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

BACKGROUND: Frailty is an important predictor of outcomes in patients with coronary artery disease (CAD) and following transcatheter aortic valve replacement (TAVR). The NOTION-3 (Third Nordic Aortic Valve Intervention) trial demonstrated that performing percutaneous coronary intervention (PCI) in addition to TAVR reduced the risk for major adverse cardiac events (MACE). Whether this benefit applies to frail patients remains uncertain.

OBJECTIVES: The aim of this study was to evaluate efficacy and safety of PCI in frail TAVR patients with CAD.

METHODS: NOTION-3 was an international, open-label, randomized superiority trial enrolling patients with CAD and severe aortic stenosis undergoing TAVR. Patients were randomized 1:1 to PCI or conservative treatment. Frailty was assessed post hoc using a calculated frailty score derived from baseline data on symptom-related limitations, daily function, and quality of life. Primary endpoint was a composite of all-cause mortality, myocardial infarction (MI), and urgent coronary revascularization. Safety endpoints included bleeding and acute kidney injury.

RESULTS: Frailty data were available for 407 patients (90%), of whom 130 (32%) were frail. During median follow-up of 2 years (Q1-Q3: 1-4 years), PCI reduced MACE in nonfrail patients (15% vs 33%; HR: 0.42; 95% CI: 0.25-0.69; P < 0.001), as well as death of any cause (P = 0.019), MI (P = 0.004), and urgent revascularization (P = 0.005). No differences were observed in frail patients. In contrast, frail patients undergoing PCI had more bleeding events (HR: 2.51; 95% CI: 1.23-5.11; P = 0.011).

CONCLUSIONS: 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. These findings require confirmation in larger prospective studies.