Coronary CT Angiography versus Intravascular Ultrasound Guidance for PCI

BACKGROUND: Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) improves clinical outcomes. Coronary computed tomographic angiography (CCTA) provides anatomical and physiological information before cardiac catheterization that may enable PCI planning. Data regarding the use of CCTA-guided PCI as compared with IVUS-guided PCI with respect to clinical outcomes are lacking. METHODS: In this investigator-initiated, international, open-label, randomized, noninferiority trial with blinded end-point adjudication, we randomly assigned patients with a clinical indication for revascularization, at least one epicardial lesion with a diameter stenosis of more than 70%, and a fractional flow reserve derived from CCTA of 0.80 or less in a 1:1 ratio to a CCTA-guided or IVUS-guided PCI strategy. The primary end point was target-vessel failure, defined as a composite of death from cardiac causes, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization, at 12 months. The noninferiority margin for the absolute risk difference was 4.5 percentage points, with a prespecified hierarchical testing strategy for superiority. RESULTS: A total of 1105 patients underwent randomization: 556 to the CCTA-guided PCI group and 549 to the IVUS-guided PCI group. The median age of the patients was 65 years, and 21.7% were women. At 12 months, target-vessel failure had occurred in 23 patients (4.1%) in the CCTA-guided PCI group and in 25 patients (4.6%) in the IVUS-guided PCI group (risk difference, -0.42 percentage points; 95% confidence interval, -2.82 to 1.99; P<0.001 for noninferiority; P = 0.73 for superiority). A total of 6 patients in the CCTA-guided PCI group and 9 patients in the IVUS-guided PCI group had clinical procedural complications. CONCLUSIONS: A CCTA-guided PCI strategy was noninferior to IVUS-guided PCI with respect to target-vessel failure at 12 months. (Funded by GE HealthCare and Heartflow; P4 ClinicalTrials.gov number, NCT05253677.).

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Publication Details

Journal
New England Journal of Medicine
Published
2026-11-01
DOI
https://doi.org/10.1056/nejmoa2610771
Primary Topic
Coronary Interventions and Diagnostics
Type
article
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article

Coronary CT Angiography versus Intravascular Ultrasound Guidance for PCI

Daniele Andreini, Carlos Adolfo Collet, Taito Arai, Richard Good et al.
4 links
New England Journal of Medicine
Coronary Interventions and Diagnostics
article

Coronary CT Angiography versus Intravascular Ultrasound Guidance for PCI

Daniele Andreini, Carlos Adolfo Collet, Taito Arai, Richard Good, Antonio Luca Bartorelli, Jonathon Leipsic, Jeroen Sonck, Frédéric Bouisset, Bjarne Linde Nørgaard, Alan J. Bagnall, Gianluca Mincione, Yader B. Sandoval, Simone Biscaglia, Hasan Jilaihawi, Tetsuya Amano, Bálint Szilveszter, Divaka Perera, Éric Van Belle, Ziad A. Ali, Niels Thue Olsen, Bernard De Bruyne, Carlo Zivelonghi, Thomas Engstrøm, James Spratt, Daniel A. Jones, Peter D. O’Kane, Gianluca Pontone, Giulio Giuseppe Stefanini, Adriaan Wilgenhof, Timothy A. Fairbairn, Brian S. H. Ko, Nicolaj B. Støttrup, Ian F. Purcell, Bruno R. da Costa, Takuya Mizukami, Kaoru Tanaka
article en

Abstract

BACKGROUND: Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) improves clinical outcomes. Coronary computed tomographic angiography (CCTA) provides anatomical and physiological information before cardiac catheterization that may enable PCI planning. Data regarding the use of CCTA-guided PCI as compared with IVUS-guided PCI with respect to clinical outcomes are lacking. METHODS: In this investigator-initiated, international, open-label, randomized, noninferiority trial with blinded end-point adjudication, we randomly assigned patients with a clinical indication for revascularization, at least one epicardial lesion with a diameter stenosis of more than 70%, and a fractional flow reserve derived from CCTA of 0.80 or less in a 1:1 ratio to a CCTA-guided or IVUS-guided PCI strategy. The primary end point was target-vessel failure, defined as a composite of death from cardiac causes, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization, at 12 months. The noninferiority margin for the absolute risk difference was 4.5 percentage points, with a prespecified hierarchical testing strategy for superiority. RESULTS: A total of 1105 patients underwent randomization: 556 to the CCTA-guided PCI group and 549 to the IVUS-guided PCI group. The median age of the patients was 65 years, and 21.7% were women. At 12 months, target-vessel failure had occurred in 23 patients (4.1%) in the CCTA-guided PCI group and in 25 patients (4.6%) in the IVUS-guided PCI group (risk difference, -0.42 percentage points; 95% confidence interval, -2.82 to 1.99; P<0.001 for noninferiority; P = 0.73 for superiority). A total of 6 patients in the CCTA-guided PCI group and 9 patients in the IVUS-guided PCI group had clinical procedural complications. CONCLUSIONS: A CCTA-guided PCI strategy was noninferior to IVUS-guided PCI with respect to target-vessel failure at 12 months. (Funded by GE HealthCare and Heartflow; P4 ClinicalTrials.gov number, NCT05253677.).

New England Journal of Medicine
Semmelweis University (HU), SHOWA Medical University (JP), Cedars-Sinai Medical Center (US), St Bartholomew's Hospital (GB), Abbott Northwestern Hospital (US), St Thomas' Hospital (GB), Humanitas University (IT), Vrije Universiteit Brussel (BE), University of British Columbia (CA), Inserm (FR), Aichi Medical University (JP), St George's, University of London (GB), Queen Mary University of London (GB), King's College London (GB), University of Toronto (CA), University of Milan (IT), Aarhus University (DK), Barts Health NHS Trust (GB), Institut Pasteur de Lille (FR), Herlev Hospital (DK), Centre Hospitalier Universitaire Vaudois (CH), Aarhus University Hospital (DK), Copenhagen University Hospital (DK), Gentofte Hospital (DK), Rigshospitalet (DK), Centre Hospitalier Universitaire de Lille (FR), Centre Hospitalier Universitaire de Toulouse (FR), University of Oxford (GB), Liverpool Heart and Chest Hospital (GB), Centro Cardiologico Monzino (IT), St. Francis Hospital (US), Aichi Medical University Hospital (JP), IRCCS Ospedale Galeazzi - Sant'Ambrogio (IT), Arcispedale Sant'Anna (IT), Universitair Ziekenhuis Brussel (BE), Minneapolis Heart Institute Foundation (US), Cedars-Sinai Smidt Heart Institute (US), Cardiovascular Research Foundation (US), William Harvey Research Institute (GB), IRCCS Humanitas Research Hospital (IT), European Genomic Institute for Diabetes (FR), Victorian Heart Hospital (AU), University Hospitals Dorset NHS Foundation Trust (GB), Ziekenhuis aan de Stroom (BE), Monash University (AU), University of Glasgow (GB), Sapienza University of Rome (IT)
GE Healthcare, HeartFlow
Good health and well-being
Openalex Percentile: Top 10%
Coronary Interventions and Diagnostics
DOISourceOpenAlex
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