ECLIPSE Trial Evaluates Orbital Atherectomy Before Coronary Stent Implantation

October 29, 2024—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 before implantation of a drug-eluting stent in severely calcified coronary arteries.

The ECLIPSE findings were presented at TCT 2024, the 36th annual Transcatheter Cardiovascular Therapeutics annual scientific symposium of the Cardiovascular Research Foundation held October 27-30 in Washington, DC.

As summarized in the TCT press release, the ECLIPSE study enrolled 2,005 patients (2,492 lesions) at 104 sites in the United States from March 2017 to April 2023. Patient characteristics included: mean age, 70 years; female, 27.0%; diabetes, 44%; and chronic kidney disease, 24%.

By angiographic core laboratory analysis, mean reference vessel diameter was 3 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.

The TCT press release stated that the patients were randomized after successful wire crossing to either the orbital atherectomy strategy (n = 1,008) or conventional balloon angioplasty (n = 997) before second-generation drug-eluting stent implantation and optimization. Procedural complications were largely similar between groups.

The primary imaging endpoint was the acute post percutaneous coronary implantation minimal stent area at the site of maximum calcification as assessed by optical coherence tomography in a prespecified cohort of 555 patients enrolled at 39 sites in the United States.

The 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, 0.82 mm²]; P = .08).

According to TCT, the primary clinical endpoint of target vessel failure was defined as the composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target vessel revascularization at 1-year follow-up.

The primary endpoint occurred in 11.5% of patients 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 = .28).

The two secondary endpoints of procedural success and strategy success without the need for crossover were similar between the two groups, noted the TCT press release.

“Compared with conventional balloon angioplasty, the routine use of orbital atherectomy did not reduce minimal stent area or target vessel failure,” commented Ajay J. Kirtane, MD, in the TCT press release. “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.”

Dr. Kirtane is 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 in New York, New York.