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紫杉醇洗脱支架与西罗莫司洗脱支架治疗糖尿病患者的效果比较:来自美国国立心肺血液研究所动态注册研究的报告。

Paclitaxel-eluting versus sirolimus-eluting stents in diabetes mellitus: a report from the National Heart, Lung, and Blood Institute Dynamic Registry.

机构信息

University of Pittsburgh Medical Center, PA, USA.

出版信息

Circ Cardiovasc Interv. 2010 Feb 1;3(1):42-9. doi: 10.1161/CIRCINTERVENTIONS.109.885996. Epub 2010 Jan 26.

Abstract

BACKGROUND

Diabetes is a powerful predictor of adverse events in patients undergoing percutaneous coronary intervention. Drug-eluting stents reduce restenosis rates compared with bare metal stents; however, controversy remains regarding which drug-eluting stents provides greater benefit in patients with diabetes. Accordingly, we compared the safety and efficacy of sirolimus-eluting stents (SES) with paclitaxel-eluting stents (PES) among diabetic patients in a contemporary registry.

METHODS AND RESULTS

Using the National Heart, Lung, and Blood Institute Dynamic Registry, we evaluated 2-year outcomes of diabetic patients undergoing percutaneous coronary interventions with SES (n=677) and PES (n=328). Clinical and demographic characteristics, including age, body mass index, insulin use, left ventricular function, and aspirin/clopidogrel use postprocedure, did not differ significantly between the groups except that PES-treated patients had a greater frequency of hypertension and hyperlipidemia. At the 2-year follow-up, no significant differences were observed between PES and SES with regard to safety or efficacy end points. PES- and SES-treated patients had similar rates of death (10.7% versus 8.2%, P=0.20), death and myocardial infarction (14.9% versus 13.6%, P=0.55), repeat revascularization (14.8% versus 17.8%, P=0.36), and stent thrombosis (1.3% versus 1.3%, P=0.95). After adjustment, no significant differences between the 2 stent types in any outcome were observed.

CONCLUSIONS

PES and SES are equally efficacious and have similar safety profiles in diabetic patients undergoing percutaneous coronary interventions in clinical practice.

摘要

背景

糖尿病是经皮冠状动脉介入治疗患者发生不良事件的有力预测因子。与金属裸支架相比,药物洗脱支架可降低再狭窄率;然而,对于糖尿病患者而言,哪种药物洗脱支架能带来更大的获益仍存在争议。因此,我们在一个当代注册研究中比较了糖尿病患者应用西罗莫司洗脱支架(SES)和紫杉醇洗脱支架(PES)的安全性和疗效。

方法和结果

我们利用美国国立心肺血液研究所动态注册研究,评估了 677 例行经皮冠状动脉介入治疗的糖尿病患者应用 SES 和 328 例行 PES 的 2 年结局。临床和人口统计学特征,包括年龄、体重指数、胰岛素使用、左心室功能和术后阿司匹林/氯吡格雷的使用,两组间无显著差异,但 PES 治疗患者高血压和高血脂的发生率更高。在 2 年随访时,PES 和 SES 在安全性或疗效终点方面无显著差异。PES 和 SES 治疗患者的死亡率(10.7%比 8.2%,P=0.20)、死亡和心肌梗死发生率(14.9%比 13.6%,P=0.55)、再次血运重建率(14.8%比 17.8%,P=0.36)和支架血栓形成率(1.3%比 1.3%,P=0.95)相似。校正后,两种支架类型在任何结局方面均无显著差异。

结论

在临床实践中,糖尿病患者行经皮冠状动脉介入治疗时,PES 和 SES 的疗效相当,安全性相似。

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