Background: The safety of a D-dimer (DD) measurement in cancer patients with clinically suspected pulmonary embolism (PE) is unclear.
Objectives: The aim of this study was to assess the accuracy of the DD test in consecutive patients with clinically suspected PE with and without cancer.
Methods: The diagnostic accuracy of DD (Tinaquant D-dimer) was first retrospectively assessed in an unselected group of patients referred for suspected PE (n = 350). Subsequently, the predictive value of the DD was validated in a group of consecutive inpatients and outpatients with clinically suspected PE prospectively enrolled in a management study (n = 519). The results of the DD test in cancer patients were assessed according to the final diagnosis of PE and the 3-month clinical follow-up.
Results: In the first study group, DD showed a sensitivity and a negative predictive value (NPV) of 100% and 100% in patients with cancer and 97% and 98% in those without malignancy, respectively. In the validation cohort, the sensitivity and NPV of DD were both 100% (95% CI 82%-100% and 72%-100%, respectively), whereas in patients without malignancy, the corresponding estimates were 93% (95% CI 87%-98%) and 97% (95% CI, 95%-99%), respectively. The specificity of DD was low in patients with (21%) and without cancer (53%).
Conclusions: A negative DD result safely excludes the diagnosis of PE in patients with cancer. Because of the low specificity, when testing 100 patients with suspected PE, a normal DD concentration safely excludes PE in 15 patients with cancer and in 43 patients without cancer.