Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, 126-1, 5ka, Anam-dong, Sungbuk-ku, Seoul 136-705, Korea.
Severance Cardiovascular Hospital, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul 120-752, Korea.
Eur Heart J. 2016 Dec 1;37(45):3409-3418. doi: 10.1093/eurheartj/ehw389. Epub 2016 Sep 15.
At present no proven standard treatment for drug-eluting stent (DES) restenosis is available, and the efficacy and safety of everolimus-eluting stent (EES) and zotarolimus-eluting stent (ZES) for DES restenosis are limited. The purpose of this prospective, randomized 9-month intracoronary ultrasound (IVUS) and 3-year clinical follow-up study was to compare the effects of EESs and ZESs on neointima volume and major adverse cardiovascular events (MACEs) such as death, myocardial infarction (MI), target lesion revascularization (TLR) and stent thrombosis in DES restenosis patients.
Patients were eligible for this study if they were between 40 and 75 years old with in-stent restenosis >50% by quantitative coronary angiographic analysis in DES or within 5 mm of the stent edges with signs of ischaemia. Eligible patients (n = 304, 146 women and 158 men) were randomly assigned to receive either EES (158 patients) or ZES (146 patients). The primary endpoint of the study was to compare neointima volume between the EES and ZES groups at the 9-month follow-up IVUS. MACEs, including death, non-fatal MI, stent thrombosis and the need for repeated TLR within 3 years, were noted. The 9-month angiographic and IVUS follow-up showed no significant differences in late lumen loss (0.40 ± 0.56 vs. 0.45 ± 0.61 mm, P = 0.57, respectively) and neointima volume (0.51 ± 0.48 vs. 0.56 ± 0.54 mm/1 mm, P = 0.47, respectively) in the EES and the ZES groups. Composite MACEs such as death, MI, stent thrombosis and TLR during 3-year follow-up were comparable between the two groups [15.8% (n = 25) in the EES group and 22.6% (n = 33) in the ZES group, P = 0.276], independent of de novo DES type, sex, age, body mass index, presence of diabetes, hypertension and dyslipidaemia.
Patients with first- and second-generation DES restenosis, both EES and ZES implantation were effective and safe in reducing neointima volume and late loss with a comparable rate of MACEs independent of cardiovascular risk factors.
目前尚无针对药物洗脱支架（DES）再狭窄的明确标准治疗方法，雷帕霉素洗脱支架（EES）和佐他莫司洗脱支架（ZES）治疗 DES 再狭窄的疗效和安全性有限。本前瞻性、随机的 9 个月冠状动脉内超声（IVUS）和 3 年临床随访研究的目的是比较 EES 和 ZES 对 DES 再狭窄患者新生内膜体积和主要不良心血管事件（MACE）如死亡、心肌梗死（MI）、靶病变血运重建（TLR）和支架血栓形成的影响。
符合以下条件的患者有资格参加本研究：年龄在 40-75 岁之间，定量冠状动脉造影分析显示 DES 内支架内再狭窄>50%，或支架边缘 5mm 内有缺血迹象。合格的患者（n=304，146 名女性和 158 名男性）被随机分配接受 EES（158 名患者）或 ZES（146 名患者）治疗。该研究的主要终点是在 9 个月 IVUS 随访时比较 EES 和 ZES 组的新生内膜体积。记录了 3 年内的 MACE 事件，包括死亡、非致命性 MI、支架血栓形成和需要重复 TLR。9 个月时的血管造影和 IVUS 随访显示，晚期管腔丢失（0.40±0.56 毫米与 0.45±0.61 毫米，P=0.57）和新生内膜体积（0.51±0.48 毫米与 0.56±0.54 毫米/1 毫米，P=0.47）在 EES 和 ZES 组之间无显著差异。在 3 年的随访中，两组的复合 MACE 事件如死亡、MI、支架血栓形成和 TLR 相当[EES 组 15.8%（n=25）和 ZES 组 22.6%（n=33），P=0.276]，与新发 DES 类型、性别、年龄、体重指数、是否存在糖尿病、高血压和血脂异常无关。
对于第一代和第二代 DES 再狭窄的患者，EES 和 ZES 植入均可有效、安全地减少新生内膜体积和晚期丢失，且 MACE 发生率相当，与心血管危险因素无关。
