Haematologica
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Published online 28 April 2008
Haematologica, Vol 93, Issue 6, 900-907 doi:10.3324/haematol.12320
Copyright © 2008 by Ferrata Storti Foundation
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Original Article

Different cut-off values of quantitative D-dimer methods to predict the risk of venous thromboembolism recurrence: a post-hoc analysis of the PROLONG study

Cristina Legnani1, Gualtiero Palareti1, Benilde Cosmi1, Michela Cini1, Alberto Tosetto2, Armando Tripodi3 for the PROLONG Investigators (on behalf of FCSA and Italian Federation of Thrombosis Centers)

1 Department of Angiology & Blood Coagulation "Marino Golinelli", University Hospital S.Orsola-Malpighi, Bologna;
2 Department of Hematology, S. Bortolo Hospital, Vicenza and
3 "Angelo Bianchi Bonomi Hemophilia & Thrombosis Center, Department of Internal Medicine, University & IRCCS Maggiore Hospital, Milan, Italy

Correspondence: Cristina Legnani, Department of Angiology and Blood Coagulation "Marino Golinelli", University Hospital S. Orsola-Malpighi, via Albertoni, 15, 40138 Bologna, Italy. E-mail:cristina.legnani{at}aosp.bo.it

Background: The PROLONG study showed that patients with venous thromboembolism who had qualitatively abnormal results in a D-dimer assay (Clearview Simplify D-dimer) after discontinuation of vitamin K antagonism benefit from resumption of treatment with vitamin K antagonism. The objective of this study was to evaluate the possible advantage of using quantitative D-dimer assays.

Design and Methods: VIDAS D-dimer Exclusion (bioMerieux), Innovance D-DIMER (Dade Behring), HemosIL D-dimer HS (Instrumentation Laboratory) and STA Liatest D-dimer (Diagnostica Stago) assays were performed in plasma aliquots sampled 30±10 days after cessation of vitamin K antagonism in 321 patients enrolled in the PROLONG study.

Results: During the follow-up without vitamin K antagonism, 25 patients had recurrent venous thromboembolism. The cut-off levels of the quantitative assays giving results most comparable with those of the qualitative test were: VIDAS = 800 ng/mL; Innovance = 800 ng/mL; HemosIL HS = 300 ng/mL; STA Liatest = 700 ng/mL. When the effect of the patients’ age (≤ 70 vs. >70 years) was analyzed, it was found that only in younger patients was the rate of recurrence of venous thromboembolism significantly higher in patients with abnormal D-dimer levels. However, using the quantitative assays and age-specific cut-off levels it was possible to determine statistically significant hazard ratios also in elderly patients (VIDAS = 600 and 1200 ng/mL, Innovance = 500 and 900 ng/mL, HemosIL HS = 250 and 450 ng/mL, STA Liatest = 700 and 1000 ng/mL, in patients aged ≤ 70 and >70 years, respectively).

Conclusions: Quantitative D-dimer assays may provide information useful for evaluating the individual risk of recurrent venous thromboembolism. They seem particularly advantageous since they allow the selection of different cut-off levels according to the age or other characteristics of the patients.

Key words: anticoagulation, D-dimer, recurrence, risk factors, venous thromboembolism.






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