Deng Xin, Hu Yiqing, Fu Guosheng, Ma Genshan, Liu Xuebo, Shi Bei, Luo Jianfang, Wang Jingfeng, Zhong Zhixiong, Cui Hanbin, Ma Likun, Qian Juying, Wang Jian'an, Lu Hao, Ge Junbo
State Key Laboratory of Cardiovascular Diseases Department of Cardiology Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases; National Clinical Research Center for Interventional Medicine Shanghai China.
Department of Cardiology Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Hangzhou China.
MedComm (2020). 2025 May 20;6(6):e70208. doi: 10.1002/mco2.70208. eCollection 2025 Jun.
Intravascular lithotripsy (IVL) is a promising therapy for calcified coronary lesions. This study evaluated the safety and effectiveness of a novel IVL system. The ronary lcified Lesion ithotripsy rocedure (COCALP) study (No. ChiCTR2300073280) was a prospective, multicenter, single-arm trial involving 266 patients with severely calcified coronary lesions. The primary endpoint was procedural success, defined as successful stent implantation with ≤30% residual stenosis and no in-hospital major adverse cardiovascular events (MACE). In a subgroup, calcium morphology was evaluated by optical coherence tomography (OCT) assessment. A total of 266 patients were included. The procedural success rate was 97.4% (95% confidence interval [CI]: 0.947-0.989), with the lower limit of the CI exceeding the prespecified performance goal ( < 0.001). No MACE occurred intraoperatively. During hospitalization, MACE occurred in five patients (1.9%), all of which were myocardial infarctions. MACE rates at 1 and 6 months were 2.3 and 3.4%, respectively. In the OCT subgroup ( = 76), IVL induced a 76.8% rate of calcification fracture. The minimal lumen area increased from 1.77 ± 0.72 to 2.59 ± 1.11 mm following IVL (< 0.001), and further expanded to 5.22 ± 1.69 mm poststenting (< 0.001). The novel IVL system demonstrated high effectiveness and safety, supporting its use for treating severely calcified coronary lesions and enhancing stent implantation success.
血管内碎石术（IVL）是一种治疗钙化冠状动脉病变的有前景的疗法。本研究评估了一种新型IVL系统的安全性和有效性。冠状动脉钙化病变碎石术（COCALP）研究（编号：ChiCTR2300073280）是一项前瞻性、多中心、单臂试验，纳入了266例严重钙化冠状动脉病变患者。主要终点是手术成功，定义为成功植入支架且残余狭窄≤30%，且无院内重大不良心血管事件（MACE）。在一个亚组中，通过光学相干断层扫描（OCT）评估钙化形态。共纳入266例患者。手术成功率为97.4%（95%置信区间[CI]：0.947 - 0.989），CI下限超过预先设定的性能目标（<0.001）。术中未发生MACE。住院期间，5例患者（1.9%）发生MACE，均为心肌梗死。1个月和6个月时的MACE发生率分别为2.3%和3.4%。在OCT亚组（n = 76）中，IVL导致钙化断裂率为76.8%。IVL后最小管腔面积从1.77±0.72增加至2.59±1.11 mm（<0.001），支架植入后进一步扩大至5.22±1.69 mm（<0.001）。新型IVL系统显示出高有效性和安全性，支持其用于治疗严重钙化冠状动脉病变并提高支架植入成功率。
