The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH (D.J.K., I.J.S.).
Bern University Hospital, Inselspital, University of Bern, Switzerland (S.W.).
Circ Cardiovasc Interv. 2019 Sep;12(9):e008152. doi: 10.1161/CIRCINTERVENTIONS.119.008152. Epub 2019 Aug 27.
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.
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).
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%.
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.
URL: https://www.clinicaltrials.gov. Unique identifier: NCT01665053.
薄壁 SYNERGY 支架具有向血管外表面释放依维莫司的生物可吸收聚合物涂层，旨在促进血管愈合并降低支架血栓形成的风险。在多中心、随机的 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 在主要终点 1 年靶病变失败率方面不劣于持久聚合物 PROMUS Element Plus 依维莫司洗脱支架。更长时间的临床随访将支持 SYNERGY 的相对疗效和安全性。
患者的 ≤3 个原生冠状动脉病变（参考血管直径为 ≥2.25-≤4.00mm；长度 ≤34mm）在 ≤2 个主要心外膜血管中，按照 1:1 的比例随机分配至 SYNERGY（N=838）或 PROMUS Element Plus（N=846）。EVOLVE II 包括一个糖尿病亚研究，该亚研究汇集了来自随机对照试验（n=263）和连续单臂亚研究（n=203）的糖尿病患者。
SYNERGY 的 5 年靶病变失败率为 14.3%，PROMUS Element Plus 为 14.2%（P=0.91）。标志性分析显示，从出院到 1 年（P=0.90）和从 1 年到 5 年（P=0.94），靶病变失败率相似。两支手臂的明确/可能的支架血栓形成均不常见（SYNERGY 为 0.7%，PROMUS Element Plus 为 0.9%；P=0.75）。心脏死亡、心肌梗死或血运重建的发生率无显著差异。在糖尿病患者中，到 1 年的靶病变失败率不劣于预设的性能目标，到 5 年的靶病变失败率为 17.0%。
SYNERGY 的结果与 PROMUS Element Plus 相似，5 年随访期间支架血栓形成和不良事件发生率较低。糖尿病患者的 5 年临床结局良好。这些数据支持 SYNERGY 在广泛患者人群中的长期安全性和有效性。
