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Diagnosis of Pulmonary Embolism by Multidetector CT Alone or Combined With Venous Ultrasonography of the Leg - Diagnosis of PE by MSCT Alone or Combined With Venous Ultrasonography of the Leg
Description:
The goal of the trial was to evaluate outcomes after evaluation for pulmonary embolus with D-dimer, multidetector computed tomography (CT), and lower extremity ultrasound compared with D-dimer and multidetector CT.
Hypothesis:
A strategy of D-dimer and multidetector CT will be noninferior in the diagnosis of pulmonary embolus.
Study Design
Study Design:
Patients Screened: 2,864
Patients Enrolled: 1,812
Mean Follow Up: 3 months
Mean Patient Age: 59 years
Female: 55
Patient Populations:
Patients ≥18 years of age, with suspected pulmonary embolus
Exclusions:
• Allergy to contrast dye
• Renal insufficiency
• Pregnancy
• Diagnosis of pulmonary embolus established and anticoagulation therapy initiated
• Patients unavailable or unwilling for follow-up
Primary Endpoints:
Change in proportion of venous thromboembolic events diagnosed 3 months after randomization
Secondary Endpoints:
Change in mortality
Drug/Procedures Used:
Patients with suspected pulmonary embolus, as assessed by the revised Geneva score, were randomized to D-dimer, CT, and lower extremity ultrasound (n = 916) or D-dimer and CT (n = 903). High-risk patients in either group could proceed to ventilation perfusion scintigraphy or pulmonary angiogram if initial testing was negative.
Concomitant Medications:
Patients were anticoagulated if diagnostic tests revealed evidence of pulmonary embolus.
Principal Findings:
The overall prevalence of pulmonary embolus was 21% in both groups. In the remaining patients who were not diagnosed with pulmonary embolus, the incidence of the primary outcome, venous thromboembolic events at 3 months of follow-up, was 0.3% in the D-dimer, ultrasound, and CT group, and 0.3% in the D-dimer and CT group (p > 0.99). There was no difference in the incidence of the primary outcome when the results were analyzed by intention-to-diagnosis or per-protocol analysis.
During follow-up, in the D-dimer, ultrasound, and CT group, there were 37 deaths (14 after confirmed pulmonary embolus), and in the D-dimer and CT group, there were 22 deaths (7 after confirmed pulmonary embolus).
Interpretation:
Among patients with suspected pulmonary embolus, evaluation with D-dimer and multidetector CT was safe and noninferior to D-dimer, multidetector CT, and lower extremity ultrasound. Both strategies led to the diagnosis of pulmonary embolus in 21% of cases. The diagnosis of venous thromboembolic events in the 3 months after evaluation was similar, at 0.3% in both groups.
The use of lower extremity ultrasound may not be necessary for all patients, except those with a contraindication to multidetector CT (for example, renal insufficiency) or high probability for pulmonary embolus in spite of initial negative testing.
References:
Righini M, Le Gal G, Aujesky D, et al. Diagnosis of pulmonary embolism by multidetector CT alone or combined with venous ultrasonography of the leg: a randomized non-inferiority trial. Lancet 2008;371:1343-52.
Keywords: Prevalence, Renal Insufficiency, Follow-Up Studies, Fibrin Fibrinogen Degradation Products, Pulmonary Embolism, Multidetector Computed Tomography, