From the Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan (H.S., T.K.); Department of Cardiology, Teikyo University Hospital, Tokyo, Japan (K. Kozuma); Division of General Medicine, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan (T. Morimoto); Department of Cardiology, Hokkaido Social Insurance Hospital, Sapporo, Japan (K.I.); Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan (K. Kadota); Department of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan (K.T.); Department of Cardiology, Iwate University Hospital, Morioka, Japan (Y.M.); Department of Cardiovascular Medicine, Wakayama Medical University Hospital, Wakayama, Japan (T.A.); Department of Cardiology, National Hospital Organization, Kyoto Medical Center, Kyoto, Japan (M.A.); Department of Cardiology, Juntendo University Shizuoka Hospital, Nagaoka, Japan (S.S.); Department of Cardiology, Saiseikai Yokohama-City Eastern Hospital, Yokohama, Japan (T. Muramatsu); Department of Cardiology, Hamamatsu Medical Center, Hamamatsu, Japan (M.K.); Department of Cardiology, Hiroshima City Hospital, Hiroshima, Japan (K.D.); Department of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan (K.N.); Department of Cardiology, Kansai Rosai Hospital, Cardiovascular Center, Hyogo, Japan (M.U.); Department of Cardiology, Okamura Memorial Hospital, Shizuoka, Japan (Y.T.); Department of Cardiology, Sakurabashi Watanabe Hospital, Osaka, Japan (K.F.); and Abbott Vascular, Abbott Park, IL (C.A.S.).
Circ Cardiovasc Interv. 2014 Jun;7(3):343-54. doi: 10.1161/CIRCINTERVENTIONS.113.001322. Epub 2014 May 6.
Long-term clinical outcomes of everolimus-eluting stent (EES) compared with sirolimus-eluting stent (SES) have not been evaluated fully yet, especially whether EES implantation could positively affect late adverse events reported after SES implantation occurring >1 year.
In this all-comer prospective multicenter randomized open-label trial, 3196 patients were assigned randomly to implant either EES (n=1596) or SES (n=1600). At 3 years, EES was noninferior to SES on the primary safety end point (all-cause death or myocardial infarction; 10.1% versus 11.5%; noninferiority P <0.001; and superiority P=0.19). Cumulative incidence of definite stent thrombosis was low and was not significantly different between the 2 groups (0.5% versus 0.6%; P=0.81). There was no significant difference in the efficacy end point of target-lesion revascularization between the EES and SES groups (6.6% versus 7.9%; P=0.16). However, the cumulative incidence of target-lesion failure (cardiac death/target-vessel myocardial infarction/ischemia-driven target-lesion revascularization) was significantly lower in the EES group than in the SES group (8.8% versus 11.4%; P=0.01). By a landmark analysis at 1 year, the cumulative incidence of very late stent thrombosis and late target-lesion revascularization was not significantly different between the 2 groups (0.2% versus 0.2%; P=0.99 and 2.2% versus 2.9%; P=0.21, respectively).
The efficacy and safety outcomes for this trial after EES implantation remained comparable with those after SES implantation through 3-year follow-up. However, improvement of clinical outcome after EES implantation compared with SES implantation was suggested by the significantly lower cumulative incidences of target-lesion failure, which has been the most widely used primary end point in the stent-versus-stent trials.
http://www.clinicaltrials.gov. Unique identifier: NCT01035450.
尚未充分评估依维莫司洗脱支架（EES）与西罗莫司洗脱支架（SES）相比的长期临床结局，特别是 EES 植入是否能够对 SES 植入后超过 1 年发生的晚期不良事件产生积极影响。
在这项所有患者入组的前瞻性多中心随机开放标签试验中，3196 例患者被随机分配至 EES 组（n=1596）或 SES 组（n=1600）。3 年时，EES 在主要安全性终点（全因死亡或心肌梗死；10.1%比 11.5%；非劣效性 P＜0.001；优效性 P=0.19）上不劣于 SES。两组间确定的支架血栓形成累积发生率较低，且无显著差异（0.5%比 0.6%；P=0.81）。EES 组和 SES 组的靶病变血运重建的疗效终点无显著差异（6.6%比 7.9%；P=0.16）。然而，EES 组的靶病变失败（心脏死亡/靶血管心肌梗死/缺血驱动的靶病变血运重建）累积发生率显著低于 SES 组（8.8%比 11.4%；P=0.01）。通过 1 年的里程碑分析，两组间非常晚期支架血栓形成和晚期靶病变血运重建的累积发生率无显著差异（0.2%比 0.2%；P=0.99 和 2.2%比 2.9%；P=0.21）。
EES 植入后 3 年的随访结果显示，该试验的疗效和安全性与 SES 植入后结果相当。然而，EES 植入后靶病变失败的累积发生率显著降低，提示与 SES 植入相比，EES 植入后的临床结局得到改善，而靶病变失败一直是支架与支架试验中最广泛使用的主要终点。
