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• W1987787364 abstract "We read with great interest the recently published work by Kucher et al. [1Kucher N. Kohler H.P. Dornhöfer T. Wallmann D. Lämmle B. Accuracy of d‐dimer/fibrinogen ratio to predict pulmonary embolism: a prospective diagnostic study.J Thromb Haemost. 2003; 1: 708-13Abstract Full Text Full Text PDF PubMed Scopus (42) Google Scholar], concerning the positive diagnosis of pulmonary embolism (PE) by a d‐dimer/fibrinogen ratio >1000. ELISA d‐dimer assays have a high sensitivity which allows exclusion of PE or deep vein thrombosis (DVT) in about 30% of outpatients clinically suspected of having the disease [2Perrier A. Desmarais S. Miron M.J. De Moerloose P.h. Lepage R. Slosman D. Didier D. Unger P.F. Patenaude J.V. Bounameaux H. Non‐invasive diagnosis of venous thromboembolism in outpatients.Lancet. 1999; 353: 190-5Abstract Full Text Full Text PDF PubMed Scopus (770) Google Scholar, 3Brown M.D. Rowe B.H. Reeves M.J. Bermingham J.M. Goldhaber S.Z. The accuracy of the enzyme‐linked immunosorbent assay d‐dimer test in the diagnosis of pulmonary embolism: a meta‐analysis.Ann Emerg Med. 2002; 40: 133-44Abstract Full Text Full Text PDF PubMed Scopus (135) Google Scholar, 4Perrier A. Bounameaux H. Cost‐effective diagnosis of deep vein thrombosis and pulmonary embolism.Thromb Haemost. 2001; 86: 475-87Crossref PubMed Scopus (101) Google Scholar]. In contrast, at the usual cut‐off value, poor specificity precludes using d‐dimer to rule in venous thromboembolism. In their recently published work [1Kucher N. Kohler H.P. Dornhöfer T. Wallmann D. Lämmle B. Accuracy of d‐dimer/fibrinogen ratio to predict pulmonary embolism: a prospective diagnostic study.J Thromb Haemost. 2003; 1: 708-13Abstract Full Text Full Text PDF PubMed Scopus (42) Google Scholar] based on a cohort of 191 outpatients with suspected PE, Kucher et al. tested the hypothesis that patients with PE have lower fibrinogen and higher d‐dimer values than patients in whom the diagnosis is suspected but safely excluded. They found that a d‐dimer/fibrinogen ratio >1000 allowed one to rule in PE in 26% (49/191) of patients with a positive predictive value of 100% [95% CI: 93–100]. As a d‐dimer below 500 µg L−1was found in 29.3% of their patients, the association of d‐dimer <500 µg L−1to exclude PE and a d‐dimer/fibrinogen ratio >1000 to rule in PE allowed a definite diagnosis in 55% of patients. Moreover, the d‐dimer/fibrinogen ratio was >1000 in 49 of 85 (58%, 95% CI: 47–68) patients with PE. One main limitation of this study is the rather small sample size, as highlighted by the wide confidence interval for the positive predictive value (100%, 95% CI: 93–100). Furthermore, we are surprised that the authors obtained a 100% negative predictive value (NPV) at 780 µg L−1. At that threshold, the NPV was only 97% (95% CI: 95–99) in a larger database including 874 outpatients clinically suspected of PE, as discussed below [2Perrier A. Desmarais S. Miron M.J. De Moerloose P.h. Lepage R. Slosman D. Didier D. Unger P.F. Patenaude J.V. Bounameaux H. Non‐invasive diagnosis of venous thromboembolism in outpatients.Lancet. 1999; 353: 190-5Abstract Full Text Full Text PDF PubMed Scopus (770) Google Scholar, 5Perrier A. Roy P.M. Aujesky D. Chagnon I. Howarth N. Gourdier A.L. Leftheriotis G. Bargouth G. Cornuz J. Hayoz D. Bounameaux H. Diagnosing pulmonary embolism with clinical assessment, d‐dimer, venous ultrasound and helical computed tomography: a multicenter management study.Am J Med. 2003; Google Scholar]. This suggests that the results could have been different in a larger sample. Another potential limitation could be the median fibrinogen value reported by the authors, which seems unusually low (median 2.7 g L−1, range 0.4–5.2 g L−1). Moreover, if standardization of d‐dimer dosage has been difficult in the past, this may be the same for fibrinogen dosage. Therefore, in the absence of a well‐admitted standardization of fibrinogen dosage [6Whitton C.M. Sands D. Hubbard A.R. Gaffney P.J. A collaborative study to establish the 2nd International Standard for Fibrinogen.Plasma Thromb Haemost. 