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西罗莫司洗脱支架与裸金属支架在冠状动脉分叉病变中的比较:非应激/贝内斯特支架疾病试验(SCANDSTENT)中冠状动脉支架置入术的亚组分析。

Comparison of sirolimus-eluting and bare metal stents in coronary bifurcation lesions: subgroup analysis of the Stenting Coronary Arteries in Non-Stress/Benestent Disease Trial (SCANDSTENT).

作者信息

Thuesen Leif, Kelbaek Henning, Kløvgaard Lene, Helqvist Steffen, Jørgensen Erik, Aljabbari Samir, Krusell Lars R, Jensen Gunnar V H, Bøtker Hans E, Saunamäki Kari, Lassen Jens F, van Weert Anton

机构信息

Skejby Sygehus, Skejby, Denmark.

出版信息

Am Heart J. 2006 Dec;152(6):1140-5. doi: 10.1016/j.ahj.2006.06.035.

Abstract

BACKGROUND

Sirolimus-eluting stent implantation improves the outcome in simple coronary artery lesions compared with bare metal stents, but there is limited evidence of their safety and efficacy when implanted in complex lesions like coronary bifurcations.

METHODS

SCANDSTENT was a randomized controlled study comparing implantation of sirolimus-eluting stents with bare-metal stents in patients with complex coronary artery disease. This substudy evaluates the angiographic and clinical outcome of 126 patients with lesions located in a coronary bifurcation.

RESULTS

The baseline characteristics of the patients were comparable: 15% had diabetes, and 1.7 stents were implanted per lesion. At follow-up, the minimum lumen diameter of the main branch was 2.35 mm in patients who received sirolimus-eluting stents compared with 1.68 mm in those who received bare-metal stents, and that of the side branch was 1.70 versus 1.19 mm (both P < .001). The late lumen loss in the main branch was 0.12 mm in the sirolimus-eluting stent group versus 0.99 mm in the bare-metal stent group and 0.03 versus 0.56 mm in the side branch (both P < .001). Thus, sirolimus-eluting stents reduced the restenosis rate from 28.3% to 4.9% in the main branch and from 43.4% to 14.8% in the side branches (both P < .001). Major adverse cardiac events occurred in 9% with sirolimus-eluting stents versus 28% with bare-metal stents (P = .01), and stent thrombosis was observed in 0% versus 9% (P = .02).

CONCLUSION

Sirolimus-eluting stent implantation improves both the angiographic and clinical outcomes considerably compared with that of bare-metal stents in patients with stenoses located in coronary bifurcations.

摘要

背景

与裸金属支架相比,西罗莫司洗脱支架植入术可改善单纯冠状动脉病变的治疗效果,但对于其植入冠状动脉分叉等复杂病变时的安全性和有效性,证据有限。

方法

SCANDSTENT是一项随机对照研究,比较了在复杂冠状动脉疾病患者中植入西罗莫司洗脱支架与裸金属支架的情况。本亚组研究评估了126例冠状动脉分叉病变患者的血管造影和临床结果。

结果

患者的基线特征具有可比性:15%患有糖尿病,每个病变植入1.7个支架。随访时,接受西罗莫司洗脱支架的患者主支最小管腔直径为2.35 mm,而接受裸金属支架的患者为1.68 mm,侧支最小管腔直径分别为1.70 mm和1.19 mm(均P < .001)。西罗莫司洗脱支架组主支的晚期管腔丢失为0.12 mm,裸金属支架组为0.99 mm,侧支分别为0.03 mm和0.56 mm(均P < .001)。因此,西罗莫司洗脱支架使主支再狭窄率从28.3%降至4.9%,侧支从43.4%降至14.8%(均P < .001)。接受西罗莫司洗脱支架的患者发生主要不良心脏事件的比例为9%,而接受裸金属支架的患者为28%(P = .01),观察到支架血栓形成的比例分别为0%和9%(P = .02)。

结论

对于冠状动脉分叉处狭窄的患者,与裸金属支架相比,植入西罗莫司洗脱支架可显著改善血管造影和临床结果。

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