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1. Comparison between different D-Dimer cutoff values to assess the individual risk of recurrent venous thromboembolism: analysis of results obtained in the DULCIS study.

Author

Palareti G, Legnani C, Cosmi B, Antonucci E, Erba N, Poli D, Testa S, and Tosetto A

Subjects
Aged, Aged, 80 and over, Anticoagulants therapeutic use, Female, Humans, Male, Middle Aged, Recurrence, Reference Values, Risk Factors, Venous Thromboembolism drug therapy, Fibrin Fibrinogen Degradation Products, Venous Thromboembolism blood, Venous Thromboembolism diagnosis
Abstract

Introduction: D-dimer assay, generally evaluated according to cutoff points calibrated for VTE exclusion, is used to estimate the individual risk of recurrence after a first idiopathic event of venous thromboembolism (VTE)., Methods: Commercial D-dimer assays, evaluated according to predetermined cutoff levels for each assay, specific for age (lower in subjects <70 years) and gender (lower in males), were used in the recent DULCIS study. The present analysis compared the results obtained in the DULCIS with those that might have been had using the following different cutoff criteria: traditional cutoff for VTE exclusion, higher levels in subjects aged ≥60 years, or age multiplied by 10., Results: In young subjects, the DULCIS low cutoff levels resulted in half the recurrent events that would have occurred using the other criteria. In elderly patients, the DULCIS results were similar to those calculated for the two age-adjusted criteria. The adoption of traditional VTE exclusion criteria would have led to positive results in the large majority of elderly subjects, without a significant reduction in the rate of recurrent event., Conclusion: The results confirm the usefulness of the cutoff levels used in DULCIS., (© 2015 The Authors. International Journal of Laboratory Hematology Published by John Wiley & Sons Ltd, Int. Jnl. Lab. Hem.)

Published
2016
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2. Age and gender specific cut-off values to improve the performance of D-dimer assays to predict the risk of venous thromboembolism recurrence.

Author

Legnani C, Cini M, Cosmi B, Carraro P, Tripodi A, Erba N, and Palareti G

Subjects
Adult, Age Factors, Aged, Aged, 80 and over, Female, Fibrinolytic Agents, Humans, Male, Middle Aged, Predictive Value of Tests, Recurrence, Retrospective Studies, Risk Factors, Sex Factors, Venous Thromboembolism drug therapy, Vitamin K antagonists & inhibitors, Young Adult, Fibrin Fibrinogen Degradation Products metabolism, Venous Thromboembolism blood, Venous Thromboembolism etiology
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.

Published
2013
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3. D-dimer testing, with gender-specific cutoff levels, is of value to assess the individual risk of venous thromboembolic recurrence in non-elderly patients of both genders: a post hoc analysis of the DULCIS study

Author

Palareti G., Legnani C., Antonucci E., Cosmi B., Poli D., Testa S., Tosetto A., Ageno W., Falanga A., Ferrini P. M., Pengo V., Prandoni P., Prisco D., Ghirarduzzi A., Veropalumbo M. R., Ugolotti M. C., Erba N., De Micheli V., Paoletti O., Luigi S., Donadini M., Rancan E., Quintavalla R., Santoro R. C., Orlandini F., Benedetti R., Cattaneo M., Lussana F., Bertinato E., Cappelli R., Pizzini A. M., D'Angelo A., Crippa L., Angeloni L., Bortolotti R., Vandelli M. R., Tripodi A., Imberti D., Moia M., Pesavento R., Magrini N., Marongiu F., Zonzin P., Piaggesi N., Silingardi M., Palareti G., Legnani C., Antonucci E., Cosmi B., Poli D., Testa S., Tosetto A., Ageno W., Falanga A., Ferrini P.M., Pengo V., Prandoni P., Prisco D., Ghirarduzzi A., Veropalumbo M.R., Ugolotti M.C., Erba N., De Micheli V., Paoletti O., Luigi S., Donadini M., Rancan E., Quintavalla R., Santoro R.C., Orlandini F., Benedetti R., Cattaneo M., Lussana F., Bertinato E., Cappelli R., Pizzini A.M., D'Angelo A., Crippa L., Angeloni L., Bortolotti R., Vandelli M.R., Tripodi A., Imberti D., Moia M., Pesavento R., Magrini N., Marongiu F., Zonzin P., Piaggesi N., Silingardi M., Palareti, G, Legnani, C, Antonucci, E, Cosmi, B, Poli, D, Testa, S, Tosetto, A, Ageno, W, Falanga, A, Ferrini, P, Pengo, V, and Prandoni, P

