Two-Year Outcomes of the ECLIPSE Trial—Coverage of CRT 2026 | SCAI

Why is this study important?   

  • Adequate lesion preparation is important prior to drug-eluting stent (DES) implantation to reduce adverse events. 
  • Lesion complexity has increased in interventional practice with a high burden of calcific coronary artery disease, including the elderly, patients with diabetes, chronic kidney disease (CKD), and those on dialysis. 

What question was this study supposed to answer?  

  • This study addressed whether plaque modification with orbital atherectomy (OA)  improved clinical outcomes compared to conventional balloon angioplasty prior to drug-eluting stent implantation (ECLIPSE trial). 
  • One-year results of this trial, that were previously reported, did not demonstrate that OA reduced target lesion failure (TLF), compared to balloon angioplasty in severely calcified lesions. A two-year follow-up was now reported. 

What did the study show?  

  • At 2 years TLF, there was no difference in TLF rates (OA 15.6% and BA 14.0%, p=0.30), which was consistent with the one-year result. 
  • Of the enrolled patients, 24% had CKD and 6% were on hemodialysis. 
  • Crossover rates were low. 
  • Intravascular imaging use was high at 62% with 40% OCT use. 
  • OA required more procedure time, equipment, and contrast use. 
  • Intravascular imaging was associated with better patient outcomes in both groups (OA and BA).  

Conclusion: 

Orbital atherectomy (OA) does not appear to be superior to conventional balloon angioplasty (BA) prior to DES placement, and routine use in lesion preparation cannot be recommended based on the one- and two-year follow-up of the ECLIPSE trial.