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Randomized Controlled Trial
. 2025 Oct 13;18(19):2338-2351.
doi: 10.1016/j.jcin.2025.08.024.

Intravascular Imaging vs Angiography Guidance for PCI of Severely Calcified Lesions: The ECLIPSE Trial

Gregg W Stone  1 , Philippe Genereux  2 , Akiko Maehara  3 , Bruce E Lewis  4 , Richard A Shlofmitz  5 , Suhail Dohad  6 , Jithendra Choudary  7 , Thom Dahle  8 , Andres M Pineda  9 , Kendrick Shunk  10 , Ehtisham Mahmud  11 , Giora Weisz  12 , Michael B Collins  12 , Khaldoon Alaswad  13 , Gautam Kumar  14 , Naresh Solankhi  15 , Daniel Dulas  16 , John D Altman  17 , Carlye Kraemer  18 , Krista M Stiefel  18 , Denise E Jones  18 , Jana R Buccola  18 , Ajay J Kirtane  3
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Free article
Randomized Controlled Trial

Intravascular Imaging vs Angiography Guidance for PCI of Severely Calcified Lesions: The ECLIPSE Trial

Gregg W Stone et al. JACC Cardiovasc Interv. .
Free article

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.

Keywords: calcification; intravascular imaging; intravascular ultrasound; optical coherence tomography; percutaneous coronary intervention.

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Conflict of interest statement

Funding Support and Author Disclosures The ECLIPSE trial was funded by Abbott Vascular. Dr Stone has received speaker honoraria from Medtronic, Amgen, and Boehringer Ingelheim; has served as a consultant to Robocath, Daiichi-Sankyo, Vectorious, Miracor, Apollo Therapeutics, Cardiac Success, Occlutech, Millennia Biopharma, Remote Cardiac Enablement, Ablative Solutions, Abbott, Valfix, Zoll, HeartFlow, Shockwave Medical, Impulse Dynamics, Adona Medical, Oxitope, HighLife, Elixir, Elucid Bio, Aria, Alleviant, FBR Medical, Myochron, and Colibri; and has equity and options in Cardiac Success, Ancora, Cagent, Applied Therapeutics, the Biostar family of funds, SpectraWAVE, Orchestra Biomed, Aria, Valfix, and Xenter. Dr Stone’s employer, Mount Sinai Hospital, receives research grants from Shockwave Medical, Biosense Webster, Bioventrix, Abbott, Abiomed, Cardiovascular Systems, Phillips, Vascular Dynamics, Pulnovo Medical, V-Wave and the Patient-Centered Outcomes Research Institute (via Weill Cornell Medical Center). Dr Genereux has served as a consultant for 4C Medical, Abbott Vascular, Abiomed, Haemonetics, Opsens, Medtronic, Pi-Cardia, Edwards Lifesciences, Puzzle Medical, Saranas, Shockwave Medical, and Teleflex; has equity and options in Pi-Cardia, Puzzle Medical, and Saranas; and has served as a principal investigator for Edwards Lifesciences. Dr Mehara has served as a consultant for Boston Scientific, Amgen, Canon, SpectraWAVE, and HeartFlow. Dr Dohad has received research and grant funding from Abbott Vascular and Boston Scientific; and has received speaker fees from Abbott Vascular and Boston Scientific. Dr Dahle has served as a consultant or speaker for Cardiovascular Systems, Abiomed, Medtronic, Edwards Lifesciences, Boston Scientific, and Shockwave Medical. Dr Shunk has received consulting fees from PercAssist and TransAortic Medical; holds patents for transesophageal magnetic resonance imaging; receives royalties from Johns Hopkins for transesophageal magnetic resonance imaging; has participated on data and safety monitoring boards for Syntactx and for the ENGULF trial; has served as a medical monitor for TransAortic Medical; is a past chair of the American College of Cardiology CathPCI Steering Committee; and has stock or stock options in Transaortic Medical and PercAssist. Dr Shunk’s institution has received research grants from Cardiovascular Systems, Boston Scientific, and Idorsia. Dr Mahmud has served as a consultant for Cardiovascular Systems, Abbott Vascular, Abiomed, MicroPort, Siemens; and has received institutional clinical trial support from Abiomed, MicroPort, Abbott Vascular, Boston Scientific, Cardiovascular Systems, and Shockwave Medical. Dr Alaswad has served as consultant for Boston Scientific, Cardiovascular Innovations, and Teleflex. Ms Kraemer, Ms Stiefel, Ms Jones, and Ms Buccola are full-time employees of Abbott. Dr Kirtane has received institutional funding to Columbia University and/or the Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Amgen, CathWorks, Concept Medical, Philips, ReCor Medical, Neurotronic, Biotronik, Chiesi, Bolt Medical, Magenta Medical, SoniVie, and Shockwave Medical. In addition to research grants, institutional funding includes fees paid to Columbia University and/or the Cardiovascular Research Foundation for consulting and/or speaking engagements in which Dr Kirtane controlled the content. Dr Kirtane has equity options in Bolt Medical and Airiver; and has received travel expenses and meals from Amgen, Medtronic, Biotronik, Boston Scientific, Abbott Vascular, CathWorks, Concept Medical, Novartis, Philips, Abiomed, ReCor Medical, Chiesi, Zoll, Shockwave Medical, and Regeneron. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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