Effect of Frailty on Cardiovascular Clinical Trials: A Systematic Review and Meta-Analysis
Pooled result · MACE, frail vs nonfrailResult — go to the resultHazard ratio 2.33 95% CI 1.87–2.91Authors' conclusion
While frailty prognosticated a higher risk of CV events and mortality, frailty did not reduce treatment efficacy. CV trial interventions appear beneficial even in the frailest group.
Study context
- Population
- Patients with cardiovascular (CV) diseases in randomized controlled trials examining the effects of frailty
- Participants
- 87,711 patients30 unique randomized controlled trials
- Comparison
- Frail vs nonfrail patients; trial interventions vs control in the frailest group
- Outcome
- Major adverse cardiac events (MACE), frail vs nonfrail
Pooled result
As reported in the abstract
Hazard ratio
2.33
95% CI 1.87–2.91
P < 0.001
Frail patientsvs nonfrail patients
HR 2.33 (95% CI 1.87–2.91); P < 0.001
Further pooled results
| Outcome | HR (95% CI) | P value | |
|---|---|---|---|
| All-cause mortality, frailvs nonfrailI2 = 75% | 2.34 (1.80–3.05) | P < 0.01 | |
| CV mortality, frailvs nonfrailI2 = 0% | 1.76 (1.60–1.93) | P < 0.001 | |
| Hospitalizations, frailvs nonfrailI2 = 92% | 2.38 (1.65–3.43) | P < 0.001 | |
| MACE in the frailest group, interventionvs controlI2 = 0% | 0.81 (0.74–0.88) | P < 0.001 | |
| Hospitalization in the frailest group, interventionvs controlI2 = 0% | 0.81 (0.72–0.90) | P < 0.001 | |
| 0.20.5125Hazard ratio (log scale) |
| Outcome | SMD (CI) | |
|---|---|---|
| Physical outcomes, interventionvs controlImproved with interventions | 0.15 (0.04–0.26) | |
| Quality of life, interventionvs controlImproved with interventions | 0.15 (0.09–0.21) | |
| −0.200.20.4Difference (linear scale) |
Mortality in the frailest group, intervention vs control
- No significant difference in mortality risk
- P > 0.05
Frailty scores, intervention vs control
- Not improved
- P > 0.05
Original publication
Effect of Frailty on Cardiovascular Clinical Trials: A Systematic Review and Meta-Analysis. JACC Adv. Published 23 June 2025. doi:10.
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