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经皮冠状动脉介入治疗中可生物降解与第二代耐用聚合物药物洗脱支架的长期疗效:系统评价与荟萃分析方案

Long-term outcomes of biodegradable versus 2nd generation durable polymer drug-eluting stents in PCI: Protocol for a systematic review and meta-analysis.

作者信息

Thuemmler Rosa J, Choudhary Trisha, Tan Yong Hui, Andrei Maria-Bianca, Liu Haipeng, Kumar Niraj S

机构信息

Institute of Applied Health Sciences, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen United Kingdom.

National Medical Research Association, Leicester, United Kingdom.

出版信息

PLoS One. 2025 Mar 19;20(3):e0319946. doi: 10.1371/journal.pone.0319946. eCollection 2025.

Abstract

BACKGROUND

More than 3 million individuals globally experience STEMI each year, with percutaneous coronary intervention (PCI) as the preferred revascularization method. While second-generation Drug Eluting Stents (DES) reduce restenosis compared to bare-metal stents, complications such as neoatherosclerosis and stent thrombosis remain. Second-generation stents, including durable polymer (DP-DES) and biodegradable polymer (BP-DES), aim to improve outcomes, though guidelines do not specify a preference. Given mixed results from prior studies and new long-term data, we aim to perform a systematic review and meta-analysis comparing long-term outcomes of DP-DES vs. BP-DES following PCI.

METHODS

This protocol has been developed following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. MEDLINE, Embase, and Scopus databases will be searched for eligible observational and interventional studies from inception up to 5th of October 2024. Screening (title/abstract and full text), data extraction, risk of bias assessment, and quality of evidence assessment will be conducted by two independent reviewers. A random-effects model will be used to meta-analyse outcomes.

DISCUSSION

DES have greatly advanced PCI for STEMI. However, long-term stent thrombosis remains an issue due to chronic inflammation and impaired healing from the stent's polymer coating. To overcome this, BP-DES were introduced to dissolve their coating within 2-9 months. However, whether BP-DES offers superior long-term outcomes compared to second-generation DP-DES remains uncertain. While previous meta-analyses have shown similar outcomes, recent studies suggest BP-DES may offer better long-term results. This review will compare long-term outcomes (≥5 years) of BP-DES vs. DP-DES, providing important insights to inform clinical practice. Systematic review registration: PROSPERO (CRD42024592579).

摘要

背景

全球每年有超过300万人发生ST段抬高型心肌梗死(STEMI),经皮冠状动脉介入治疗(PCI)是首选的血运重建方法。与裸金属支架相比,第二代药物洗脱支架(DES)可减少再狭窄,但仍存在新动脉粥样硬化和支架血栓形成等并发症。第二代支架,包括耐用聚合物(DP-DES)和可生物降解聚合物(BP-DES),旨在改善治疗效果,尽管指南并未明确表明偏好。鉴于先前研究结果不一以及新的长期数据,我们旨在进行一项系统评价和荟萃分析,比较PCI术后DP-DES与BP-DES的长期疗效。

方法

本方案是根据系统评价和荟萃分析方案的首选报告项目制定的。将检索MEDLINE、Embase和Scopus数据库,以查找从数据库创建至2024年10月5日的符合条件的观察性和干预性研究。筛选(标题/摘要和全文)、数据提取、偏倚风险评估和证据质量评估将由两名独立的评审员进行。将使用随机效应模型对结果进行荟萃分析。

讨论

DES极大地推动了STEMI的PCI治疗。然而,由于慢性炎症和支架聚合物涂层导致的愈合受损,长期支架血栓形成仍然是一个问题。为了克服这一问题,引入了BP-DES,使其涂层在2至9个月内溶解。然而,与第二代DP-DES相比,BP-DES是否能提供更好的长期疗效仍不确定。虽然之前的荟萃分析显示结果相似,但最近的研究表明BP-DES可能提供更好的长期结果。本综述将比较BP-DES与DP-DES的长期疗效(≥5年),为临床实践提供重要见解。系统评价注册:PROSPERO(CRD42024592579)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b1d4/11922205/636d9eebc6d4/pone.0319946.g001.jpg

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