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.

This article has been cited by other articles:

				B. Cosmi, C. Legnani, A. Tosetto, V. Pengo, A. Ghirarduzzi, S. Testa, D. Prisco, D. Poli, A. Tripodi, F. Marongiu, et al. Usefulness of repeated D-dimer testing after stopping anticoagulation for a first episode of unprovoked venous thromboembolism: the PROLONG II prospective study Blood, January 21, 2010; 115(3): 481 - 488. [Abstract] [Full Text] [PDF]

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