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在土耳其南部一个真实世界的未选择人群中,接受佐他莫司与紫杉醇洗脱支架治疗的冠状动脉疾病患者的两年结果:一项前瞻性非随机登记研究。

Two-year outcome of Turkish patients treated with Zotarolimus versus Paclitaxel eluting stents in an unselected population with coronary artery disease in the real world: a prospective non-randomized registry in southern Turkey.

机构信息

Başkent University School of Medicine, Department of Cardiology, Antalya.

出版信息

Int J Med Sci. 2011 Jan 8;8(1):68-73. doi: 10.7150/ijms.8.68.

Abstract

BACKGROUND

Our purpose was to investigate the clinical outcomes of Zotarolimus- and Paclitaxel-eluting stents in Turkish patients with coronary artery disease (CAD). In general, the outcome of drug-eluting stent (DES) placement has a proven efficacy in randomized trials. However, the difference in efficacy between the Zotarolimus and Paclitaxel-eluting stents in unselected Turkish patients is controversial. Therefore, we investigated the clinical outcomes of these two drug-eluting stents in the real-world.

METHODS

We created a registry and prospectively analyzed data on a consecutive series of all patients who presented to our institution with symptomatic coronary artery disease between February 2005 and March 2007 and who were treated with the zotarolimus- or the paclitaxel-eluting stent. The follow-up period was approximately two years. The primary end-point was major cardiac events, and the secondary end-point was definite stent thrombosis. Informed consent was obtained from all subjects, and the study protocol was approved by the local ethical committee.

RESULTS

In total, 217 patients were treated with either the zotarolimus-eluting stent (n = 116) or the paclitaxel-eluting stent (n = 101). The lesions in the 2 arms of the study were treated similarly by conventional technique. At 24-month follow-up the paclitaxel-eluting stent group showed significantly higher non-Q wave myocardial infarction (2.6% vs 5.9%, p: 0.02), Q wave myocardial infarction (1.7% vs 5.9%, p: 0.049), coronary artery binding graft surgery (2.6% vs 6.9%, p: 0.002), and late stent thrombosis (1.7% vs 3.9%, p: 0.046).

CONCLUSIONS

Zotarolimus-eluting stents demonstrated better clinical outcomes than Paclitaxel-eluting stents in a daily routine practice of coronary intervention in an unselected Turkish population.

摘要

背景

我们的目的是调查在土耳其患有冠状动脉疾病(CAD)的患者中,使用佐他莫司和紫杉醇洗脱支架的临床结果。一般来说,药物洗脱支架(DES)置入的结果在随机试验中已被证明是有效的。然而,在未选择的土耳其患者中,佐他莫司和紫杉醇洗脱支架的疗效存在争议。因此,我们在真实世界中研究了这两种药物洗脱支架的临床结果。

方法

我们创建了一个注册处,并前瞻性地分析了 2005 年 2 月至 2007 年 3 月期间因有症状的冠状动脉疾病而到我院就诊并接受佐他莫司或紫杉醇洗脱支架治疗的所有连续患者的数据。随访期约为两年。主要终点是主要心脏事件,次要终点是明确的支架血栓形成。所有患者均获得知情同意,研究方案获得当地伦理委员会批准。

结果

总共 217 例患者接受了佐他莫司洗脱支架(n = 116)或紫杉醇洗脱支架(n = 101)治疗。研究的两支中病变均采用常规技术进行治疗。在 24 个月的随访中,紫杉醇洗脱支架组的非 Q 波心肌梗死(2.6% vs 5.9%,p:0.02)、Q 波心肌梗死(1.7% vs 5.9%,p:0.049)、冠状动脉旁路移植术(2.6% vs 6.9%,p:0.002)和晚期支架血栓形成(1.7% vs 3.9%,p:0.046)的发生率明显更高。

结论

在未选择的土耳其人群的冠状动脉介入日常实践中,佐他莫司洗脱支架的临床结果优于紫杉醇洗脱支架。

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