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心脏磁共振成像与基于侵袭性的策略在胸痛和检测到轻度升高的血清肌钙蛋白的患者中的比较:一项随机临床试验。

Cardiac Magnetic Resonance Imaging Versus Invasive-Based Strategies in Patients With Chest Pain and Detectable to Mildly Elevated Serum Troponin: A Randomized Clinical Trial.

机构信息

Department of Emergency Medicine (C.D.M., S.AM., A.S., L.K., B.H., J.S.), Wake Forest School of Medicine, Winston-Salem, NC.

Department of Epidemiology and Prevention (S.A.M.), Wake Forest School of Medicine, Winston-Salem, NC.

出版信息

Circ Cardiovasc Imaging. 2023 Jun;16(6):e015063. doi: 10.1161/CIRCIMAGING.122.015063. Epub 2023 Jun 20.

Abstract

BACKGROUND

The optimal diagnostic strategy for patients with chest pain and detectable to mildly elevated serum troponin is not known. The objective was to compare clinical outcomes among an early decision for a noninvasive versus an invasive-based care pathway.

METHODS

The CMR-IMPACT trial (Cardiac Magnetic Resonance Imaging Strategy for the Management of Patients with Acute Chest Pain and Detectable to Elevated Troponin) was conducted at 4 United States tertiary care hospitals from September 2013 to July 2018. A convenience sample of 312 participants with acute chest pain symptoms and a contemporary troponin between detectable and 1.0 ng/mL were randomized early in their care to 1 of 2 care pathways: invasive-based (n=156) or cardiac magnetic resonance (CMR)-based (n=156) with modification allowed as the patient condition evolved. The primary outcome was a composite including death, myocardial infarction, and cardiac-related hospital readmission or emergency visits.

RESULTS

Participants (N=312, mean age, 60.6 years, SD 11.3; 125 women [59.9%]), were followed over a median of 2.6 years (95% CI, 2.4-2.9). Early assigned testing was initiated in 102 out of 156 (65.3%) CMR-based and 110 out of 156 (70.5%) invasive-based participants. The primary outcome (CMR-based versus invasive-based) occurred in 59% versus 52% (hazard ratio, 1.17 [95% CI, 0.86-1.57]), acute coronary syndrome after discharge 23% versus 22% (hazard ratio, 1.07 [95% CI, 0.67-1.71]), and invasive angiography at any time 52% versus 74% (hazard ratio, 0.66 [95% CI, 0.49-0.87]). Among patients completing CMR imaging, 55 out of 95 (58%) were safely identified for discharge based on a negative CMR and did not have angiography or revascularization within 90 days. Therapeutic yield of angiography was higher in the CMR-based arm (52 interventions in 81 angiographies [64.2%] versus 46 interventions in 115 angiographies [40.0%] in the invasive-based arm [=0.001]).

CONCLUSIONS

Initial management with CMR or invasive-based care pathways resulted in no detectable difference in clinical and safety event rates. The CMR-based pathway facilitated safe discharge, enriched the therapeutic yield of angiography, and reduced invasive angiography utilization over long-term follow-up.

REGISTRATION

URL: https://www.

CLINICALTRIALS

gov; Unique identifier: NCT01931852.

摘要

背景

对于胸痛且血清肌钙蛋白检测到轻度升高的患者,最佳的诊断策略尚不清楚。本研究旨在比较早期选择非侵入性与侵入性治疗路径的临床结局。

方法

CMR-IMPACT 试验(心脏磁共振成像策略管理急性胸痛和可检测到升高的肌钙蛋白患者)于 2013 年 9 月至 2018 年 7 月在美国 4 家三级护理医院进行。对 312 名有急性胸痛症状且肌钙蛋白处于可检测到和 1.0ng/ml 之间的患者进行了一项便利样本研究,他们在治疗的早期被随机分为 2 种治疗路径之一:侵入性(n=156)或心脏磁共振(CMR)(n=156),根据患者病情的变化允许进行修改。主要结局包括死亡、心肌梗死以及与心脏相关的住院再入院或急诊就诊的复合终点。

结果

312 名参与者(平均年龄 60.6 岁,标准差 11.3;125 名女性[59.9%])的中位随访时间为 2.6 年(95%CI,2.4-2.9)。102 名(65.3%)CMR 组和 110 名(70.5%)侵入性组在早期进行了指定检查。主要结局(CMR 组与侵入性组)发生率分别为 59%和 52%(风险比,1.17[95%CI,0.86-1.57]),出院后急性冠状动脉综合征发生率分别为 23%和 22%(风险比,1.07[95%CI,0.67-1.71]),任何时候行侵入性血管造影术的发生率分别为 52%和 74%(风险比,0.66[95%CI,0.49-0.87])。在完成 CMR 成像的患者中,95 名患者中有 55 名(58%)基于 CMR 检查结果为阴性,被安全识别并出院,且在 90 天内没有进行血管造影术或血运重建术。CMR 组的血管造影术治疗效果更高(81 次血管造影中有 52 次干预[64.2%],而 115 次血管造影中有 46 次干预[40.0%],在侵入性组,P=0.001)。

结论

初始管理采用 CMR 或基于侵入性的治疗路径,在临床和安全性结局方面无显著差异。CMR 组能够安全出院,增加了血管造影术的治疗效果,并在长期随访中减少了侵入性血管造影术的应用。

登记

URL:https://www.clinicaltrials.gov;唯一标识符:NCT01931852。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b7b8/10287041/82ee3a20dbd9/nihms-1897189-f0001.jpg

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