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准分子激光血管成形术或球囊血管成形术治疗复杂冠状动脉病变后的临床事件:一项随机试验的亚组分析

Clinical events following excimer laser angioplasty or balloon angioplasty for complex coronary lesions: subanalysis of a randomised trial.

作者信息

Appelman Y E, Piek J J, Redekop W K, de Feyter P J, Koolen J J, David G K, Strikwerda S, Tijssen J G, Serruys P W, van Swijndregt E, van Gemert M J, Lie K I

机构信息

Department of Cardiology, University of Amsterdam, Netherlands.

出版信息

Heart. 1998 Jan;79(1):34-8. doi: 10.1136/hrt.79.1.34.

Abstract

OBJECTIVES

To compare clinical outcome in patients with complex coronary lesions treated with either excimer laser coronary angioplasty (ELCA) or balloon angioplasty.

PATIENTS AND DESIGN

308 patients with stable angina and a coronary lesion of more than 10 mm in length were randomised to ELCA (151 patients, 158 lesions) or balloon angioplasty (157 patients, 167 lesions). The primary clinical end points were death, myocardial infarction, coronary bypass surgery, or repeated coronary angioplasty of the randomised segment during six months of follow up. Subanalysis was performed to identify a subgroup of patients with a beneficial clinical outcome following ELCA or balloon angioplasty.

SETTING

Two university hospitals and one general hospital.

RESULTS

There were no deaths. Myocardial infarction, coronary bypass surgery, and repeated angioplasty occurred in 4.6, 10.6, and 21.2%, respectively, of patients treated with ELCA compared with 5.7, 10.8, and 18.5%, respectively, of those treated with balloon angioplasty. ELCA did not yield a favourable clinical outcome in subgroups of patients with long (more than 20 mm) coronary lesions, calcified lesions, small diseased vessels (< or = 2.5 mm reference diameter), or total coronary occlusions. There was a worse clinical outcome in patients with tandem lesions treated with ELCA compared with balloon angioplasty (9/18 v 3/26 lesions; p = 0.01); while a trend towards an unfavourable clinical outcome was found in patients with vessels with a reference diameter of more than 2.5 mm (23/66 v 13/63 lesions, p = 0.07) and left circumflex coronary lesions (12/41 v 6/42 lesions, p = 0.08).

CONCLUSIONS

The findings indicate a worse clinical outcome in patients with lesions of more than 10 mm treated with ELCA compared with balloon angioplasty who have tandem coronary lesions and in those with vessels with a reference diameter of more than 2.5 mm and left circumflex coronary lesions.

摘要

目的

比较准分子激光冠状动脉成形术(ELCA)与球囊血管成形术治疗复杂冠状动脉病变患者的临床结局。

患者与设计

308例稳定型心绞痛且冠状动脉病变长度超过10毫米的患者被随机分为ELCA组(151例患者,158处病变)和球囊血管成形术组(157例患者,167处病变)。主要临床终点为随访6个月期间的死亡、心肌梗死、冠状动脉搭桥手术或随机分组节段的重复冠状动脉血管成形术。进行亚组分析以确定ELCA或球囊血管成形术后临床结局良好的患者亚组。

地点

两家大学医院和一家综合医院。

结果

无死亡病例。ELCA治疗的患者中心肌梗死、冠状动脉搭桥手术和重复血管成形术的发生率分别为4.6%、10.6%和21.2%,而球囊血管成形术治疗的患者中分别为5.7%、10.8%和18.5%。ELCA在冠状动脉病变长(超过20毫米)、钙化病变、病变血管小(参考直径≤2.5毫米)或冠状动脉完全闭塞的患者亚组中未产生良好的临床结局。与球囊血管成形术相比,ELCA治疗串联病变患者的临床结局更差(9/18对3/26处病变;p = 0.01);而在参考直径超过2.5毫米的血管病变患者(23/66对13/63处病变,p = 0.07)和左旋支冠状动脉病变患者(12/41对6/42处病变,p = 0.08)中发现临床结局有不良趋势。

结论

研究结果表明,与球囊血管成形术相比,ELCA治疗长度超过10毫米病变的患者,在有串联冠状动脉病变以及参考直径超过2.5毫米的血管病变和左旋支冠状动脉病变患者中临床结局更差。

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