Intravascular lithotripsy (IVL) has better 12-month safety outcomes compared with atherectomy devices (AT) during percutaneous coronary intervention (PCI) in calcified coronary lesions, according to new data from the ROLLING STONE Registry. The registry data, presented in a late-breaking clinical trial session at Cardiovascular Research Technologies (CRT) 2025 on Saturday, confirmed the feasibility and high safety and efficacy of both IVL and AT in an unselected population — with similar procedural success rates and fewer major adverse cardiovascular events (MACE) at 30-days and cardiovascular death in the IVL group. Speaking on behalf of ROLLING STONE investigators at CRT 2025, Enrico Cerrato, MD, PhD, from San Luigi Gonzaga University and Rivoli Infermi Hospital, Turin, Italy, noted that, while IVL has proven to be a safe and effective plaque modification technique in specific subset of patients, large prospective data from real world practice remains lacking. “ROLLING-STONE stands as the largest prospective investigator initiated multicenter registry, including >1000 all-comers patients treated with different debulking devices,” Dr. Cerrato said in his presentation. “After propensity matching, IVL seems to have better 12-month safety outcomes compared to AT in our registry,” he added. Study setup The objective of the ROLLING-STONE trial was to compare the performance of IVL vs AT (rotational and orbital atherectomy) during PCI in a real-life all-comers population. The registry prospectively enrolled 1,005 consecutive patients treated with IVL (n = 544) or AT (n = 380) in 23 centers in Italy, and 81 patients treated with both IVL and AT were excluded in the analysis. The primary efficacy endpoint was as procedural success, defined as successful delivery of the device, residual stenosis <30% and absence of in-hospital MACE (defined as cardiac death, myocardial infarction or target vessel revascularization), said Dr. Cerrato. The primary safety endpoint was freedom from MACE at 30 days. The analysis showed that procedural success was similar among both groups (85.4% in IVL vs 86.3% in AT; p=0.70), with similar intraprocedural complications except for an 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), said Dr. Cerrato. The primary safety endpoint of 30-days MACE, however, showed significant differences in IVL vs AT (5.7% vs. 8.6%; hazard ratio [HR]=0.60, 95%CI 0.36-0.99, p=0.045) driven by significant differences in 30-day risk of cardiovascular death (IVL = 1.7% vs AT = 3.9%, HR 0.40, 95%CI 0.18 - 0.92, p=0.03), he said. These differences in MACE were not observed at either 6 months (8.7% vs 10%; HR 0.89, 95%CI 0.57 -1.41, p=0.63) or 12 months (11% vs 14%; HR 0.71, 95%CI 0.49 -1.04, p=0.08). However, a significant difference in risk of cardiovascular death remained, even at 1-year (HR 0.45, IVL 2.2% vs. AT 4.6%; 95% CI 0.21 - 0.97, p=0.04). After propensity score matching, MACE were similar between IVL and AT at 30 days (3.1% IVL vs 7.0% AT HR 0.44, 95%CI 0.15 -1.27, p=0.13) and 6 months (7.0% vs 9.3% HR 0.69, 95%CI 0.32 -1.50, p=0.35), but were significantly lower at 12 months in the IVL group (7.0% vs 14.2%, HR 0.44, 95%CI 0.21 -0.90, p=0.024), said Dr. Cerrato, noting that inverse probability weighting analysis confirmed the same findings (HR 0.44, 95% CI 0.22 -0.90, p= 0.025). Image Credit: Bailey G. Salimes Image Caption: Enrico Cerrato, MD, PhD, presents his late-breaking clinical trial Saturday, March 8, 2025, at Cardiovascular Research Technologies (CRT).