Sebastian Jaramillo, Juan Pinilla, Francesco Stabile, Vinicius Bittar de Pontes, Mohammad Cheikh Ibrahim, Webster Donaldy, Wilton Gomes
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A two-sided P value less than 0.05 was considered statistically significant. Prespecified subgroup analyses were conducted based on follow-up duration.</p><p><strong>Results: </strong>A total of seven randomized controlled trials (RCTs) and four observational studies comprising 11 954 patients were included, of whom 5947 (49.7%) received PF-DES. In the pooled analysis, no statistically significant differences were observed between PF-DES and BP-DES in terms of cardiac death [risk ratio: 1.12, 95% confidence interval (CI): 0.96-1.31, P = 0.15], target lesion failure (risk ratio: 1.09, 95% CI: 0.81-1.46, P = 0.58), stent thrombosis (risk ratio: 0.90, 95% CI: 0.58-1.41, P = 0.64), target lesion revascularization (risk ratio: 1.28, 95% CI: 0.81-2.02, P = 0.28), or target vessel revascularization (risk ratio: 1.05, 95% CI: 0.70-1.58, P = 0.79). Likewise, no significant subgroup effect was observed regarding longer-term follow-up outcomes.</p><p><strong>Conclusion: </strong>This meta-analysis found comparable safety and efficacy outcomes between PF-DES and BP-DES in patients undergoing PCI; however, further RCTs are needed to evaluate long-term outcomes and newer-generation stent models.</p>","PeriodicalId":10702,"journal":{"name":"Coronary artery disease","volume":" ","pages":"316-326"},"PeriodicalIF":2.0000,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Comparative efficacy of polymer-free versus biodegradable-polymer drug-eluting stents in percutaneous coronary intervention: an updated systematic review and meta-analysis.\",\"authors\":\"Sebastian Jaramillo, Juan Pinilla, Francesco Stabile, Vinicius Bittar de Pontes, Mohammad Cheikh Ibrahim, Webster Donaldy, Wilton Gomes\",\"doi\":\"10.1097/MCA.0000000000001602\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Biodegradable polymer drug-eluting stents (BP-DES) are currently used in percutaneous coronary intervention (PCI). Polymer-free drug-eluting stents (PF-DES) have the potential to mitigate any risk associated with BP-DES; however, the relative efficacy and safety of these interventions remain to be fully elucidated.</p><p><strong>Methods: </strong>A systematic search of PubMed, Embase, and Cochrane Central was performed from inception to January 2025 to identify randomized controlled trials and observational studies comparing PF-DES with BP-DES in patients undergoing PCI. Heterogeneity was assessed using the I ² statistic. A two-sided P value less than 0.05 was considered statistically significant. Prespecified subgroup analyses were conducted based on follow-up duration.</p><p><strong>Results: </strong>A total of seven randomized controlled trials (RCTs) and four observational studies comprising 11 954 patients were included, of whom 5947 (49.7%) received PF-DES. In the pooled analysis, no statistically significant differences were observed between PF-DES and BP-DES in terms of cardiac death [risk ratio: 1.12, 95% confidence interval (CI): 0.96-1.31, P = 0.15], target lesion failure (risk ratio: 1.09, 95% CI: 0.81-1.46, P = 0.58), stent thrombosis (risk ratio: 0.90, 95% CI: 0.58-1.41, P = 0.64), target lesion revascularization (risk ratio: 1.28, 95% CI: 0.81-2.02, P = 0.28), or target vessel revascularization (risk ratio: 1.05, 95% CI: 0.70-1.58, P = 0.79). 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引用次数: 0
摘要
