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西罗莫司洗脱支架与紫杉醇洗脱支架治疗糖尿病患者冠状动脉疾病的对比研究

Sirolimus-eluting stents versus Paclitaxel-eluting stents in the treatment of coronary artery disease in patients with diabetes mellitus.

作者信息

Kuchulakanti Pramod K, Chu William W, Torguson Rebecca, Clavijo Leonardo, Wolfram Roswitha, Mishra Sundeep, Xue Zhenyi, Gevorkian Natalie, Suddath William O, Satler Lowell F, Kent Kenneth M, Pichard Augusto D, Waksman Ron

机构信息

Department of Internal Medicine, Division of Cardiology, Washington Hospital Center, Washington, District of Columbia, USA.

出版信息

Am J Cardiol. 2006 Jul 15;98(2):187-92. doi: 10.1016/j.amjcard.2006.01.074. Epub 2006 May 19.

Abstract

This study was performed to compare the safety and efficacy of sirolimus-eluting stents (SESs) and paclitaxel-eluting stents (PESs) on the outcomes of diabetic patients. Recent data with drug-eluting stents have shown improved clinical outcomes in diabetic patients. This study compared outcomes between the 2 available drug-eluting stents, SESs and PESs. From the prospective drug-eluting stent registries at the investigators' institution, 1,320 consecutive diabetic patients treated with SESs (n=873, 1,293 lesions) and PESs (n=447, 733 lesions) were identified and their in-hospital and 1- and 6-month clinical outcomes compared. Baseline characteristics showed more men, more patients with previous coronary bypass surgery, and smaller ejection fractions in the PES group and more obese patients in the SES group. Procedural characteristics were similar except for more left anterior descending artery and proximal lesions and the greater use of glycoprotein IIb/IIIa inhibitors in the SES group and more type C lesions, direct stenting, and stents per patient in the PES group. In-hospital complications were similar. Clinical follow-up at 1 month was also similar between the 2 groups, including subacute stent thrombosis. At 6 months, the 2 groups had similar mortality (7% vs 7%), myocardial infarctions (18% vs 21%), target lesion revascularization, target vessel revascularization, major adverse cardiac events (11% vs 12%), and late thrombosis (0.3% vs 0%). Subanalysis of insulin-treated diabetic patients showed no significant differences in outcomes in the 2 groups. No significant differences were found between SESs and PESs on Cox regression analysis for hazard ratios. In conclusion, SESs and PESs are associated with similar efficacy and safety with regard to repeat revascularization rates, major adverse cardiac events, and stent thrombosis up to 6 months for the treatment of coronary artery disease in patients with diabetes mellitus regardless of insulin therapy.

摘要

本研究旨在比较西罗莫司洗脱支架(SES)和紫杉醇洗脱支架(PES)对糖尿病患者治疗效果的安全性和有效性。近期有关药物洗脱支架的数据显示,糖尿病患者的临床治疗效果有所改善。本研究比较了两种可用的药物洗脱支架SES和PES的治疗效果。从研究者所在机构的前瞻性药物洗脱支架登记处,确定了1320例连续接受SES(n = 873,1293处病变)和PES(n = 447,733处病变)治疗的糖尿病患者,并比较了他们的住院期间以及1个月和6个月时的临床治疗效果。基线特征显示,PES组男性更多、既往有冠状动脉搭桥手术的患者更多、射血分数更小,而SES组肥胖患者更多。除了SES组左前降支和近端病变更多、糖蛋白IIb/IIIa抑制剂使用更多,以及PES组C型病变更多、直接支架置入术更多和每位患者置入支架更多外,手术特征相似。住院并发症相似。两组在1个月时的临床随访情况也相似,包括亚急性支架血栓形成。在6个月时,两组的死亡率(7%对7%)心肌梗死(18%对21%)、靶病变血运重建、靶血管血运重建、主要不良心脏事件(11%对12%)和晚期血栓形成(0.3%对0%)相似。对胰岛素治疗的糖尿病患者的亚组分析显示,两组的治疗效果无显著差异。在Cox回归分析中,SES和PES在危险比方面未发现显著差异。总之,对于糖尿病患者的冠状动脉疾病治疗,无论是否接受胰岛素治疗,在重复血运重建率、主要不良心脏事件和长达6个月的支架血栓形成方面,SES和PES的疗效和安全性相似。

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