ROLLOUT of ROLLER COASTR-EPIC22: Intravascular Lithotripsy Matches Rotational Atherectomy in Stent Expansion for Calcified Coronary Lesions

Severely calcified coronary lesion subsets remain among the most formidable challenges in percutaneous coronary intervention (PCI), often compromising device delivery and stent expansion, contributing to suboptimal outcomes. The ROLLER COASTR-EPIC22 trial represents the first randomized head-to-head comparison of three plaque modification techniques—rotational atherectomy (RA), intravascular lithotripsy (IVL), and excimer laser coronary angioplasty (ELCA)—in this high-risk population.

This multicenter, prospective, randomized trial enrolled 171 patients with moderate to severe angiographic coronary calcification across eight high-volume Spanish centers. Patients were randomly assigned 1:1:1 to RA, IVL, or ELCA before drug-eluting stent implantation. The primary endpoint was stent expansion by optical coherence tomography (OCT), defined as minimum stent area (MSA) divided by reference vessel area. The study was powered for non-inferiority with RA as the reference comparator, though statistical power was diminished due to fewer than anticipated interpretable final OCT images.

In the intention-to-treat analysis, IVL achieved a mean stent expansion of 85.6% ± 13.3%, statistically non-inferior to RA (86.4% ± 14.1%; P=0.77). ELCA, with an expansion of 80.3% ± 13.3%, did not meet the prespecified non-inferiority margin compared to RA. However, in per-protocol analyses and cases without crossover to another technique, the difference between ELCA and RA became non-significant.

Minimum stent areas were similar across groups (RA: 5.5 ± 2.1 mm²; IVL: 5.4 ± 1.8 mm²; ELCA: 5.1 ± 1.8 mm²). Device success, angiographic, procedural, and clinical success rates were high and comparable across all arms. Procedural success was achieved in 93% of cases overall. Serious procedural complications were infrequent, with four coronary perforations (two in RA, two in ELCA), all managed successfully; none were reported in the IVL group.

Crossover to a second plaque modification technique occurred in 10.5% to 14% of cases, primarily due to uncrossable lesions in the ELCA and IVL groups, and undilatable lesions in the RA group—highlighting the complementary mechanisms of action across technologies and the value of sequential use of different modification techniques for select lesions.

The findings from ROLLER COASTR-EPIC22 affirm the safety and efficacy of IVL as a viable alternative to RA in the treatment of calcified coronary lesions, offering comparable stent expansion with potentially fewer complications. While ELCA fell short in the primary analysis, selected use based on lesion morphology may still be appropriate. These results support a nuanced, lesion-specific approach to plaque modification, with intracoronary imaging playing a pivotal role in guiding device selection.

This well-designed study notably lacked orbital atherectomy, ultra high-pressure non-compliant balloon angioplasty, and cutting or scoring balloon angioplasty as alternative modification strategies. Future studies powered for clinical outcomes and incorporating imaging-based lesion characterization will be key to further optimizing treatment strategies in this complex cohort.

References

Jurado-Román A, Gómez-Menchero A, Rivero-Santana B, et al. Rotational Atherectomy, Lithotripsy, or Laser for Calcified Coronary Stenosis: The ROLLER COASTR-EPIC22 Trial. J Am Coll Cardiol Intv. 2025 Mar, 18 (5) 606–618. https://doi.org/10.1016/j.jcin.2024.11.012