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准分子激光血管成形术与球囊血管成形术治疗阻塞性冠状动脉疾病的随机试验

Randomised trial of excimer laser angioplasty versus balloon angioplasty for treatment of obstructive coronary artery disease.

作者信息

Appelman Y E, Piek J J, Strikwerda S, Tijssen J G, de Feyter P J, David G K, Serruys P W, Margolis J R, Koelemay M J, Montauban van Swijndregt E W, Koolen J J

机构信息

University of Amsterdam Department of Cardiology, Netherlands.

出版信息

Lancet. 1996 Jan 13;347(8994):79-84. doi: 10.1016/s0140-6736(96)90209-3.

DOI:10.1016/s0140-6736(96)90209-3
PMID:8538345
Abstract

BACKGROUND

Excimer laser coronary angioplasty is reported to give excellent procedural results for treatment of complex coronary lesions, but this method has not been compared with balloon angioplasty in a randomised trial.

METHODS

Patients (n = 308) with stable angina and coronary lesions longer than 10 mm on visual assessment were included. 151 patients (158 lesions) were assigned randomly to laser angioplasty and 157 (167 lesions) to balloon angioplasty. The primary clinical endpoints were death, myocardial infarction, coronary bypass surgery, or repeat coronary angioplasty of the randomised segment during 6 months of follow-up. The primary angiographic endpoint was the minimal lumen diameter at follow-up in relation to the baseline value (net gain), as determined by quantitative coronary angiography.

FINDINGS

Laser angioplasty was followed by balloon angioplasty in 98% of procedures. The angiographic success rate was 80% in patients treated with laser angioplasty compared with 79% in patients treated with balloon angioplasty. There were no deaths. Myocardial infarction, coronary bypass surgery, and repeat angioplasty occurred in 4.6%, 10.6%, and 21.2%, respectively, of the patients in the laser angioplasty group compared with 5.7%, 10.8%, and 18.5% of the balloon angioplasty group. Net mean (SD) gain in minimal lumen diameter was 0.40 (0.69) mm in patients treated with laser angioplasty and 0.48 (0.66) mm in those treated with balloon angioplasty (p = 0.34). The restenosis rate (> 50% diameter stenosis) was 51.6% in the laser angioplasty group versus 41.3% in the balloon angioplasty group (p = 0.13).

INTERPRETATION

Excimer laser angioplasty followed by balloon angioplasty provides no benefit additional to balloon angioplasty alone with respect to the initial and long-term clinical and angiographic outcome in the treatment of obstructive coronary artery disease.

摘要

背景

据报道,准分子激光冠状动脉成形术在治疗复杂冠状动脉病变方面能取得优异的手术效果,但该方法尚未在随机试验中与球囊血管成形术进行比较。

方法

纳入视觉评估显示患有稳定型心绞痛且冠状动脉病变长度超过10毫米的患者(n = 308)。151例患者(158处病变)被随机分配至激光血管成形术组,157例患者(167处病变)被分配至球囊血管成形术组。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再次冠状动脉成形术。主要血管造影终点为随访时的最小管腔直径相对于基线值的变化(净增益),通过定量冠状动脉造影确定。

研究结果

98%的手术在激光血管成形术后进行了球囊血管成形术。接受激光血管成形术治疗的患者血管造影成功率为80%,而接受球囊血管成形术治疗的患者为79%。无死亡病例。激光血管成形术组患者中心肌梗死、冠状动脉搭桥手术和再次血管成形术的发生率分别为4.6%、10.6%和21.2%,而球囊血管成形术组分别为5.7%、10.8%和18.5%。接受激光血管成形术治疗的患者最小管腔直径的平均(标准差)净增益为0.40(0.69)毫米,接受球囊血管成形术治疗的患者为0.48(0.66)毫米(p = 0.34)。激光血管成形术组的再狭窄率(直径狭窄>50%)为51.6%,球囊血管成形术组为41.3%(p = 0.13)。

解读

对于阻塞性冠状动脉疾病的治疗,在初始及长期临床和血管造影结局方面,准分子激光血管成形术联合球囊血管成形术并不比单纯球囊血管成形术更具优势。

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