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缺血性静息性心绞痛复杂病变的血管成形术:不稳定型心绞痛溶栓与血管成形术(TAUSA)试验结果

Angioplasty of complex lesions in ischemic rest angina: results of the Thrombolysis and Angioplasty in Unstable Angina (TAUSA) trial.

作者信息

Mehran R, Ambrose J A, Bongu R M, Almeida O D, Israel D H, Torre S, Sharma S K, Ratner D E

机构信息

Department of Medicine, Mount Sinai Hospital, New York, New York, USA.

出版信息

J Am Coll Cardiol. 1995 Oct;26(4):961-6. doi: 10.1016/0735-1097(95)00271-3.

Abstract

OBJECTIVES

This study sought to analyze the role of complex lesion morphology on the acute results of angioplasty.

BACKGROUND

Acute complications of angioplasty are higher in unstable than in stable angina. The unstable culprit lesion is usually complex, indicative of plaque disruption and thrombus formation. Previous nonrandomized studies have shown that the presence of intracoronary thombus increases morbidity after coronary angioplasty. The role of complex morphology in coronary angioplasty outcome was studied in a prespecified subgroup analysis of a large multicenter coronary angioplasty trial.

METHODS

The results of coronary angioplasty from the Thrombolysis and Angioplasty in Unstable Angina (TAUSA) trial were analyzed. This large trial randomized 469 patients in double-blinded manner to receive either intracoronary urokinase or placebo during coronary angioplasty of the culprit lesion in ischemic rest angina with or without recent infarction. The study presented here analyzes in detail the results of coronary angioplasty in complex versus simple lesions in the urokinase and placebo groups. Complex lesions were defined before angioplasty by a core laboratory as having one or more of the following: irregular borders, overhanging edges, ulcerations or intraluminal filling defects proximal or distal to the lesion.

RESULTS

Of the 469 patients, 458 had identifiable culprit lesions, of which 245 were complex and 213 were simple. Complex lesions were associated with a higher abrupt closure rate than simple lesions (10.6% vs. 3.3%, respectively, p < 0.003). Patients with complex lesions also had higher recurrent in-hospital angina (p < 0.02) and emergent bypass surgery (p < 0.02). Further analysis of complex lesions revealed that abrupt closure was particularly high in the urokinase group (15.0% vs 5.9% for the placebo group, p < 0.03), and most abrupt closures were thrombotic. Composite clinical end points were also significantly higher with complex lesions and urokinase. In the placebo group, complex lesions had a higher abrupt closure rate as well as postcoronary angioplasty filling defects, but clinical end points were not significantly different.

CONCLUSIONS

Complex lesions before coronary angioplasty increase acute complication rates after coronary angioplasty. Urokinase as administered in the TAUSA trial had significant adverse effects, especially in complex lesions. However, even in the placebo arm, complex lesions were associated with higher complication rates than simple lesions. Newer antithrombotic measures that particularly target the platelet may eventually decrease complication rates in these lesions.

摘要

目的

本研究旨在分析复杂病变形态对血管成形术急性结果的作用。

背景

不稳定型心绞痛患者血管成形术的急性并发症高于稳定型心绞痛患者。不稳定的罪犯病变通常较为复杂,提示斑块破裂和血栓形成。既往非随机研究表明,冠状动脉内血栓的存在会增加冠状动脉血管成形术后的发病率。在一项大型多中心冠状动脉血管成形术试验的预先指定亚组分析中,研究了复杂形态在冠状动脉血管成形术结果中的作用。

方法

分析了不稳定型心绞痛溶栓与血管成形术(TAUSA)试验中冠状动脉血管成形术的结果。这项大型试验以双盲方式将469例患者随机分为两组,在对有或无近期梗死的静息性缺血性心绞痛罪犯病变进行冠状动脉血管成形术期间,分别给予冠状动脉内尿激酶或安慰剂。本文呈现的研究详细分析了尿激酶组和安慰剂组中复杂病变与简单病变的冠状动脉血管成形术结果。在血管成形术前,核心实验室将复杂病变定义为具有以下一种或多种特征:边界不规则、边缘悬垂、溃疡或病变近端或远端的管腔内充盈缺损。

结果

在469例患者中,458例有可识别的罪犯病变,其中245例为复杂病变,213例为简单病变。复杂病变的急性闭塞率高于简单病变(分别为10.6%和3.3%,p<0.003)。复杂病变患者的院内复发性心绞痛(p<0.02)和急诊搭桥手术发生率也更高(p<0.02)。对复杂病变的进一步分析显示,尿激酶组的急性闭塞率特别高(15.0%,而安慰剂组为5.9%,p<0.03),且大多数急性闭塞是血栓性的。复杂病变和尿激酶治疗的复合临床终点也显著更高。在安慰剂组中,复杂病变的急性闭塞率以及冠状动脉血管成形术后的充盈缺损更高,但临床终点无显著差异。

结论

冠状动脉血管成形术前的复杂病变会增加冠状动脉血管成形术后的急性并发症发生率。TAUSA试验中使用的尿激酶有显著的不良反应,尤其是在复杂病变中。然而,即使在安慰剂组,复杂病变的并发症发生率也高于简单病变。特别针对血小板的新型抗血栓措施最终可能会降低这些病变的并发症发生率。

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