Different D-dimer assays with age-adjusted cutoffs to exclude pulmonary embolism : secondary analysis of ADJUST-PE study

Article Article scientifique Article Different D-dimer assays with age-adjusted cutoffs to exclude pulmonary embolism : secondary analysis of ADJUST-PE study eng 2025-04-17 2025-08 author Robert-Ebadi Helia Division of Angiology and Hemostasis, Department of Medicine, Faculty of Medicine, Geneva University Hospitals, Geneva, Switzerland. Electronic address: helia.robert-ebadi@hug.ch. 640824 Département de médecine (DEMED) author Combescure Christophe 0000-0003-2631-4780 Division of Clinical Epidemiology, Department of Health and Community Medicine, Faculty of Medicine, Geneva University Hospitals, Geneva, Switzerland. 670542 Département de santé et médecine communautaire (MECOM) author Bulla Oana Hemostasis Laboratory, Diagnostic Department, Faculty of Medicine, Geneva University Hospitals, Geneva, Switzerland. 29557 author Righini Marc Philip 0000-0003-1211-2969 Division of Angiology and Hemostasis, Department of Medicine, Faculty of Medicine, Geneva University Hospitals, Geneva, Switzerland. 38989 Département de médecine (DEMED) author Fontana Pierre 0000-0003-1546-0774 Division of Angiology and Hemostasis, Department of Medicine, Faculty of Medicine, Geneva University Hospitals, Geneva, Switzerland; Hemostasis Laboratory, Diagnostic Department, Faculty of Medicine, Geneva University Hospitals, Geneva, Switzerland. 135328 Département de médecine (DEMED) 2531-2539 10.1016/j.jtha.2025.04.007 40252844 1538-7836 https://www.sciencedirect.com/science/article/pii/S1538783625002570 Background: The multicenter prospective ADJUST-PE study proved the safety of an age-adjusted D-dimer (AADD) cutoff to exclude pulmonary embolism (PE). Objectives: Assess the safety of different D-dimer (DD) assays using AADD in patients included in ADJUST-PE in Geneva compared with the originally used VIDAS DD Exclusion test. Methods: This was a preplanned secondary analysis. The VIDAS DD Exclusion test was repeated to ensure reproducible results in thawed samples. Other tests performed were Innovance DD test, STA Liatest, Tina-quant DD, and the point-of-care LumiraDx test. The main outcome was venous thromboembolic risk (VTE) at initial testing or within 3 months after PE exclusion by a negative DD test using AADD ("failure rate"). The secondary outcome measure was to compare each assay with VIDAS in the classification of patients as having a negative vs positive AADD result. Results: A total of 602 patients were included and 597 were available for analysis. Fourteen percent had PE confirmed at baseline. Failure rates were <2% for all tests. The risk of a change in classification from positive original VIDAS AADD to negative AADD result was similar to the repeated VIDAS (comparator) for Innovance and LumiraDx and higher for STA Liatest and Tina-quant. For the latter 2 assays, 3 and 5 patients with negative AADD had PE, respectively. Conclusion: Innovance and LumiraDx assays had similar safety in excluding PE by AADD compared with VIDAS. STA Liatest and Tina-quant classified a higher proportion of patients with a negative AADD, among whom 3 and 5 had PE, respectively. D-dimer Age-adjusted cutoff Diagnosis Pulmonary embolism Humans Pulmonary Embolism / diagnosis Pulmonary Embolism / blood Fibrin Fibrinogen Degradation Products / analysis Female Male Aged Middle Aged Prospective Studies Predictive Value of Tests Reproducibility of Results Venous Thromboembolism / diagnosis Venous Thromboembolism / blood Biomarkers / blood Age Factors Risk Factors Adult Aged, 80 and over Switzerland Dewey 613 Dewey 616 Dewey 618 Swiss National Science Foundation Age-adjusted D-dimer cut-off levels to rule out pulmonary embolism: a prospective outcome study. 130863 CH 56 Département de médecine 221 217 Centre de recherche clinique 201 64 Département de santé et médecine communautaires 22A false 11 Plaquettes et antithrombotiques 13 88 Epidémiologie clinique et biostatistique 115 477 Maladie thromboembolique veineuse 808 Journal of thrombosis and haemostasis 23 8 1c631b68-f8dd-45d4-9c46-5a6d464770be Article (Published version) Public ADJUST_DD_VF.pdf 886270 application/pdf CC BY-4.0 4acf376840cf28efaf74c62371906a6ae080a1b582431672cff0c8f54a886f62 openAccess Faculté de médecine / Section de médecine clinique / Département de médecine Faculté de médecine / Centre de recherche clinique Faculté de médecine / Section de médecine clinique / Département de santé et médecine communautaires

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Different D-dimer assays with age-adjusted cutoffs to exclude pulmonary embolism : secondary analysis of ADJUST-PE study	Journal of thrombosis and haemostasis			2025	16	279

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