The routine use of orbital atherectomy did not improve minimal stent area (MSA) or reduce target vessel failure (TVF) at one year compared with conventional balloon angioplasty prior to implantation of a drug-eluting stent (DES) in severely calcified coronary lesions, based on findings from the ECLIPSE trial presented at TCT 2024.

The study enrolled 2,005 patients (2,492 lesions) from 104 sites in the U.S. between March 2017 and April 2023. The mean patient age was 70 years, 27% 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. Researchers noted that more than half of patients (62%) underwent intravascular imaging during the trial.

Following successful wire crossing, patients were randomly assigned to either the orbital atherectomy strategy (n=1,008) or conventional balloon angioplasty (n=997) prior to second generation DES implantation and optimization. The primary clinical endpoint of TVF at one-year follow-up, occurred in 11.5% in the orbital atherectomy group compared with 10.0% in the traditional balloon angioplasty group. The two secondary endpoints of procedural success and strategy success without the need for crossover were similar between both groups.

Additionally, MSA areas were not appreciably different between the two groups (7.67 ± 2.27 for orbital atherectomy vs. 7.42 ± 2.54 for balloon angioplasty) as assessed by optical coherence tomography in a pre-specified cohort of 555 subjects enrolled at 39 US sites.

"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, FACC, in presenting the findings. "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."