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一项关于多层螺旋冠状动脉计算机断层扫描评估急性胸痛的随机对照试验。

A randomized controlled trial of multi-slice coronary computed tomography for evaluation of acute chest pain.

作者信息

Goldstein James A, Gallagher Michael J, O'Neill William W, Ross Michael A, O'Neil Brian J, Raff Gilbert L

机构信息

William Beaumont Hospital, Royal Oak, Michigan 48073, USA.

出版信息

J Am Coll Cardiol. 2007 Feb 27;49(8):863-71. doi: 10.1016/j.jacc.2006.08.064. Epub 2007 Feb 12.

DOI:10.1016/j.jacc.2006.08.064
PMID:17320744
Abstract

OBJECTIVES

This study sought to compare the safety, diagnostic efficacy, and efficiency of multi-slice computed tomography (MSCT) with standard diagnostic evaluation of low-risk acute chest pain patients.

BACKGROUND

Over 1 million patients have emergency center evaluations for acute chest pain annually, at an estimated diagnostic cost of over $10 billion. Multi-slice computed tomography has a high negative predictive value for exclusion of coronary artery stenoses.

METHODS

We randomized patients to MSCT (n = 99) versus SOC (n = 98) protocols. The MSCT patients with minimal disease were discharged; those with stenosis >70% underwent catheterization, whereas cases with intermediate lesions or non-diagnostic scans underwent stress testing. Outcomes included: safety (freedom from major adverse events over 6 months), diagnostic efficacy (clinically correct and definitive diagnosis), as well as time and cost of care.

RESULTS

Both approaches were completely (100%) safe. The MSCT alone immediately excluded or identified coronary disease as the source of chest pain in 75% of patients, including 67 with normal coronary arteries and 8 with severe disease referred for invasive evaluation. The remaining 25% of patients required stress testing, owing to intermediate severity lesions or non-diagnostic scans. During the index visit, MSCT evaluation reduced diagnostic time compared with SOC (3.4 h vs. 15.0 h, p < 0.001) and lowered costs (1,586 dollars vs. 1,872 dollars, p < 0.001). Importantly, MSCT patients required fewer repeat evaluations for recurrent chest pain (MSCT, 2 of 99 (2.0%) patients vs. SOC, 7 of 99 (7%) patients; p = 0.10).

CONCLUSIONS

Multi-slice computed tomographic coronary angiography can definitively establish or exclude coronary disease as the cause of chest pain. However, inability to determine the physiological significance of intermediate severity coronary lesions and cases with inadequate image quality are present limitations. (Study of Coronary Artery Computed Tomography to Diagnose Emergency Chest Pain CR; http://clinicaltrials.gov/ct/show/NCT00273832?order=1; NCT00273832).

摘要

目的

本研究旨在比较多层螺旋计算机断层扫描(MSCT)与低风险急性胸痛患者标准诊断评估的安全性、诊断效能及效率。

背景

每年有超过100万患者因急性胸痛在急诊中心接受评估,估计诊断费用超过100亿美元。多层螺旋计算机断层扫描对排除冠状动脉狭窄具有较高的阴性预测价值。

方法

我们将患者随机分为MSCT组(n = 99)和标准治疗组(SOC,n = 98)。MSCT检查结果轻微的患者出院;狭窄>70%的患者接受导管插入术,而病变程度中等或扫描结果无法诊断的患者接受负荷试验。结果包括:安全性(6个月内无重大不良事件)、诊断效能(临床诊断正确且明确)以及护理时间和费用。

结果

两种方法均完全(100%)安全。仅MSCT就能立即排除或确定75%的患者胸痛源于冠心病,其中67例冠状动脉正常,8例严重病变患者转诊接受侵入性评估。其余25%的患者因病变程度中等或扫描结果无法诊断而需要接受负荷试验。在首次就诊期间,与标准治疗组相比,MSCT评估缩短了诊断时间(3.4小时对15.0小时,p < 0.001)并降低了费用(1586美元对1872美元,p < 0.001)。重要的是,MSCT组因复发性胸痛需要再次评估的患者较少(MSCT组,99例中有2例(2.0%)患者,标准治疗组,99例中有7例(7%)患者;p = 0.10)。

结论

多层螺旋计算机断层扫描冠状动脉造影可明确确定或排除冠心病为胸痛病因。然而,无法确定中等程度冠状动脉病变的生理意义以及图像质量不佳的病例存在局限性。(冠状动脉计算机断层扫描诊断急诊胸痛研究CR;http://clinicaltrials.gov/ct/show/NCT00273832?order=1;NCT00273832)

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