Meta-analysis of Outcomes From Drug-eluting Stent Implantation in Femoropopliteal Arteries
Mingxuan Li, Haixia Tu, Yu Yan, Zhen Guo, Haitao Zhu, Jiangliang Niu, Mengchen Yin
Abstract
In recent years, studies of drug-eluting stent (DES) for femoropopliteal artery diseases (FPADs) have been gradually published. To explore whether this type of stent is superior to the traditional bare metal stent (BMS), we performed this study.
Methods
A systematic search for randomized controlled trials (RCTs) in Excerpta Medica Database (Embase), PubMed, Web of Science (WOS), and Cochrane Library was performed on November 29, 2022. We innovatively adopted the hazard ratio (HR), the most appropriate indicator, as a measure of the outcomes that fall under the category of time-to-event data. The HRs was extracted directly or indirectly. Then, the meta-analyses using random effects model were performed. The bias risks of included papers were assessed by the Cochrane Risk of Bias 2.0 tool. This study was registered on the PROSPER platform (CRD42023391944) and not funded.
Introduction
Femoropopliteal artery disease (FPAD) is the most common peripheral artery disease (PAD) [1]. Nowadays, the endovascular-first strategy is now recommended for the majority of symptomatic FPAD patients [2–4]. The complex anatomical and dynamic challenges (such as compression, shortening, torsion) increase the limitations of endovascular treatment strategy [4–6]. Among numerous endovascular treatment modalities, bare metal stent implantation (BMSI) is one of the most proven for its superiority, especially in comparison with the percutaneous transluminal angioplasty (PTA) i.e., plain old balloon angioplasty (POBA) alone [7–11]. However, the cumulative rate of in-stent restenosis (ISR) at 1 year after BMSI is still ≈30% [7, 9, 12], and that of longer lesions is even ≈50% [12, 13]. After success in the field of coronary artery diseases, drug-eluting stents (DESs) have been gradually applied to femoropopliteal (FP) artery lesions. In the BATTLE trial, Gouëffic et al. reported no statistically significant difference in DES implantation (DESI) regarding the ability to avoid postoperative ISR compared to BMSI (Cox model, P = 0.64) [14].
Materials and methods
According to the PRISMA framework, this study was registered on the PROSPERO platform (CRD42023391944). The data for analyses were from published RCTs and no new participants were included. Therefore, no ethical approvals and consent forms of the participants were required. The PRISMA 2020 checklist is shown in S1 Table.
Results
We initially identified 1,234 articles by searching 4 academic databases, of which 507 were evaluated after removing duplicates. And 23 articles were retained after the title abstract sieve. After reviewing the full text, 7 RCTs were finally included in this study [14–17, 31–33]. Among them, one [31] reported the pooled, longer-term follow-up results from 2 periods [34, 35] of the SIROCCO trial. The PRISMA flowchart of study selection is shown in Fig 1.
Discussion
This study systematically reviewed and analyzed multiple follow-up outcomes of DESI performed in FP arteries by including 7 RCTs. The results show that, compared to the traditional BMSI, there were no clear superiority or inferiority of DESI in terms of ISR-free survival, PP survival, and TLR-free survival. For FP lesions, the recognized disadvantage of PTA alone is a high rate of restenosis and concomitant need for TLR [4]. Unlike the coronary, PAD involves longer segments, often at multiple levels with decreased flow rates leading to restenosis even when immediate angiographic results are excellent [11]. To address this limitation, BMSs began to be applied in FPADs in the 1980s [4]. The BMS, represented by nitinol stent, can provide radial support and compression resistance, resulting in extended patency of target lesions [7]. However, stents left in the vascular lumen have brought new problems. The core one is ISR, which reduces the PP and relapses clinical manifestations of ischemia, thus requiring the TLR. Even many studies have reported that the cumulative ISR rate at the first postoperative year after BMSI for FPADs had exceeded 30% [7, 9, 36, 37].
Conclusions
The results of this study show that, for FPADs, the DES has not yet demonstrated superiority or inferiority to BMS, in the ability to maintain PP, avoid ISR and TLR.
Citation: Li M, Tu H, Yan Y, Guo Z, Zhu H, Niu J, et al. (2023) Meta-analysis of outcomes from drug-eluting stent implantation in femoropopliteal arteries. PLoS ONE 18(9): e0291466. https://doi.org/10.1371/journal.pone.0291466
Editor: Redoy Ranjan, BSMMU: Bangabandhu Sheikh Mujib Medical University, BANGLADESH
Received: July 10, 2023; Accepted: August 25, 2023; Published: September 21, 2023
Copyright: © 2023 Li et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Data Availability: All relevant data are within the paper and its Supporting Information files.
Funding: The authors received no specific funding for this work.
Competing interests: The authors have declared that no competing interests exist.
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0291466#abstract0
