Age-adjusted D-dimer cut-off levels to rule out venous thromboembolism in patients with non-high pre-test probability: Clinical performance and cost-effectiveness analysis

J Thromb Haemost. 2021 May;19(5):1271-1282. doi: 10.1111/jth.15278. Epub 2021 Mar 22.

Abstract

Background: As aging was found to be associated with increased D-dimer levels, the question arose whether D-dimer measurement was useful in the diagnostic strategy of venous thromboembolism (VTE) in elderly patients.

Aim of the study: To compare retrospectively the performance of six diagnostic strategies based on the three-level Wells scores and various cut-off levels for D-dimer, evaluated using the HemosIL D-Dimer HS 500 assay, in a derivation cohort of 644 outpatients with non-high pretest probability (PTP) of VTE. The clinical usefulness of the best-performing strategy was then confirmed in a multicenter validation study involving 1255 consecutive outpatients with non-high PTP.

Results: The diagnostic strategy based on the age-adjusted cut-off level calculated by multiplying the patient's age by 10 above 50 years was found to perform the best in the derivation study with a better sensitivity-to-specificity ratio than the conventional strategy based on the fixed cut-off level (500 ng/ml), a higher specificity and a negative predictive value (NPV) above 99%. Such an increase in test specificity was confirmed in the validation cohort, with the NPV remaining above 99%. Taking into account the local reimbursement rates of diagnostic tests, using this strategy led to a 6.9% reduction of diagnostic costs for pulmonary embolism and a 5.1% reduction for deep vein thrombosis, as imaging tests would be avoided in a higher percentage of patients.

Conclusion: The diagnostic strategy of VTE based on the age-adjusted cut-off level for D-dimer in patients over 50 years was found to be safe, with NPV above 99%, and cost-effective.

Keywords: D-dimer; ageage adjusted; cut-off level; elderly patients.

Publication types

  • Multicenter Study

MeSH terms

  • Aged
  • Cost-Benefit Analysis
  • Fibrin Fibrinogen Degradation Products
  • Humans
  • Middle Aged
  • Probability
  • Pulmonary Embolism* / diagnosis
  • Retrospective Studies
  • Venous Thromboembolism* / diagnosis

Substances

  • Fibrin Fibrinogen Degradation Products
  • fibrin fragment D