Valvular & structural heart disease

Percutaneous Coronary Intervention in Frail Patients Undergoing Transcatheter Aortic Valve Replacement: A NOTION-3 Substudy

JACC Cardiovasc IntervPublished Secondary analysis of the NOTION-3 randomised trial

Primary result · MACE in nonfrail patientsResult — go to the resultHazard ratio 0.42 95% CI 0.25–0.69

Authors' conclusion

In nonfrail patients with CAD undergoing TAVR, PCI lowered the risk for MACE, all-cause mortality, and MI compared to conservative treatment. In frail patients, PCI increased bleeding without clinical benefit.

Study context

Population
Patients with coronary artery disease (CAD) and severe AS undergoing transcatheter aortic valve replacement (TAVR), by frailty status130 (32%) frail
Participants
407 patients
Comparison
Percutaneous coronary intervention (PCI) vs conservative treatment in TAVR patients, by frailty
Primary endpoint
Composite of:
  • All-cause mortality
  • MI
  • Urgent coronary revascularization (MACE)
Methodological detailsinternational, open-label, superiority, post hoc frailty assessment
  • International
  • Open-label
  • Superiority
  • Post hoc frailty assessment

Primary result

MACE in nonfrail patients · median follow-up 2 years (Q1-Q3: 1-4 years)

Hazard ratio

0.42

95% CI 0.25–0.69

P < 0.001

By group

PCIvs Conservative treatment
HR 0.42 (95% CI 0.25–0.69); P < 0.001

As reported in the abstract

Further findings

Components of major adverse cardiac events (MACE) in nonfrail patients

PCI reduced death of any cause
P = 0.019
PCI reduced myocardial infarction (MI)
P = 0.004
PCI reduced urgent revascularization
P = 0.005

Safety

OutcomeHR (95% CI)P value
Bleeding events in frail patientsMore bleeding with PCI2.51 (1.23–5.11)P = 0.011

Original publication

Percutaneous Coronary Intervention in Frail Patients Undergoing Transcatheter Aortic Valve Replacement: A NOTION-3 Substudy. JACC Cardiovasc Interv. Published 13 April 2026. doi:10.1016/j.jcin.2025.12.028

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