- The ECLIPSE trial evaluated orbital atherectomy (OA) vs conventional balloon dilatation (BA) in patients with de novo severely calcified lesions.
- The trial found no difference in target vessel failure (TVF) at one year between the two groups. The minimum stent area at the maximum calcium site was similar, but there was a numerical increase in favor of OA
Severe coronary artery calcification has been associated with stent under expansion, procedural complications, and also with increased rates of early and late mayor cardiovascular events in 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. Orbital atherectomy (OA) allows optimal lesion preparation by ablating and fracturing calcium, allowing adequate stent expansion. In balloon un-crossable or non-dilatable coronary lesions, orbital atherectomy allows stent delivery and expansion. The additional benefit of orbital atherectomy in calcified coronary lesions with equipoise for the use of conventional balloon dilatation (BA) is unknown.
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 was compared with conventional balloon angioplasty prior to drug-eluting stent implantation. Patient population included individuals with stable ischemic heart disease or acute coronary syndromes (non–ST-segment elevation MI [STEMI] or unstable angina) or stabilized recent STEMI (>48 hours prior to randomization procedure were included. Key angiographic inclusion criteria required de novo (non-restenotic) native coronary artery target lesion(s) with diameter stenosis ≥70% and <100%, or a stenosis ≥50% and <70% with evidence of ischemia on a stress test or with abnormal invasive physiology. Target lesions must have angiographic or intravascular imaging evidence of severe calcium at the lesion site. Severe angiographic calcification was defined as the presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least 1 location, with total length of calcium ≥15 mm and extending at least partially into the target lesion. Severe calcification was defined by intravascular ultrasound (IVUS) or OCT as the presence of ≥270° of calcium in at least 1 imaging cross-section. The trial aimed 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 was the acute post-procedural in-stent minimal cross-sectional area as assessed by optical coherence tomography in a 500-subject cohort. Enrollment was completed in 2023 with total clinical follow-up planned for 2 years. Findings were presented by Dr Ajay Kirtane atTCT 2024, the annual scientific symposium of the Cardiovascular Research Foundation (CRF).
A total of 2,005 patients (2,492 lesions) were enrolled at 104 sites in the United States, and randomized to orbital atherectomy (n = 1,008; Diamondback 360; Abbott) or conventional balloon angioplasty (n = 997) prior to second generation drug-eluting stent implantation and optimization. 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. Procedural success was high, at about 86% in each group. The rate of crossover was 2.0% in the orbital atherectomy group and 4.9% in the conventional balloon arm. Procedural complications were generally low and similar for orbital atherectomy and balloon angioplasty, with the only exception being a higher incidence of slow flow in the former (1.4% vs 0.4%; P = 0.03). 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, there was no difference between groups, 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. Other 1-year clinical outcomes were low and similar between the group
“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. He also added that “ 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.”
Généreux P, Kirtane AJ, Kandzari DE, Armstrong EJ, Krucoff MW, Redfors B, Ben-Yehuda O, Lerew DR, Ali ZA, Maehara A, O’Neill WW, Stone GW. 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. Am Heart J. 2022 Jul;249:1-11. doi: 10.1016