Subjects
Male, medicine.medical_specialty, Patients, medicine.drug_class, Cardiology, 030204 cardiovascular system & hematology, Individual risk, Cohort Studies, Fibrin Fibrinogen Degradation Products, 03 medical and health sciences, 0302 clinical medicine, Sex Factors, Predictive Value of Tests, Recurrence, Risk Factors, Internal medicine, Post-hoc analysis, D-dimer, Internal Medicine, medicine, Cutoff, Humans, 030212 general & internal medicine, Prospective Studies, Aged, business.industry, Gender, Anticoagulants, Venous Thromboembolism, Vitamin K antagonist, Middle Aged, Confidence interval, Telemedicine, Venous thromboembolism, Discontinuation, Im - Original, Emergency Medicine, Female, business
Abstract

Male patients, especially the young, are at a higher risk of recurrent venous thromboembolism (RVTE) than females. Recent scientific reports show the use of D-dimer does not help predict RVTE risk in males. In the present report, we reviewed the data obtained in the DULCIS study (main report published in Blood 2014), focusing on D-dimer results recorded in non-elderly patients of both genders included in the study, and their relationship with RVTE events occurring during follow-up. Using specifically designed cutoff values for positive/negative interpretation, serial D-dimer measurements (performed during warfarin treatment and up to 3 months after discontinuation of anticoagulation) in 475 patients (males 57.3%) aged ≤ 65 years were obtained. D-dimer resulted positive in 46.3% and 30.5% of males and females, respectively (p = 0.001). Following management procedure, anticoagulation was stopped in 53.7% of males and 69.5% of females, who had persistently negative D-dimer results. The rate of subsequent recurrent events was 1.7% (95% CI 0.5–4.5%) and 0.4% (95% CI 0–2.5%) patient-years in males and females, respectively, with upper limits of confidence intervals always below the level of risk considered acceptable by international scientific societies for stopping anticoagulation (

Published
2019

4. Comparison between different D-Dimer cutoff values to assess the individual risk of recurrent venous thromboembolism: Analysis of results obtained in the DULCIS study

Author

Palareti, G, Legnani, C, Cosmi, B, Antonucci, E, Erba, N, Poli, D, Testa, S, Tosetto, A, De Micheli, V, Ghirarduzzi, A, Veropalumbo, MR, Chiara, UM, Prisco, D, Aterotrombotiche, M, Paoletti O, Falanga, A, Luigi, S, Donadini, M, Rancan, E, Quintavalla, R, Ferrini, PM, Santoro, RC, Orlandini, F, Benedetti, R, Cattaneo, M, Lussana, F, Bertinato, E, Cappelli, R, Pizzini, AM, Angeloni, L, D'angelo, A, Crippa, L, Bortolotti, R, Vandelli, MR, Palareti, G, Legnani, C, Cosmi, B, Antonucci, E, Erba, N, Poli, D, Testa, S, Tosetto, A, De Micheli, V, Ghirarduzzi, A, Veropalumbo, M, Chiara, U, Prisco, D, Aterotrombotiche, M, Paoletti, O, Falanga, A, Luigi, S, Donadini, M, Rancan, E, Quintavalla, R, Ferrini, P, Santoro, R, Orlandini, F, Benedetti, R, Cattaneo, M, Lussana, F, Bertinato, E, Cappelli, R, Pizzini, A, Angeloni, L, D'Angelo, A, Crippa, L, Bortolotti, R, Vandelli, M, G. PALARETI, C. LEGNANI, B. COSMI, E. ANTONUCCI, N. ERBA, D. POLI, S. TESTA, A. TOSETTO, and ON BEHALF OF THE DULCIS (D-DIMER-ULTRASONOGRAPHY IN COMBINATION ITALIAN STUDY) INVESTIGATORS

Subjects
0301 basic medicine, Male, Cutoff criteria, medicine.medical_specialty, recurrence, Clinical Biochemistry, venous thromboembolism, Individual risk, Clinical biochemistry, Fibrin Fibrinogen Degradation Products, 03 medical and health sciences, Reference Values, Risk Factors, Internal medicine, D-dimer, medicine, Cutoff, Humans, Aged, Aged, 80 and over, business.industry, Biochemistry (medical), Anticoagulants, Hematology, General Medicine, Middle Aged, Surgery, Recurrent event, 030104 developmental biology, Reference values, Female, business, Venous thromboembolism
Abstract

