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Randomized Controlled Trial
. 2025 Apr 12;405(10486):1240-1251.
doi: 10.1016/S0140-6736(25)00450-7. Epub 2025 Mar 30.

Orbital atherectomy versus balloon angioplasty before drug-eluting stent implantation in severely calcified lesions eligible for both treatment strategies (ECLIPSE): a multicentre, open-label, randomised trial

Ajay J Kirtane  1 , Philippe Généreux  2 , Bruce Lewis  3 , Richard A Shlofmitz  4 , Suhail Dohad  5 , Jithendra Choudary  6 , Thom Dahle  7 , Andres M Pineda  8 , Kendrick Shunk  9 , Akiko Maehara  10 , Alexandra Popma  11 , Bjorn Redfors  12 , Ziad A Ali  13 , Mitchell Krucoff  14 , Ehrin Armstrong  15 , David E Kandzari  16 , William O'Neill  17 , Carlye Kraemer  18 , Krista M Stiefel  18 , Denise E Jones  18 , Jeff Chambers  19 , Gregg W Stone  20 ; ECLIPSE Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Orbital atherectomy versus balloon angioplasty before drug-eluting stent implantation in severely calcified lesions eligible for both treatment strategies (ECLIPSE): a multicentre, open-label, randomised trial

Ajay J Kirtane et al. Lancet. .

Abstract

Background: Coronary artery calcification is common among patients undergoing percutaneous coronary intervention (PCI), and severe coronary artery lesion calcification is associated with increased procedural complexity, stent under-expansion, and high rates of intraprocedural complications and out-of-hospital adverse events. Whether calcium ablation before stent implantation can mitigate these adverse events is not currently established. We aimed to prospectively compare orbital atherectomy with a balloon angioplasty-based strategy before stent implantation for the treatment of severely calcified coronary lesions.

Methods: In this multicentre, open-label, randomised controlled trial conducted at 104 medical centres in the USA, patients (aged ≥18 years) with severely calcified coronary lesions were randomly assigned (1:1) to orbital atherectomy or balloon angioplasty before PCI with drug-eluting stents using a web-based system (block sizes of four and six) and stratified by intended treatment of single versus multiple lesions and enrolling site. Randomly assigned lesions were deemed by operators to be eligible for both treatment strategies. Operators and patients were not masked to treatment. The two powered coprimary study endpoints were target vessel failure at 1 year (a composite of cardiac death, target vessel myocardial infarction, or ischaemia-driven target vessel revascularisation) and post-procedural minimal stent area at the site of maximal calcification, as assessed by intravascular optical coherence tomography in an imaging patient cohort. Primary analyses were by intention-to-treat. The trial is registered at ClinicalTrials.govNCT03108456, and 2-year follow-up is ongoing.

Findings: From March 27, 2017, to April 13, 2023, 2005 patients with 2492 lesions were randomly assigned to lesion preparation with orbital atherectomy (1008 patients with 1250 lesions) or balloon angioplasty (997 with 1242 lesions) before stent implantation. Median patient age was 70·0 years (IQR 64·0-76·0). 541 (27·0%) of 2005 patients were female and 1464 (73·0%) were male. Angiographically severe calcium was confirmed by the core laboratory in 1088 (97·1%) of 1120 lesions assigned to orbital atherectomy and 1068 (97·0%) of 1101 lesions assigned to balloon angioplasty. PCI was guided by intravascular imaging in 627 (62·2%) of 1008 patients in the orbital atherectomy group and 619 (62·1%) of 997 in the balloon angioplasty group. Target vessel failure events within 1 year occurred in 113 of 1008 patients in the orbital atherectomy group (1-year target vessel failure 11·5% [95% CI 9·7 to 13·7]) and in 97 of 997 patients in the balloon angioplasty group (10·0% [8·3 to 12·1]; absolute difference 1·5% [96% CI -1·4 to 4·4]; hazard ratio 1·16 [96% CI 0·87 to 1·54], p=0·28). Among those in the optical coherence tomography substudy cohort (276 patients with 286 lesions in the orbital atherectomy group and 279 patients with 292 lesions in the balloon angioplasty group), the mean minimal stent area at the site of maximal calcification was 7·67 mm2 (SD 2·27) in the orbital atherectomy group and 7·42 mm2 (2·54) in the balloon angioplasty group (mean difference 0·26 [99% CI -0·31 to 0·82]; p=0·078). Cardiac death events within 1 year occurred in 39 of 1008 patients in the orbital atherectomy group and in 26 of 997 in the balloon angioplasty group.

Interpretation: Routine treatment with orbital atherectomy before drug-eluting stent implantation did not increase minimal stent area or reduce the rate of target vessel failure at 1 year compared with a balloon angioplasty-based approach in severely calcified lesions deemed eligible for both treatment strategies. These data support a balloon-first approach for most calcified coronary artery lesions that can be crossed and dilated before stent implantation, guided by intravascular imaging.

Funding: Abbott Vascular (Abbott).

