JACC Cardiovasc Interv. 2025 Oct 13;18(19):2338-2351. doi: 10.1016/j.jcin.2025.08.024.
ABSTRACT
BACKGROUND: Few studies have examined whether intravascular imaging (IVI) guidance during percutaneous coronary intervention (PCI) of calcified lesions improves clinical outcomes.
OBJECTIVES: The aim of this study was to determine from a large-scale randomized trial of PCI in severely calcified lesions whether IVI guidance improves event-free survival.
METHODS: In the ECLIPSE (Evaluation of Treatment Strategies for Severe Calcific Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug-Eluting Stents) trial, 2,005 patients with severely calcified lesions were randomized to orbital atherectomy (OA) vs balloon angioplasty (BA) prior to drug-eluting stent placement. IVI with optical coherence tomography or intravascular ultrasound (IVUS) was allowed at operator discretion. The primary clinical outcome was the 1-year rate of target vessel failure (TVF).
RESULTS: IVI guidance was used in 1,246 of 2,005 patients (62.1%), including optical coherence tomography in 819 and/or IVUS in 513, while 759 of 2,005 patients (37.9%) underwent PCI with angiographic guidance alone. Median follow-up duration was 365 days (Q1-Q3: 365-365 days). The 1-year Kaplan-Meier estimated rate of TVF was lower among patients with IVI guidance compared with angiographic guidance alone (9.3% vs 13.2%; adjusted HR: 0.74; 95% CI: 0.56-0.97; P = 0.03). The effect of IVI guidance was consistent in patients randomized to OA vs BA (Pinteraction = 0.48). The 1-year rate of TVF was 7.7% after optical coherence tomographic guidance compared with 12.2% after IVUS guidance (adjusted HR: 0.78; 95% CI: 0.52-1.18; P = 0.24).
CONCLUSIONS: IVI guidance during PCI of severely calcified lesions was associated with improved 1-year clinical outcomes compared with angiographic guidance alone, whether OA or BA was used for vessel preparation prior to drug-eluting stent placement. The adjusted difference in 1-year TVF rates were not significantly different with optical coherence tomographic guidance and IVUS guidance.
PMID:41093451 | DOI:10.1016/j.jcin.2025.08.024
