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Percutaneous Coronary Intervention in Frail Patients Undergoing Transcatheter Aortic Valve Replacement

Ratcovich, Hanna ; Holmvang, Lene ; Sadjadieh, Golnaz ; Jabbari, Reza ; Glinge, Charlotte ; Sabbah, Muhammad ; Veien, Karsten Tange ; Niemela, Matti ; Freeman, Phillip and Linder, Rickard , et al. (2026) In JACC: Cardiovascular Interventions 19(7). p.828-839
Abstract

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... (More)

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.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
aging, coronary artery disease, frailty, PCI, transcatheter aortic valve replacement
in
JACC: Cardiovascular Interventions
volume
19
issue
7
pages
12 pages
publisher
Elsevier
external identifiers
  • pmid:41986033
  • scopus:105034972271
ISSN
1936-8798
DOI
10.1016/j.jcin.2025.12.028
language
English
LU publication?
yes
additional info
Publisher Copyright: © 2026 American College of Cardiology Foundation.
id
e61b2c58-549d-45b3-ba7f-f735f97f4cd1
date added to LUP
2026-06-18 12:44:27
date last changed
2026-07-03 19:44:04
@article{e61b2c58-549d-45b3-ba7f-f735f97f4cd1,
  abstract     = {{<p>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 &lt; 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.</p>}},
  author       = {{Ratcovich, Hanna and Holmvang, Lene and Sadjadieh, Golnaz and Jabbari, Reza and Glinge, Charlotte and Sabbah, Muhammad and Veien, Karsten Tange and Niemela, Matti and Freeman, Phillip and Linder, Rickard and Sørensen, Rikke and Ioanes, Dan and Terkelsen, Christian Juhl and Ellert-Gregersen, Julia and Christiansen, Evald and Eftekhari, Ashkan and Piuhola, Jarkko and Kajander, Olli and Koul, Sasha and Savontaus, Mikko and Karjalainen, Pasi and Rück, Andreas and Angerås, Oskar and Bieliauskas, Gintautas and Jørgensen, Troels Højsgaard and Søndergaard, Lars and De Backer, Ole and Engstrøm, Thomas and Lønborg, Jacob}},
  issn         = {{1936-8798}},
  keywords     = {{aging; coronary artery disease; frailty; PCI; transcatheter aortic valve replacement}},
  language     = {{eng}},
  month        = {{04}},
  number       = {{7}},
  pages        = {{828--839}},
  publisher    = {{Elsevier}},
  series       = {{JACC: Cardiovascular Interventions}},
  title        = {{Percutaneous Coronary Intervention in Frail Patients Undergoing Transcatheter Aortic Valve Replacement}},
  url          = {{http://dx.doi.org/10.1016/j.jcin.2025.12.028}},
  doi          = {{10.1016/j.jcin.2025.12.028}},
  volume       = {{19}},
  year         = {{2026}},
}