Dr. Berkant Öztürk, Dr. Mustafa Yenerçağ

Name of the study:
ECLIPSE: A Large-scale, Randomized Trial of Orbital Atherectomy vs. Conventional Balloon Angioplasty in Severely Calcified Coronary Arteries Prior to DES Implantation

Published in Congress: TCT 2024, Presenter: Ajay J. Kirtane

Link: https://www.tctmd.com/slide/eclipse-large-scale-randomized-trial-orbital-atherectomy-vs-conventional-balloon-angioplasty

Introduction:
Interventional cardiologists have many tools at their fingertips to address calcified lesions including angioplasty with conventional balloons as well as cutting and scoring balloons, orbital and rotational atherectomy, and lithotripsy. These new data indicate that the simplest—and notably the cheapest—approach might be the most reasonable.

Objective:
The goal of the trial was to evaluate orbital atherectomy prior to drug-eluting stent (DES) implantation compared with conventional percutaneous coronary intervention (PCI) without atherectomy among patients with calcified coronary lesions. The trial only included lesions deemed crossable with a balloon by operators, and almost two-thirds of cases were guided by any intravascular imaging.

Methods:
For the study, Kirtane and colleagues randomized 2,005 patients (mean age 69.9 years; 73% male) with severely calcified lesions as confirmed by core lab analysis to undergo PCI at one of 104 US centers with a lesion preparation strategy of either orbital atherectomy (n = 1,008; Diamondback 360; Abbott) or conventional balloon angioplasty (n = 997) between March 2017 and April 2023. Notably, all patients were considered eligible for balloon angioplasty by angiogram, and any lesions in which the wire couldn’t cross were excluded from the trial.

Results:
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. 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).
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.

Conclusions:
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.

Comment:
Orbital atherectomy offers no advantages in treating severely calcified lesions over conventional balloon angioplasty before DES implantation, according to new data from the randomized ECLIPSE trial. This trial 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.