Nakamura Masato, Kuriyama Nehiro, Tanaka Yutaka, Yamazaki Seiji, Kawasaki Tomohiro, Muramatsu Takashi, Kadota Kazushige, Ashikaga Takashi, Takahashi Akihiko, Otsuji Satoru, Ando Kenji, Ishida Masaru, Nakamura Shigeru, Ito Yoshiaki, Iijima Raisuke, Nakazawa Gaku, Shite Junya, Honye Junko, Ako Junya, Yokoi Hiroyoshi, Kozuma Ken, Otake Hiromasa, Masumura Kazuho, Yamada Tomomi, Sotomi Yohei
Division of Minimally Invasive Treatment in Cardiovascular Medicine, Toho University Ohashi Medical Center, 2-22-36, Ohashi, Meguro-Ku, Tokyo, 153-8515, Japan.
Department of Cardiology, Miyazaki Medical Association Hospital, Miyazaki, Japan.
Cardiovasc Interv Ther. 2025 Jul;40(3):553-564. doi: 10.1007/s12928-025-01130-9. Epub 2025 May 12.
Evaluation of calcified lesions by intravascular imaging has revealed that atherectomy devices have only limited impact. However, subsequent use of coronary intravascular lithotripsy (IVL) may increase treatment effectiveness without increasing risk of complications. This study was designed to evaluate the safety and effectiveness of IVL use after atherectomy in severely calcified coronary lesions as pre-treatment for drug-eluting stents (DES). The Dual-Prep registry is a multicenter, prospective registry of consecutive image-guided percutaneous coronary interventions (PCI). The primary effectiveness and safety endpoints were procedural success (residual stenosis < 50% by quantitative coronary angiography) without an in-hospital major adverse cardiac event (MACE) and 30-day freedom from MACE, respectively. Baseline vessel calcification score and final DES expansion were evaluated by optical coherence tomography (OCT). A total of 118 patients with 120 lesions were enrolled at 20 sites. The calcification score of lesions after atherectomy by core-lab assessment was 4.0 in all cases. Rotational atherectomy was applied prior to IVL in 83.9% cases with mean burr size of 1.57 ± 0.20 mm; IVL was subsequently successfully delivered in all cases (mean balloon diameter 3.02 ± 0.45 mm), followed by DES deployment (mean diameter 3.19 ± 0.51 mm, length of 36.3 ± 16.0 mm). The primary efficacy and safety endpoints were met in 98.3% and 98.3% of cases, respectively. A DES expansion index < 0.8 was seen in 42.2%, and an eccentricity index < 0.7 was not observed in any patient. In severely calcified lesions, image-guided atherectomy followed by IVL lesion preparation demonstrated high procedural success rates and satisfactory non-eccentric stent expansion. This approach may be considered for lesions where an 'IVL-first' strategy may not be feasible. jRCT1032230384 (Oct 7, 2023).
血管内成像对钙化病变的评估显示，旋切装置的影响有限。然而，随后使用冠状动脉血管内碎石术（IVL）可能会提高治疗效果，且不增加并发症风险。本研究旨在评估在严重钙化冠状动脉病变中，旋切术后使用IVL作为药物洗脱支架（DES）预处理的安全性和有效性。Dual-Prep注册研究是一项多中心、前瞻性的连续影像引导经皮冠状动脉介入治疗（PCI）注册研究。主要有效性和安全性终点分别为手术成功（定量冠状动脉造影显示残余狭窄<50%）且无院内主要不良心脏事件（MACE）以及30天无MACE。通过光学相干断层扫描（OCT）评估基线血管钙化评分和最终DES扩张情况。在20个中心共纳入了118例患者的120处病变。经核心实验室评估，旋切术后病变的钙化评分为4.0。83.9%的病例在IVL之前应用了旋磨术，平均磨头尺寸为1.57±0.20mm；随后所有病例均成功进行了IVL（平均球囊直径3.02±0.45mm），接着进行DES植入（平均直径3.19±0.51mm，长度36.3±16.0mm）。主要疗效和安全性终点分别在98.3%和98.3%的病例中达到。42.2%的病例观察到DES扩张指数<0.8，且未在任何患者中观察到偏心率指数<0.7。在严重钙化病变中，影像引导下旋切后进行IVL病变预处理显示出高手术成功率和令人满意的非偏心支架扩张。对于“IVL优先”策略可能不可行的病变，可考虑这种方法。jRCT1032230384（2023年10月7日）
