title: Age and gender specific cut-off values to improve the performance of D-dimer assays to predict the risk of venous thromboembolism recurrence.
abstract: The Prolong study shows that continuing vitamin K antagonists (VKA) in patients with abnormal D-dimer (evaluated by a qualitative assay, Clearview Simplify D-dimer) results in a significant reduction of venous thromboembolism (VTE) recurrence. The present study retrospectively analyzes a subgroup of patients enrolled in the Prolong study with a view to calculate cut-off values for six quantitative D-dimer methods to predict the risk of VTE recurrence. We measured D-dimer levels by VIDAS D-dimer Exclusion (bioMerieux), STA Liatest D-dimer (DiagnosticaStago), HemosIL D-dimer and HemosIL D-dimer HS (Instrumentation Laboratory), Innovance D-dimer (Siemens) and AutoDimer (Trinity Biotech) in frozen plasma aliquots sampled 30 ± 10 days after VKA cessation in 390 patients enrolled in the Prolong study. During follow-up (562.7 years), 28 patients had recurrent VTE (7.2%, 5.0% person-years). Since D-dimer levels are positively correlated with age and significantly lower in men, we calculated method-specific cut-off values according to age and gender. The HRs for VTE recurrence calculated using method-specific cut-off values based on age and gender are higher than those using cut-off values indicated by the manufacturers for VTE exclusion in symptomatic outpatients. These data suggest that method-specific cut-off values calculated according to patient age and gender can be more accurate in identifying patients at a higher risk for VTE recurrence. These method-specific cut-off values are being evaluated in the ongoing prospective management multicenter DULCIS study.
authors.affiliation: Department of Angiology and Blood Coagulation Marino Golinelli, University Hospital S.Orsola-Malpighi, Via Albertoni, 15, 40138, Bologna, Italy. cristina.legnani@aosp.bo.it
authors.forename: Cristina
authors.initials: C
authors.lastname: Legnani
authors.forename: Michela
authors.initials: M
authors.lastname: Cini
authors.forename: Benilde
authors.initials: B
authors.lastname: Cosmi
authors.forename: Paolo
authors.initials: P
authors.lastname: Carraro
authors.forename: Armando
authors.initials: A
authors.lastname: Tripodi
authors.forename: Nicoletta
authors.initials: N
authors.lastname: Erba
authors.forename: Gualtiero
authors.initials: G
authors.lastname: Palareti
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005338:Fibrin Fibrinogen Degradation Products / Q000378:metabolism*; D005343:Fibrinolytic Agents; D006801:Humans; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D012008:Recurrence; D012189:Retrospective Studies; D012307:Risk Factors; D012737:Sex Factors; D054556:Venous Thromboembolism / Q000097:blood* / Q000188:drug therapy / Q000209:etiology*; D014812:Vitamin K / Q000037:antagonists & inhibitors; D055815:Young Adult
chemical_list: D005338:Fibrin Fibrinogen Degradation Products; D005343:Fibrinolytic Agents; C036309:fibrin fragment D; D014812:Vitamin K