The ROLLING-STONE Study: Intravascular Lithotripsy or Mechanical Debulking for the Treatment of Complex Calcified Coronary Arteries—Coverage of CRT 2025 | SCAI
Mar 10th 2025 | News & Clinical Trials

The ROLLING-STONE Study: Intravascular Lithotripsy or Mechanical Debulking for the Treatment of Complex Calcified Coronary Arteries—Coverage of CRT 2025

Calcium Modification (Atherectomy, DCB, IVL)

Why is this study important? 

  • Intravascular lithotripsy (IVL) has been demonstrated to be safe and effective in treating calcified coronary lesions
  •  There are no comparative trials evaluating different plaque modification techniques

What question was this study supposed to answer? 

  • Prospective registry evaluating outcomes of IVL compared to atherectomy (AT), either rotational or orbital in a real-world population 

What did the study show? 

  • Moderate to severe calcified de novo lesions by angiography or imaging, in-stent restenosis (ISR), and under expanded stents were included 
  • Procedure technique was at the discretion of the operator 
  • Study enrolled 1005 (21% women) patients from 23 sites in Italy; <5% of sites had surgical backup 
  • >80% radial access and 1/3 of cases underwent intravascular imaging 
  • 77% of cases were rotational atherectomy in the AT group 
  • 56% had diabetes and 46% were acute coronary syndrome cases. 80% of patients had multivessel disease, 25% chronic total occlusion and 23 % left main disease. Left main debulking was used in 10% of cases. Lesions treated with AT had longer stented segments and higher radiation exposure 
  • Procedural success rate was similar among groups (85.4% in IVL, 86.3% in AT; p=0.70 with similar intraprocedural complications except for higher rate of access site complications in AT group (2.5% vs. 0.7% in IVL, p=0.03) and a trend toward higher incidence of abrupt vessel closure in AT (1.9% vs. 0.6% in IVL, p=0.06) 
  • There were significant differences in MACE at 30 days in the IVL groups compared to AT (5.7% vs. 8.6%; p=0.045) primarily due to reduction in cardiovascular death (1.7% vs 3.9%; p=0.03). At 12 months, MACE (11% vs 14%; p=0.08) and cardiovascular death (4.6% vs 2.2%; p=0.04) were comparable. After propensity matching, at 12 months, MACE was significantly lower in the IVL group (7.0% vs 14.2% p=0.024) suggesting better safety outcomes with IVL