Boston Scientific Corporation, Marlborough, MA, USA.
EuroIntervention. 2018 Apr 20;13(17):2047-2050. doi: 10.4244/EIJ-D-17-00529.
Long-term data on bioabsorbable polymer-coated everolimus-eluting stents (BP-EES) are limited. The EVOLVE trial compared the safety and efficacy of two dose formulations of the SYNERGY BP-EES with the permanent polymer-coated PROMUS Element EES (PE).
The EVOLVE study was a prospective, multicentre, non-inferiority trial that randomised 291 patients with de novo coronary lesions (length: ≤28 mm; diameter: ≥2.25 to ≤3.5 mm) to receive PE (n=98), SYNERGY (n=94), or SYNERGY half-dose (n=99). At five years, there were no significant differences in the rates of TLF or individual components between groups. TLR rates trended lower in both SYNERGY arms than in the PE arm (TLR: 1.1% SYNERGY and 1.0% SYNERGY half-dose vs. 6.1% PE; p=0.07 and p=0.06, respectively). TVR was numerically lower in the SYNERGY arms compared to the PE arm (TVR: 3.3% SYNERGY and 4.2% SYNERGY half-dose vs. 10.2% PE; p=0.06 and p=0.11, respectively). No incidence of stent thrombosis was reported in any arm up to five years.
The EVOLVE trial represents the longest-term follow-up of the SYNERGY stent available to date, demonstrating its continued safety and efficacy for the treatment of selected de novo atherosclerotic lesions up to five years.
生物可吸收聚合物涂层依维莫司洗脱支架（BP-EES）的长期数据有限。EVOLVE 试验比较了两种剂量 SYNERGY BP-EES 与永久性聚合物涂层 PROMUS Element EES（PE）的安全性和疗效。
EVOLVE 研究是一项前瞻性、多中心、非劣效性试验，将 291 例新发冠状动脉病变（长度：≤28mm；直径：≥2.25 至≤3.5mm）患者随机分为 PE（n=98）、SYNERGY（n=94）或 SYNERGY 半剂量（n=99）组。五年时，各组间 TLFTLF 或各组成部分的发生率无显著差异。TLR 率在 SYNERGY 两个臂均低于 PE 臂（TLR：SYNERGY 组 1.1%和 SYNERGY 半剂量组 1.0%，PE 组 6.1%；p=0.07 和 p=0.06）。与 PE 组相比，SYNERGY 组的 TVR 数值较低（TVR：SYNERGY 组 3.3%和 SYNERGY 半剂量组 4.2%，PE 组 10.2%；p=0.06 和 p=0.11）。在五年内，任何组均未报告支架血栓形成的发生率。
EVOLVE 试验代表了迄今为止 SYNERGY 支架最长时间的随访，证明其在治疗选定的新发动脉粥样硬化病变方面具有持续的安全性和疗效，最长可达五年。
