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TAXCO 研究 6 个月光学相干断层成像随访:超薄可生物降解聚合物涂层西罗莫司洗脱支架与持久聚合物涂层依维莫司洗脱支架的新生内膜覆盖率比较。

Comparison of neointimal coverage between ultrathin biodegradable polymer-coated sirolimus-eluting stents and durable polymer-coated everolimus-eluting stents: 6 months optical coherence tomography follow-up from the TAXCO study.

机构信息

Department of Cardiology, Shree B.D. Mehta Mahavir Heart Institute, Surat, Gujarat, India.

Interventional Cardiology Department, University of São Paulo, São Paulo, Brazil.

出版信息

Catheter Cardiovasc Interv. 2021 Feb 15;97(3):423-430. doi: 10.1002/ccd.28833. Epub 2020 Apr 3.

DOI:10.1002/ccd.28833
PMID:32243050
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7984091/
Abstract

AIM

The TAXCO study was designed to compare the degree of neointimal coverage and the prevalence of malapposition at 6 months subsequent to implantation of ultrathin biodegradable polymer-coated sirolimus-eluting stents (SES) and durable polymer-coated everolimus-eluting stents (EES) of thin strut thickness using optical coherence tomography (OCT).

METHODS

The TAXCO study included a total of 42 patients who gave consent and underwent OCT examination between August 2017 and September 2017. Of 42, five patients' OCT examinations were of insufficient quality for quantitative analysis. Thus, the OCT analysis group consisted of 37 patients. Among them, 16 patients were treated with Xience (Abbott Vascular) and 21 with Tetriflex (Sahajanand Medical Technologies Pvt. Ltd., Surat, India), 6 (±1) months earlier at our institution. The OCT was performed using a C7 Dragonfly™ imaging catheter (St. Jude Medical Inc.). All OCT images were analyzed at an independent core laboratory (Cardiovascular Research Center, São Paulo, Brazil) by analysts who were blinded to patient and procedural information.

RESULTS

A total of 763 crosssections (6,882 struts) were analyzed in Xience group, and 1,127 crosssections (9,968 struts) in Tetriflex group. At 6 months, on per-lesion basis, no significant differences were observed between Xience group and Tetriflex group in mean percentage of uncovered struts (1.87 ± 3.86 vs. 2.42 ± 3.46, p = .137) and malapposed struts (0.05 ± 0.2 vs. 0.21 ± 0.69, p = .302). Strut-level neointimal thickness also did not differ between Xience group and Tetriflex group (0.18 ± 0.12 vs. 0.14 ± 0.08 mm, p = .286).

CONCLUSION

This OCT study found no significant difference in strut coverage and neointimal thickness at 6 months after implantation of biodegradable polymer-coated Tetriflex, when compared with durable polymer-coated Xience.

摘要

目的

TAXCO 研究旨在使用光学相干断层扫描(OCT)比较超薄生物可降解聚合物涂层西罗莫司洗脱支架(SES)和耐用聚合物涂层依维莫司洗脱支架(EES)植入后 6 个月时的新生内膜覆盖率和贴壁不良的发生率。

方法

TAXCO 研究共纳入 42 例患者,这些患者均同意并于 2017 年 8 月至 2017 年 9 月间接受了 OCT 检查。在这 42 例患者中,有 5 例患者的 OCT 检查质量不够进行定量分析。因此,OCT 分析组包括 37 例患者。其中,16 例患者接受了 Xience(雅培血管)治疗,21 例患者接受了 Tetriflex(萨哈扬纳德医疗技术私人有限公司,苏拉特,印度)治疗,均于 6(±1)个月前在我们机构进行。OCT 使用 C7 Dragonfly™成像导管(圣犹达医疗公司)进行。所有 OCT 图像均由一个独立的核心实验室(巴西圣保罗心血管研究中心)的分析人员进行分析,这些分析人员对患者和程序信息均不知情。

结果

在 Xience 组共分析了 763 个横截面(6882 个支架),在 Tetriflex 组共分析了 1127 个横截面(9968 个支架)。在基于病变的基础上,Xience 组和 Tetriflex 组在未覆盖支架的平均百分比(1.87±3.86 对 2.42±3.46,p=0.137)和贴壁不良支架的百分比(0.05±0.2 对 0.21±0.69,p=0.302)方面均无显著差异。Xience 组和 Tetriflex 组的支架内新生内膜厚度也无差异(0.18±0.12 对 0.14±0.08mm,p=0.286)。

结论

这项 OCT 研究发现,与耐用聚合物涂层的 Xience 相比,在植入生物可降解聚合物涂层的 Tetriflex 后 6 个月时,在支架覆盖率和新生内膜厚度方面,两组之间没有显著差异。

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