Kozuma Ken, Kimura Takeshi, Kadota Kazushige, Suwa Satoru, Kimura Kazuo, Iwabuchi Masashi, Kawai Kazuya, Miyazawa Akiyoshi, Kawamura Masaki, Nakao Koichi, Asano Ryuta, Yamamoto Takashi, Suzuki Nobuaki, Aoki Jiro, Kyono Hiroyuki, Nakazawa Gaku, Tanabe Kengo, Morino Yoshihiro, Igarashi Keiichi
Department of Cardiology, Teikyo University Hospital, 2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8606, Japan,
Cardiovasc Interv Ther. 2013 Oct;28(4):344-51. doi: 10.1007/s12928-013-0179-7. Epub 2013 Apr 23.
Several recent randomized trials comparing everolimus-eluting stent (EES) and sirolimus-eluting stent (SES) reported similar clinical outcomes. This study was aimed to clarify the differences in the angiographic findings of EES as compared to SES. Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial is a prospective multicenter randomized open-label trial comparing EES with SES in Japan. From February to July 2010, 3197 patients were randomly assigned to receive either EES or SES. Of these, angiographic sub-study enrolled 571 patients (EES 285 patients, SES 286 patients). Angiograms were assessed qualitatively and quantitatively at procedure and at 8-12 months in the independent core angiographic laboratory. Late loss of the proximal edges tended to be greater in the EES group than that in the SES group (0.12 ± 0.49 vs. 0.04 ± 0.43 mm, P = 0.05), although late loss in the other segments was similar between the 2 groups. Edge restenosis was mainly observed in EES group, whereas body restenosis was demonstrated in half of SES group. Stent fracture was observed only in the SES group (1.5 %), and peri-stent contrast staining (PSS) tended to be more frequently observed in the SES group than in the EES group (3.6 and 1.5 %, P = 0.18). Restenotic response in the proximal edge was more prominent in the EES group as compared to the SES group. Abnormal angiographic findings such as stent fracture and PSS tended to be more frequent in the SES group.
最近几项比较依维莫司洗脱支架（EES）和西罗莫司洗脱支架（SES）的随机试验报告了相似的临床结果。本研究旨在阐明EES与SES在血管造影结果上的差异。西罗莫司洗脱支架与依维莫司洗脱支架试验的随机评估是一项前瞻性多中心随机开放标签试验，在日本比较EES和SES。2010年2月至7月，3197例患者被随机分配接受EES或SES。其中，血管造影亚研究纳入了571例患者（EES组285例，SES组286例）。在独立的核心血管造影实验室对血管造影进行了定性和定量评估，分别在手术时和8至12个月时进行。EES组近端边缘的晚期丢失往往比SES组更大（0.12±0.49 vs.0.04±0.43 mm，P = 0.05），尽管两组其他节段的晚期丢失相似。边缘再狭窄主要在EES组观察到，而体部再狭窄在SES组中有一半出现。仅在SES组观察到支架断裂（1.5%），SES组比EES组更频繁地观察到支架周围造影剂染色（PSS）（3.6%和1.5%，P = 0.18）。与SES组相比，EES组近端边缘的再狭窄反应更明显。SES组中支架断裂和PSS等异常血管造影结果往往更频繁。
