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

PCI术中可生物降解支架与第二代耐久聚合物药物洗脱支架的长期疗效比较:系统评价和荟萃分析方案

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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).

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