背景：生物可降解聚合物药物洗脱支架（BP-DES）目前用于经皮冠状动脉介入治疗（PCI）。无聚合物药物洗脱支架（PF-DES）具有降低BP-DES相关风险的潜力；然而，这些干预措施的相对有效性和安全性仍有待充分阐明。方法：系统检索PubMed、Embase和Cochrane Central从成立到2025年1月，以确定比较PF-DES和BP-DES在PCI患者中的随机对照试验和观察性研究。采用I²统计量评估异质性。双侧P值小于0.05认为有统计学意义。根据随访时间进行预先指定的亚组分析。结果：共纳入7项随机对照试验（RCTs）和4项观察性研究，共11,954例患者，其中5947例（49.7%）接受了PF-DES治疗。在合并分析中，PF-DES和BP-DES在心脏死亡[危险比：1.12,95%可信区间（CI）： 0.96-1.31, P = 0.15]、靶病变失败（危险比：1.09,95% CI: 0.81-1.46, P = 0.58）、支架内血栓形成（危险比：0.90,95% CI: 0.58-1.41, P = 0.64）、靶病变血管重建术（危险比：1.28,95% CI: 0.81-2.02, P = 0.28）或靶血管重建术（危险比：1.05,95% CI: 0.95）方面无统计学差异。0.70-1.58, p = 0.79)。同样，在长期随访结果方面没有观察到显著的亚组效应。结论：本荟萃分析发现，在PCI患者中，PF-DES和BP-DES的安全性和有效性结果相当；然而，需要进一步的随机对照试验来评估长期结果和新一代支架模型。
Comparative efficacy of polymer-free versus biodegradable-polymer drug-eluting stents in percutaneous coronary intervention: an updated systematic review and meta-analysis.
Background: Biodegradable polymer drug-eluting stents (BP-DES) are currently used in percutaneous coronary intervention (PCI). Polymer-free drug-eluting stents (PF-DES) have the potential to mitigate any risk associated with BP-DES; however, the relative efficacy and safety of these interventions remain to be fully elucidated.
Methods: A systematic search of PubMed, Embase, and Cochrane Central was performed from inception to January 2025 to identify randomized controlled trials and observational studies comparing PF-DES with BP-DES in patients undergoing PCI. Heterogeneity was assessed using the I ² statistic. A two-sided P value less than 0.05 was considered statistically significant. Prespecified subgroup analyses were conducted based on follow-up duration.
Results: A total of seven randomized controlled trials (RCTs) and four observational studies comprising 11 954 patients were included, of whom 5947 (49.7%) received PF-DES. In the pooled analysis, no statistically significant differences were observed between PF-DES and BP-DES in terms of cardiac death [risk ratio: 1.12, 95% confidence interval (CI): 0.96-1.31, P = 0.15], target lesion failure (risk ratio: 1.09, 95% CI: 0.81-1.46, P = 0.58), stent thrombosis (risk ratio: 0.90, 95% CI: 0.58-1.41, P = 0.64), target lesion revascularization (risk ratio: 1.28, 95% CI: 0.81-2.02, P = 0.28), or target vessel revascularization (risk ratio: 1.05, 95% CI: 0.70-1.58, P = 0.79). Likewise, no significant subgroup effect was observed regarding longer-term follow-up outcomes.
Conclusion: This meta-analysis found comparable safety and efficacy outcomes between PF-DES and BP-DES in patients undergoing PCI; however, further RCTs are needed to evaluate long-term outcomes and newer-generation stent models.
期刊介绍：
Coronary Artery Disease welcomes reports of original research with a clinical emphasis, including observational studies, clinical trials, translational research, novel imaging, pharmacology and interventional approaches as well as advances in laboratory research that contribute to the understanding of coronary artery disease. Each issue of Coronary Artery Disease is divided into four areas of focus: Original Research articles, Review in Depth articles by leading experts in the field, Editorials and Images in Coronary Artery Disease. The Editorials will comment on selected original research published in each issue of Coronary Artery Disease, as well as highlight controversies in coronary artery disease understanding and management.
Submitted artcles undergo a preliminary review by the editor. Some articles may be returned to authors without further consideration. Those being considered for publication will undergo further assessment and peer-review by the editors and those invited to do so from a reviewer pool.
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