Optical coherence tomography characterization of degradation kinetics between second- and third-generation resorbable magnesium scaffold

IF 2.1 3区 医学 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS Catheterization and Cardiovascular Interventions Pub Date : 2024-09-23 DOI:10.1002/ccd.31238
Masaru Seguchi MD, PhD, Philine Baumann-Zumstein BSc, Armin Fubel PhD, Martin Pritsch, Alp Aytekin MD, PhD, Philipp Nicol MD, Jonas Altevogt, Michael Joner MD
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Abstract

Aims

This preclinical study aimed to establish optical coherence tomography (OCT)-derived parameters that could be used in the clinical setting for assessing strut degradation in the third-generation drug-eluting resorbable magnesium scaffold (DREAMS-3G), and characterize the comparative degradation profile against its precursor device (MagmarisTM scaffold).

Methods and Results

Twelve DREAMS-3G and 10 MagmarisTM scaffolds were implanted in juvenile pigs, and OCT images obtained at baseline and follow-up (6 or 12 months). Strut degradation was assessed by planimetric analysis and compared with OCT-derived indices to validate their diagnostic accuracy. A total of 3327 struts of DREAMS-3G and 2995 struts of the MagmarisTM scaffold were delineated by OCT. DREAMS-3G exhibited a significantly higher number of visible struts per analyzed frame at 6 months than the MagmarisTM scaffold, in the absence of significant differences at 12 months. Attenuation index (AtI) analysis indicated DREAMS-3G degradation was less advanced at 6 months but more advanced at 12 months compared to the MagmarisTM scaffold. These OCT-derived indices significantly correlated with the results of the planimetric analysis.

Conclusion

The current preclinical study validated OCT indices that may serve as clinical surrogate markers for scaffold degradation. AtI analysis indicated that DREAMS-3G showed less degradation at 6 months but more advanced degradation at 12 months compared to the MagmarisTM scaffold, which corroborates the findings from planimetric analysis.

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第二代和第三代可吸收镁支架降解动力学的光学相干断层扫描表征。
目的:这项临床前研究旨在建立光学相干断层扫描(OCT)得出的参数,这些参数可用于临床环境,以评估第三代药物洗脱可吸收镁支架(DREAMS-3G)的支架降解情况,并描述与其前体设备(MagmarisTM 支架)的降解情况比较:将 12 个 DREAMS-3G 和 10 个 MagmarisTM 支架植入幼猪体内,并在基线和随访(6 个月或 12 个月)时获取 OCT 图像。通过平面分析评估支架降解情况,并与 OCT 衍生指数进行比较,以验证其诊断准确性。OCT 共对 3327 根 DREAMS-3G 支架和 2995 根 MagmarisTM 支架进行了划定。与 MagmarisTM 支架相比,DREAMS-3G 在 6 个月时每分析帧的可见支柱数量明显较多,但在 12 个月时则无明显差异。衰减指数(AtI)分析表明,与 MagmarisTM 支架相比,DREAMS-3G 在 6 个月时降解程度较低,但在 12 个月时降解程度更高。这些源自 OCT 的指数与平面分析的结果明显相关:目前的临床前研究验证了可作为支架降解临床替代标记的 OCT 指标。AtI 分析表明,与 MagmarisTM 支架相比,DREAMS-3G 在 6 个月时降解程度较低,但在 12 个月时降解程度更高,这与平面分析的结果相吻合。
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来源期刊
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.
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