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血管内碎石术治疗钙化性冠状动脉病变的疗效和安全性:系统评价和荟萃分析。

Efficacy and Safety of Intravascular Lithotripsy in Calcified Coronary Lesions: A Systematic Review and Meta-Analysis.

机构信息

Department of Internal Medicine, The University of Toledo, Toledo, OH, USA.

Department of Internal Medicine, The University of Toledo, Toledo, OH, USA.

出版信息

Cardiovasc Revasc Med. 2022 Mar;36:73-82. doi: 10.1016/j.carrev.2021.05.009. Epub 2021 May 19.

DOI:10.1016/j.carrev.2021.05.009
PMID:34024748
Abstract

BACKGROUND

Intravascular lithotripsy (IVL) is a recently introduced therapeutic modality in the management of calcified coronary lesions (CCAD). IVL delivers sonic pressure waves to modulate calcium, hence promote vessel compliance and optimize stent deployment.

METHODS

We performed a comprehensive literature search for studies that evaluated the utility of adjunctive IVL. The primary outcomes of our study were the clinical success, defined as the ability of IVL to produce residual diameter stenosis <50% (RDS < 50%) after stenting with no evidence of in-hospital major adverse cardiac events, and the angiographic success, defined as success in facilitating stent delivery with RDS < 50% and without serious angiographic complications. The secondary outcomes included post-IVL and post-stenting changes in lumen area, calcium angle, and the maximum calcium thickness. Proportional analysis was used for binary data and mean difference was used for continuous data. All meta-analyses were conducted using a random-effect model and 95% confidence intervals (CIs) were included.

RESULTS

A total of eight single-arm observational studies, including 980 patients (1011 lesions), were included. 48.8% of the patients presented with acute coronary syndrome. Severe calcifications were present in 97% of lesions. Clinical success was achieved in 95.4% of patients (95%CI:92.9%-97.9%). Angiographic success was achieved in 97% of patients (95%CI:95%-99%). There was an overall increase in postprocedural lumen area as well as significant reduction of calcium angle and maximum calcium thickness.

CONCLUSIONS

IVL seems to have excellent efficacy and safety in the management of CCAD. However, adequately powered RCTs are needed to evaluate IVL compared to other calcium/plaque modifying techniques.

摘要

背景

血管内碎石术(IVL)是一种最近引入的治疗钙化性冠状动脉病变(CCAD)的方法。IVL 传递声波压力波以调节钙,从而促进血管顺应性并优化支架部署。

方法

我们对评估辅助 IVL 效用的研究进行了全面的文献检索。我们研究的主要结果是临床成功,定义为 IVL 在支架置入后能够产生残余直径狭窄<50%(RDS<50%)且无院内主要不良心脏事件证据的能力,以及血管造影成功,定义为成功地在不发生严重血管造影并发症的情况下促进支架输送且 RDS<50%。次要结果包括 IVL 后和支架置入后的管腔面积、钙角和最大钙厚度的变化。比例分析用于二项数据,均值差异用于连续数据。所有荟萃分析均采用随机效应模型进行,并包含 95%置信区间(CI)。

结果

共纳入 8 项单臂观察性研究,包括 980 例患者(1011 处病变)。48.8%的患者出现急性冠状动脉综合征。97%的病变存在严重钙化。95.4%的患者达到临床成功(95%CI:92.9%-97.9%)。97%的患者达到血管造影成功(95%CI:95%-99%)。术后管腔面积总体增加,钙角和最大钙厚度显著减少。

结论

IVL 似乎在治疗 CCAD 方面具有出色的疗效和安全性。然而,需要进行足够大的 RCT 来评估 IVL 与其他钙/斑块修饰技术的比较。

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