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比较心脏磁共振引导与血管造影引导治疗稳定型冠状动脉疾病患者:前瞻性随机对照试验结果。

Comparing Cardiac Magnetic Resonance-Guided Versus Angiography-Guided Treatment of Patients With Stable Coronary Artery Disease: Results From a Prospective Randomized Controlled Trial.

机构信息

Department of Internal Medicine II, University of Ulm, Ulm, Germany.

Department of Internal Medicine II, University of Ulm, Ulm, Germany.

出版信息

JACC Cardiovasc Imaging. 2018 Jul;11(7):987-996. doi: 10.1016/j.jcmg.2018.05.007.

Abstract

OBJECTIVES

The purpose of this study was the prospective and randomized evaluation of cardiovascular endpoints and quality of life in patients with stable coronary artery disease comparing a cardiac magnetic resonance (CMR)-based management strategy with a coronary angiography-based approach.

BACKGROUND

Evidence from trials prospectively evaluating the role of CMR in clinical pathways and decision processes is limited.

METHODS

Patients with symptomatic CAD were randomized to diagnostic coronary angiography (group 1) or adenosine stress CMR (group 2). The primary endpoint was the composite of cardiac death and nonfatal myocardial infarction. Quality of life was assessed using the Seattle Angina Questionnaire at baseline and during follow-up.

RESULTS

Two hundred patients were enrolled. In group 1, 45 revascularizations (45.9%) were performed. In group 2, 27 patients (28.1%) were referred to revascularization because of ischemia on CMR. At 12-month follow-up, 7 primary events occurred: 3 in group 1 (event rate 3.1%) and 4 in group 2 (event rate 4.2%), with no statistically significant difference (p = 0.72). Within the next 2 years, 6 additional events could be observed, giving 4 events in group 1 and 9 events in group 2 (event rate 4.1% vs. 9.4%; p = 0.25). Group 2 showed significant quality-of-life improvement after 1 year in comparison to group 1.

CONCLUSIONS

A CMR-based management strategy for patients with stable coronary artery disease was safe, reduced revascularization procedures, and resulted in better quality of life at 12-month follow-up, though noninferiority could not be proved. Optimal timing for reassessment remains to be investigated. (Magnetic Resonance Adenosine Perfusion Imaging as Gatekeeper of Invasive Coronary Intervention [MAGnet]; NCT02580851).

摘要

目的

本研究旨在前瞻性、随机评估稳定型冠状动脉疾病患者的心血管终点和生活质量,比较基于心脏磁共振(CMR)的管理策略与基于冠状动脉造影的方法。

背景

前瞻性评估 CMR 在临床路径和决策过程中作用的试验证据有限。

方法

将有症状的 CAD 患者随机分为诊断性冠状动脉造影组(组 1)或腺苷应激 CMR 组(组 2)。主要终点是心脏死亡和非致死性心肌梗死的复合终点。在基线和随访期间使用西雅图心绞痛问卷评估生活质量。

结果

共纳入 200 例患者。在组 1 中,进行了 45 例血运重建(45.9%)。在组 2 中,27 例(28.1%)因 CMR 上的缺血而被推荐行血运重建。在 12 个月随访时,发生了 7 例主要事件:组 1 中有 3 例(事件发生率为 3.1%),组 2 中有 4 例(事件发生率为 4.2%),无统计学显著差异(p=0.72)。在接下来的 2 年内,还观察到 6 例额外的事件,组 1 中有 4 例,组 2 中有 9 例(事件发生率分别为 4.1%和 9.4%;p=0.25)。与组 1 相比,组 2 在 1 年后生活质量显著改善。

结论

对于稳定型冠状动脉疾病患者,基于 CMR 的管理策略是安全的,减少了血运重建手术,并且在 12 个月随访时生活质量得到改善,但未能证明非劣效性。最佳再评估时间仍有待研究。(磁共振腺苷灌注成像作为有创性冠状动脉介入治疗的守门员[MAGnet];NCT02580851)。

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