Standardised versus visual assessment of device success after percutaneous coronary intervention.

Asahi Oshima, Pruthvi C Revaiah, Nozomu Kanehama, Adrian Wlodarczak, Helge Möllmann, Raul Moreno, Milosz Dziarmaga, Manel Sabaté, Jacek Legutko, Marc Silvestri, Julien Lemoine, Anirban Choudhury, Hüseyin Ince, Alper Öner, Faisal Sharif, Simone Biscaglia, Janusz Kochman, Joanna Wykrzykowska, Maciej Lesiak, Ignacio J Amat-Santos, Abhishek Kumar, Nicolas Meneveau, Martin Landt, Michael Magro, Azfar Zaman, Murugapathy Veerasamy, Giuseppe Tarantini, Bruno Farah, Peter O'kane, Bruno Garcia Del Blanco, Joan Antoni Gomez-Hospital, Robert Jozwa, Thomas Schmitz, Richard Anderson, Stephan Achenbach, Angela Hoye, Andrew McNeice, Alexander Lauten, Eric Van Belle, Stanislaw Bartus, Piotr Wacinski, Sen Devadathan, Adrian Bednarek, Szymon Wlodarczak, Aishwarya Gurav, Jacopo Farina, Gonçalo Ferraz-Costa, Jerzy Paluszkiewicz, Kotaro Miyashita, Akihiro Tobe, Albert Chinhenzva, Scot Garg, Sofia Sunny, Gráinne Ní Bheoláin, Emma Harte, Tsung-Ying Tsai, Yoshinobu Onuma, Patrick W Serruys

Journal: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 2026;22(19):e1048-e1063

PMID: 42837202

View on PubMed

Abstract

BACKGROUND

The European Association of Percutaneous Cardiovascular Interventions (EAPCI)-endorsed algorithm for defining device success has not yet been prospectively tested against standardised quantitative coronary angiography (QCA) by a core lab.

AIMS

We sought to assess whether visually evaluated device success by the operator at the end of percutaneous coronary intervention (PCI) aligns with the EAPCI-endorsed standardised definition adjudicated by the core lab and to evaluate its association with clinical outcomes.

METHODS

This prespecified analysis of the Multivessel TALENT trial included 1,548 patients with three-vessel disease randomised to treatment with either Supraflex Cruz or SYNERGY stents. PCI was attempted in 4,052 lesions. The core lab assessed post-PCI residual in-stent percentage diameter stenosis (%DS) by QCA (target <20%) and exploratory delta (Δ) angiography-derived fractional flow reserve (angio-FFR) across the stent(s) (target <0.05). Device success was evaluated using the site-reported data (visual evaluation of in-stent %DS), core lab QCA, core lab angio-FFR, and combined core lab QCA+angio-FFR. The lesion-oriented composite endpoint (LOCE; comprising cardiovascular death, target vessel myocardial infarction, or target lesion revascularisation) was assessed at 1 year.

RESULTS

Site-reported device success was 97.4%. Core lab definitions yielded lower rates: 93.8% for Δangio-FFR <0.05, 88.0% for residual %DS <20%, and 83.2% for QCA+angio-FFR (all p<0.001 vs site report after Bonferroni correction). Lesions not meeting QCA-based device success had a higher incidence of LOCE than those meeting the definition (12.0% vs 9.1%; log-rank p=0.041). Device success and LOCE rates did not differ between the two stents for any definition.

CONCLUSIONS

In this prespecified lesion-level substudy, standardised assessment using the EAPCI device success algorithm with core lab QCA reclassified a substantial proportion of operator-adjudicated successes and identified lesions at higher 1-year LOCE risk. (ClinicalTrials.gov: NCT04390672).

