News — WASHINGTON, DC – Results from the large-scale randomized ECLIPSE trial found that a lesion preparation strategy of routine orbital atherectomy had similar outcomes compared with conventional balloon angioplasty prior to implantation of a drug-eluting stent (DES) in severely calcified coronary arteries.
Findings were reported today at TCT 2024, the annual scientific symposium of the Cardiovascular Research Foundation (CRF). TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine.
Severe coronary artery calcification has been associated with stent underexpansion, procedural complications, and increased rates of early and late adverse clinical events among patients undergoing percutaneous coronary intervention. Coronary atherectomy can ablate and fracture calcium, improving lesion compliance, thus facilitating stent delivery and expansion. To date, no lesion preparation strategy for severely calcified coronary artery lesions has definitively shown to improve clinical outcomes in an adequately powered randomized trial.
From March 2017 to April 2023, a total of 2,005 patients (2,492 lesions) were enrolled at 104 sites in the United States. The mean patient age was 70 years; 27.0% were female, 44% had diabetes and 24% had chronic kidney disease. By angiographic core laboratory analysis, mean reference vessel diameter was 3.0 mm, mean lesion length was 28.7 mm, and 97.1% of lesions met criteria for severe calcification. A large proportion (62%) of patients underwent intravascular imaging in the trial.
Patients were randomized after successful wire crossing to either the orbital atherectomy strategy (n=1,008) or conventional balloon angioplasty (n=997) prior to second generation drug-eluting stent implantation and optimization. Procedural complications were largely similar between groups.
The primary imaging endpoint consisted of the acute post-PCI minimal stent area at the site of maximum calcification as assessed by optical coherence tomography (OCT) in a pre-specified cohort of 555 subjects enrolled at 39 sites in the United States. Stent areas were not appreciably different between the two groups [7.67 ± 2.27 for orbital atherectomy versus 7.42 ± 2.54 for balloon angioplasty, 99% CI 0.26 (-0.31, 0.82mm2), p=0.08].
The primary clinical endpoint of target vessel failure (TVF), defined as the composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target vessel revascularization at one year follow-up, occurred in 11.5% in the orbital atherectomy group compared with 10.0% in the traditional balloon angioplasty group [Hazard Ratio 1.16 (96% CI 0.87, 1.54), p=0.28]. The two secondary endpoints of procedural success and strategy success without the need for crossover were similar between both groups.
“Compared with conventional balloon angioplasty, the routine use of orbital atherectomy did not reduce minimal stent area or target vessel failure,” said Ajay J. Kirtane, MD, SM, Director of Columbia Interventional Cardiovascular Care at NewYork-Presbyterian/Columbia University Irving Medical Center and Professor of Medicine at the Columbia University Irving Medical Center. “The high use of intravascular imaging within this trial was remarkable and was associated with improved outcomes in both treatment groups. But the take-home message for me is that we showed that adequate stent expansion and low rates of adverse outcomes are achievable with conventional balloon angioplasty if meticulous attention is paid to lesion preparation, further highlighting the importance of randomized trials to inform treatment strategies.”
The study was funded by Abbott Vascular (formerly Cardiovascular Systems, Inc).
Dr. Kirtane reported the following disclosures: institutional funding to Columbia University and/or 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 Cardiovascular Research Foundation for consulting and/or speaking engagements in which Dr. Kirtane controlled the content. Personal: equity options in Bolt Medical and Airiver; Travel Expenses/Meals from Amgen, Medtronic, Biotronik, Boston Scientific, Abbott Vascular, CathWorks, Concept Medical, Novartis, Philips, Abiomed, ReCor Medical, Chiesi, Zoll, Shockwave and Regeneron.
About CRF® and TCT®
The Cardiovascular Research Foundation® (CRF®) is a global leader in interventional cardiovascular medicine, driving innovation, spearheading groundbreaking research, and transforming education in the field. Through its relentless pursuit of excellence, CRF® not only accelerates medical breakthroughs but also equips healthcare professionals with the tools and knowledge necessary to enhance survival rates and elevate the quality of life for millions worldwide. CRF’s centers of excellence include the CRF Skirball Center for Innovation, CRF Clinical Trials Center, CRF Center for Education, CRF Digital, TCTMD, and Structural Heart: The Journal of the Heart Team.
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