Intravascular lithotripsy (IVL) and atherectomy (AT) devices have similar safety and efficacy profiles across all patients eligible for the procedures, an analysis of the ROLLING STONE registry shows. However, after propensity matching, IVL has better safety outcomes at 12-months post-procedure. The corresponding data were reported online in JACC: Cardiovascular Interventions by co-first authors Enrico Cerrato, MD, PhD, and Marco Pavani, MD, both of the San Luigi Gonzaga University Hospital and Orbassano and ASLTO3 Infermi Hospital, Turin, Italy, along with their colleagues. IVL and AT are used to debulk calcified coronary arteries in patients undergoing percutaneous coronary intervention (PCI) so revascularization can be successful. Prospective, real-world data are lacking for the use of IVL, especially compared with AT techniques (rotational and orbital AT). ROLLING STONE (Intravascular Lithotripsy and/or Mechanical Debulking for Severely Calcified Coronary Artery Lesions) was a prospective, multicenter, open-label, investigator-initiated, all-comers registry that took place across 23 hospitals in Italy. The registry was used to compare patients who underwent a procedure with a debulking system: IVL, rotational AT and orbital AT. The devices used were the Rotoblator/ROTAPRO System (Boston Scientific), Diamondback 360 Coronary Orbital Atherectomy System (Cardiovascular Systems) and the Shockwave Medical Coronary IVL Catheter (Shockwave Medical). Procedural success (residual stenosis <30%, absence of major in-hospital adverse cardiac events [MACE] [cardiac death, myocardial infarction, target vessel revascularization]) was the primary efficacy endpoint in the study. Freedom from MACE at 30-days post-procedure was the primary safety endpoint. A total of 544 patients underwent IVL (mean age=75 years, 19% female), and 380 underwent AT (mean age=76 years, 25% female). Excluded were 81 patients who received both IVL and AT. Both groups had similar rates of the primary efficacy endpoint (IVL=85.4% and AT=86.3%; relative risk=1.01; 95% confidence interval [CI]=0.88-1.17). Patients in the IVL group had significantly lower rates of MACE at 30 days (5.7%) compared with patients in the AT group (8.6%) (hazard ratio [HR]=0.60, 95% CI=0.36-0.99, p=0.045). IVL patients mainly had lower rates of cardiovascular death (1.7%) compared with AT patients (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% in AT; HR: 0.43; 95% CI: 0.21-0.89; p = 0.022),” the authors noted. Limitations include the fact that participants in this study were not randomized, details on specific operator rationale for selecting patients for each device were not collected, individual operator experience was not recorded, no core-lab-adjudicated quantitative calcium scores from imaging (such as intravascular ultrasound [IVUS]) were available and patients in the AT group underwent rotational or orbital AT. Despite these limitations, this study was able to demonstrate procedural success in very high-risk patients with complicated anatomies. Registries often do not include these types of patients. Investigators in this study utilized the data from the ROLLING STONE registry to show that IVL is safe, feasible and efficient compared with AT. IVL may even be safer in the long term. “In the absence of head-to-head clinical trials, our findings should be considered as hypothesisgenerating, given that the design of any observational registry is inherently susceptible to selection biases, both measured and unmeasured, that can influence outcomes,” the authors concluded. Source: Cerrato E, Pavani M, Zecchino S, et al. Intravascular lithotripsy or mechanical debulking in complex calcified coronary arteries: Multicenter, Prospective ROLLING STONE study. JACC: Cardiovasc Interv. 2026 February (Article in Press). Image Credit: Acronym – stock.adobe.com