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冠状动脉疾病中无聚合物与可生物降解聚合物药物洗脱支架的比较:临床、血管造影及光学相干断层扫描结果的最新系统评价和荟萃分析

Polymer-Free Versus Biodegradable Polymer Drug-Eluting Stents in Coronary Artery Disease: Updated Systematic Review and Meta-Analysis of Clinical, Angiographic, and OCT Outcomes.

作者信息

Marchetta Marcello, Sasso Stefano, Paragliola Vincenzo, Parato Andrea Giovanni, De Angelis Diego, Russo Giulio, Albano Giovanni, Benedetto Daniela, Moretti Federico, Valenti Francesco, Massaro Gianluca, Chiricolo Gaetano, Tesauro Manfredi, Sangiorgi Giuseppe Massimo

机构信息

Division of Cardiology, University of Rome "Tor Vergata", 00133 Rome, Italy.

Division of Cardiology, University of Messina, 98168 Messina, Italy.

出版信息

Biomedicines. 2025 Jun 14;13(6):1470. doi: 10.3390/biomedicines13061470.

Abstract

: Polymer-free drug-eluting stents (PF-DESs) aim to mitigate long-term adverse effects associated with polymer-based platforms. However, clinical comparisons with biodegradable polymer DESs (BP-DESs) remain limited. The objective of this review is to assess the efficacy and safety of PF-DESs versus thin-struts (<100 μm) BP-DESs in patients undergoing percutaneous coronary intervention (PCI). : We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing PF-DESs and BP-DESs in adults undergoing PCI. PubMed, Embase, and CENTRAL were searched up to 1 February 2025. A random-effects model was used to calculate pooled risk ratios (RR) or mean differences (MD) with 95% confidence intervals (CI). Outcomes included myocardial infarction (MI), all-cause and cardiac death, target lesion revascularization (TLR), stent thrombosis, and angiographic/OCT parameters. Subgroup and sensitivity analyses were conducted for outcomes with high heterogeneity (I > 50%). : Nine RCTs ( = 9597) were included. At 12 months, no significant differences were found between PF-DESs and BP-DESs for TLR (RR 1.51; 95% CI: 0.83-2.75), MI, or stent thrombosis. At 24 months, MI and all-cause death were similar between groups. A subgroup analysis showed lower cardiac death with the BioFreedom stent (RR 0.57; 95% CI: 0.35-0.90), not observed in non-BioFreedom devices. No significant differences were detected in angiographic or OCT outcomes, though heterogeneity was high. : PF-DESs and BP-DESs demonstrated comparable clinical performance. The observed benefit in cardiac death with BioFreedom may reflect device-specific effects and merits further investigation.

摘要

无聚合物药物洗脱支架(PF-DESs)旨在减轻与基于聚合物的平台相关的长期不良反应。然而,与可生物降解聚合物药物洗脱支架(BP-DESs)的临床比较仍然有限。本综述的目的是评估在接受经皮冠状动脉介入治疗(PCI)的患者中,PF-DESs与薄支柱(<100μm)BP-DESs的疗效和安全性。 我们对比较PF-DESs和BP-DESs用于接受PCI的成人的随机对照试验(RCTs)进行了系统评价和荟萃分析。截至2025年2月1日,检索了PubMed、Embase和CENTRAL。采用随机效应模型计算合并风险比(RR)或平均差(MD)及95%置信区间(CI)。结局包括心肌梗死(MI)、全因死亡和心源性死亡、靶病变血运重建(TLR)、支架血栓形成以及血管造影/OCT参数。对异质性高(I²>50%)的结局进行亚组分析和敏感性分析。 纳入了9项RCT(n = 9597)。在12个月时,PF-DESs和BP-DESs在TLR(RR 1.51;95%CI:0.83-2.75)、MI或支架血栓形成方面未发现显著差异。在24个月时,两组间MI和全因死亡相似。亚组分析显示,BioFreedom支架的心源性死亡较低(RR 0.57;95%CI:0.35-0.90),在非BioFreedom装置中未观察到。血管造影或OCT结局未检测到显著差异,尽管异质性较高。 PF-DESs和BP-DESs表现出相当的临床性能。观察到的BioFreedom在心源性死亡方面的益处可能反映了特定装置的效应,值得进一步研究。

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