Randomized evaluation of vessel preparation with orbital atherectomy prior to drug-eluting stent implantation in severely calcified coronary artery lesions: Design and rationale of the ECLIPSE trial
Philippe Généreux, Ajay J Kirtane, David E Kandzari, Ehrin J Armstrong, Mitchell W Krucoff, Björn Redfors, Ori Ben-Yehuda, Darin R Lerew, Ziad A Ali, Akiko Maehara, William W O'Neill, Gregg W Stone, Philippe Généreux, Ajay J Kirtane, David E Kandzari, Ehrin J Armstrong, Mitchell W Krucoff, Björn Redfors, Ori Ben-Yehuda, Darin R Lerew, Ziad A Ali, Akiko Maehara, William W O'Neill, Gregg W Stone
Abstract
Background: Severe coronary artery calcification has been associated with stent underexpansion, procedural complications, and increased rates of early and late adverse clinical events in patients undergoing percutaneous coronary intervention. To date, no lesion preparation strategy has been shown to definitively improve outcomes of percutaneous coronary intervention for calcified coronary artery lesions.
Study design and objectives: ECLIPSE (NCT03108456) is a prospective, randomized, multicenter trial designed to evaluate two different vessel preparation strategies in severely calcified coronary artery lesions. The routine use of the Diamondback 360 Coronary Orbital Atherectomy System is compared with conventional balloon angioplasty prior to drug-eluting stent implantation. The trial aims to enroll approximately 2000 subjects with a primary clinical endpoint of target vessel failure, defined as the composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target vessel revascularization assessed at 1 year. The co-primary endpoint is the acute post-procedural in-stent minimal cross-sectional area as assessed by optical coherence tomography in a 500-subject cohort. Enrollment is anticipated to complete in 2022 with total clinical follow-up planned for 2 years.
Conclusions: ECLIPSE is a large-scale, prospective randomized trial powered to demonstrate whether a vessel preparation strategy of routine orbital atherectomy system is superior to conventional balloon angioplasty prior to implantation of drug-eluting stents in severely calcified coronary artery lesions.
Conflict of interest statement
Conflict of interest Dr Généreux: Speaker fee – Abiomed, Edwards Lifesciences, Medtronic; Shockwave, Teleflex, consultant – Abbott Vascular, Abiomed, Boston Scientific, Cardiovascular System Inc, Cordis, Edwards Lifesciences, iRythm, Medtronic, Opsens, Pi-Cardia, Saranas, Siemens Healthcare, SIG.NUM, Soundbite Medical Solutions Inc. Teleflex; 4C Medical, Equity/options – Pi-Cardia, Puzzle Medical, Saranas, SIG.NUM, Soundbite Medical. Dr Kirtane: Institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical. In addition to research grants, institutional funding includes fees paid to Columbia University and/or Cardiovascular Research Foundation for speaking engagements and/or consulting. Personal: Consulting – Neurotronic; travel expenses/meals from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. Dr Kandzari: Institutional research/grant support – Abbott Vascular, Biotronik, Boston Scientific, Cardiovascular Systems, Medtronic, Teleflex; personal consulting honoraria – Cardiovascular Systems, Medtronic. Dr Armstrong: Consultant for Abbott Vascular, Boston Scientific, Cardiovascular Systems Inc, Intact Vascular, Gore, Medtronic, Philips, and Shockwave. Dr Krucoff: Consulting/speaker fee: Abbott Vascular, Biosensors, Boston Scientific, Cardiovascular System Inc, Medtronic, OrbusNeich, SMT, Terumo; Research grants: Abbott Vascular, Biosensors, Boston Scientific, Cardiovascular System Inc, Medtronic, OrbusNeich, SMT, Terumo, Cook, Gore. Dr Lerew: Employee – Cardiovascular Systems, Inc. Dr Ali: Institutional research grants to Columbia University – Abbott, Cardiovascular Systems Inc; consultant – Amgen, AstraZeneca, Boston Scientific.; equity – Shockwave. Dr Maehara: Grant support and consultant - Abbott Vascular and Boston Scientific. Dr O'Neill: Consultant - Edwards Lifesciences, Abbott, and Boston Scientific. Dr Stone: Speaker or other honoraria from Cook and Terumo; Consultant to Valfix, TherOx, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, Matrizyme, Cardiomech, Elucid Bio, Occlutech; Equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, MedFocus family of funds, Valfix. Other authors: None.
Copyright © 2022. Published by Elsevier Inc.
Source: PubMed