D-dimer Thresholds to Exclude Pulmonary Embolism among COVID-19 Patients in the Emergency Department: Derivation with Independent Validation,Clinical and Applied Thrombosis/Hemostasis

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D-dimer Thresholds to Exclude Pulmonary Embolism among COVID-19 Patients in the Emergency Department: Derivation with Independent Validation
Clinical and Applied Thrombosis/Hemostasis ( IF 2.9 ) Pub Date : 2022-08-09 , DOI: 10.1177/10760296221117997
Joseph R Bledsoe _{1,

2} , Daniel Knox ₃ , Ithan D Peltan ₃ , Scott C Woller ₄ , James F Lloyd ₅ , Gregory L Snow ₆ , Benjamin D Horne _{7,

8} , Jean M Connors ₉ , Jeffrey A Kline ₁₀

Affiliation

Department of Emergency Medicine, Intermountain Healthcare, Salt Lake City, UT, USA.
Department of Emergency Medicine, 158423Stanford Medicine, Stanford, CA, USA.
Department of Medicine, Division of Pulmonary/Critical Care, Intermountain Medical Center and University of Utah, Salt Lake City, UT, USA.
Department of Internal Medicine, Intermountain Medical Center Department of Medicine and University of Utah, Salt Lake City, UT, USA.
Medical Informatics and Analytics, Intermountain Healthcare, Salt Lake City, UT, USA.
Intermountain Healthcare, Office of Research, Statistical Data Center, Salt Lake City, UT, USA.
Intermountain Medical Center Heart Institute, Salt Lake City, UT, USA.
Division of Cardiovascular Medicine, Department of Medicine, Stanford University, Stanford, CA, USA.
Department of Hematology, Brigham and Womens Hospital, Boston, MA, USA.
Department of Emergency Medicine, 12267Wayne State University School of Medicine, Detroit, MI, USA.

Objective

To derive and validate a D-dimer cutoff for ruling out pulmonary embolism (PE) in COVID-19 patients presenting to the emergency department (ED).

Methods

A retrospective cohort study was performed in an integrated healthcare system including 22 adult ED's between March 1, 2020, and January 31, 2021. Results were validated among patients enrolled in the RECOVER Registry, representing data from 154 ED's from 26 US states. Consecutive ED patients with laboratory confirmed COVID-19, a D-dimer performed within 48 h of ED arrival, and with objectively confirmed PE were compared to those without PE. After identifying a D-dimer threshold at which the 95% confidence lower bound of the negative predictive value for PE was higher than 98% in the derivation cohort, it was validated using RECOVER registry data.

Results

Among 3978 patients with a D-dimer result, 3583 with confirmed COVID-19 infection were included in the derivation cohort. Overall, PE incidence was 4.1% and a D-dimer cutoff of <2 μ/mL (2000 ng/mL) was associated with a NPV of 98.5% (95% CI = 98.0%−98.9%). In the validation cohort of 13,091 patients with a D-dimer, 7748 had confirmed COVID-19 infection, and the PE incidence was 1.14%. A D-dimer cutoff of <2 μ/mL was associated with a NPV of 99.5% (95% CI = 99.3%−99.7%).

Conclusion

A D-dimer cutoff of <2 μ/ml was associated with a high negative predictive value for PE among patients with COVID-19. However, the resultant sensitivity for PE result at that threshold without pre-test probability assessment would be considered clinically unsafe.

中文翻译：

急诊科 COVID-19 患者排除肺栓塞的 D-二聚体阈值：独立验证推导

客观的

推导和验证 D-二聚体截止值，以排除在急诊科 (ED) 就诊的 COVID-19 患者的肺栓塞 (PE)。

方法

一项回顾性队列研究在 2020 年 3 月 1 日至 2021 年 1 月 31 日期间在包括 22 名成人 ED 的综合医疗保健系统中进行。结果在 RECOVER 登记处登记的患者中得到验证，代表来自美国 26 个州的 154 名 ED 的数据。将实验室确诊为 COVID-19 的连续 ED 患者（一种 D-二聚体在 ED 到达后 48 小时内进行，客观证实为 PE）与没有 PE 的患者进行比较。在确定推导队列中 PE 阴性预测值的 95% 置信下限高于 98% 的 D-二聚体阈值后，使用 RECOVER 注册数据对其进行验证。

结果

在 3978 名具有 D-二聚体结果的患者中，3583 名确诊为 COVID-19 感染的患者被纳入推导队列。总体而言，PE 发生率为 4.1%，D-二聚体截止值< 2 μ/mL (2000 ng/mL) 与 NPV 为 98.5% (95% CI = 98.0%−98.9%) 相关。在 13,091 名 D-二聚体患者的验证队列中，7748 名确诊 COVID-19 感染，PE 发病率为 1.14%。< 2 μ/mL的 D-二聚体截止值与 99.5% 的 NPV 相关（95% CI = 99.3%−99.7%）。