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Publications

Journal Article Ahead of print 2 citations

PubMed: 41911016 DOI: 10.1056/NEJMoa2601521

Intravascular Ultrasound-Guided or Angiography-Guided Complex High-Risk PCI.

N Engl J Med

Authors: Roberto Diletti, Joost Daemen, Benjamin Faurie, Marco Barbierato, Didier Tchétché, Thomas Hovasse, Koen Teeuwen, Jin M Cheng, Martin Landt, Gianluca Campo, Johan Bennett, Fernando Alfonso, Kambis Mashayekhi, Raul Moreno, Youssef S Abdelwahed, Ton Heestermans, Jose M de la Torre Hernandez, John C Murphy, Ignacio Amat-Santos, Joseph Dens, Alfonso Franzé, David M Leistner, Angie Ghattas, James C Spratt, Adrian P Banning, Jan G P Tijssen, Ernest Spitzer, Nicolas M Van Mieghem

Affiliations

  • Department of Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands.
  • Infirmerie Protestante de Lyon, Caluire-et-Cuire, France.
  • Department of Cardiology, Ospedale dell'Angelo, Azienda Unità Locale Socio-Sanitaria 3 Serenissima, Mestre, Italy.
  • Clinique Pasteur, Toulouse, France.
  • Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier-Ramsay Santé, Massy, France.
  • Department of Cardiology, Catharina Hospital, Eindhoven, the Netherlands.
  • Department of Cardiology, Albert Schweitzer Hospital, Dordrecht, the Netherlands.
  • Segeberger Kliniken, Bad Segeberg, Germany.
  • Department of Cardiology, Azienda Ospedaliero Universitaria di Ferrara, Ferrara, Italy.
  • Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium.
  • Department of Cardiology, Hospital Universitario de La Princesa, Universidad Autónoma de Madrid, Instituto de Investigación Sanitaria Hospital Universitario de La Princesa, Centro de Investigación Biomédica en Red en Enfermedades Cardiovasculares (CIBER-CV), Madrid.
  • Clinic of Internal Medicine and Cardiology, Heart Center Lahr, Lahr, Germany.
  • Department of Cardiology, Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación Sanitaria Hospital La Paz, CIBER-CV, Madrid.
  • Department of Cardiology, Angiology and Intensive Care Medizin, Deutsches Herzzentrum der Charité, Charité-Universitätsmedizin Berlin, Berlin.
  • Deutsches Zentrum für Herz-Kreislauf-Forschung, Partner Site Berlin, Berlin.
  • Department of Cardiology, Noordwest Ziekenhuisgroep, Alkmaar, the Netherlands.
  • Department of Cardiology, Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Marqués de Valdecilla, Santander, Spain.
  • Royal Victoria Hospital, Belfast, United Kingdom.
  • Department of Cardiology, Hospital Clínico Universitario de Valladolid, Valladolid, Spain.
  • CIBER-CV, Madrid.
  • Ziekenhuis Oost-Limburg, Genk, Belgium.
  • Division of Cardiology, Rivoli Hospital, Rivoli, Italy.
  • Department of Cardiology, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt, Germany.
  • Golden Jubilee National Hospital, Glasgow, United Kingdom.
  • Department of Cardiology, City St. George's, University of London, London.
  • Oxford Heart Centre, John Radcliffe Hospital, Oxford University Hospitals, NHS Foundation Trust, Oxford, United Kingdom.
  • European Cardiovascular Research Institute, Rotterdam, the Netherlands.
  • Department of Cardiology, Amsterdam University Medical Center, Amsterdam.
  • Cardialysis, Rotterdam, the Netherlands.

Abstract

BACKGROUND

Intravascular ultrasound (IVUS) guidance during percutaneous coronary intervention (PCI) has been associated with increased stent optimization and reduced adverse events among patients with complex coronary-artery lesions, but adoption of this strategy in Western countries remains low. Although practice guidelines recommend intracoronary imaging for anatomically complex lesions, evidence from current European practice is limited.

METHODS

In this investigator-initiated, international, open-label, randomized, controlled trial, we assigned patients undergoing complex PCI to either IVUS-guided PCI, performed with the use of prespecified stent-optimization criteria, or angiography-guided PCI. The primary end point was target-vessel failure, defined as a composite of death from cardiac causes, target-vessel myocardial infarction, or clinically indicated target-vessel revascularization.

RESULTS

Of the 2020 patients who underwent randomization, 1010 in the IVUS-guided PCI group and 1009 in the angiography-guided PCI group were included in the primary analysis. The mean age of the patients was 69 years, 79.4% were men, and 27.4% presented with an acute coronary syndrome. The mean procedure duration was 88.8 minutes with IVUS-guided PCI and 66.2 minutes with angiography-guided PCI. Dilation with balloon angioplasty after stent implantation was performed in 91.3% of the IVUS-guided PCI procedures and in 84.5% of the angiography-guided PCI procedures. At a median follow-up of 19.0 months (interquartile range, 15.2 to 23.4), target-vessel failure had occurred in 140 patients (13.9%) in the IVUS-guided PCI group and in 112 patients (11.1%) in the angiography-guided PCI group (hazard ratio, 1.25; 95% confidence interval, 0.97 to 1.60; P = 0.08). Procedural complications occurred in 11.3% of the IVUS-guided PCI procedures and in 10.2% of the angiography-guided PCI procedures. The frequency of adverse events appeared to be similar in the two groups.

CONCLUSIONS

Among patients undergoing complex high-risk PCI, a strategy of routine IVUS-guided PCI performed with the use of prespecified stent-optimization criteria was not associated with a lower risk of target-vessel failure than angiography-guided PCI alone. (Funded by Boston Scientific; IVUS-CHIP ClinicalTrials.gov number, NCT04854070.).

MeSH

Stents, Angiography, Drug-Related Side Effects And Adverse Reactions, Wounds And Injuries

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