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比较依维莫司洗脱支架和西罗莫司洗脱支架治疗长段冠状动脉病变患者的疗效:一项随机 LONG-DES-III(经皮治疗长段 native 冠状动脉病变的药物洗脱支架-III 试验)研究。

Comparison of everolimus- and sirolimus-eluting stents in patients with long coronary artery lesions: a randomized LONG-DES-III (Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III) Trial.

机构信息

Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.

出版信息

JACC Cardiovasc Interv. 2011 Oct;4(10):1096-103. doi: 10.1016/j.jcin.2011.05.024.

Abstract

OBJECTIVES

This study compared everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) for long coronary lesions.

BACKGROUND

Outcomes remain relatively unfavorable for stent-based coronary intervention of lesions with long diseased segments.

METHODS

This randomized, multicenter, prospective trial compared the use of long EES with SES in 450 patients with long (≥ 25 mm) native coronary lesions. The primary endpoint of the trial was in-segment late luminal loss at 9-month angiographic follow-up.

RESULTS

The EES and SES groups had similar baseline characteristics. Lesion length was 34.0 ± 15.4 mm in the EES group and 34.3 ± 13.5 mm in the SES group (p = 0.85). Nine-month angiographic follow-up was performed in 80% of the EES group and 81% of the SES group (p = 0.69). In-segment late loss as the primary study endpoint was significantly larger in the EES group than in the SES group (0.17 ± 0.41 mm vs. 0.09 ± 0.30 mm, p for noninferiority = 0.96, p for superiority = 0.04). The in-segment binary restenosis rate was also higher in the EES group than in the SES group (7.3% vs. 2.7%, p = 0.046). However, in-stent late loss (0.22 ± 0.43 mm vs. 0.18 ± 0.28 mm, p = 0.29) and in-stent binary restenosis rate (3.9% vs. 2.7%, p = 0.53) were similar among the 2 groups. The incidence of any clinical outcomes (death, myocardial infarction, stent thrombosis, target lesion revascularization, and composite outcomes) was not statistically different between the 2 groups.

CONCLUSIONS

For patients with long native coronary artery disease, EES implantation was associated with greater angiographic in-segment late loss and higher rates of in-segment restenosis compared with SES implantation. However, clinical outcomes were both excellent and not statistically different.

摘要

目的

本研究比较了依维莫司洗脱支架(EES)和西罗莫司洗脱支架(SES)治疗长段冠状动脉病变的效果。

背景

对于病变段较长的支架介入治疗,其结果仍相对不理想。

方法

这项随机、多中心、前瞻性试验比较了 450 例长(≥25mm)原发性冠状动脉病变患者使用长 EES 与 SES 的效果。试验的主要终点是 9 个月血管造影随访时的节段内晚期管腔丢失。

结果

EES 组和 SES 组的基线特征相似。EES 组病变长度为 34.0±15.4mm,SES 组为 34.3±13.5mm(p=0.85)。EES 组和 SES 组分别有 80%和 81%的患者完成了 9 个月的血管造影随访(p=0.69)。EES 组节段内晚期丢失作为主要研究终点显著大于 SES 组(0.17±0.41mm 比 0.09±0.30mm,非劣效性检验 p 值=0.96,优效性检验 p 值=0.04)。EES 组节段内再狭窄率也高于 SES 组(7.3%比 2.7%,p=0.046)。然而,支架内晚期管腔丢失(0.22±0.43mm 比 0.18±0.28mm,p=0.29)和支架内再狭窄率(3.9%比 2.7%,p=0.53)在两组间相似。两组间任何临床结局(死亡、心肌梗死、支架血栓形成、靶病变血运重建和复合结局)的发生率均无统计学差异。

结论

对于长段原发性冠状动脉疾病患者,与 SES 植入相比,EES 植入与更大的节段内晚期管腔丢失和更高的节段内再狭窄率相关。然而,临床结局均良好且无统计学差异。

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