Kimura Takeshi, Saito Shigeru, Ando Kenji, Ito Yoshiaki, Kozuma Ken, Yajima Junji, Nakamura Masato, Hagiwara Nobuhisa, Yasuda Satoshi, Fukamachi Daisuke, Shinke Toshiro, Ueno Takafumi, Allocco Dominic J
Kyoto University Hospital Kyoto Japan.
Shonan Kamakura General Hospital Kanagawa Japan.
Circ Rep. 2020 Dec 11;3(1):9-17. doi: 10.1253/circrep.CR-20-0114.
SYNERGY is a thin-strut, platinum-chromium metal alloy stent with an ultrathin abluminal everolimus-eluting bioabsorbable polymer. EVOLVE II was a global randomized controlled trial that enrolled 1,684 patients treated with either a SYNERGY or durable polymer PROMUS Element Plus (PE+) everolimus-eluting stent, including 155 patients from Japanese sites. This substudy analyzed 5-year clinical outcomes in the Japanese and non-Japanese cohorts. Patients aged ≥18 years with ≤3 native coronary artery lesions (reference vessel diameter ≥2.25-≤4.00 mm; length ≤34 mm) in ≤2 major vessels were randomized 1 : 1 to receive either SYNERGY (n=74 patients in Japan) or PE+ (n=81 patients in Japan). Five-year target lesion failure (TLF) was observed in 8.3% SYNERGY- and 11.2% PE+-treated patients (P=0.54). There were no cardiac deaths, and rates of target lesion revascularization and myocardial infarction were comparable between treatment arms. One patient in the SYNERGY arm experienced a very late definite stent thrombosis (ST); no ST occurred in the PE+ arm (P=0.30). Despite differences in baseline clinical and lesion characteristics, the 5-year TLF rates were not significantly different in SYNERGY-treated patients either in (8.3%) or outside (14.8%) Japan (P=0.14). In Japanese patients with coronary artery disease, SYNERGY showed comparable efficacy to PE+, with low rates of adverse events over 5 years. Similarly, 5-year clinical outcomes were favorable in Japanese vs. non-Japanese patients implanted with SYNERGY.
SYNERGY是一种带有超薄管腔外依维莫司洗脱生物可吸收聚合物的细支撑铂铬金属合金支架。EVOLVE II是一项全球随机对照试验，纳入了1684例接受SYNERGY或耐用聚合物PROMUS Element Plus（PE+）依维莫司洗脱支架治疗的患者，其中包括155例来自日本研究点的患者。这项亚研究分析了日本和非日本队列的5年临床结局。年龄≥18岁、≤2支主要血管中≤3处原位冠状动脉病变（参考血管直径≥2.25 -≤4.00 mm；长度≤34 mm）的患者按1:1随机分组，分别接受SYNERGY（日本74例患者）或PE+（日本81例患者）治疗。接受SYNERGY治疗的患者5年靶病变失败（TLF）率为8.3%，接受PE+治疗的患者为11.2%（P = 0.54）。未发生心源性死亡，治疗组间靶病变血运重建率和心肌梗死发生率相当。SYNERGY组有1例患者发生极晚期明确支架血栓形成（ST）；PE+组未发生ST（P = 0.30）。尽管基线临床和病变特征存在差异，但在日本接受SYNERGY治疗的患者（8.3%）和日本以外地区（14.8%），5年TLF率无显著差异（P = 0.14）。在日本冠心病患者中，SYNERGY与PE+疗效相当，5年不良事件发生率较低。同样，植入SYNERGY的日本患者与非日本患者的5年临床结局良好。
