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雷帕霉素洗脱支架与裸金属支架治疗ST段抬高型心肌梗死患者的对比研究

Firebird sirolimus eluting stent versus bare mental stent in patients with ST-segment elevation myocardial infarction.

作者信息

Gao Hai, Yan Hong-bing, Zhu Xiao-ling, Li Nan, Ai Hui, Wang Jian, Li Shi-ying, Yang Duo

机构信息

Emergency Center for Heart, Lung and Vessel Diseases, Beijing Anzhen Hospital of Capital University of Medical Sciences, Beijing 100029, China.

出版信息

Chin Med J (Engl). 2007 May 20;120(10):863-7.

Abstract

BACKGROUND

There are few evidences about the value of drug eluting stent in patients with ST-segment elevation myocardial infarction (STEMI). We prospectively designed a randomized controlled trial to compare the safety and efficacy of Firebird sirolimus eluting stent (Firebird stent) and bare metal stent (BMS).

METHODS

Patients with STEMI enrolled during one year period were randomized to undergo implantation of Firebird stent or BMS, and clinical and angiographic follow-up. The primary endpoint of the present study was in-lesion late lumen loss (LLL) at 6 months, and secondary endpoint includes stent thrombosis and major adverse cardiac events (MACE) at 6 months.

RESULTS

During one year period, 156 patients were randomized into the Firebird stent group (101 patients with an average age of 57.8 years) or the BMS group (55 patients with 59.7 years on average). Six-month angiographic follow-up was available in 66.3% and 63.7% of patients assigned to Firebird stent and BMS, respectively. At 6-month follow-up, mortality, target vessel revascularization (TVR) and MACE were 2.0%, 6.9% and 9.9% in the Firebird stent group, while 3.6%, 30.9% and 36.4% in the BMS group (P < 0.05). Subacute thrombosis occurred in 1 patient in both groups, respectively. The mean LLL was 0.18 mm in the Firebird stent group versus 0.72 mm in the BMS group.

CONCLUSION

Implantation of Firebird sirolimus eluting stent for STEMI may greatly reduce TVR and MACE at 6 months with low incidence of acute/subacute stent thrombosis compared with BMS.

摘要

背景

关于药物洗脱支架在ST段抬高型心肌梗死(STEMI)患者中的价值,证据较少。我们前瞻性地设计了一项随机对照试验,以比较火鸟西罗莫司洗脱支架(火鸟支架)和裸金属支架(BMS)的安全性和有效性。

方法

入选的STEMI患者在一年期间被随机分为接受火鸟支架或BMS植入,并进行临床和血管造影随访。本研究的主要终点是6个月时病变处晚期管腔丢失(LLL),次要终点包括6个月时的支架血栓形成和主要不良心脏事件(MACE)。

结果

在一年期间,156例患者被随机分为火鸟支架组(101例,平均年龄57.8岁)或BMS组(55例,平均年龄59.7岁)。分别有66.3%和63.7%分配至火鸟支架和BMS组的患者进行了6个月的血管造影随访。在6个月随访时,火鸟支架组的死亡率、靶血管重建(TVR)和MACE分别为2.0%、6.9%和9.9%,而BMS组分别为3.6%、30.9%和36.4%(P<0.05)。两组各有1例患者发生亚急性血栓形成。火鸟支架组的平均LLL为0.18mm,而BMS组为0.72mm。

结论

与BMS相比,STEMI患者植入火鸟西罗莫司洗脱支架可在6个月时显著降低TVR和MACE,急性/亚急性支架血栓形成发生率较低。

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