Diagnostic accuracy of age-adjusted D-dimer for pulmonary embolism among Emergency Department patients with suspected SARS-COV-2: A Canadian COVID-19 Emergency Department Rapid Response Network study

Abstract

Importance: Ruling out pulmonary embolism (PE) among patients presenting to the Emergency Department (ED) with suspected or confirmed SARS-COV-2 is challenging due to symptom overlap, known increased pro-thrombotic risk, and unclear D-dimer test interpretation. Objective: Our primary objective was to assess the diagnostic accuracy of standard and age-adjusted D-dimer test thresholds for predicting 30-day pulmonary embolism (PE) diagnosis in patients with suspected SARS-COV-2 infection. Design, Setting, and Participants: This was a retrospective observational study using data from 50 sites enrolling patients into the Canadian COVID-19 ED Rapid Response Network (CCEDRRN) registry between March 1, 2020 to July 2, 2021. Adults (≥18 years) with SARS-COV-2 testing performed at index ED visit were included if they had any of the following presenting complaints: chest pain, shortness of breath, hypoxia, syncope/presyncope, or hemoptysis. We excluded patients with duplicate records or no valid provincial healthcare number. Main Outcomes and Measures: Our primary end point was 30-day PE diagnosis based on a positive computed tomography pulmonary angiogram (CTPA) or hospital discharge diagnosis code of PE. The outcome measure was the diagnostic accuracy of an age adjusted D-dimer strategy as compared to absolute D-dimer thresholds (500 - 5000 ng/mL). Results: 52,038 patients met inclusion criteria. Age-adjusted D-dimer had a sensitivity (SN) of 96% (95% CI 93-98%) and a specificity (SP) of 48% (95% CI 48-49%) which was comparable to the most sensitive absolute threshold of 500 ng/mL (SN 98%, 95% CI 96-99%; SP 41%, 95% CI 40-42%). Other absolute D-dimer thresholds did not perform well enough for clinical reliability (SN <90%). Both age-adjusted and absolute D-dimer performed better in SARS-COV-2 negative patients as compared to SARS-COV-2 positive patients for predicting 30-day PE diagnosis (c-statistic 0.88 vs 0.80). Conclusions and Relevance: In this large Canadian cohort of ED patients with suspected SARS-COV-2 infection, an age-adjusted D-dimer strategy had similar sensitivity and superior specificity to the most sensitive D-dimer threshold of 500 ng/mL for predicting 30-day PE diagnosis irrespective of SARS-COV-2 infection status. Adopting an age-adjusted D-dimer strategy in patients with suspected SARS-COV-2 may help avoid unnecessary CTPA testing without compromising safety.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Protocols

https://www.cmajopen.ca/content/9/1/E261

Funding Statement

The Canadian Institutes of Health Research (447679), Ontario Ministry of Colleges and Universities (C-655-2129), Saskatchewan Health Research Foundation (5357), Genome BC (COV024, VAC007), Fondation du CHU de Quebec (Octroi No. 4007) and the Public Health Agency of Canada provided peer-reviewed funding. The BC Academic Health Science Network and BioTalent Canada provided non-peer reviewed funding. These organizations are not-for-profit, and had no role in study conduct, analysis, or manuscript preparation.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

We received ethics approval for this work from the following institutional research ethics boards: Alberta - University of Calgary Conjoint Health Research Ethics Board (REB20-0534); British Columbia - University of British Columbia Clinical Research Ethics Board (H20-01015); Manitoba - University of Manitoba Health Research Ethics Board (H2020:261); New Brunswick - Horizon Health Network Research Ethics Board (100890); Nova Scotia - Nova Scotia Health Authority Research Ethics Board (1025682); Ontario - Queens University Health Sciences & Affiliated Teaching Hospitals Research Ethics Board (2165); Quebec - Centre integre de sante et de services sociaux de Chaudiere-Appalaches(MP-23-2021-766); Saskatchewan - University of Saskatchewan Biomedical Research Ethics Board (1935).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Data Availability

CCEDRRN accepts applications for access to data by external investigators, prioritizing data requests by network Members. https://www.ccedrrn.com/knowledge-users

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