评估钴铬合金支架植入新发冠状动脉病变患者安全性和有效性的前瞻性注册研究。

Prospective registry evaluating safety and efficacy of cobalt-chromium stent implantation in patients with de novo coronary lesions.

作者信息

Buszman Paweł, Trznadel Stanisław, Zurakowski Aleksander, Milewski Krzysztof, Kinasz Leszek, Król Marek, Kondys Marek

机构信息

Department of Cardiology, Silesian Medical Center, Katowice, Poland.

出版信息

Kardiol Pol. 2007 Sep;65(9):1041-6; discussion 1047-8.

PMID:17975751

Abstract

BACKGROUND

Cobalt-chromium (Co-Cr) stents are a new type of endovascular prostheses characterised by better mechanical properties than traditional stainless steel stents.

AIM

To assess the safety and efficacy of percutaneous coronary interventions (PCI) using the new Co-Cr Kos stent (Balton, Poland).

METHODS

A total of 59 patients with coronary artery diseases (76% men, aged 60+/-9 years, diabetes - 16.9%, smoking - 62.7%, 11.8% - acute myocardial infarction) underwent PCI for de novo lesions in native coronary vessels. The patients were followed for 6 months for the occurrence of cardiac events. Quantitative coronary angiography was performed at baseline and after 6 months.

RESULTS

In total, we implanted 62 stents in 59 coronary arteries. The mean diameter of the stents was 3.18+/-0.18 mm, and length - 14.62+/-2.12 mm. During a one-month follow-up period no cardiac events were noted. During a 6-month follow-up no death or new myocardial infarction were recorded. Control angiography was done in 55 (92%) subjects. Repeated target vessel revascularisation due to recurrent angina or in-stent restenosis was required in 10 (17%) patients; however, off-line core evaluation found significant re-narrowing in implanted stents (>50% diameter stenosis) only in 6 cases (10.9%). The mean late vessel lumen loss was 0.55+/-0.6 mm and stenosis 25.2+/-17.9%.

CONCLUSIONS

Implantation of the new Co-Cr Kos stent during PCI is safe and effective.

摘要

背景

钴铬（Co-Cr）支架是一种新型血管内假体，其机械性能优于传统不锈钢支架。

目的

评估使用新型Co-Cr Kos支架（波兰Balton公司）进行经皮冠状动脉介入治疗（PCI）的安全性和有效性。

方法

共有59例冠心病患者（男性占76%，年龄60±9岁，糖尿病患者占16.9%，吸烟者占62.7%，急性心肌梗死患者占11.8%）因原生冠状动脉新发病变接受PCI治疗。对患者进行6个月的随访，观察心脏事件的发生情况。在基线和6个月后进行定量冠状动脉造影。

结果

我们共在59条冠状动脉中植入了62个支架。支架的平均直径为3.18±0.18毫米，长度为14.62±2.12毫米。在1个月的随访期内未观察到心脏事件。在6个月的随访中，未记录到死亡或新发心肌梗死。55例（92%）患者进行了对照血管造影。10例（17%）患者因复发性心绞痛或支架内再狭窄需要再次进行靶血管血运重建；然而，离线核心评估发现仅6例（10.9%）植入支架出现明显再狭窄（直径狭窄>50%）。平均晚期血管腔丢失为0.55±0.6毫米，狭窄率为25.2±17.9%。