ROLLER COASTR-EPIC22: Comparison of Plaque Modification Techniques in Severely Calcified Coronary Lesions

The presence of coronary calcium significantly limits the success of percutaneous coronary interventions (PCI), primarily due to suboptimal stent expansion. This can lead to major adverse cardiovascular events (MACE), such as stent thrombosis or the need for repeat revascularization. Proper selection of the plaque modification technique (PMT) could improve these outcomes. Characterizing and assessing calcium severity through intravascular imaging is essential for this.

The researchers of the ROLLER COASTR-EPIC22 study aimed to compare the effectiveness and efficiency of different PMTs in severely calcified lesions. They assessed intravascular lithotripsy (IVL) and excimer laser (EL) against rotational atherectomy (RA) prior to stent implantation.

Researchers designed a multicenter, prospective study involving eight high-volume centers in Spain. It included patients with acute coronary syndromes (ACS) or chronic coronary syndromes (CCS), with reference vessels ranging from 2.5 to 4.0 mm and moderate to severe calcification evidenced by angiography. Exclusion criteria included ST-segment elevation myocardial infarction (STEMI) culprit lesions, patients in cardiogenic shock, or subjects unable to tolerate dual antiplatelet therapy (DAPT). Randomization followed a 1:1:1 ratio for plaque preparation with RA, EL, or IVL. The use of OCT was recommended before dilation and mandatory upon PCI completion.

The primary endpoint was stent expansion percentage measured by OCT (the ratio between the minimum stent area and the mean reference area). Secondary endpoints included device success (no need for additional PMT), angiographic success (residual stenosis ≤20%), and procedural success (absence of MACE).

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A total of 171 patients (77.2% men) were included, with a mean age of 70.9±8.2 years. Of these, 64.3% had CCS and 35.7% ACS. The left anterior descending artery was the most frequently treated vessel (71.3%), with severe calcification in 82.5% of the lesions. Transradial or ulnar access was used in 84.2% of cases.

Device success was similar across all three groups, with the need for a second PMT in some cases (10.5%-14%). There were no significant differences in the minimum stent area (MSA: RA, 5.5±2.1 mm²; IVL, 5.4±1.8 mm²; EL, 5.1±1.8 mm²). Stent expansion was comparable between IVL and RA (RA, 86.4%±14.1%; IVL, 85.6%±13.3%), thus demonstrating the non-inferiority of IVL in all analyses. However, EL did not reach the non-inferiority threshold compared to RA based on MSA.

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The complication rate was low and similar across the three groups (four perforations, all resolved in the cath lab), with no procedure-related mortality.

Conclusions

This study provides valuable information on the randomized comparison of different plaque modification techniques. IVL was shown to be non-inferior to RA in terms of stent expansion as assessed by OCT. Complication rates were low, and MSA was similar across all evaluated techniques.

Original Title: Rotational Atherectomy, Lithotripsy, or Laser for Calcified Coronary Stenosis: The ROLLER COASTR-EPIC22 Trial.

Reference: Jurado-Román A, Gómez-Menchero A, Rivero-Santana B, Amat-Santos IJ, Jiménez-Valero S, Caballero-Borrego J, Ojeda S, Miñana G, Gonzálvez-García A, Tébar-Márquez D, Camacho-Freire S, Ocaranza-Sánchez R, Domínguez A, Galeote G, Moreno R. Rotational Atherectomy, Lithotripsy, or Laser for Calcified Coronary Stenosis: The ROLLER COASTR-EPIC22 Trial. JACC Cardiovasc Interv. 2025 Jan 29:S1936-8798(24)01708-4. doi: 10.1016/j.jcin.2024.11.012. Epub ahead of print. PMID: 39918495.