Rolling Stone: Registry of Intravascular Lithotripsy vs Atherectomy Use in Complex Calcified Lesions

Severe coronary calcification represents one of the main challenges in performing percutaneous coronary intervention, both due to the higher risk of stent underexpansion and the increased incidence of periprocedural complications. To reduce event rates, adequate plaque preparation is essential, with appropriate selection of plaque-modifying or “debulking” devices. In current practice, atherectomy (AT)—rotational or orbital—and intravascular lithotripsy (IVL) are among the most widely used tools for managing this challenging anatomical scenario.

However, prospective comparative data between these two strategies are limited. The ROLLING STONE registry is a prospective, multicenter study including 23 high-volume Italian centers, designed to compare the efficacy and safety of IVL versus atherectomy devices (rotational or orbital) in patients undergoing percutaneous coronary intervention for calcified coronary lesions.

A total of 1005 patients treated with debulking using IVL and/or AT were included; 81 cases in which a hybrid strategy was used were excluded, resulting in a final population of 924 patients (544 in the IVL group and 380 in the AT group).

The primary efficacy endpoint was procedural success, defined as residual stenosis <30% and absence of in-hospital MACE (cardiac death, myocardial infarction, or target vessel revascularization). The primary safety endpoint was the absence of MACE at 30 days; the secondary endpoint was MACE at 12 months.

Read also: Can TAVI Be Safely Performed in Patients With Bicuspid Aortic Valve?

Intravascular Lithotripsy vs Atherectomy in Calcified Coronary Lesions: Are There Differences in Efficacy and Safety?

Procedural success was similar between both strategies: 85.4% in the IVL group vs 86.3% in the AT group (RR 1.01; 95% CI: 0.88–1.17; p=0.70). The in-hospital MACE rate was 4.4% in the IVL group vs 7.3% in the AT group (RR 0.62; 95% CI: 0.36–1.08). At 30 days, IVL was associated with a lower incidence of MACE (5.7% vs 8.6%; HR 0.60; 95% CI: 0.36–0.99; p=0.045), mainly driven by a reduction in cardiovascular mortality (HR 0.40; p=0.030).

After adjustment using propensity score and inverse probability weighting (IPW), IVL showed a lower rate of MACE at 12 months (6.8% vs 14.3%; HR 0.43; 95% CI: 0.21–0.89; p=0.022). Regarding periprocedural safety, major angiographic complications were infrequent and comparable between groups, whereas access-site complications were more frequent in the AT group (2.5% vs 0.7%; p=0.03), likely related to lower radial access use in this group.

Read also: FFR Assessment for the Selection of Hypertensive Patients Who Benefit from Renal Stenting.

The differences observed in early events and in the adjusted 12-month analysis should be interpreted in light of baseline and anatomical differences between groups, including greater lesion complexity and longer stent lengths in the AT group.

Conclusions: Comparative 30-Day and 12-Month Outcomes in Coronary Debulking PCI

In patients with calcified coronary artery disease undergoing percutaneous coronary intervention, IVL and atherectomy demonstrated similar efficacy with an adequate safety profile. After statistical adjustment, IVL was associated with a lower incidence of events at 12 months, positioning it as a valuable alternative within the available therapeutic armamentarium.

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

Reference: Cerrato E, Pavani M, Zecchino S, Leoncini M, Zanda G, Abdirashid M, Cordone S, Nicolino A, Franzè A, Bernardi A, Lio V, Boi A, Marengo G, Presutti DG, Vadalà P, Secco GG, Conrotto F, Vergallo R, Menozzi A, Berchialla P, Tomassini F, Patti G, Musumeci G, Chinaglia A, Varbella F. Intravascular Lithotripsy or Mechanical Debulking in Complex Calcified Coronary Arteries: Multicenter, Prospective ROLLING STONE Study. JACC Cardiovasc Interv. 2026 Jan 24:S1936-8798(25)03190-5. doi: 10.1016/j.jcin.2025.11.033. Epub ahead of print. PMID: 41609534.