“HERDOO2” clinical decision rule to guide duration of anticoagulation in women with unprovoked venous thromboembolism. Can I use any d-Dimer?

• Published in: Thrombosis research 2018-09, Vol.169, p.82-86
• Main Authors: Rodger, Marc A., Le Gal, Gregoire, Langlois, Nicole J., Gin, Barron, Mallick, Ranjeeta, Giulivi, Antonio, Freedman, Marisa, Kovacs, Michael J.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Anticoagulants - administration & dosage; Anticoagulants - therapeutic use; Blood Coagulation Tests; Concordance; d-Dimer; Decision Support Systems, Clinical; Female; Fibrin Fibrinogen Degradation Products - analysis; Human health and pathology; Humans; Kappa; Life Sciences; Middle Aged; Recurrence; Risk Factors; Risk stratification; Venous thromboembolism; Venous Thromboembolism - blood; Venous Thromboembolism - drug therapy; Venous Thromboembolism - etiology
• ISSN: 0049-3848; 1879-2472
• DOI: 10.1016/j.thromres.2018.07.020

The “HERDOO2 rule” is a prospectively validated clinical decision rule used to identify low-risk women who can safely discontinue anticoagulants after completing 5–12 months of anticoagulant treatment for unprovoked venous thromboembolism. The VIDAS®d-Dimer (DD) assay, a component of the rule, was used in the derivation and validation of the rule at half the usual diagnostic cut-point for exclusion of venous thrombosis. It is unknown if other commercial DD assays used at a corresponding cut-point will categorize patients at high concordance with the VIDAS® DD. To determine if other available automated quantitative DD assays have high enough concordance with the VIDAS® DD assay to allow their use within the “HERDOO2” clinical decision rule. Frozen plasma samples from a sub-set (n = 248) of female participants in the “HERDOO2” validation study were tested using five DD assays: VIDAS®, Innovance®, HemosIL®, Tina-quant® and Liatest®, with duplicate testing for 50 samples. First, using the mean DD for 50 samples with duplicate results, we determined the optimal cut-point values for each test that corresponded with a VIDAS® DD result of 250 μg/L using linear regression analysis. Next, kappa analysis was conducted on the DD results of the remaining 198 samples to determine concordance between each tested DD at the respective optimal cut-point and the VIDAS® DD at 250 μg/L. In a separate analysis we determined the concordance at half the usual venous thrombosis exclusion cut-point. Regression analysis of the DD results in 50 samples identified the optimal cut-point for each DD assay to match a VIDAS® DD cut-point of 250 μg/L: Innovance® 177 μg/L, Liatest® 233 μg/L, Tina-quant® 48 μg/L and HemosIL® 56 μg/L. Next, in 198 different samples, the concordance of VIDAS® DD (≥250 μg/L or