2000; 84: 258-62Crossref PubMed Scopus (41) Google Scholar], the described d‐dimer/fibrinogen ratio may not be reproducible and widely useful. We calculated the diagnostic performances of a d‐dimer/fibrinogen ratio > 1000 in a subset of 156 randomly selected patients suspected of PE for whom some plasma was left from two previously published studies [2Perrier A. Desmarais S. Miron M.J. De Moerloose P.h. Lepage R. Slosman D. Didier D. Unger P.F. Patenaude J.V. Bounameaux H. Non‐invasive diagnosis of venous thromboembolism in outpatients.Lancet. 1999; 353: 190-5Abstract Full Text Full Text PDF PubMed Scopus (770) Google Scholar, 5Perrier A. Roy P.M. Aujesky D. Chagnon I. Howarth N. Gourdier A.L. Leftheriotis G. Bargouth G. Cornuz J. Hayoz D. Bounameaux H. Diagnosing pulmonary embolism with clinical assessment, d‐dimer, venous ultrasound and helical computed tomography: a multicenter management study.Am J Med. 2003; Google Scholar]. Specificity was 95% (95% CI: 89–98) but positive predictive value was only 75% (95% CI: 51–91), which does not support the use of the d‐dimer/fibrinogen ratio to rule in PE. Previous studies have tried to assess the possibility of using elevated d‐dimer thresholds to rule in PE. In a management study including 671 outpatients suspected of PE, Perrier et al. showed that at a cut‐off of 4000 µg L−1the specificity of the test was 93.1% [7Perrier A. Desmarais S. Goehring C. De Moerloose P.h. Morabia A. Unger P.F. Slosman D. Junod A. Bounameaux H. d‐dimer testing for suspected pulmonary embolism.Am J Respir Crit Care Med. 1997; 156: 492-6Crossref PubMed Scopus (260) Google Scholar]. Posterior analysis of these data [8Bounameaux H. De Moerloose P.h. Perrier A. Miron M.J. d‐dimer testing in suspected venous thromboembolism: an update.Q J Med. 1997; 90: 437-42Crossref Scopus (152) Google Scholar] suggested that an outpatient clinically suspected of PE who presents with a d‐dimer level > 4000 µg L−1has a likelihood ratio of 5 of having PE, which may be sufficient to initiate anticoagulant treatment before objective confirmation of the disease, at least in patients with intermediate clinical probability of PE. To our knowledge, there is no other study based on a large cohort that could confirm the fact that a very elevated d‐dimer value can predict the disease. Therefore, we retrospectively analyzed the data of two prospective studies including outpatients with suspected PE to assess whether adopting high d‐dimer thresholds might allow to obtain a positive predictive value as high as that described by Kucher et al. using the d‐dimer/fibrinogen ratio. We also evaluated the specificity and positive predictive value of high d‐dimer thresholds in the subgroup of high clinical probability patients. The original studies [2Perrier A. Desmarais S. Miron M.J. De Moerloose P.h. Lepage R. Slosman D. Didier D. Unger P.F. Patenaude J.V. Bounameaux H. Non‐invasive diagnosis of venous thromboembolism in outpatients.Lancet. 