Intravascular lithotripsy (IVL) has demonstrated effectiveness in the treatment of calcified lesions in selected patients with stable coronary disease. The authors sought to assess the performance of coronary IVL in calcified coronary lesions in a real-life, all comers, setting. The REPLICA-EPIC18 study prospectively enrolled consecutive patients treated with IVL in 26 centers in Spain. An independent core laboratory performed the angiographic analysis and event adjudication. The primary effectiveness endpoint assessed procedural success (successful IVL delivery, final diameter stenosis <20%, and absence of in-hospital major adverse cardiovascular events [MACE]). The primary safety endpoint measured freedom from MACE at 30 days. A predefined substudy compared outcomes between acute coronary syndrome (ACS) and chronic coronary syndrome (CCS) patients. A total of 426 patients (456 lesions) were included, 63% of the patients presenting with ACS. IVL delivery was successful in 99% of cases. Before IVL, 49% of lesions were considered undilatable. The primary effectiveness endpoint was achieved in 66% of patients, with similar rates among CCS patients (68%) and ACS patients (65%). Likewise, there were no significant differences in angiographic success after IVL between CCS and ACS patients. The rate of MACE at 30 days (primary safety endpoint) was 3% (1% in CCS and 5% in ACS patients [ = 0.073]). Coronary IVL proved to be a feasible and safe procedure in a “real-life” setting, effectively facilitating stent implantation in severely calcified lesions. Patients with ACS on admission showed similar angiographic success rates but showed a trend toward higher 30-day MACE compared with patients with CCS. (REPLICA-EPIC18 study [Registry of Coronary Lithotripsy in Spain]; )

中文翻译：

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钙化冠状动脉冠状动脉碎石术的前瞻性、多中心、真实世界登记：REPLICA-EPIC18 研究

血管内碎石术（IVL）已被证明可以有效治疗选定的稳定型冠状动脉疾病患者的钙化病变。作者试图在现实生活中的所有环境中评估冠状动脉 IVL 在钙化冠状动脉病变中的表现。 REPLICA-EPIC18 研究前瞻性地招募了西班牙 26 个中心接受 IVL 治疗的连续患者。一个独立的核心实验室进行了血管造影分析和事件裁决。主要有效性终点评估手术成功（IVL 成功输送、最终直径狭窄 <20%，以及不存在院内主要不良心血管事件 [MACE]）。主要安全终点测量 30 天时无 MACE 情况。一项预先确定的子研究比较了急性冠脉综合征 (ACS) 和慢性冠脉综合征 (CCS) 患者的结果。总共纳入 426 名患者（456 个病变），其中 63% 的患者出现 ACS。 IVL 交付的成功率高达 99%。在 IVL 之前，49% 的病变被认为是不可扩张的。 66% 的患者实现了主要有效性终点，CCS 患者 (68%) 和 ACS 患者 (65%) 的比率相似。同样，CCS 和 ACS 患者之间 IVL 后血管造影的成功率也没有显着差异。 30 天时的 MACE 发生率（主要安全终点）为 3%（CCS 患者为 1%，ACS 患者为 5% [ = 0.073]）。事实证明，冠状动脉 IVL 在“现实生活”环境中是一种可行且安全的手术，可有效促进严重钙化病变的支架植入。与 CCS 患者相比，ACS 患者入院时表现出相似的血管造影成功率，但 30 天 MACE 呈较高趋势。 （REPLICA-EPIC18 研究 [西班牙冠状动脉碎石术登记处]；）