Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
JACC Cardiovasc Interv. 2011 Oct;4(10):1096-103. doi: 10.1016/j.jcin.2011.05.024.
This study compared everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) for long coronary lesions.
Outcomes remain relatively unfavorable for stent-based coronary intervention of lesions with long diseased segments.
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.
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.
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.
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。
对于病变段较长的支架介入治疗,其结果仍相对不理想。
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。
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。
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。