1999; 353: 190-5Abstract Full Text Full Text PDF PubMed Scopus (770) Google Scholar, 5Perrier A. Roy P.M. Aujesky D. Chagnon I. Howarth N. Gourdier A.L. Leftheriotis G. Bargouth G. Cornuz J. Hayoz D. Bounameaux H. Diagnosing pulmonary embolism with clinical assessment, d‐dimer, venous ultrasound and helical computed tomography: a multicenter management study.Am J Med. 2003; Google Scholar] took place in Angers, Lausanne, Montreal and Geneva and included 1409 patients. However, as both studies used a 500 µg L−1cut‐off to exclude venous thromboembolism, quantitative results of d‐dimer >1000 µg L−1were available only in Montreal and Geneva, which reduced the available data for analysis to 874 patients. All patients underwent a sequential diagnostic work‐up including clinical probability assessment, a rapid quantitative ELISA d‐dimer test, and venous compression ultrasonography of the lower limbs if the d‐dimer level was above 500 µg L−1. Further tests were carried out when ultrasonography did not show a proximal DVT: ventilation‐perfusion lung scan in the first study, helical computed tomography scan in the second study. Finally, pulmonary angiography was performed only if the non‐invasive work‐up was inconclusive in high clinical probability patients. The prevalence of PE was 22% (192/874). Patients were categorized as low clinical probability (526/874, 60%) intermediate clinical probability (284/874, 33%) and high clinical probability (64/874, 7%). Specificity and positive predictive value are shown in Table 1. These results are disappointing: even if increasing the cut‐off of d‐dimer progressively increases specificity, the positive predictive value reaches 81% in the best of cases. Moreover, in this cohort, although the specificity of d‐dimer for a cut‐off value of 7000 µg L−1is 99% (95% CI: 98–99), the positive predictive value is only 80% (95% CI: 68–88). Moreover, the proportion of patients with d‐dimer level above that threshold is low (5% of all patients), limiting the clinical usefulness of such a diagnostic criterion. Therefore, ruling in PE by elevated d‐dimer levels is inaccurate and of limited clinical usefulness, as few patients have such high d‐dimer values. Moreover, clinicians may feel quite uncomfortable in ruling in PE without using any imaging technique.Table 1Effect of varying the d‐dimer cut‐off value on the test's characteristics in 874 patientsd‐dimer cut‐offvalue (µg L−1)Specificity, % (95% CI)Positive predictive value, % (95% CI)False positive d‐dimer, nd‐dimer abovecut‐off value, n(%)100070 (67–73)46 (42–52)205372 (43)200088 (86–91)61 (54–67)80205 (24)300093 (91–95)68 (60–75)49152 (17)400096 (94–97)72 (63–80)29103 (12)500097 (97–99)76 (66–84)2084 (10)600098 (98–99)80 (68–88)1260 (7)700099 (98–99)81 (68–91)844 (5)800099 (98–100)81 (66–91)737 (4)900099 (99–100)78 (61–89)732 (4)10 00099 (99–100)75 (61–91)525 (3) Open table in a new tab Combining elevated d‐dimer levels and high clinical probability should theoretically improve both specificity and positive predictive value of the test [9Linkins L.A. Bates S.M. Ginsberg J.S. Kearon C. Use of different d‐dimer levels to exclude venous thromboembolism depending on clinical pretest probability.J Thromb Haemost. 2003; 1: OCGoogle Scholar]. This is confirmed by our data as, in this subgroup of patients, a 100% (95% CI: 83–100) value of specificity and a 100% (95% CI: 87–100) value of positive predictive value are reached at the much lower cut‐off level of 4000 µg L−1. However, owing to the small number of patients, 95% confidence intervals are quite large and do not allow firm recommendations. Moreover, high clinical probability patients represent only 7.2% of our cohort and only 26 such patients (3%) have d‐dimer levels >4000 µg L−1. In conclusion, using a higher d‐dimer threshold to rule in PE is inaccurate and cannot be recommended, even in patients with a high clinical probability of having the disease. In our hands, the d‐dimer/fibrinogen ratio described by Kucher et al. did not fulfil its promise and its value should be confirmed in a larger patient population before being used in routine diagnostic algorithms." @default.
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• W1987787364 title "Potential role of d‐dimer to rule in pulmonary embolism: a rebuttal" @default.
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