Optical Coherence Tomography Assessment in Patients Treated With Rotational Atherectomy Versus Modified Balloons: PREPARE-CALC OCT

Background: Percutaneous intervention of calcified coronary lesions often requires lesion preparation with either balloon dilatation or atherectomy. We sought to evaluate the impact of lesion preparation strategy on stent expansion following preparation of severely calcified coronary lesions with modified (cutting/scoring) balloons (MB) versus rotational atherectomy (RA) and to evaluate the impact of calcium burden as assessed by optical coherence tomography (OCT) on acute stent performance. Methods: In the PREPARE-CALC trial (Comparison of Strategies to Prepare Severely Calcified Coronary Lesions), 200 patients with severely calcified coronary lesions were randomly assigned to receive either lesion preparation with MB or RA. In 122 patients, OCT was performed before lesion preparation and at the end of the procedure. The principal end point of this OCT sub-analysis was stent expansion as assessed by OCT. The key secondary end points included stent asymmetry and eccentricity. Results: The maximal calcific arc (257.5±96.7° versus 248.7±82.1°, P =0.59), thickness (1.34±0.29 versus 1.32±0.27 mm, P =0.76), and length of calcification (21.1±9.7 versus 24.0±10.9 mm, P =0.12) did not differ between the MB versus RA group. Lesion preparation with MB versus RA lead to comparable stent expansion (73.5±13.3% versus 73.1±12.2%, respectively, P =0.85). The use of RA did not have a significant impact on stent asymmetry or eccentricity compared with the use of MB. Length of calcified plaque appeared to be increased in patients with stent underexpansion, while thickness of calcified plaque was increased in patients with stent asymmetry. Target lesion revascularization at 9 months was 3.3% when MB was used and 1.6% when RA was performed ( P =0.62). Conclusions: In this OCT sub-analysis from the PREPARE-CALC trial, calcified plaque length was increased in patients with stent underexpansion, while its thickness was higher in patients with stent asymmetry, with no impact of the lesion preparation strategy. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02502851.