SummaryIntroduction D-dimer assay, generally evaluated according to cutoff points calibrated for VTE exclusion, is used to estimate the individual risk of recurrence after a first idiopathic event of venous thromboembolism (VTE). Methods Commercial D-dimer assays, evaluated according to predetermined cutoff levels for each assay, specific for age (lower in subjects

Published
2016

5. D-dimer to guide the duration of anticoagulation in patients with venous thromboembolism: a management study

Author

Palareti G, Cosmi B, Legnani C, Antonucci E, De Micheli V, Ghirarduzzi A, Poli D, Testa S, Tosetto A, Pengo V, Prandoni P, Erba N, Veropalumbo MR, Chiara UM, Prisco D, Paoletti O, Falanga A, Luigi S, Donadini M, Rancan E, Quintavalla R, Ferrini PM, Santoro RC, Orlandini F, Benedetti R, Cattaneo M, Lussana F, Bertinato E, Cappelli R, Pizzini AM, Angeloni L, D'Angelo A, Crippa L, Bortolotti R, Vandelli MR, Ageno W, Tripodi A, Imberti D, Moia M, Pesavento R, Magrini N, Marongiu F, Zonzin P, Piaggesi N, Silingardi M, Palareti, G, Cosmi, B, Legnani, C, Antonucci, E, De Micheli, V, Ghirarduzzi, A, Poli, D, Testa, S, Tosetto, A, Pengo, V, Prandoni, P, Erba, N, Veropalumbo, M, Chiara, U, Prisco, D, Paoletti, O, Falanga, A, Luigi, S, Donadini, M, Rancan, E, Quintavalla, R, Ferrini, P, Santoro, R, Orlandini, F, Benedetti, R, Cattaneo, M, Lussana, F, Bertinato, E, Cappelli, R, Pizzini, A, Angeloni, L, D'Angelo, A, Crippa, L, Bortolotti, R, Vandelli, M, Ageno, W, Tripodi, A, Imberti, D, Moia, M, Pesavento, R, Magrini, N, Marongiu, F, Zonzin, P, Piaggesi, N, Silingardi, M, Gualtiero Palareti, Benilde Cosmi, Cristina Legnani, Emilia Antonucci, Valeria De Micheli, Angelo Ghirarduzzi, Daniela Poli, Sophie Testa, Alberto Tosetto, Vittorio Pengo, and and Paolo Prandoni, on behalf of the DULCIS (D-dimer and ULtrasonography in Combination Italian Study) Investigators

Subjects
Male, medicine.medical_specialty, Time Factors, Immunology, Biochemistry, Drug Administration Schedule, Fibrin Fibrinogen Degradation Products, Pregnancy, Recurrence, Internal medicine, D-dimer, medicine, Humans, D-dimer, venous thromboembolism, vitamin K antagonists, Vein, Aged, Hematology, business.industry, Hazard ratio, Anticoagulants, Cell Biology, Venous Thromboembolism, Middle Aged, medicine.disease, Thrombosis, Confidence interval, Surgery, Clinical trial, medicine.anatomical_structure, Treatment Outcome, Withholding Treatment, Female, business, anticoagulation, fibrin fragment d substance, venous thromboembolism, recurrence risk, Follow-Up Studies
Abstract

The optimal duration of anticoagulation in patients with venous thromboembolism (VTE) is uncertain. We investigated whether persistently negative D-dimers in patients with vein recanalization or stable thrombotic burden can identify subjects at low recurrence risk. Outpatients with a first VTE (unprovoked or associated with weak risk factors) were eligible after at least 3 months (12 in those with residual thrombosis) of anticoagulation. They received serial D-dimer measurements using commercial assays with predefined age/sex-specific cutoffs and were followed for up to 2 years. Of 1010 patients, anticoagulation was stopped in 528 (52.3%) with persistently negative D-dimer who subsequently experienced 25 recurrences (3.0% pt-y; 95% confidence interval [CI], 2.0-4.4%). Of the remaining 482 patients, 373 resumed anticoagulation and 109 refused it. Recurrent VTE developed in 15 patients (8.8% pt-y; 95% CI, 5.0-14.1) of the latter group and in 4 of the former (0.7% pt-y; 95% CI, 0.2-1.7; hazard ratio = 2.92; 95% CI, 1.87-9.72; P = .0006). Major bleeding occurred in 14 patients (2.3% pt-y; 95% CI, 1.3-3.9) who resumed anticoagulation. Serial D-dimer measurement is suitable in clinical practice for the identification of VTE patients in whom anticoagulation can be safely discontinued. This study was registered at clinicaltrials.gov as #NCT00954395.

