Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, 54 Shogoin Kawahara-cho, Kyoto, Japan 606-8507.
Circulation. 2012 Sep 4;126(10):1225-36. doi: 10.1161/CIRCULATIONAHA.112.104059. Epub 2012 Jul 23.
Several recent randomized trials comparing everolimus-eluting stent (EES) and sirolimus-eluting stent (SES) reported similar outcomes. However, only 1 trial was powered for a clinical end point, and no trial was powered for evaluating target-lesion revascularization.
Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial is a prospective multicenter randomized open-label trial comparing EES with SES in Japan. The trial was powered for evaluating noninferiority of EES relative to SES in terms of target-lesion revascularization. From February and July 2010, 3197 patients were randomly assigned to receive either EES (1597 patients) or SES (1600 patients). At 1 year, the primary efficacy end point of target-lesion revascularization occurred in 65 patients (4.3%) in the EES group and in 76 patients (5.0%) in the SES group, demonstrating noninferiority of EES to SES (P(noninferiority)<0.0001, and P(superiority)=0.34). Cumulative incidence of definite stent thrombosis was low and similar between the 2 groups (0.32% versus 0.38%, P=0.77). An angiographic substudy enrolling 571 patients (EES, 285 patients and SES, 286 patients) demonstrated noninferiority of EES relative to SES regarding the primary angiographic end point of in-segment late loss (0.06±0.37 mm versus 0.02±0.46 mm, P(noninferiority)<0.0001, and P(superiority)=0.24) at 278±63 days after index stent implantation.
One-year clinical and angiographic outcome after EES implantation was noninferior to and not different from that after SES implantation in a stable coronary artery disease population with relatively less complex coronary anatomy. One-year clinical outcome after both EES and SES use was excellent with a low rate of target-lesion revascularization and a very low rate of stent thrombosis.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01035450.
几项比较依维莫司洗脱支架（EES）和西罗莫司洗脱支架（SES）的近期随机试验报告了相似的结果。然而，只有 1 项试验具有临床终点的效能，并且没有试验具有评估靶病变血运重建的效能。
依维莫司洗脱支架与西罗莫司洗脱支架随机评估试验是一项在日本进行的前瞻性多中心随机开放标签试验，比较了 EES 与 SES。该试验旨在评估 EES 在靶病变血运重建方面相对于 SES 的非劣效性。2010 年 2 月至 7 月，3197 例患者被随机分配至 EES 组（1597 例）或 SES 组（1600 例）。在 1 年时，EES 组有 65 例（4.3%）患者发生靶病变血运重建的主要疗效终点，SES 组有 76 例（5.0%）患者发生该终点，表明 EES 不劣于 SES（P（非劣效性）<0.0001，P（优效性）=0.34）。两组间确定的支架血栓形成的累积发生率较低且相似（0.32%比 0.38%，P=0.77）。一项纳入 571 例患者（EES 组 285 例，SES 组 286 例）的血管造影亚研究表明，EES 在支架内晚期丢失的主要血管造影终点方面相对于 SES 不劣（0.06±0.37 mm 比 0.02±0.46 mm，P（非劣效性）<0.0001，P（优效性）=0.24），该终点在指数支架植入后 278±63 天测量。
在稳定性冠状动脉疾病人群中，EES 植入后 1 年的临床和血管造影结果不劣于 SES 植入后的结果，且与 SES 植入后的结果无差异，这些患者的冠状动脉解剖结构相对较简单。EES 和 SES 使用后的 1 年临床结果均非常出色，靶病变血运重建率低，支架血栓形成率极低。
