Paclitaxel-Coated versus Uncoated Balloon for Femoropopliteal In-Stent Restenosis: A Systematic Review and Meta-Analysis

² Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, 610041 Chengdu, Sichuan, China

³ NHC Key Laboratory of Chronobiology (Sichuan University), 610041 Chengdu, Sichuan, China

⁴ The Joint Laboratory for Lung Development and Related Diseases of West China Second University Hospital, Sichuan University and School of Life Sciences of Fudan University, West China Institute of Women and Children’s Health, West China Second University Hospital, Sichuan University, 610041 Chengdu, Sichuan, China

⁵ Sichuan Birth Defects Clinical Research Center, West China Second University Hospital, Sichuan University, 610041 Chengdu, Sichuan, China

⁶ Department of Pediatrics, The Affiliated Hospital of Southwest Medical University, 646000 Luzhou, Sichuan, China

⁷ Sichuan Clinical Research Center for Birth Defects, 646000 Luzhou, Sichuan, China

⁸ Mianyang Central Hospital, School of Medicine, University of Electronic Science and Technology of China, 621000 Mianyang, Sichuan, China

⁹ Department of Orthopaedics, Orthopedic Research Institute, West China Hospital, Sichuan University, 610041 Chengdu, Sichuan, China

^*Correspondence: liuhm@scu.edu.cn (Hanmin Liu)
Academic Editor: Mohammad Reza Movahed

Rev. Cardiovasc. Med. 2022, 23(9), 315; https://doi.org/10.31083/j.rcm2309315

Submitted: 9 April 2022 | Revised: 19 May 2022 | Accepted: 20 June 2022 | Published: 14 September 2022

(This article belongs to the Section Cardiovascular Intervention and Therapeutics)

This is an open access article under the CC BY 4.0 license.

Abstract

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).

Keywords

lower extremity artery disease

femoropopliteal artery

in-stent restenosis

paclitaxel

drug-coated balloon

Funding

2019YFS0037/Sichuan Science and Technology Program

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