Background:Optimal plaque preparation of calcified coronary lesions is key to prevent stent failure. The purpose of this study was to determine the strategy success and safety of intravascular lithotripsy (IVL) in calcified lesions of an all-comers cohort.Methods:Patients with calcified coronary lesions were screened in 3 centers. Seventy-one patients were eligible for IVL. Patients were assigned to (group A) primary IVL therapy for patients with calcified de-novo lesions (n=39 lesions), (group B) secondary IVL therapy for patients with calcified lesions in which noncompliant balloon dilatation failed (n=22 lesions), and (group C) tertiary IVL therapy in patients with stent underexpansion after previous stenting (n=17 lesions). Primary end point was strategy success (stent expansion with <20% in-stent residual stenosis) and safety outcomes (procedural complications, in-hospital major adverse cardiovascular event).Results:Seventy-eight calcified lesions were treated using the Shockwave C² balloon. Mean diameter stenosis of calcified lesions was 71.8±13.1% at baseline, decreased to 45.1±17.4% immediately after IVL, and to 17.5±15.2% after stenting. Mean minimal lumen diameter was 1.01±0.49 mm at baseline and increased to 1.90±0.61 after IVL, and to 2.88±0.56 mm after stenting. The primary end point of strategy success was reached in 84.6% (group A), 77.3% (group B), and 64.7% (group C). Device delivery and IVL treatment were possible in all lesions. Four type b dissections were observed without further sequelae. No patient suffered from in-hospital major adverse cardiovascular event. Seven Shockwave balloons ruptured during treatment without any sequelae.Conclusions:IVL provides a valid strategy for lesion preparation in severely calcified coronary lesions with high success rate, low procedural complications, and low major adverse cardiovascular event rates.

中文翻译：

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钙化冠状动脉病变的血管内碎石术：一项前瞻性，观察性，多中心登记。

背景：钙化冠状动脉病变的最佳斑块准备是预防支架衰竭的关键。这项研究的目的是确定在所有人群的钙化病变中血管内碎石术（IVL）的策略成功与安全性。方法：在3个中心对患有钙化病变的患者进行了筛查。有71名患者符合IVL的条件。患者被分为（A组）原发性IVL治疗钙化病灶（n = 39个病灶），（B组）二级IVL治疗钙化病灶球囊扩张不合格（n = 22个病灶） ，以及（C组）第三次IVL治疗在先前支架置入术后支架扩张不足的患者中（n = 17个病变）。主要终点是策略成功（使用<^2个气球。钙化病灶的平均直径狭窄在基线时为71.8±13.1％，在IVL后立即降至45.1±17.4％，在支架置入后降至17.5±15.2％。平均最小管腔直径在基线时为1.01±0.49 mm，在IVL后增加至1.90±0.61，在支架置入后增加至2.88±0.56 mm。策略成功的主要终点达到84.6％（A组），77.3％（B组）和64.7％（C组）。在所有病变中均可以进行器械递送和IVL治疗。观察到四种b型解剖，没有进一步的后遗症。没有患者遭受院内重大不良心血管事件的折磨。结论：IVL为严重钙化的冠状动脉病变提供了有效的治疗策略，成功率高，手术并发症少，