025)
1. Background & Rationale
• The ESPRIT trial previously showed that targeting SBP <120 mmHg significantly reduced MACE compared to <140 mmHg in high-risk hypertensive patients.
• The impact of frailty status on the risk–benefit balance of intensive BP control was unclear.
2. Study Design
• Post-hoc analysis of the ESPRIT trial, a multicenter, open-label, randomized controlled trial in China.
• Included 11,255 hypertensive patients with high cardiovascular risk.
• Randomized to:
• Intensive treatment: target SBP <120 mmHg.
• Standard treatment: target SBP <140 mmHg.
• Median follow-up: 3.4 years.
• Participants stratified by frailty index (FI):
• Non-frail (FI ≤ 0.210): 19%
• Moderately frail (FI 0.211–0.310): 51.3%
• Severely frail (FI ≥ 0.311): 29.8%
3. Key Endpoints
• Primary outcome: Major adverse cardiovascular events (MACE) — composite of MI, revascularization, heart failure events, stroke, or cardiovascular death.
• Secondary outcomes:
• All-cause mortality.
• Composite kidney outcome.
• Safety outcomes: Hypotension, electrolyte abnormalities, falls with injury, and AKI.
4. Main Findings
• BP targets were reached similarly in the standard group regardless of frailty.
• Frail patients in the intensive group reached targets more slowly, but final SBP/DBP values were similar across all subgroups.
• Frailty did not modify the effect of intensive vs. standard treatment on:
• MACE
• All-cause mortality
• Kidney outcomes
(All P for interaction > 0.05)
• Adverse events were generally low and consistent across frailty groups, except for injurious falls, which were slightly more common in frail patients (P = 0.007).
• Subgroup analysis by age (<70 vs ≥70 years) yielded consistent results.
5. Conclusion
• Intensive BP-lowering to SBP <120 mmHg is effective and generally safe in frail and non-frail hypertensive patients at high cardiovascular risk.
• Estimated benefits (per 1000 severely frail patients treated for 3.4 years):
• Prevents 30 MACE
• Prevents 21 deaths
• May cause 16 kidney outcomes and 7 injurious falls
• Clinical Implication: Supports the use of intensive BP control regardless of frailty status.