Background:The feasibility of intravascular lithotripsy (IVL) for modification of severe coronary artery calcification (CAC) was demonstrated in the Disrupt CAD I study (Disrupt Coronary Artery Disease). We next sought to confirm the safety and effectiveness of IVL for these lesions.Methods:The Disrupt CAD II study was a prospective multicenter, single-arm post-approval study conducted at 15 hospitals in 9 countries. Patients with severe CAC with a clinical indication for revascularization underwent vessel preparation for stent implantation with IVL. The primary end point was in-hospital major adverse cardiac events (cardiac death, myocardial infarction, or target vessel revascularization). An optical coherence tomography substudy was performed to evaluate the mechanism of action of IVL, quantifying CAC characteristics and calcium plaque fracture. Independent core laboratories adjudicated angiography and optical coherence tomography, and an independent clinical events committee adjudicated major adverse cardiac events.Results:Between May 2018 and March 2019, 120 patients were enrolled. Severe CAC was present in 94.2% of lesions. Successful delivery and use of the IVL catheter was achieved in all patients. The post-IVL angiographic acute luminal gain was 0.83±0.47 mm, and residual stenosis was 32.7±10.4%, which further decreased to 7.8±7.1% after drug-eluting stent implantation. The primary end point occurred in 5.8% of patients, consisting of 7 non–Q-wave myocardial infarctions. There was no procedural abrupt closure, slow or no reflow, or perforations. In 47 patients with post-percutaneous coronary intervention optical coherence tomography, calcium fracture was identified in 78.7% of lesions with 3.4±2.6 fractures per lesion, measuring 5.5±5.0 mm in length.Conclusions:In patients with severe CAC who require coronary revascularization, IVL was safely performed with high procedural success and minimal complications and resulted in substantial calcific plaque fracture in most lesions.Clinical Trial Registration:URL: https://www.clinicaltrials.gov. Unique identifier: NCT03328949.

中文翻译：

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冠状动脉血管内碎石术治疗严重钙化冠状动脉狭窄的安全性和有效性：Disrupt CAD II研究。

背景：Disrupt CAD I研究（Disrupt冠状动脉疾病）证明了血管内碎石术（IVL）改善严重冠状动脉钙化（CAC）的可行性。方法：Disrupt CAD II研究是一项在9个国家/地区的15家医院进行的前瞻性多中心，单臂批准后研究。患有严重CAC且具有血管重建临床指征的患者，需要进行血管准备，以使用IVL植入支架。主要终点是院内重大不良心脏事件（心脏死亡，心肌梗塞或目标血管血运重建）。进行了光学相干层析成像子研究，以评估IVL的作用机制，量化CAC特征和钙斑破裂。独立的核心实验室对血管造影和光学相干断层扫描术进行了裁决，独立的临床事件委员会对重大的不良心脏事件进行了裁决。结果：2018年5月至2019年3月，招募了120例患者。94.2％的病变中存在严重的CAC。所有患者均成功完成了IVL导管的递送和使用。IVL后血管造影的急性腔增大为0.83±0.47 mm，残余狭窄为32.7±10.4％，在药物洗脱支架植入后进一步降低至7.8±7.1％。主要终点发生在5.8％的患者中，包括7个非Q波心肌梗塞。没有手术突然闭合，缓慢或没有回流或穿孔。在47例经皮冠状动脉介入治疗后的光学相干断层扫描中，有78例发现了钙质骨折。7％的病变为每个病变3.4±2.6骨折，长度为5.5±5.0 mm。结论：对于需要冠脉血管重建的重度CAC患者，安全地进行IVL，手术成功率高，并发症少，并导致实质性钙化斑块骨折在大多数病变中。临床试验注册：URL：https://www.clinicaltrials.gov。唯一标识符：NCT03328949。