ECLIPSE Trial—A Large-Scale, Randomized Trial of Orbital Atherectomy vs. Conventional Balloon Angioplasty in Severely Calcified Coronary Arteries Prior to DES Implantation—Coverage of TCT 2024 | SCAI

Why is this study important? 

  • Patients with severely calcified lesions require proper lesion preparation to improve procedural success. 
  • It is unknown whether routine atherectomy before percutaneous coronary intervention (PCI) will improve patient outcomes.  

What question was this study supposed to answer? 

The trial evaluated orbital atherectomy before drug-eluting stent (DES) implantation compared with conventional PCI without atherectomy among patients with calcified coronary lesions. 

What did the study show? 

  • Patients with calcified coronary lesions were randomized to orbital atherectomy before DES implantation (n = 1,008) vs. conventional PCI without atherectomy (n = 997). The primary imaging outcome, mean post-PCI minimal stent area at the 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 outcome:  
  • 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).  
  • 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 associated with the device. 

Key takeaway

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. Calcified coronary arteries remain a high-risk subset of PCI regardless of treatment approach. However, the use of Orbital atherectomy in these patients should be tailored based on patient composites and lesion characteristics based on intravascular imaging. 

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