Vascular Healing After Biodegradable Polymer Sirolimus-Eluting Versus Durable Polymer Everolimus-Eluting Stents in Chronic Total Occlusions

IF 2.1 3区医学 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS

Catheterization and Cardiovascular Interventions Pub Date : 2025-01-29 DOI:10.1002/ccd.31423

Geng Wang, Yi Li, Wen Lu, Yawei Xu, Xi Su, Shaoliang Chen, Yang Li, Yaling Han, the TARGET CTO OCT substudy Investigators

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引用次数: 0

Abstract

Background

Biodegradable polymer stents may reduce the risk of neoatherosclerosis and stent thrombosis. Limited data is available for biodegradable polymer sirolimus-eluting stent (BP-SES) and durable polymer drug-eluting stents (DP-EES) in chronic total occlusions (CTO).

Aim

This study was to evaluate healing patterns of BP-SES versus DP-EES in CTO at 3 and 13 months based on optical coherence tomography (OCT).

Methods

The TARGET-CTO study is a prospective, multicenter, randomized noninferiority controlled trial for BP-SES compared to DP-EES in CTO. In the current predefined subanalysis, 44 consecutive patients underwent OCT follow-up at 3 and 13 months. The primary endpoint was mean neo-intimal thickness at 3 months.

Results

At 3 months, mean neo-intimal thickness was 47.6 ± 15.7 µm in BP-SES and 62.5 ± 37.3 µm in DP-EES (p = 0.384), meeting the noninferiority for BP-SES (p_{noninferiority} < 0.001). Mean neo-intimal thickness at 13 months was 76.4 ± 34.1 µm in BP-SES and 106.6 ± 54.9 µm in DP-EES (p = 0.086). No significant differences in strut coverage were observed at 3 or 13 months. At 13 months significantly higher percentages of frames with layered neo-intima and neoatherosclerosis were observed in DP-EES compared to BP-SES (p = 0.015 and p = 0.021, respectively).

Conclusions

BP-SES was noninferior to DP-EES in terms of neo-intimal thickness at 3 months and healing responses at 3-month follow-up were comparable. At 13 months, less advanced neoatherosclerosis patterns were observed in BP-SES as compared to DP-EES.

Abstract Image

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生物可降解聚合物西罗莫司洗脱支架与耐用聚合物依维莫司洗脱支架治疗慢性全闭塞后血管愈合。

背景：可生物降解聚合物支架可以降低新动脉粥样硬化和支架血栓形成的风险。生物可降解聚合物西罗莫司洗脱支架（BP-SES）和耐用聚合物药物洗脱支架（DP-EES）治疗慢性全闭塞（CTO）的数据有限。目的：本研究基于光学相干断层扫描（OCT）评估BP-SES与DP-EES在CTO 3个月和13个月的愈合模式。方法：TARGET-CTO研究是一项前瞻性、多中心、随机、非效性对照试验，比较BP-SES与DP-EES在CTO中的疗效。在当前的预定义亚分析中，44名连续患者在3个月和13个月进行了OCT随访。主要终点是3个月时的平均新内膜厚度。结果：3个月时，BP-SES的平均新内膜厚度为47.6±15.7µm， DP-EES的平均新内膜厚度为62.5±37.3µm (p = 0.384)，符合BP-SES的非效性（p非效性）结论：BP-SES在3个月时的新内膜厚度不低于DP-EES， 3个月随访时的愈合反应具有可比性。在13个月时，与DP-EES相比，BP-SES组观察到的晚期新动脉粥样硬化模式较少。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Catheterization and Cardiovascular Interventions 医学-心血管系统

CiteScore

5.40

自引率

8.70%

发文量

419

审稿时长

2 months

期刊介绍： Catheterization and Cardiovascular Interventions is an international journal covering the broad field of cardiovascular diseases. Subject material includes basic and clinical information that is derived from or related to invasive and interventional coronary or peripheral vascular techniques. The journal focuses on material that will be of immediate practical value to physicians providing patient care in the clinical laboratory setting. To accomplish this, the journal publishes Preliminary Reports and Work In Progress articles that complement the traditional Original Studies, Case Reports, and Comprehensive Reviews. Perspective and insight concerning controversial subjects and evolving technologies are provided regularly through Editorial Commentaries furnished by members of the Editorial Board and other experts. Articles are subject to double-blind peer review and complete editorial evaluation prior to any decision regarding acceptability.