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

BACKGROUND

Coronary calcification negatively affects the safety and effectiveness of percutaneous coronary intervention. There is a lack of randomized comparisons among different plaque modification techniques.

OBJECTIVES

The aim of this study was to compare rotational atherectomy (RA), excimer laser coronary angioplasty (ELCA), and intravascular lithotripsy (IVL) for the treatment of patients with calcified coronary stenosis.

METHODS

Patients with moderate to severe calcified coronary lesions were randomly assigned to percutaneous coronary intervention with RA, IVL, or ELCA. The primary endpoint was the percentage of stent expansion by optical coherence tomography. An intention-to-treat, noninferiority analysis was conducted.

RESULTS

A total of 171 patients (77.2% men [n = 132], mean age 70.9 ± 8.2 years) were enrolled, 57 in each treatment arm. Clinical presentation was chronic coronary syndrome in 64.3% of patients (n = 110) and acute coronary syndrome in 35.7% (n = 61). Severe angiographic calcification was observed in 82.5% of lesions (n = 141). Procedural success rate and final minimum stent area (RA, 5.5 ± 2.1 mm; IVL, 5.4 ± 1.8 mm; ELCA, 5.1 ± 1.8 mm) were similar among the 3 arms. IVL proved to be noninferior to RA, with no differences in stent expansion (RA, 86.4% ± 14.1%; IVL, 85.6% ± 13.3%; P = 0.77). ELCA did not reach noninferiority in the intention-to-treat analysis. The rate of complications was low, with no significant differences in the 3 arms but numerically lower with IVL.

CONCLUSIONS

In the first randomized trial comparing RA, IVL, and ELCA for the treatment of patients with calcified coronary lesions, IVL was noninferior to RA in terms of stent expansion. ELCA did not reach this noninferiority margin compared with RA. No significant differences were observed among the 3 arms regarding minimum stent area, procedural success rate, and complications, which were numerically lower with IVL.