无聚合物与可生物降解聚合物药物洗脱支架在经皮冠状动脉介入治疗患者中的应用：一项评估盲、非劣效性、随机对照试验

IF 7.6 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Eurointervention Pub Date : 2025-01-06 DOI:10.4244/EIJ-D-24-00657

Raffaele Piccolo, Paolo Calabrò, Greta Carrara, Attilio Varricchio, Cesare Baldi, Giovanni Napolitano, Ciro De Simone, Ciro Mauro, Eugenio Stabile, Gianluca Caiazzo, Tullio Tesorio, Marco Boccalatte, Bernardino Tuccillo, Plinio Cirillo, Luigi Di Serafino, Fiorenzo Simonetti, Attilio Leone, Domenico Angellotti, Giuseppe Bottiglieri, Enrico Russolillo, Gennaro Galasso, Rocco Perrotta, Arturo Cesaro, Tullio Niglio, Michele Capasso, Alessandra Spinelli, Stefano Cristiano, Antonella Faretra, Dario Bruzzese, Alaide Chieffo, Giuseppe Tarantini, Sergio Leonardi, Simone Biscaglia, Francesco Costa, Salvatore Cassese, Eugene McFadden, Dik Heg, Anna Franzone, Giulio G Stefanini, Davide Capodanno, Giovanni Esposito, For The Parthenope Investigators

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引用次数: 0

摘要

背景：关于经皮冠状动脉介入治疗（PCI）患者使用无聚合物药物洗脱支架的数据很少。目的：我们的目的是确定无聚合物依维莫司洗脱支架（AES）的有效性和安全性，与可生物降解聚合物依维莫司洗脱支架（EES）相比，使用基于水库的药物递送技术。方法：这是一项随机、研究者发起、评估盲、非劣效性试验，在意大利的14家医院进行（ClinicalTrials.gov: NCT04135989）。所有接受PCI的患者被随机分配到无聚合物AES或可生物降解聚合物EES。主要终点是器械导向的复合终点，包括1年随访时心血管死亡、靶血管心肌梗死或靶病变血运重建。结果：在2020年1月至2022年6月期间，共有2,107例患者（3,042例冠状动脉病变）被随机分为无聚合物AES（1,051例）或可生物降解聚合物EES（1,056例）。在1年的随访中，主要终点发生在86例（8.2%）随机分配到无聚合物AES组的患者和76例（7.2%）随机分配到可生物降解聚合物EES组的患者(风险差为1%，单侧95%置信区间上限为2.9%；P为非劣效性=0.041)。各组间主要终点成分的发生率无显著差异。然而，在随机分配到无聚合物支架的患者中，明确或可能的支架血栓更频繁地发生(1.0% vs 0.3%；风险比3.72,95% CI: 1.04-13.33；结论：在接受PCI治疗的所有患者中，尽管无聚合物AES与早期支架血栓形成风险增加相关，但在1年随访中，在器械导向的复合终点方面，无聚合物AES并不逊色于生物降解聚合物EES。

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Polymer-free versus biodegradable-polymer drug-eluting stent in patients undergoing percutaneous coronary intervention: an assessor-blind, non-inferiority, randomised controlled trial.

Background: Few data are available on polymer-free drug-eluting stents in patients undergoing percutaneous coronary intervention (PCI).

Aims: We aimed to determine the efficacy and safety of a polymer-free amphilimus-eluting stent (AES), using a reservoir-based technology for drug delivery, compared with a biodegradable-polymer everolimus-eluting stent (EES).

Methods: This was a randomised, investigator-initiated, assessor-blind, non-inferiority trial conducted at 14 hospitals in Italy (ClinicalTrials.gov: NCT04135989). All-comer patients undergoing PCI were randomly assigned to either polymer-free AES or biodegradable-polymer EES. The primary endpoint was a device-oriented composite endpoint, including cardiovascular death, target vessel myocardial infarction, or target lesion revascularisation at 1-year follow-up.

Results: Between January 2020 and June 2022, a total of 2,107 patients with 3,042 coronary lesions were randomised to polymer-free AES (1,051 patients) or biodegradable-polymer EES (1,056 patients). At 1-year follow-up, the primary endpoint occurred in 86 (8.2%) patients randomised to polymer-free AES and 76 (7.2%) patients randomised to biodegradable-polymer EES (risk difference 1%, upper limit of the 1-sided 95% confidence interval [CI] of 2.9%; p for non-inferiority=0.041). There were no significant differences in the incidence of the components of the primary endpoint between groups. However, definite or probable stent thrombosis occurred more frequently in patients randomised to polymer-free stents (1.0% vs 0.3%; hazard ratio 3.72, 95% CI: 1.04-13.33; p=0.044) due to an increased risk of early stent thrombosis within 30 day Conclusions: In all-comer patients undergoing PCI, polymer-free AES were non-inferior to biodegradable-polymer EES at 1-year follow-up in terms of a device-oriented composite endpoint despite being associated with an increased risk of early stent thrombosis.

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来源期刊

Eurointervention CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

10.30

自引率

4.80%

发文量

380

审稿时长

3-8 weeks

期刊介绍： EuroIntervention Journal is an international, English language, peer-reviewed journal whose aim is to create a community of high quality research and education in the field of percutaneous and surgical cardiovascular interventions.