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Conflict of interest statement

Declaration of interests AJK reports research grants and consulting fees paid to Columbia University 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; equity options in Bolt Medical; and support for meeting attendance from Amgen, Medtronic, Biotronik, Boston Scientific, Abbott Vascular, CathWorks, Concept Medical, Novartis, Philips, Abiomed, ReCor Medical, Chiesi, Zoll, Shockwave, and Regeneron. PG reports consultancy, advisor, and speaker fees from Abbott Vascular; consultancy, advisor, and speaker fees from Abiomed; consultancy fees from Boston Scientific; consultancy, advisor, and speaker fees, a proctor role, and an institutional research grant from Edwards Lifesciences; consultancy, advisor, and speaker fees from Medtronic; consultancy fees from Haemonetics; equity and consultancy fees from Pi-Cardia; equity and consultancy fees from Puzzle Medical; consultancy and speaker fees from Shockwave; equity and consultancy fees from Soundbite Medical; consultancy fees from Teleflex; consultancy fees from 4C Medical; consultancy and advisor fees from Egnite; and was a coprimary investigator for the ECLIPSE trial (funded by Abbott Vascular), a primary investigator for the EARLY-TAVR and PROGRESS trials (funded by Edwards Lifesciences), and a primary investigator for the ALTA Valve Feasibility study (funded by 4C Medical). RAS is a Chairman of Cardiology at St Francis Hospital. SD reports fellowship grants from Abbott Vascular and Cardiovascular Systems paid to Cedars Sinai Medical Center and Smidt Heart Institute, and payment for lectures on complex PCI and optical coherence tomography from Abbott Vascular. TD reports honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Cardiovascular Systems; and participation on the ECLIPSE crossover committee and the advisory board for Abbott Vascular for the ECLIPSE study. AMP reports consulting fees and support for meeting attendance from Cardiovascular Systems. KS reports grants or contracts paid to institution from Cardiovascular Systems (for the ECLIPSE trial), Boston Scientific, and Idorsia; royalties with Johns Hopkins for transoesophageal MRI; consulting fees from PercAssist and TransAortic Medical; payment or honoraria for being a faculty lecturer from Cardiovascular Innovations; support for meeting attendance from PercAssist; participation on a data safety monitoring board or advisory board for Syntactx, TransAortic Medical FIM, and the ENGULF trial; a role as Chair for the CathPCI Steering Committee (American College of Cardiology) Ex officio; and stock or stock options with PercAssist. AM reports consulting fees paid to Cardiovascular Research Foundation from Boston Scientific, Abbott Vascular, and Philips; consulting fees from Amgen; and payments for participation on a data safety monitoring board or advisory board for SpectraWave. AP reports grants or contracts from Abbott/Cardiovascular Systems to the Cardiovascular Research Foundation for the coordination of the core laboratories, clinical events committee, and the academic research organisation in the ECLIPSE study. ZAA reports institutional grants from Abbott, Abiomed, Acist Medical, Amgen, AstraZeneca, Boston Scientific, Cardiovascular Systems, Chiesi, Gore, HeartFlow, Inari, Medtronic, Nipro, Philips, Shockwave, and Siemens; personal fees from Acist Medical, AstraZeneca, Boston Scientific, Philips, and Shockwave; and equity from Elucid, Lifelink, Spectrawave, and Vital Connect. MK reports research funding paid to the institution from CSI and Abbott Vascular, and grants, consulting fees, lecturer fees, and support for meeting attendance from CSI and Abbott Vascular. EA reports consulting fees from Abbott Vascular, Boston Scientific, Medtronic, and Shockwave Medical; and is a board member with the VIVA Foundation. DEK reports grants or contracts from Medtronic, Teleflex, Orbus Neich, Biotronik and Boston Scientific; consulting fees from Medtronic and Ablative Solutions; support for meeting attendance from Medtronic; participation on a data safety monitoring board or advisory board for BALT medical; stock or stock options with BioStar Capital and Vantis Medical; and is Chair of the CathPCI Steering Committee of the American College of Cardiology. WO reports consulting fees from Abbott Vascular, Abiomed, and Edwards Lifesciences. CK reports stock and stock options (stocks through long-term incentive plan) with T Abbott Laboratories. KMS reports stock and stock options (stock through long-term incentive plan) at Abbott Laboratories. DEJ reports stock and stock options with Abbott and is an Abbott employee. JC reports past employment with CSI and Abbott Vascular; royalties from Teleflex, Equity Picardia, and Fast Wave; consultancy work for Zoll; and is a founder, chairperson, and chief medical officer of 4C Medical. GWS reports research grants paid to Mount Sinai Hospital from Shockwave, Biosense-Webster, Abbott, Abiomed, Bioventrix, Cardiovascular Systems, Phillips, Vascular Dynamics, Pulnovo, V-wave and PCORI (via Weill Cornell Medical Center); speaker honoraria from Pulnovo, Medtronic, Amgen, Boehringer Ingelheim, Abiomed; serves as a consultant to CorFlow, Cardiomech, Robocath, Daiichi Sankyo, Vectorious, Miracor, Apollo Therapeutics, Elucid Bio, Abbott, Cardiac Success, Occlutech, Millennia Biopharma, Remote Cardiac Enablement, Ablative Solutions, Valfix, Zoll, HeartFlow, Shockwave, Impulse Dynamics, Adona Medical, Oxitope, HighLife, Elixir, Aria; and equity or options from Cardiac Success, Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Valfix, and Xenter. All other authors declare no competing interests.

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