BACKGROUND The thin-strut SYNERGY stent has an abluminal everolimus-eluting bioabsorbable polymer coating designed to facilitate vascular healing and reduce risk of stent thrombosis. In the multicenter, randomized EVOLVE II trial (The EVOLVE II Clinical Trial to Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion[s]), SYNERGY was noninferior to the durable polymer PROMUS Element Plus everolimus-eluting stent for the primary end point of 1-year target lesion failure. Longer-term clinical follow-up will support the relative efficacy and safety of SYNERGY. METHODS Patients with ≤3 native coronary lesions (reference vessel diameter ≥2.25-≤4.00 mm; length ≤34 mm) in ≤2 major epicardial vessels were randomized 1:1 to SYNERGY (N=838) or PROMUS Element Plus (N=846). EVOLVE II included a Diabetes substudy which pooled patients with diabetes mellitus from the randomized controlled trial (n=263) and from a sequential, single-arm substudy (N=203). RESULTS The 5-year target lesion failure rate was 14.3% for SYNERGY and 14.2% for PROMUS Element Plus (P=0.91). Landmark analysis demonstrated similar rates of target lesion failure from discharge to 1-year (P=0.90) and from 1 to 5 years (P=0.94). Definite/probable stent thrombosis was infrequent in both arms (SYNERGY 0.7% versus PROMUS Element Plus 0.9%; P=0.75). There were no significant differences in the rates of cardiac death, myocardial infarction, or revascularization. Among patients with diabetes mellitus, the target lesion failure rate to 1-year was noninferior to a prespecified performance goal and to 5 years was 17.0%. CONCLUSIONS SYNERGY demonstrated comparable outcomes to PROMUS Element Plus, with low rates of stent thrombosis and adverse events through 5 years of follow-up. Five-year clinical outcomes were favorable in patients with diabetes mellitus. These data support the long-term safety and effectiveness of SYNERGY in a broad range of patients. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT01665053.

中文翻译：

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植入细支，可生物吸收的聚合物涂层，依维莫司洗脱的SYNERGY支架植入后的临床结果。

背景技术细杆状SYNERGY支架具有可在体外进行依维莫司洗脱的可生物吸收的聚合物涂层，旨在促进血管愈合并降低支架血栓形成的风险。在多中心随机EVOLVE II试验（评估SYNERGY支架系统治疗动脉粥样硬化病变的EVOLVE II临床试验）中，SYNERGY不逊于耐用聚合物PROMUS Element Plus依维莫司洗脱支架作为主要终点1年目标病变失败率。长期临床随访将支持SYNERGY的相对疗效和安全性。方法将≤2个主要心外膜血管中≤3个天然冠状动脉病变（参考血管直径≥2.25-≤4.00mm；长度≤34mm）的患者按1：1比例随机分配至SYNERGY（N = 838）或PROMUS Element Plus（N = 846） ）。EVOLVE II包括一个糖尿病子研究，该研究汇集了来自随机对照试验（n = 263）和连续单臂子研究（N = 203）的糖尿病患者。结果SYNERGY和PROMUS Element Plus的5年目标病变失败率分别为14.3％和14.2％（P = 0.91）。具有里程碑意义的分析表明，从出院至1年（P = 0.90）和1至5年（P = 0.94）的目标病变失败率相似。两组均不发生明确的/可能的支架血栓（SYNERGY 0.7％vs PROMUS Element Plus 0.9％； P = 0.75）。心源性死亡，心肌梗塞或血运重建率无显着差异。在糖尿病患者中，至1年的目标病变失败率不逊于预定的绩效目标，至5年的目标病变失败率为17.0％。结论协同作用显示了与PROMUS Element Plus相当的结果，通过5年的随访，支架血栓形成率低，且不良事件发生率低。糖尿病患者的五年临床结局是有利的。这些数据支持SYNERGY在众多患者中的长期安全性和有效性。临床试验注册网址：https：//www.clinicaltrials.gov。唯一标识符：NCT01665053。