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血管内碎石术与冠状动脉钙化病变旋磨术的比较:临床结果的系统评价和更新的荟萃分析

Intravascular Lithotripsy Versus Rotational Atherectomy for Calcified Coronary Lesions: A Systematic Review and an Updated Meta-Analysis of Clinical Outcomes.

作者信息

Suruagy-Motta Ricardo Fonseca Oliveira, Cabeça Lucas Silva, Da Silva Anderson Matheus Pereira, Neves Gabriel Rezende, Camarotti Maria Tereza, Lima Luan Cavalcante Vilaça, Cunha Ariane Barros Mesquita, Bertoli Edmundo Damiani, Vieira Laila Leite Pacheco, Rocha Thiago José Matos, Oliveira Marcos Danillo

机构信息

Department of Medicine, Cesmac University Center, Maceió, Brazil.

Department of Medicine, Federal University of Pará, Belém, Brazil.

出版信息

Catheter Cardiovasc Interv. 2025 Jul;106(1):563-572. doi: 10.1002/ccd.31591. Epub 2025 May 12.

DOI:10.1002/ccd.31591
PMID:40356295
Abstract

BACKGROUND

Severe coronary artery calcification (CAC) remains a significant challenge in interventional cardiology, especially in elderly and comorbid patients, such as diabetes or chronic kidney disease. CAC often leads to complications such as stent thrombosis and restenosis, therefore leading to bad clinical outcomes and increased major adverse cardiovascular events (MACE) rates. Traditional approaches, including rotational atherectomy (RA), are commonly used to treat calcified plaques; however, are limited by procedural complexity, length of procedures, and risk of vascular injury. In contrast, intravascular lithotripsy (IVL) has emerged as a novel therapy using acoustic pressure waves to break calcified plaques with minimal vascular trauma. Despite its increasing use, direct comparisons between IVD and RA in the context of severe CAC are scant and leave critical evidence gaps for therapy optimization. This study compares IVL and RA outcomes to improve strategies for severe CAC management.

AIMS

This study aims at comparing the clinical outcomes such as procedural success, safety evaluations and clinical efficacy of IVL with RA in the treatment of severe CAC.

METHODS

A systematic review and meta-analysis were conducted following PRISMA 2020 guidelines and registered in PROSPERO (CRD42024626551). Searches were performed in PubMed, ScienceDirect, Embase, and Scopus databases using the descriptors "Rotablator," "Lithotripsy," and "Coronary Disease" combined with Boolean operators ("AND" and "OR"). Eligible studies directly compared IVL and RA, assessing outcomes such as procedural success, safety, and efficacy. Inclusion criteria were directed to retrospective cohorts and randomized studies with at least 6 months of follow-up, excluding case reports, reviews, and conference abstracts. Two independent reviewers performed data extraction with a third resolving discrepancies. The ROBINS-I tool was used to assess the risk of bias in non-randomized studies, while statistical analyses were done using R software (version 4.3.2).

RESULTS

Eleven studies with a total of 2120 patients were included. IVL demonstrated significant benefits over RA, such as reduced use of contrast (MD: -17.45 mL; 95% CI: -32.79 to -2.11) and lower procedural time (MD: -27.90 min; 95% CI: -30.11 to -25.68; I² = 92.3%). IVL also effectively treated complex lesions, such as bifurcations and calcified left main arteries, by fragmenting plaques with minimal vascular trauma and reduced procedural risks. While luminal gain showed no differences between groups (MD: -0.07 mm²; 95% CI: -0.34 to 0.35), IVL provided higher rates of stent deployment success and lower target lesion revascularization, indicating better long-term vessel patency. The meta-analysis for mortality outcome showed a pooled OR of 0.55 (95% CI: 0.28-1.06; I² = 1%; p = 0.42) under the common-effect model and 0.70 (95% CI: 0.35-1.42) under the random-effects model, with negligible heterogeneity (I² = 1%). These consistent findings across studies reinforce IVL as a safer and effective strategy for severe CAC and warrant further trials to establish long-term benefits.

CONCLUSION

IVL showed slight advantages over RA in severe CAC, including reduced contrast use, shorter procedure times, and fewer complications. Further trials are needed to confirm these findings and to reduce the heterogeneity of the studies.

摘要

背景

严重冠状动脉钙化(CAC)仍然是介入心脏病学中的一项重大挑战,尤其是在老年患者以及患有糖尿病或慢性肾病等合并症的患者中。CAC常导致支架血栓形成和再狭窄等并发症,进而导致不良临床结局并增加主要不良心血管事件(MACE)发生率。包括旋磨术(RA)在内的传统方法常用于治疗钙化斑块;然而,这些方法受到操作复杂性、手术时间以及血管损伤风险的限制。相比之下,血管内碎石术(IVL)已成为一种新型治疗方法,它利用声压波以最小的血管创伤破碎钙化斑块。尽管其应用越来越广泛,但在严重CAC背景下,IVL与RA之间的直接比较却很少,这为治疗优化留下了关键的证据空白。本研究比较IVL和RA的治疗效果,以改进严重CAC的管理策略。

目的

本研究旨在比较IVL与RA在治疗严重CAC时的临床结局,如手术成功率、安全性评估和临床疗效。

方法

按照PRISMA 2020指南进行系统评价和荟萃分析,并在PROSPERO(CRD42024626551)注册。在PubMed、ScienceDirect、Embase和Scopus数据库中进行检索,使用描述词“旋磨术”、“碎石术”和“冠状动脉疾病”并结合布尔运算符(“AND”和“OR”)。符合条件的研究直接比较IVL和RA,评估手术成功率、安全性和疗效等结局。纳入标准针对至少有6个月随访期的回顾性队列研究和随机研究,排除病例报告、综述和会议摘要。两名独立的评审员进行数据提取,由第三名评审员解决分歧。ROBINS-I工具用于评估非随机研究中的偏倚风险,而统计分析使用R软件(版本4.3.2)进行。

结果

共纳入11项研究,总计2120例患者。IVL显示出优于RA的显著益处,如造影剂使用减少(MD:-17.45 mL;95% CI:-32.79至-2.11)和手术时间缩短(MD:-27.90分钟;95% CI:-30.11至-25.68;I² = 92.3%)。IVL还通过以最小的血管创伤破碎斑块并降低手术风险,有效治疗了复杂病变,如分叉病变和钙化左主干病变。虽然两组间管腔增益无差异(MD:-0.07 mm²;95% CI:-0.34至0.35),但IVL的支架置入成功率更高,靶病变血运重建率更低,表明长期血管通畅性更好。死亡率结局的荟萃分析显示,在固定效应模型下合并OR为0.55(95% CI:0.28 - 1.06;I² = 1%;p = 0.42),在随机效应模型下为0.70(95% CI:0.35 - 1.42),异质性可忽略不计(I² = 1%)。这些研究中的一致发现强化了IVL作为严重CAC的一种更安全有效的策略,值得进一步试验以确定其长期益处。

结论

在严重CAC中,IVL相较于RA显示出轻微优势,包括造影剂使用减少、手术时间缩短和并发症更少。需要进一步试验来证实这些发现并减少研究的异质性。

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