Intravascular Lithotripsy or Mechanical Debulking in Complex Calcified Coronary Arteries: Multicenter, Prospective ROLLING STONE Study

Background: Prospective data on the contemporary use of different coronary calcium debulking techniques are lacking. Objectives: The authors compared intravascular lithotripsy (IVL) vs atherectomy (AT) devices (rotational and orbital atherectomy) in a real-world all-comer population. Methods: The ROLLING STONE Registry prospectively enrolled patients treated with IVL and/or AT across 23 Italian centers. Primary efficacy endpoint was procedural success (residual stenosis <30% and absence of in-hospital major adverse cardiac events (MACE) (cardiac death, myocardial infarction, target vessel revascularization). Primary safety endpoint was freedom from MACE at 30 days, whereas the secondary endpoint was MACE at 12 months. Propensity score matching and inverse probability weighting were applied to compare 30-day and 12-month safety endpoints. Results: A total of 1,005 patients were enrolled, including 544 (59%) in the IVL group vs 380 (41%) in the AT group, excluding 81 patients treated with both. Primary efficacy endpoint was similar between groups (85.4% in IVL vs 86.3% in AT; relative risk: 1.01; 95% CI: 0.88-1.17). MACE rate at 30 days was significantly lower in the IVL group (5.7% vs 8.6%; HR: 0.60; 95% CI: 0.36-0.99; P = 0.045), driven primarily by lower rate of cardiovascular death (1.7% vs 3.9%; HR: 0.40; 95% CI: 0.18-0.92; P = 0.030). After propensity score matching (n = 320) and inverse probability weighting (n = 532), the MACE rate at 12 months was significantly lower in the IVL group (6.8% vs 14.3%; HR: 0.43; 95% CI: 0.21-0.89; P = 0.022). Conclusions: The study confirms the feasibility, safety, and efficacy of IVL and AT in an unselected population, with similar procedural success rates. After propensity matching, IVL seems to demonstrate in our cohort a better 12-month safety outcome. (Intravascular Lithotripsy and/or Mechanical Debulking for Severely Calcified Coronary Artery Lesions [ROLLING-STONE]; NCT05016726).