Published
2014

6. Duration of anticoagulation after isolated pulmonary embolism

Author

Cristina Legnani, Angelo Ghirarduzzi, Benilde Cosmi, Alberto Tosetto, Emilia Antonucci, Nicoletta Erba, Gualtiero Palareti, Sophie Testa, Vittorio Pengo, Daniela Poli, Paolo Prandoni, Palareti G, Cosmi B, Antonucci E, Legnani C, Erba N, Ghirarduzzi A, Poli D, Testa S, Tosetto A, Pengo V, and Prandoni P

Subjects
Adult, Male, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Deep vein, Subgroup analysis, 030204 cardiovascular system & hematology, RECURRENT VENOUS THROMBOEMBOLISM, Body Mass Index, Fibrin Fibrinogen Degradation Products, 03 medical and health sciences, Sex Factors, 0302 clinical medicine, RISK-FACTOR, Risk Factors, Internal medicine, Prevalence, EPIDEMIOLOGY, Humans, Medicine, Thrombolytic Therapy, In patient, DEEP-VEIN THROMBOSIS, Prospective Studies, cardiovascular diseases, 030212 general & internal medicine, Blood Coagulation, Aged, Venous Thrombosis, business.industry, Anticoagulants, Venous Thromboembolism, Middle Aged, medicine.disease, Thrombosis, Pulmonary embolism, Surgery, COMMUNITY, medicine.anatomical_structure, Multivariate Analysis, Female, Ultrasonography, Pulmonary Embolism, business, Venous thromboembolism
Abstract

In the D-dimer and ULtrasonography in Combination Italian Study (DULCIS), serial D-dimer measurement in combination with assessment of residual thrombosis (in patients with deep vein thrombosis (DVT)) identified patients who safely discontinued anticoagulation after an unprovoked venous thromboembolism (VTE).In this subgroup analysis, the value of D-dimer tests was assessed in patients with isolated pulmonary embolism (PE) compared with those with DVT, with or without PE (DVT/PE). The DULCIS database was reanalysed in relation to this target.26.8% of the DULCIS patients had isolated PE as the index event; this was more prevalent in females (34.1%) than in males (21.1%; pversus 3.8% ppy; nonsignificant) who stopped anticoagulation for negative D-dimer, but it was markedly high (11.2% ppy; pversus two (7.4%) out of 27; p=0.0085).Serial D-dimer assessment can inform on the risk of recurrent VTE and help determine the duration of anticoagulation in patients with isolated PE.

Published
2016

7. Age and gender specific cut-off values to improve the performance of D-dimer assays to predict the risk of venous thromboembolism recurrence

Author

Armando Tripodi, Paolo Carraro, Nicoletta Erba, Cristina Legnani, Gualtiero Palareti, Michela Cini, Benilde Cosmi, Legnani C, Cini M, Cosmi B, Carraro P, Tripodi A, Erba N, and Palareti G.

Subjects
Adult, Male, medicine.medical_specialty, Vitamin K, VITAMIN K ANTAGONISTS, law.invention, Fibrin Fibrinogen Degradation Products, Young Adult, Sex Factors, Randomized controlled trial, Anticoagulation, d-dimer, Recurrence, Risk factors, Venous thromboembolism, Fibrinolytic Agents, law, Predictive Value of Tests, Recurrence, Risk Factors, Internal medicine, D-dimer, Internal Medicine, Medicine, Humans, Young adult, Aged, Retrospective Studies, Aged, 80 and over, business.industry, Age Factors, Retrospective cohort study, Venous Thromboembolism, Middle Aged, Surgery, Predictive value of tests, Emergency Medicine, Female, Fresh frozen plasma, business, Venous thromboembolism, Fibrinolytic agent
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.

Published
2011

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