The Christ Hospital and Lindner Research Center, Cincinnati, Ohio, USA.
Careggi University Hospital, Florence, Italy.
JACC Cardiovasc Interv. 2021 Jun 28;14(12):1337-1348. doi: 10.1016/j.jcin.2021.04.015. Epub 2021 May 3.
The aim of this pooled analysis was to assess the cumulative safety and effectiveness of coronary intravascular lithotripsy (IVL).
The clinical outcomes of IVL to optimize target lesion preparation in severely calcified de novo coronary stenoses have been examined in 4 prospective studies (Disrupt CAD I [NCT02650128], Disrupt CAD II [NCT03328949], Disrupt CAD III [NCT03595176], and Disrupt CAD IV [NCT04151628]).
Patient data were pooled from the Disrupt CAD studies, which shared uniform study criteria, endpoint definitions and adjudication, and procedural follow-up. The primary safety endpoint was freedom from major adverse cardiovascular events (composite of cardiac death, all myocardial infarction, or target vessel revascularization) at 30 days. The primary effectiveness endpoint was procedural success, defined as stent delivery with a residual stenosis ≤30% by quantitative coronary angiography without in-hospital major adverse cardiovascular events. Secondary outcomes included serious angiographic complications, target lesion failure, cardiac death, and stent thrombosis at 30 days.
Between December 2015 and April 2020, 628 patients were enrolled at 72 sites from 12 countries. Presence of severe calcification was confirmed in 97.0% of target lesions with an average calcified segment length of 41.5 ± 20.0 mm. The primary safety and effectiveness endpoints were achieved in 92.7% and 92.4% of patients, respectively. At 30 days, the rates of target lesion failure, cardiac death, and stent thrombosis were 7.2%, 0.5%, and 0.8%. Rates of post-IVL and final serious angiographic complications were 2.1% and 0.3%, with no IVL-associated perforations, abrupt closure, or episodes of no reflow.
In the largest cohort of patients treated with coronary IVL assessed to date, coronary IVL safely facilitated successful stent implantation in severely calcified coronary lesions with a high rate of procedural success.
本汇总分析旨在评估冠状动脉内碎石术（IVL）的累积安全性和有效性。
4 项前瞻性研究（Disrupt CAD I [NCT02650128]、Disrupt CAD II [NCT03328949]、Disrupt CAD III [NCT03595176]和 Disrupt CAD IV [NCT04151628]）已经研究了 IVL 优化严重钙化新发冠状动脉狭窄靶病变准备的临床结果。
患者数据来自 Disrupt CAD 研究的汇总，这些研究共享统一的研究标准、终点定义和裁定以及程序随访。主要安全性终点是 30 天无重大不良心血管事件（心脏死亡、所有心肌梗死或靶血管血运重建的复合终点）。主要有效性终点是程序成功，定义为通过定量冠状动脉造影术输送支架，残余狭窄≤30%，且院内无重大不良心血管事件。次要结局包括严重血管造影并发症、靶病变失败、心脏死亡和 30 天内支架血栓形成。
2015 年 12 月至 2020 年 4 月，来自 12 个国家的 72 个地点共纳入 628 例患者。97.0%的靶病变存在严重钙化，平均钙化节段长度为 41.5±20.0mm。92.7%和 92.4%的患者分别达到主要安全性和有效性终点。30 天时，靶病变失败、心脏死亡和支架血栓形成的发生率分别为 7.2%、0.5%和 0.8%。IVL 后和最终严重血管造影并发症的发生率分别为 2.1%和 0.3%，无 IVL 相关穿孔、急性闭塞或无再流事件。
在迄今为止评估的接受冠状动脉 IVL 治疗的最大患者队列中，冠状动脉 IVL 安全地促进了严重钙化冠状动脉病变中支架的成功植入，且程序成功率较高。
