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纳入年龄、性别和基因表达的精准医学血液检测评估有稳定阻塞性冠状动脉疾病症状女性患者的临床效用:来自 PRESET 登记研究的分析。

The Clinical Utility of a Precision Medicine Blood Test Incorporating Age, Sex, and Gene Expression for Evaluating Women with Stable Symptoms Suggestive of Obstructive Coronary Artery Disease: Analysis from the PRESET Registry.

机构信息

1 Section of Cardiology, Yale University, New Haven, Connecticut.

2 Division of Cardiology, UCLA, Torrance, California.

出版信息

J Womens Health (Larchmt). 2019 May;28(5):728-735. doi: 10.1089/jwh.2018.7203. Epub 2019 Jan 17.

DOI:10.1089/jwh.2018.7203
PMID:30653377
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6537117/
Abstract

Evaluating women with symptoms suggestive of coronary artery disease (CAD) remains challenging. A blood-based precision medicine test yielding an age/sex/gene expression score (ASGES) has shown clinical validity in the diagnosis of obstructive CAD. We assessed the effect of the ASGES on the management of women with suspected obstructive CAD in a community-based registry. The prospective PRESET (A Registry to Evaluate Patterns of Care Associated with the Use of Corus CAD in Real World Clinical Care Settings) Registry (NCT01677156) enrolled 566 patients presenting with symptoms suggestive of stable obstructive CAD from 21 United States primary care practices from 2012 to 2014. Demographics, clinical characteristics, and referrals to cardiology or further functional and/or anatomical cardiac studies after ASGES testing were collected for this subgroup analysis of women from the PRESET Registry. Patients were followed for 1-year post-ASGES testing. This study cohort included 288 women with a median age 57 years. The median body mass index was 29.2, with hyperlipidemia and hypertension present in 48% and 43% of patients, respectively. Median ASGES was 8.5 (range 1-40), with 218 (76%) patients having low (≤15) ASGES. Clinicians referred 9% (20/218) low ASGES versus 44% (31/70) elevated ASGES women for further cardiac evaluation (odds ratio 0.14,  < 0.0001, adjusted for patient demographics and clinical covariates). Across the score range, higher ASGES were associated with a higher likelihood of posttest cardiac referral. At 1-year follow-up, low ASGES women experienced fewer major adverse cardiac events than elevated ASGES women (1.3% vs. 4.2% respectively,  = 0.16). Incorporation of ASGES into the diagnostic workup demonstrated clinical utility by helping clinicians identify women less likely to benefit from further cardiac evaluation.

摘要

评估有冠状动脉疾病(CAD)症状提示的女性仍然具有挑战性。一种基于血液的精准医学检测方法可提供年龄/性别/基因表达评分(ASGES),已显示出在诊断阻塞性 CAD 方面的临床有效性。我们在一个基于社区的登记处评估了 ASGES 对疑似阻塞性 CAD 女性的管理效果。这项前瞻性的 PRESET(评估 Corus CAD 在真实世界临床护理环境中的使用相关护理模式的登记)登记研究(NCT01677156)纳入了 2012 年至 2014 年间来自美国 21 个初级保健机构的 566 名有稳定阻塞性 CAD 症状提示的患者。对 PRESET 登记处的女性亚组分析中,收集了人口统计学、临床特征以及 ASGES 检测后的心血管科转诊或进一步功能和/或解剖学心脏研究情况。患者在 ASGES 检测后 1 年进行随访。该研究队列包括 288 名中位年龄为 57 岁的女性。中位体质指数为 29.2,分别有 48%和 43%的患者存在血脂异常和高血压。中位 ASGES 为 8.5(范围 1-40),218 名(76%)患者的 ASGES 低(≤15)。临床医生将 9%(20/218)的低 ASGES 患者和 44%(31/70)的高 ASGES 患者转诊进行进一步心脏评估(比值比 0.14, < 0.0001,调整了患者人口统计学和临床协变量)。在整个评分范围内,较高的 ASGES 与更高的术后心脏转诊可能性相关。在 1 年随访时,低 ASGES 女性经历的主要不良心脏事件少于高 ASGES 女性(分别为 1.3%和 4.2%, = 0.16)。将 ASGES 纳入诊断性检查显示出临床实用性,可帮助临床医生识别不太可能从进一步心脏评估中获益的女性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a447/6537117/1f0ae9f14fdc/fig-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a447/6537117/1f0ae9f14fdc/fig-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a447/6537117/1f0ae9f14fdc/fig-1.jpg

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The Expressed Genome in Cardiovascular Diseases and Stroke: Refinement, Diagnosis, and Prediction: A Scientific Statement From the American Heart Association.心血管疾病和中风中的表达基因组:细化、诊断与预测:美国心脏协会的科学声明
Circ Cardiovasc Genet. 2017 Aug;10(4). doi: 10.1161/HCG.0000000000000037.
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过去十年中女性心血管健康的进展:实践指南建议。
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