Paclitaxel-Coated Balloon Versus Uncoated Balloon Angioplasty for Coronary In-Stent Restenosis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

IF 4.6 Q2 MATERIALS SCIENCE, BIOMATERIALS

ACS Applied Bio Materials Pub Date : 2024-08-31 DOI:10.1016/j.amjcard.2024.08.028

Ahmad Al-Abdouh MD, MS , Dealla Samadi MD , Fares Sukhon MD , Mohammed Mhanna MD , Ahmad Jabri MD , Laith Alhuneafat MD , Taqwa Alabduh , Anas Bizanti MD , Luai Madanat MD , Mohammad Alqarqaz MD , Timir K. Paul MD, PhD , Amartya Kundu MD

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引用次数: 0

Abstract

In-stent restenosis (ISR) accounts for 10% of percutaneous coronary intervention (PCI) in the United States. Paclitaxel-coated balloons (PCBs) have been evaluated as a therapy for coronary ISR in multiple randomized controlled trials (RCTs). We searched PubMed/MEDLINE, Cochrane Library, and ClinicalTrials.gov (from inception to April 1, 2024) for RCTs evaluating PCBs versus uncoated balloon angioplasty (BA) in patients with coronary ISR. The outcomes of interest were target lesion revascularization (TLR), major adverse cardiovascular events (MACEs), all-cause mortality, cardiovascular mortality, myocardial infarction (MI), and stent thrombosis. We pooled the estimates using an inverse variance random-effects model. The effect sizes were reported as risk ratio (RR) with 95% confidence interval (CI). A total of 6 RCTs with 1,343 patients were included. At a follow-up ranging from 6 to 12 months from randomization, the use of PCBs was associated with a statistically significant decrease in TLR (RR 0.28, 95% CI 0.11 to 0.68) and MACE (RR 0.35, 95% CI 0.20 to 0.64) compared with BA for coronary ISR. However, there was no significant difference in risk between PCBs and BA in terms of all-cause mortality (RR 0.56, 95% CI 0.14 to 2.31), cardiovascular mortality (RR 0.61, 95% CI 0.02 to 16.85), MI (RR 0.60, 95% CI 0.27 to 1.31), and stent thrombosis (RR 0.13, 95% CI 0.00 to 5.06). In conclusion, this meta-analysis suggests that PCBs compared with uncoated BA for the treatment of coronary ISR at intermediate-term follow-up of 1 year were associated with a significant decrease in TLR and MACE without any difference in mortality, MI, or stent thrombosis.

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紫杉醇涂层球囊与非涂层球囊血管成形术治疗冠状动脉支架内再狭窄：随机对照试验的系统回顾和元分析》。

在美国，支架内再狭窄（ISR）占经皮冠状动脉介入治疗（PCI）的 10%。在多项随机对照试验（RCTs）中，紫杉醇涂层球囊（PCBs）已被评估为冠状动脉 ISR 的一种疗法。我们检索了 PubMed/MEDLINE、Cochrane 图书馆和 ClinicalTrials.gov（从开始到 2024 年 4 月 1 日），以寻找在冠状动脉 ISR 患者中评估 PCB 与无涂层球囊血管成形术 (BA) 的 RCT。研究结果包括靶病变血运重建（TLR）、主要不良心血管事件（MACE）、全因死亡率、心血管死亡率、心肌梗死（MI）和支架血栓形成。我们采用逆方差随机效应模型对估计值进行了汇总。效应大小以风险比 (RR) 和 95% 置信区间 (CI) 的形式报告。共纳入了 6 项研究，1343 名患者。在随机化后 6-12 个月的随访中，与冠状动脉 ISR 的 BA 相比，使用多氯联苯可显著降低 TLR（RR 0.28；95% CI 0.11 至 0.68）和 MACE（RR 0.35；95% CI 0.20 至 0.64）。然而，在全因死亡率（RR 0.56；95% CI 0.14 至 2.31）、心血管死亡率（RR 0.61；95% CI 0.02 至 16.85）、心肌梗死（RR 0.60；95% CI 0.27 至 1.31）和支架血栓形成（RR 0.13；95% CI 0.00 至 5.06）方面，PCBs 和 BA 的风险没有明显差异。总之，这项荟萃分析表明，在为期一年的中期随访中，PCBs 与未涂层 BA 相比，在治疗冠状动脉 ISR 时可显著降低 TLR 和 MACE，但在死亡率、心肌梗死或支架血栓形成方面没有任何差异。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

ACS Applied Bio Materials Chemistry-Chemistry (all)

CiteScore

9.40

自引率

2.10%

发文量

464