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在土耳其南部一项前瞻性、非随机登记研究中,在未经选择的冠心病患者中比较西罗莫司洗脱支架与紫杉醇洗脱支架的疗效:24 个月随访结果。

Efficacy of sirolimus-eluting stents compared with paclitaxel-eluting stents in an unselected population with coronary artery disease: 24-month outcomes of patients in a prospective non-randomized registry in Southern Turkey.

机构信息

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

出版信息

Int J Med Sci. 2010 Jun 10;7(4):191-6. doi: 10.7150/ijms.7.191.

Abstract

BACKGROUND

The efficacy of drug-eluting stents has been shown in randomized trials, but some controversy exists regarding which stent sirolimus-eluting or paclitaxel-eluting is more effective in unselected Turkish patients. Therefore, we investigated the clinical outcomes of patients who were treated with one type of these 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 sirolimus- or the paclitaxel-eluting stent. The follow-up period after stent implantation was approximately 24 months. The primary end point was a major cardiac event, and the secondary end point was stent thrombosis. Informed consent was obtained from all subjects, and the study protocol was approved by the local ethical committee.

RESULTS

In total, 204 patients were treated with either the sirolimus-eluting stent (n = 103) 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, patients who received the paclitaxel-eluting stent showed significantly higher rates of non-Q-wave myocardial infarction (1.9% vs 5.9%; P: .002), target vessel revascularization (1.9% vs 4.9%; P: .002), coronary artery bypass graft surgery (1.9% vs 6.9%; P: .001), and late stent thrombosis (1.9% vs 3.9%, P: .002).

CONCLUSIONS

Patients who received the sirolimus-eluting stent showed better clinical outcomes compared with those who had the paclitaxel-eluting-stent.

摘要

背景

药物洗脱支架的疗效已在随机试验中得到证实,但在未选择的土耳其患者中,哪种支架——西罗莫司洗脱支架或紫杉醇洗脱支架更有效仍存在一些争议。因此,我们在真实世界中研究了接受其中一种药物洗脱支架治疗的患者的临床结局。

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就诊于我们机构并接受西罗莫司或紫杉醇洗脱支架治疗的连续系列患者的数据。支架植入后的随访期约为 24 个月。主要终点是重大心脏事件,次要终点是支架血栓形成。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

共有 204 例患者分别接受西罗莫司洗脱支架(n = 103)或紫杉醇洗脱支架(n = 101)治疗。研究的两个臂中的病变均采用常规技术进行治疗。在 24 个月的随访中,接受紫杉醇洗脱支架治疗的患者发生非 Q 波心肌梗死的比率明显较高(1.9%比 5.9%;P:.002)、靶血管血运重建(1.9%比 4.9%;P:.002)、冠状动脉旁路移植术(1.9%比 6.9%;P:.001)和晚期支架血栓形成(1.9%比 3.9%,P:.002)。

结论

与接受紫杉醇洗脱支架治疗的患者相比,接受西罗莫司洗脱支架治疗的患者临床结局更好。

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