Address: CORRIB Research Centre for Advanced Imaging and Core Laboratory, University of Galway, Galway, Ireland.; Department of Cardiology, School of Medicine, University of Galway, Galway, Ireland.; Cardiology Department, Galway University Hospital, Galway, Ireland.; Division of Cardiology, Copper Health Centre Inc., Lubin, Poland.; Faculty of Medicine, Wroclaw University of Science and Technology, Wroclaw, Poland.; Department of Internal Medicine I, St-Johannes-Hospital, Dortmund, Germany.; Department of Cardiology. La Paz University Hospital, Madrid, Spain.; IdiPaz-Hospital La Paz Institute for Health Research, Madrid, Spain.; CIBER-CV (Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares), Madrid, Spain.; Department of Cardiology, Poznan University of Medical Sciences, Poznań, Poland.; CIBER-CV (Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares), Madrid, Spain.; Interventional Cardiology Department, Bellvitge University Hospital, BIO-HEART Cardiovascular Diseases Research Group, Bellvitge Biomedical Research Institute (IDIBELL), University of Barcelona, Barcelona, Spain.; Department of Interventional Cardiology, Institute of Cardiology, Jagiellonian University Medical College, Kraków, Poland.; Clinical Department of Interventional Cardiology, The St. John Paul II Hospital, Kraków, Poland.; Department of Cardiology, GCS Axium Rambot, Aix-en-Provence, France.; Department of Cardiology, Clinique Louis Pasteur, Essey-lès-Nancy, France.; Morriston Cardiac Centre, Swansea, United Kingdom.; Rostock University Medical Center, Rostock, Germany.; Department of Cardiology, Vivantes Klinikum Am Urban and Neukölln, Berlin, Germany.; Rostock University Medical Center, Rostock, Germany.; Klinikum Leverkusen Academic Teaching Hospital, University of Cologne, Leverkusen, Germany.; Department of Cardiology, School of Medicine, University of Galway, Galway, Ireland.; Cardiology Department, Galway University Hospital, Galway, Ireland.; CÚRAM, University of Galway, Galway, Ireland.; Cardiology Unit, Azienda Ospedaliera Universitaria di Ferrara, Ferrara, Italy.; 1st Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.; Department of Cardiology, University Medical Center, Groningen, the Netherlands.; CIBER-CV (Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares), Madrid, Spain.; Cardiology Department, University Clinic Hospital of Valladolid, Valladolid, Spain.; Royal Albert Edward Infirmary, Wigan, United Kingdom and Wigan and Leigh Teaching Hospitals NHS Foundation, Wigan, United Kingdom.; Department of Cardiology, University Hospital Besançon, Besançon, France.; SINERGIES, University of Burgundy Franche-Comté, Besançon, France.; F-CRIN FACT Network, Paris, France.; Heart Centre, Segeberger Kliniken GmbH, Bad Segeberg, Germany.; Department of Cardiology, Elisabeth-TweeSteden Hospital, Tilburg, the Netherlands.; Cardiothoracic Centre, Freeman Hospital and Vascular Biology and Medicine, Newcastle University, Newcastle upon Tyne, United Kingdom.; Yorkshire Heart Centre, Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom.; Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, United Kingdom.; Interventional Cardiology Unit, Department of Cardiac, Thoracic, Vascular Sciences, and Public Health, University of Padua Medical School, Padua, Italy.; Department of Cardiology, Clinique Pasteur, Toulouse, France.; Royal Bournemouth Hospital, University Hospitals Dorset NHS Foundation Trust, Bournemouth, United Kingdom.; CIBER-CV (Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares), Madrid, Spain.; Department of Cardiology, Hospital Universitario Vall d'Hebron, Barcelona, Spain.; CIBER-CV (Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares), Madrid, Spain.; Heart Institute, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain, and Bioheart Group, Cardiovascular, Respiratory and Systemic Diseases and cellular aging Programme, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.; Department of Cardiology and Invasive Cardiology, Provincial Hospital, Szczecin, Poland.; Elisabeth-Krankenhaus Essen GmbH, Essen, Germany.; University Hospital of Wales, Cardiff, United Kingdom.; Department of Cardiology, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany.; Centre for Atherothrombosis and Metabolic Disease, Hull York Medical School, University of Hull, Hull, United Kingdom.; Department of Cardiology, Royal Victoria Hospital, Belfast, United Kingdom.; Department of General and Interventional Cardiology and Rhythmology, Academic Medical Center Erfurt, Health and Medical University Erfurt, Erfurt, Germany.; Department of Interventional Cardiology for Coronary, Valves and Structural Heart Diseases, Valve Research and Innovation Committee, Lille University Hospital, Lille University, Inserm, Institut Pasteur de Lille, U1011-EGID, Lille, France.; 2nd Department of Cardiology, Institute of Cardiology, Jagiellonian University Medical College, Kraków, Poland.; Clinical Department of Interventional Cardiology, Medical University of Lublin, Lublin, Poland.; University Center for Cardiology and Cardiac Surgery, University Hospital 4, Lublin, Poland.; Cardiology, Royal Cornwall Hospital NHS Trust, Truro, United Kingdom.; CORRIB Research Centre for Advanced Imaging and Core Laboratory, University of Galway, Galway, Ireland.; CORRIB Research Centre for Advanced Imaging and Core Laboratory, University of Galway, Galway, Ireland.; Division of Cardiology, Copper Health Centre Inc., Lubin, Poland.; CORRIB Research Centre for Advanced Imaging and Core Laboratory, University of Galway, Galway, Ireland.; Department of Cardiology, University Medical Center, Groningen, the Netherlands.; CORRIB Research Centre for Advanced Imaging and Core Laboratory, University of Galway, Galway, Ireland.; Department of Cardiology, Unidade Local de Saúde de Coimbra, Coimbra, Portugal.; Coimbra Institute for Clinical and Biomedical Research (iCBR), Faculty of Medicine, University of Coimbra, Coimbra, Portugal.; CORRIB Research Centre for Advanced Imaging and Core Laboratory, University of Galway, Galway, Ireland.; Department of Cardiology, Poznan University of Medical Sciences, Poznań, Poland.; Department of Cardiology, Royal Blackburn Hospital, Blackburn, United Kingdom.; School of Medicine, University of Lancashire, Preston, United Kingdom.

DOI: 10.4244/EIJ-D-26-00413

MeSH Terms: Humans, Percutaneous Coronary Intervention, Coronary Angiography, Treatment Outcome, Female, Male, Fractional Flow Reserve, Myocardial, Middle Aged, Coronary Artery Disease, Stents, Aged, Drug-Eluting Stents, Algorithms