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<p>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&#xa0;mm² vs. 3.45 ± 1.26&#xa0;mm²; <i>p</i> = 0.007). ΔMLA was also greater in the NCB group (1.49 ± 0.97&#xa0;mm² vs. 0.94 ± 0.65&#xa0;mm²; <i>p</i> = 0.001). The NCB achieved more cracks per MLA cross-Sect.&#xa0; (2 [IQR 1–2] vs. 1 [IQR 1–1]; <i>p</i> = 0.014) and a lower incidence of malignant dissection (12% vs. 30%; <i>p</i> = 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.</p> Graphic Abstract <p></p>

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

  • 期刊论文

  • 发表日期：

    2026年5月26日

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  • Yoshiki Kawai,
  • Yuta Nakamura,
  • Tomohiro Kouchi,
  • Hiroki Nakai,
  • Shingo Sato,
  • Makoto Takeyama,
  • Takahiro Sato,
  • Masashiro Matsushita,
  • Jiro Ando,
  • Takayuki Warisawa

摘要

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.

Graphic Abstract