General Hospital of Shenyang Military Region, Shenyang, China.
EuroIntervention. 2017 Nov 20;13(10):1210-1217. doi: 10.4244/EIJ-D-17-00271.
The EVOLVE China randomised study sought to evaluate the clinical safety and effectiveness of the SYNERGY bioabsorbable polymer-coated everolimus-eluting stent (EES) for the treatment of patients with coronary heart disease in China.
Eligible patients with de novo native coronary artery lesions were randomised (1:1) to receive the SYNERGY or PROMUS Element Plus stent. The primary endpoint was in-stent late loss at nine months. Secondary endpoints included death, MI, revascularisation, and stent thrombosis up to 12 months. A total of 412 subjects were randomised (205 SYNERGY; 207 PROMUS Element Plus) at 14 sites in China from October 2013 to July 2014. SYNERGY was non-inferior to PROMUS Element Plus for the primary endpoint of nine-month in-stent late loss: SYNERGY 0.20±0.33 mm vs. PROMUS Element Plus 0.17±0.38 mm with an upper one-sided 97.5% confidence interval of the difference (0.10 mm), significantly less than the non-inferiority margin (0.15 mm; p<0.0008). Clinical adverse event rates were low and not significantly different between groups at nine and 12 months (all p>0.05).
In the EVOLVE China trial, the SYNERGY bioabsorbable polymer-coated EES was noninferior to the PROMUS Element Plus permanent polymer-coated EES for the primary endpoint of late loss at nine months.
EVOLVE China 随机研究旨在评估 SYNERGY 可生物吸收聚合物涂层依维莫司洗脱支架（EES）在中国治疗冠心病患者的临床安全性和有效性。
符合条件的初发原生冠状动脉病变患者以 1:1 的比例随机（随机）接受 SYNERGY 或 PROMUS Element Plus 支架治疗。主要终点是 9 个月时的支架内晚期损失。次要终点包括 12 个月时的死亡、心肌梗死、血运重建和支架血栓形成。2013 年 10 月至 2014 年 7 月，在中国的 14 个地点共随机入组 412 例患者（SYNERGY 205 例；PROMUS Element Plus 207 例）。SYNERGY 在 9 个月时支架内晚期损失的主要终点不劣于 PROMUS Element Plus：SYNERGY 0.20±0.33mm 与 PROMUS Element Plus 0.17±0.38mm，差异的单侧 97.5%置信区间为 0.10mm，明显小于非劣效性边界（0.15mm;p<0.0008）。9 个月和 12 个月时，两组的临床不良事件发生率均较低且无显著差异（均 p>0.05）。
在 EVOLVE China 试验中，SYNERGY 可生物吸收聚合物涂层 EES 在 9 个月时的晚期损失主要终点不劣于 PROMUS Element Plus 永久性聚合物涂层 EES。
