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• W1901649037 abstract "We read with interest the comments by Le Gal and Bounameaux [1] who have raised two relevant and unsettled issues regarding the clinical use of d-dimer for predicting the risk of recurrent venous thromboembolism (VTE) after anticoagulation withdrawal. The first issue concerns the optimal cut-off of d-dimer for prediction of VTE recurrence, while the second issue concerns the optimal timing of d-dimer measurements, that is whether it is more useful to measure d-dimer during anticoagulation or after oral anticoagulant therapy (OAT) withdrawal. Measuring d-dimer during OAT would be clinically more relevant as it would avoid subjecting patients to long periods without OAT. However, such an approach would miss those patients with recurrent VTE in whom d-dimer increases after OAT withdrawal. In fact we have shown that using a cut-off of 500 ng mL−1, at the time of OAT withdrawal only 15.5% of subjects have an altered d-dimer, while the proportion increases to 46.2% after 3 months [2]. We have demonstrated that the presence of altered rather than normal d-dimer results at 1 month was associated with a significantly higher rate of recurrences. This was found in all subjects investigated (16.5 vs. 5.8%, P < 0.000) as well as in some subgroups, such as in patients whose index event was unprovoked (16.5 vs. 7.0%, P = 0.0226), in carriers of thrombophilia (27.1 vs. 4.2%, P < 0.000) and also in non-carriers of thrombophilia (12.3 vs. 6.2%, P = 0.038) [3]. In our previous papers, we chose a d-dimer cut-off value of 500 ng mL−1, which is the same usually employed for the diagnosis of acute thrombosis. Such an approach may be questionable as prediction of recurrent VTE might require a different cut-off. To address this issue, we have evaluated d-dimer measurements (VIDAS d-dimer ELISA method, bioMerieux, Lion, France) performed in a cohort of 282 patients with a first episode of idiopathic or unprovoked VTE at the time of OAT withdrawal (T1), 30 ± 10 days (T2) and 3 months afterwards (T3). Among these subjects 33 recurrences were observed during a 2-year follow-up. As suggested by Le Gal and Bouneameaux, we performed ROC analysis for the measurement of d-dimer results obtained at T1, however, the area under the curve was 0.598 (95% CI: 0.492–0.704; P = 0.062) indicating an inadequate discriminative power (figure 1). We then performed ROC analysis for the d-dimer measurement obtained at T2. The area under the curve was 0.644 (95% CI: 0.547–0.742; P = 0.007), with improved discriminatory power (figure 1). The d-dimer cut-off value of 411 ng mL−1 was associated with a sensitivity of 0.91 (95% CI: 0.757–0.981) and a specificity of 0.40 (0.334–0.462) and negative predictive value of 0.969 (0.910–0.994). ROC curve analysis of the performance of VIDAS d-dimer for recurrent venous thromboembolism during anticoagulation (upper panel) and one month after anticoagulation suspension (lower panel). In idiopathic VTE, this cut-off value is slightly lower than the cut-off value we considered in our previous papers with improved negative predictive value. In subjects with idiopathic VTE, the d-dimer cut-off value of 500 ng mL−1 was associated with a sensitivity of 0.697 (95% CI: 0.513–0.844), a specificity of 0.522 (95% CI: 0.457–0.586) and a negative predictive value of 0.929 (95% CI: 0.873–0.965) at one month after OAT withdrawal [3]. Our d-dimer cut-off values (500 or 411 ng mL−1) are higher than the cut-off value considered by Eichinger et al. [4]which however, was associated with a slightly lower negative predictive value (0.92). Given the different assays employed in our papers and in the paper by Eichinger et al. [4], cut-offs could differ according to the assay employed. Our data also confirm that measuring d-dimer during anticoagulation has a limited usefulness as the ROC analysis provides an area under the curve not significantly different from 0.50. During anticoagulation, the majority of subjects with recurrences have low d-dimer levels with an associated lower negative predictive value. These data also confirm that d-dimer measurements at one month after OAT withdrawal are more useful than during anticoagulation, although at the ROC analysis the area under the curve can still be considered as having a limited discriminative power. Our data indicate that attempts to find a d-dimer level that would be highly predictive of recurrence and might justify OAT prolongation seems illusory as the overall discriminative power of d-dimer for recurrent VTE seems poor. However, it is premature to base any clinical decision about withdrawal on the basis of prospective studies whose aim was only to assess the value of d-dimer as risk factor for recurrent VTE and in which post-hoc analyzes were conducted. Any clinical decisions should be based on appropriately designed intervention studies. A randomized clinical trial (the PROLONG study) coordinated by our group is ongoing in Italy in centers affiliated with the National Federation of Anticoagulation Clinics. In this study a rapid qualitative bedside d-dimer test (Simplify, d-dimer; Agen Biomedical Limited, Brisbane, QLD, Australia [5]) is employed to allow its use also in settings where a laboratory is not easily available. d-dimer is determined at 30 ± 10 days after OAT withdrawal: OAT suspension is maintained in subjects with negative d-dimer, while subjects with a positive d-dimer are randomized to restart OAT or maintain OAT suspension. Follow-up is 18 months after randomization and final results should be available at the beginning of 2005." @default.
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• W1901649037 date "2004-09-01" @default.
• W1901649037 modified "2023-10-01" @default.
• W1901649037 title "d‐Dimer testing for predictive recurrence risk in venous thromboembolism: looking for a useful threshold: reply to a rebuttal" @default.
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• W1901649037 doi "https://doi.org/10.1111/j.1538-7836.2004.00893.x" @default.
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