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生物可降解聚合物和耐用聚合物药物洗脱支架植入术后的早期血管愈合:RESTORE注册研究的3个月血管内镜评估

Early vessel healing after implantation of biodegradable-polymer and durable-polymer drug-eluting stent: 3-month angioscopic evaluation of the RESTORE registry.

作者信息

Suzuki Satoshi, Sotomi Yohei, Kobayashi Tomoaki, Hamanaka Yuma, Nakatani Shimpei, Shiojima Ichiro, Sakata Yasushi, Hirayama Atsushi, Higuchi Yoshiharu

机构信息

Department of Cardiology, Osaka Police Hospital, 10-31, Kitayama, Tennoji, 543-0035, Osaka, Japan.

Department of Medicine II, Kansai Medical University, Hirakata, Japan.

出版信息

Int J Cardiovasc Imaging. 2019 Jun;35(6):973-980. doi: 10.1007/s10554-019-01580-2. Epub 2019 Mar 14.

Abstract

The purpose of this study was to evaluate the vessel healing status 3 months after stent implantation of bioresorbable-polymer drug-eluting stents (BP-DESs) in comparison with durable-polymer DESs (DP-DESs) by angioscopy. Study design was a single-center all-comer prospective cohort study: the RESTORE registry (UMIN000033009). All patients who received successful angioscopic examination at planned 3-month follow-up after the DES implantation in the native coronary artery were enrolled. We evaluated main, maximum, minimum strut coverage grades and coverage heterogeneity score defined as a difference between maximum and minimum coverage grades. All lesions were divided into three segments: proximal, mid, and distal segments. A total of 108 patients (66.6 ± 10 years) with 124 lesions were analyzed (BP-DES 57 patients 61 lesions 226 segments vs. DP-DES 57 patients 63 lesions 203 segments; six patients had both BP-DES and DP-DES). Patient and lesion demographics, procedural characteristics were well balanced. Main coverage grade (mean ± standard error; 1.08 ± 0.02 vs. 1.05 ± 0.03, p = 0.354) and minimum coverage grade (1.00 ± 0.00 vs. 1.00 ± 0.00, p > 0.999) were not significantly different between BP-DES and DP-DES groups. Maximum coverage grade was significantly higher in the BP-DES than in the DP-DES (1.45 ± 0.04 vs. 1.35 ± 0.04, p = 0.049). Coverage heterogeneity score did not differ between BP-DES and DP-DES groups (1.05 ± 0.07 vs. 0.90 ± 0.07, p = 0.162). At 3-month follow-up, the current BP-DES had higher maximum stent coverage than the contemporary DP-DES, while main and minimum coverage grades and heterogeneity of the neointimal coverage were comparable. Further prospective randomized trials should be conducted to evaluate the clinical significance of the present imaging results.

摘要

本研究旨在通过血管内镜评估生物可吸收聚合物药物洗脱支架(BP-DES)与耐用聚合物药物洗脱支架(DP-DES)在支架植入3个月后的血管愈合情况。研究设计为单中心全人群前瞻性队列研究:RESTORE注册研究(UMIN000033009)。纳入所有在冠状动脉原位植入DES后计划进行的3个月随访时接受成功血管内镜检查的患者。我们评估了主要、最大、最小支架梁覆盖等级以及定义为最大和最小覆盖等级之差的覆盖异质性评分。所有病变分为三段:近端、中段和远端。共分析了108例患者(66.6±10岁)的124个病变(BP-DES组57例患者61个病变226段,DP-DES组57例患者63个病变203段;6例患者同时植入了BP-DES和DP-DES)。患者和病变的人口统计学特征、手术特点均衡。BP-DES组和DP-DES组之间的主要覆盖等级(均值±标准误;1.08±0.02对1.05±0.03,p = 0.354)和最小覆盖等级(1.00±0.00对1.00±0.00,p>0.999)无显著差异。BP-DES组的最大覆盖等级显著高于DP-DES组(1.45±0.04对1.35±0.04,p = 0.049)。BP-DES组和DP-DES组之间的覆盖异质性评分无差异(1.05±0.07对0.90±0.07,p = 0.162)。在3个月随访时,当前的BP-DES比当代的DP-DES具有更高的最大支架覆盖,而新生内膜覆盖的主要和最小覆盖等级以及异质性相当。应进行进一步的前瞻性随机试验以评估当前影像学结果的临床意义。

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