Intravascular ultrasound evaluation of novel non-compliant versus conventional semi-compliant cutting balloon for calcified coronary lesions.

Cutting balloons (CBs) are valuable tools for modifying calcified coronary lesions. However, few comparative studies have assessed the efficacy of different CBs in real-world practice. Therefore, we evaluated the dilatation efficacy and safety of a novel non-compliant CB (NCB) in a head-to-head comparison with a conventional semi-compliant CB (CCB). This single-center, prospective observational study included 50 consecutive calcified lesions treated with the NCB as the initial interventional device. Another 50 consecutive lesions treated with the CCB were retrospectively analyzed as a historical control. All lesions underwent intravascular ultrasound (IVUS) evaluation before and after dilatation with CB. The primary endpoints were post-modification minimum lumen area (post-CB MLA), change in MLA (ΔMLA), and crack formation at the MLA site. Secondary endpoints included the incidence of coronary dissection, perforation, and slow/no-reflow. Baseline patient and lesion characteristics were generally comparable between groups. Post-CB MLA was significantly larger in the NCB group than in the CCB group (4.26 ± 1.62 mm² vs. 3.45 ± 1.26 mm²; p = 0.007). ΔMLA was also greater in the NCB group (1.49 ± 0.97 mm² vs. 0.94 ± 0.65 mm²; p = 0.001). The NCB achieved more cracks per MLA cross-Sect.  (2 [IQR 1-2] vs. 1 [IQR 1-1]; p = 0.014) and a lower incidence of malignant dissection (12% vs. 30%; p = 0.048). No coronary perforations or slow/no-reflow events occurred in either group. The NCB demonstrated superior lesion preparation performance, while maintaining a comparable safety profile, compared with the CCB in de-novo calcified lesions.