Five-year outcomes of a drug-coated polymer-free biolimus-eluting stent versus an ultrathin-strut biodegradable-polymer sirolimus-eluting stent.

IF 9.5 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Eurointervention Pub Date : 2025-06-02 DOI:10.4244/EIJ-D-24-00586

Lisette Okkels Jensen, Lars Jakobsen, Ashkan Eftekhari, Julia Ellert-Gregersen, Nicolaj Brejnholt Støttrup, Thomas Engstrøm, Johnny Kahlert, Philip Freeman, Karsten Tange Veien, Rebekka Vibjerg Jensen, Jens Flensted Lassen, Anders Junker, Evald Høj Christiansen

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引用次数: 0

Abstract

Background: The biolimus A9-coated polymer-free stent was not non-inferior for target lesion failure (TLF) when compared with an ultrathin-strut biodegradable-polymer sirolimus-eluting stent within 1 year in the Randomized Comparison of a Polymer-Free Biolimus-eluting BIOFREEDOM Stent With a Biodegradable-Polymer Sirolimus-eluting ORSIRO Stent in Patients Treated With Percutaneous Coronary Intervention (SORT OUT IX) trial.

Aims: We aimed to assess the 5-year outcomes of the drug-coated polymer-free biolimus-eluting stent versus an ultrathin-strut biodegradable-polymer sirolimus-eluting stent.

Methods: The SORT OUT IX trial was a registry-based, randomised, all-comer population trial. The primary endpoint, TLF, was defined as the composite of cardiac death, myocardial infarction (MI) not related to any segment other than the target lesion, or target lesion revascularisation (TLR) within 1 year. Follow-up was extended to 5 years.

Results: A total of 3,151 patients were randomly assigned to receive either the polymer-free biolimus-coated stent (1,572 patients [1,966 lesions]) or the ultrathin-strut biodegradable-polymer sirolimus-eluting stent (1,579 patients [1,985 lesions]). Only 0.3% of participants were lost to follow-up, and all of those were due to emigration. At 5 years, TLF was 14.1% in the polymer-free biolimus-coated stent group and 12.0% in the ultrathin-strut biodegradable-polymer sirolimus-eluting stent group (rate ratio [RR] 1.19, 95% confidence interval [CI]: 0.97-1.44). Cardiac death, MI and definite stent thrombosis did not differ between the two groups. Clinically driven TLR was 7.6% versus 5.0% (RR 1.56, 95% CI: 1.17-2.07) and was higher in the polymer-free biolimus-coated stent group at 5 years, attributable to a higher risk of TLR within the first year.

Conclusions: Five-year TLF did not differ significantly between the drug-coated biolimus-eluting stent group and the ultrathin-strut biodegradable-polymer stent group, but the risk of TLR was higher in the drug-coated biolimus-eluting stent group.

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药物包膜无聚合物生物莫司洗脱支架与超薄支架生物可降解聚合物西罗莫司洗脱支架的5年疗效对比

背景：在经皮冠状动脉介入治疗（SORT OUT IX）试验中，与超薄支撑生物可降解聚合物西罗莫司洗脱支架相比，1年内无聚合物生物莫司洗脱biofredom支架与生物可降解聚合物西罗莫司洗脱ORSIRO支架随机比较中，生物莫司a9涂层无聚合物支架在靶病变失败（TLF）方面并非不差。目的：我们旨在评估药物包膜无聚合物生物莫司洗脱支架与超薄支架生物可降解聚合物西罗莫司洗脱支架的5年预后。方法：SORT OUT IX试验是一项基于注册的、随机的、全角人群试验。主要终点TLF被定义为1年内心源性死亡、心肌梗死（MI）与靶病变以外的任何节段无关或靶病变血运重建（TLR）的复合。随访时间延长至5年。结果：共有3151例患者被随机分配接受无聚合物生物莫司涂层支架（1572例患者[1966个病变]）或超薄支架生物可降解聚合物西罗莫司洗脱支架（1579例患者[1985个病变]）。只有0.3%的参与者失去了随访，所有这些都是由于移民。5年时，无聚合物生物莫司涂层支架组TLF为14.1%，超薄支架生物可降解聚合物西罗莫司洗脱支架组TLF为12.0%（比率比[RR] 1.19, 95%可信区间[CI]: 0.97-1.44）。心源性死亡、心肌梗死和支架内血栓形成在两组之间没有差异。临床驱动的TLR为7.6%对5.0% (RR 1.56, 95% CI: 1.17-2.07)，无聚合物生物脂涂层支架组5年时TLR更高，这是由于第一年发生TLR的风险更高。结论：药物包膜生物泥洗脱支架组与超薄支架可生物降解聚合物支架组5年TLF无显著差异，但药物包膜生物泥洗脱支架组发生TLR的风险更高。

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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.