Kuramitsu Shoichi, Kazuno Yoshio, Sonoda Shinjo, Domei Takenori, Jinnouchi Hiroyuki, Yamaji Kyohei, Soga Yoshimitsu, Shirai Shinichi, Ando Kenji, Saito Shigeru
Department of Cardiology, Kokura Memorial Hospital, 3-2-1 Asano, Kokurakita-ku, Kitakyushu 802-8555, Japan
Department of Cardiology, Kokura Memorial Hospital, 3-2-1 Asano, Kokurakita-ku, Kitakyushu 802-8555, Japan.
Eur Heart J Cardiovasc Imaging. 2016 Jan;17(1):34-40. doi: 10.1093/ehjci/jev203. Epub 2015 Sep 1.
The Ultimaster bioresorbable polymer sirolimus-eluting stent (BP-SES) is a newly developed drug-eluting stent (DES) that consists of a thin-strut, cobalt chromium with bioresorbable polymer coated only albuminally. We sought to compare tissue coverage in coronary lesions treated with BP-SES with the XIENCE permanent polymer everolimus-eluting stent (PP-EES) using optical coherence tomography (OCT).
A total of 36 patients participated in the CENTURY II trial in our institution and were randomly assigned to BP-SES (n = 15) and PP-EES (n = 21). Of these, 27 patients (13 BP-SES and 14 PP-EES) underwent OCT at 9-month follow-up. Tissue coverage and apposition were assessed on each strut, and the results in both groups were compared using multilevel logistic or linear regression models with random effects at three levels: patient, lesion, and struts. A total of 6450 struts (BP-SES, n = 2951; PP-EES, n = 3499) were analysed. Thirty and 79 uncovered struts (1.02 and 2.26%, P = 0.35), and 3 and 4 malapposed struts (0.10 and 0.11%, P = 0.94) were found in BP-SES and PP-EES groups, respectively. Mean neointimal thickness did not significantly differ between both groups (110 ± 10 vs. 93 ± 10 µm, P = 0.22). No significant differences in per cent neointimal volume obstruction (13.2 ± 4.6 vs. 10.5 ± 4.9%, P = 0.14) or other areas-volumetric parameters were detected between both groups.
BP-SES shows an excellent vascular healing response at 9-month follow-up, which is similar to PP-EES.
Ultimaster生物可吸收聚合物西罗莫司洗脱支架（BP-SES）是一种新开发的药物洗脱支架（DES），它由薄支柱、仅白蛋白涂层的生物可吸收聚合物钴铬合金组成。我们试图使用光学相干断层扫描（OCT）比较BP-SES与XIENCE永久聚合物依维莫司洗脱支架（PP-EES）治疗的冠状动脉病变中的组织覆盖情况。
共有36例患者参与了我们机构的CENTURY II试验，并被随机分配至BP-SES组（n = 15）和PP-EES组（n = 21）。其中，27例患者（13例BP-SES和14例PP-EES）在9个月随访时接受了OCT检查。评估每个支柱的组织覆盖和贴壁情况，并使用具有患者、病变和支柱三个水平随机效应的多级逻辑或线性回归模型比较两组结果。共分析了6450个支柱（BP-SES组，n = 2951；PP-EES组，n = 3499）。BP-SES组和PP-EES组分别发现30个和79个未覆盖支柱（1.02%和2.26%，P = 0.35），以及3个和4个贴壁不良支柱（0.10%和0.11%，P = 0.94）。两组间平均新生内膜厚度无显著差异（110±10 vs. 93±10 µm，P = 0.22）。两组间新生内膜体积阻塞百分比（13.2±4.6 vs. 10.5±4.9%，P = 0.14）或其他面积-体积参数均未检测到显著差异。
在9个月随访时，BP-SES显示出与PP-EES相似的良好血管愈合反应。
