紫杉醇涂层球囊与未涂层球囊治疗股腘动脉支架内再狭窄：一项系统评价和荟萃分析。
Paclitaxel-Coated versus Uncoated Balloon for Femoropopliteal In-Stent Restenosis: A Systematic Review and Meta-Analysis.
作者信息
Li Qiwei, Wang Li, Zhu Lu, Wu Yong, Wu Limin, Liu Hanmin
机构信息
Department of Pediatric Pulmonology and Immunology, West China Second University Hospital, Sichuan University, 610041 Chengdu, Sichuan, China.
Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, 610041 Chengdu, Sichuan, China.
出版信息
Rev Cardiovasc Med. 2022 Sep 14;23(9):315. doi: 10.31083/j.rcm2309315. eCollection 2022 Sep.
BACKGROUND
Several prospective controlled trials to date have assessed the safety and efficacy of paclitaxel-coated balloon angioplasty (PCBA) versus uncoated balloon angioplasty (UCBA) for femoropopliteal (FP) in-stent restenosis (ISR). Therefore, this meta-analysis of prospective controlled trials aimed to summarize the results of these trials and present reliable conclusions.
METHODS
We systematically searched the PubMed, Embase, Cochrane Library, Web of Science, ClinicalTrials.gov, and CNKI databases for prospective randomized controlled trials (published between January 1, 2008, and July 31, 2021; no language restrictions) comparing PCBA with UCBA in the management of FP ISR. The main endpoints were recurrent restenosis, primary patency, freedom from target lesion revascularization (TLR), clinical improvement, ankle-brachial index (ABI), and major adverse events (MAEs). We assessed the pooled data using a fixed effects model.
RESULTS
Of the 206 identified studies, seven were eligible and included in our analysis (N = 593 participants). Compared with UCBA, PCBA yielded a reduction in recurrent restenosis (odds ratio [OR], 0.22; 95% confidence interval [CI], 0.13-0.38), a better primary patency (OR, 3.59; 95% CI, 1.72-7.47), an improved likelihood of freedom from TLR (OR, 2.70; 95% CI, 1.36-5.35), greater clinical improvement (OR, 2.38; 95% CI, 1.50-3.79), and a similar mean difference in ABI (0.02; 95% CI, -0.11-0.14) and OR in MAEs (0.71; 95% CI, 0.24-2.14).
CONCLUSIONS
PCBA as a treatment strategy can achieve better short-term outcomes of FP ISR management, including potent recurrent restenosis-lowering and symptom-improving capacity without increased MAEs. Therefore, it is a promising therapeutic strategy for patients with FP ISR.
SYSTEMATIC REVIEW REGISTRATION
This work was registered in PROSPERO, the international prospective register of systematic reviews (number: CRD42021261574).
背景
迄今为止，已有多项前瞻性对照试验评估了紫杉醇涂层球囊血管成形术（PCBA）与非涂层球囊血管成形术（UCBA）治疗股腘动脉（FP）支架内再狭窄（ISR）的安全性和有效性。因此，这项前瞻性对照试验的荟萃分析旨在总结这些试验的结果并得出可靠的结论。
方法
我们系统检索了PubMed、Embase、Cochrane图书馆、科学网、ClinicalTrials.gov和中国知网数据库，以查找比较PCBA与UCBA治疗FP ISR的前瞻性随机对照试验（发表于2008年1月1日至2021年7月31日之间；无语言限制）。主要终点为再发再狭窄、初始通畅率、免于靶病变血管重建（TLR）、临床改善情况、踝肱指数（ABI）和主要不良事件（MAE）。我们使用固定效应模型评估汇总数据。
结果
在检索到的206项研究中，有7项符合纳入标准并纳入我们的分析（N = 593名参与者）。与UCBA相比，PCBA可降低再发再狭窄（优势比[OR]，0.22；95%置信区间[CI]，0.13 - 0.38），提高初始通畅率（OR，3.59；95% CI，1.72 - 7.47），增加免于TLR的可能性（OR，2.70；95% CI，1.36 - 5.35），带来更大的临床改善（OR，2.38；95% CI，1.50 - 3.79），ABI的平均差异相似（0.02；95% CI， - 0.11 - 0.14），MAE的OR也相似（0.71；95% CI，0.24 - 2.14）。
结论
PCBA作为一种治疗策略，在FP ISR管理中可实现更好的短期效果，包括有效降低再发再狭窄和改善症状的能力，且不增加MAE。因此，对于FP ISR患者而言，它是一种有前景的治疗策略。
系统评价注册
本研究已在国际前瞻性系统评价注册库PROSPERO中注册（编号：CRD42021261574）。
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