接受经皮冠状动脉介入治疗患者中无聚合物与可生物降解聚合物药物洗脱支架的比较：一项评估者盲法、非劣效性随机对照试验
Polymer-free versus biodegradable-polymer drug-eluting stent in patients undergoing percutaneous coronary intervention: an assessor-blind, non-inferiority, randomised controlled trial.
作者信息
Piccolo Raffaele, Calabrò Paolo, Carrara Greta, Varricchio Attilio, Baldi Cesare, Napolitano Giovanni, De Simone Ciro, Mauro Ciro, Stabile Eugenio, Caiazzo Gianluca, Tesorio Tullio, Boccalatte Marco, Tuccillo Bernardino, Cirillo Plinio, Di Serafino Luigi, Simonetti Fiorenzo, Leone Attilio, Angellotti Domenico, Bottiglieri Giuseppe, Russolillo Enrico, Galasso Gennaro, Perrotta Rocco, Cesaro Arturo, Niglio Tullio, Capasso Michele, Spinelli Alessandra, Cristiano Stefano, Faretra Antonella, Bruzzese Dario, Chieffo Alaide, Tarantini Giuseppe, Leonardi Sergio, Biscaglia Simone, Costa Francesco, Cassese Salvatore, McFadden Eugene, Heg Dik, Franzone Anna, Stefanini Giulio G, Capodanno Davide, Esposito Giovanni, Parthenope Investigators For The
机构信息
Department of Advanced Biomedical Sciences, University of Naples "Federico II", Naples, Italy.
Department of Translational Medical Sciences, University of Campania "Luigi Vanvitelli", Caserta, Italy and Division of Cardiology, A.O.R.N. "Sant'Anna e San Sebastiano", Caserta, Italy.
出版信息
EuroIntervention. 2025 Jan 6;21(1):58-72. doi: 10.4244/EIJ-D-24-00657.
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.
背景
关于接受经皮冠状动脉介入治疗（PCI）的患者使用无聚合物药物洗脱支架的数据很少。
目的
我们旨在确定一种基于储库技术进行药物递送的无聚合物安普利姆洗脱支架（AES）与可生物降解聚合物依维莫司洗脱支架（EES）相比的疗效和安全性。
方法
这是一项由研究者发起、评估者盲法的非劣效性随机试验，在意大利的14家医院进行（ClinicalTrials.gov：NCT04135989）。所有接受PCI的患者被随机分配至无聚合物AES组或可生物降解聚合物EES组。主要终点是一个以器械为导向的复合终点，包括1年随访时的心血管死亡、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2107例患有3042处冠状动脉病变的患者被随机分配至无聚合物AES组（1051例患者）或可生物降解聚合物EES组（1056例患者）。在1年随访时，主要终点发生在86例（8.2%）被随机分配至无聚合物AES组的患者和76例（7.2%）被随机分配至可生物降解聚合物EES组的患者中（风险差异1%，单侧95%置信区间[CI]的上限为2.9%；非劣效性检验p=0.041）。两组之间主要终点各组成部分的发生率无显著差异。然而，由于30天内早期支架血栓形成风险增加，随机分配至无聚合物支架的患者中明确或可能的支架血栓形成更频繁（1.0%对0.3%；风险比3.72，95%CI：1.04 - 13.33；p=0.044）。
结论
在接受PCI的所有患者中，无聚合物AES在1年随访时，就以器械为导向的复合终点而言不劣于可生物降解聚合物EES，尽管其与早期支架血栓形成风险增加相关。
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