Combined D‐dimer and clinical probability are useful for exclusion of recurrent deep venous thrombosis

Abstract

It is estimated that up to one-third of patients with a history of deep venous thrombosis (DVT) present with symptoms of recurrent DVT. Our objective was to investigate both the diagnostic value of D-dimer (DD) and safety of a standard diagnostic algorithm including clinical assessment, plasma DD levels, and compression venous ultrasound as diagnostic tools in outpatients presenting with clinically suspected acute recurrent DVT of the lower limbs. We have enrolled 105 outpatients with a previous history of confirmed DVT and clinically suspected recurrent DVT. A 3-month follow-up period was carried out for patients in whom DVT was initially excluded. Prevalence of DVT in our study population was 44.8% (47/105). DD was negative in 17.1% of cases (18/105) and DVT could be ruled out in 15.2% of patients evaluated (16/105) on the basis of an unlikely clinical probability and a negative DD result. Only one false negative DD result in a patient scored as likely for DVT was found. Sensitivity, specificity, positive and negative predictive value of DD for the diagnosis of DVT were 97.9% (95% CI 88.9-99.6%), 29.3% (95% CI 19.2-42.0%), 52.9% (95% CI 42.5-63.0) and 94.4% (95% CI 74.2%-99.0), respectively. Sensitivity was 100% (95% CI 75.7-100) in the group of patients in whom DVT was considered unlikely. A diagnostic strategy combining clinical evaluation and DD has proved to be useful for the exclusion of DVT in subjects with clinically suspected recurrent DVT, especially in patients included in the lower clinical pretest probability group. Am. J. Hematol. 82:41-44, 2007. V V C 2006 Wiley-Liss, Inc.

Diagnosis of DVT

“…Tables 7 and 8 summarize the quality of evidence and frequency of potential clinical outcomes for the various diagnostic strategies. [160][161][162][163][164][165][166][167][168] …”

“…Five prospective cohort management studies have reported results for strategies involving D-dimer testing in patients with suspected recurrent DVT. 32,165,[167][168] In two studies in which a negative sensitive D-dimer was used either in combination with an unlikely pretest probability using the modifi ed Wells model (n 5 16 patients) 167 or a CUS at presentation that was either normal or showed an increase in residual diameter of , 4 mm (n 5 75) 166 to exclude recurrence, no patients experienced VTE during 3 months of follow-up. However, the fi rst strategy may have limited usefulness, as the combination of D-dimer and pretest probability assessment was able to exclude recurrence in only 15% of patients.…”

“…However, the fi rst strategy may have limited usefulness, as the combination of D-dimer and pretest probability assessment was able to exclude recurrence in only 15% of patients. 167 Two larger prospective cohort studies suggest that negative results of sensitive assays exclude DVT in outpatients with suspected recurrent DVT (false-negative frequencies of 2% 165 and 5% 168 ). In a randomized trial of 1,096 outpatients with suspected DVT, of whom 102 had prior VTE, the combination of an unlikely pretest probability (using the modifi ed Wells model) and negative D-dimer (either moderate or high sensitivity) had a frequency of VTE during 3-month follow-up of 0.9% (95% CI, 0.3%-3.3%).…”

D-Dimer Assays in Diagnosis and Management of Thrombotic and Bleeding Disorders

“…Five prospective cohort management studies have reported results for strategies involving D-dimer testing in patients with suspected recurrent DVT. 19,[47][48][49][50] In a randomized trial of 1,096 outpatients with suspected DVT, of whom 102 had prior VTE, 19 the combination of an unlikely pretest probability (using the modified Wells model, which includes a history of previous VTE as one of the factors used to determine clinical probability) and negative D-dimer (either moderate or high sensitivity) had a frequency of VTE during 3-month follow-up of 0.9% (95% CI, 0.3 to 3.3%); however, results for the 102 patients with suspected recurrence were not presented separately. In two studies in which a negative sensitive D-dimer was used either in combination with an unlikely pretest probability using the modified Wells model 48 or a compression ultrasound at presentation that was either normal or showed an increase in residual diameter of less than 4 mm 49 to exclude recurrence, no patients experienced VTE during 3 months of follow-up.…”

“…However, the first strategy may have limited utility as the combination of a negative D-dimer and unlikely pretest probability occurred in only 15% of patients. 48 Two larger prospective cohort studies suggest that negative results with highly sensitive assays exclude DVT in outpatients with suspected recurrent disease. 47,50 …”