David Geffen School of Medicine at University of California at Los Angeles.
University of California at Los Angeles, Torrance.
Am J Med. 2017 Apr;130(4):482.e11-482.e17. doi: 10.1016/j.amjmed.2016.11.021. Epub 2016 Dec 16.
Identifying patients with obstructive coronary artery disease can be challenging for primary care physicians. Advances in precision medicine may help augment clinical tools and redefine the paradigm for evaluating coronary artery disease in the outpatient setting. A blood-based age/sex/gene expression score (ASGES) incorporating key features of precision medicine has shown clinical validity with a 96% negative predictive value and 89% sensitivity in estimating a symptomatic patient's current likelihood of obstructive coronary artery disease. To better characterize the clinical utility of the ASGES and measure its impact on clinician decision-making, a community-based registry was established.
The prospective PRESET Registry (NCT01677156) enrolled stable, nonacute adult patients presenting with typical or atypical symptoms suggestive of obstructive coronary artery disease from 21 US primary care practices from August 2012 to August 2014. Demographics, clinical characteristics, and ASGES results (predefined as low [ASGES ≤15] or elevated [ASGES >15]) were collected, as were referrals to Cardiology or further functional/anatomic cardiac testing after ASGES testing. Patients were followed for 1 year post ASGES testing.
Among the 566-patient cohort (median age 56 years), clinicians referred 26/252 (10%) of patients with low scores vs 137/314 (44%) of patients with elevated scores to Cardiology or advanced cardiac testing for further evaluation (unadjusted odds ratio 0.15, P <.0001; adjusted odds ratio after accounting for clinical covariates = 0.18, P <.0001). Data on 84 patients referred for advanced cardiac testing showed abnormal findings in 0 of 13 (0%) low ASGES and 10 of 71 (14%) elevated ASGES patients. Major adverse cardiovascular events and revascularization were noted in 3/252 (1.2%) patients with low ASGES and 14/314 (4.5%) patients with elevated ASGES score (P <.03).
In this community-based cardiovascular registry, the ASGES demonstrated clinical utility in the evaluation of patients with suspected obstructive coronary artery disease. Low-score patients were less likely to undergo cardiac referral, were unlikely to have positive findings on further cardiac work-up, and had a low rate of adverse cardiovascular events in 1-year follow-up. Our work provides evidence supporting the value of using precision medicine in the delivery of cardiovascular care.
识别患有阻塞性冠状动脉疾病的患者对初级保健医生来说具有挑战性。精准医学的进步可能有助于增强临床工具，并重新定义在门诊环境中评估冠状动脉疾病的模式。一种基于血液的年龄/性别/基因表达评分（ASGES），纳入了精准医学的关键特征，其阴性预测值为 96%，敏感性为 89%，在评估有症状患者当前发生阻塞性冠状动脉疾病的可能性方面具有临床有效性。为了更好地描述 ASGES 的临床实用性，并衡量其对临床医生决策的影响，建立了一个基于社区的注册中心。
前瞻性 PRESET 注册研究（NCT01677156）纳入了 2012 年 8 月至 2014 年 8 月来自美国 21 个初级保健机构的 566 例稳定、非急性成年患者，这些患者表现出典型或非典型的阻塞性冠状动脉疾病症状。收集了人口统计学、临床特征和 ASGES 结果（定义为低 [ASGES ≤15] 或高 [ASGES >15]），以及 ASGES 检测后转诊至心脏病学或进一步功能/解剖心脏检查的情况。对患者进行了 1 年的 ASGES 检测后随访。
在 566 例患者队列中（中位年龄 56 岁），低评分患者中，临床医生将 26/252（10%）例患者与高评分患者中 137/314（44%）例患者转诊至心脏病学或高级心脏检查以进行进一步评估（未调整比值比 0.15，P<.0001；校正临床协变量后比值比为 0.18，P<.0001）。对 84 例转诊进行高级心脏检查的患者的数据显示，低 ASGES 评分患者中有 0 例（0%）出现异常，高 ASGES 评分患者中有 10 例（14%）出现异常。低 ASGES 评分患者中有 3 例（1.2%）和高 ASGES 评分患者中有 14 例（4.5%）发生主要不良心血管事件和血运重建（P<.03）。
在这个基于社区的心血管注册中心，ASGES 在评估疑似阻塞性冠状动脉疾病患者方面具有临床实用性。低评分患者接受心脏转诊的可能性较小，进一步心脏检查的阳性结果可能性较小，在 1 年随访中不良心血管事件发生率较低。我们的工作为使用精准医学提供心血管护理提供了证据支持。
