Orbital Atherectomy vs. Conventional Balloon Angioplasty in Severely Calcified Coronary Arteries Prior to DES Implantation - ECLIPSE

Oct 29, 2024
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
Abbott
Date Presented:
10/29/2024
Date Published:
10/29/2024
Original Posted Date:
10/29/2024
References

Contribution To Literature:

The ECLIPSE trial failed to show that orbital atherectomy prior to DES implantation is superior to conventional PCI without atherectomy.

Description:

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.

Study Design

  • Randomized
  • Parallel

Patients with calcified coronary lesions were randomized to orbital atherectomy prior to DES implantation (n = 1,008) vs. conventional PCI without atherectomy (n = 997).

  • Total number of enrollees: 2,005
  • Duration of follow-up: 12 months
  • Mean patient age: 70 years
  • Percentage female: 26%
  • Percentage with diabetes: 43%

Inclusion criteria:

  • Patients with calcific coronary lesion (stable coronary disease, non-ST-elevation acute coronary syndrome of stabilized ST-elevation myocardial infarction)
  • Via angiogram: opacities involving both sides of the coronary artery within the target lesion (total length ≥15 mm), or
  • Via intravascular ultrasound/optical coherence tomography: ≥270° of calcium

Other salient features/characteristics:

  • Chronic kidney disease: 23%
  • Severe coronary calcium: 97%
  • Mean number of passes with orbital atherectomy: 3.8
  • Use of slow speed: 72%
  • Use of slow and fast speed: 25%
  • Use of fast speed: 3%
  • In the orbital atherectomy group, 2.0% had to crossover to another type of therapy
  • In the conventional PCI group, 4.9% had to crossover to another type of therapy

Principal Findings:

The primary imaging outcome, mean post-PCI minimal stent area at site of maximum calcification, was: 7.67 mm2 in the orbital atherectomy group vs. 7.42 mm2 in the conventional PCI group (p = 0.08).

The primary clinical outcome, target vessel failure at 1 year, was: 11.5% in the orbital atherectomy group vs. 10.0% in the conventional PCI group (p = 0.28).

Secondary outcomes:

  • Dissection: 6.9% in the orbital atherectomy group vs. 6.3% in the conventional PCI group (p = 0.57)
  • Coronary perforation: 1.8% in the orbital atherectomy group vs. 1.0% in the conventional PCI group (p = 0.14)
  • Slow flow: 1.4% in the orbital atherectomy group vs. 0.4% in the conventional PCI group (p = 0.03)
  • All-cause death at 30 days: 1.0% in the orbital atherectomy group vs. 0.3% in the conventional PCI group (p = 0.05)
  • Cardiac death at 30 days: 0.8% in the orbital atherectomy group vs. 0.0% in the conventional PCI group (p = 0.005); two of these deaths were related to the device and two were possibly related to the device

Interpretation:

Among patients with calcified coronary lesions, the ECLIPSE trial failed to show that orbital atherectomy prior to DES implantation is superior to conventional PCI without atherectomy. The minimum stent area at maximum calcium site was similar between treatment groups; however, there was a numerical increase in this outcome, which favored orbital atherectomy. There was no difference in target vessel failure at 1 year. At 30 days, there was an increase in all-cause and cardiovascular mortality in the orbital atherectomy group, of which two were related to the device and two were possibly related to the device. The mechanism for the increase in mortality is not known since the incidence of dissection and perforation was similar between treatment groups.

A limitation of the trial is that it was largely conducted before intravascular lithotripsy was available (used in 0.2% of the orbital atherectomy group and 0.6% of the conventional PCI group). Patients were eligible for enrollment if there was considered to be treatment equipoise; therefore, patients with extremely calcified coronary lesions in which the operator felt that atherectomy was clearly warranted would have been excluded from enrollment. Calcified coronary arteries remain a high-risk subset of PCI regardless of treatment approach. Orbital atherectomy remains an effective adjunctive treatment option to allow for procedure success; however, best practice always needs to be employed.

References:

Presented by Dr. Ajay J. Kirtane at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2024), Washington, DC, October 29, 2024.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Aortic Surgery

Keywords: Atherectomy, Drug-Eluting Stents, Percutaneous Coronary Intervention, TCT24, Transcatheter Cardiovascular Therapeutics


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