AimsThis 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 ResultsTwelve 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.ConclusionThe 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.

中文翻译：

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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) 衍生参数，这些参数可用于临床环境中评估第三代药物洗脱可吸收镁支架 (DREAMS-3G) 中的支柱降解，并表征比较降解曲线方法和结果将 12 个 DREAMS-3G 和 10 个 MagmarisTM 支架植入幼猪体内，并在基线和随访（6 或 12 个月）时获得 OCT 图像。通过平面分析评估支柱退化，并与 OCT 衍生指数进行比较，以验证其诊断准确性。 OCT 共描绘出 DREAMS-3G 的 3327 个支柱和 MagmarisTM 支架的 2995 个支柱。 DREAMS-3G 在 6 个月时显示出每个分析框架的可见支柱数量明显高于 MagmarisTM 支架，而在 12 个月时没有显着差异。衰减指数 (AtI) 分析表明，与 MagmarisTM 支架相比，DREAMS-3G 降解在 6 个月时进展较慢，但在 12 个月时降解较严重。这些 OCT 衍生指数与平面分析的结果显着相关。结论当前的临床前研究验证了 OCT 指数可以作为支架降解的临床替代标志物。 AtI 分析表明，与 MagmarisTM 支架相比，DREAMS-3G 在 6 个月时表现出较少的降解，但在 12 个月时表现出更严重的降解，这证实了平面分析的结果。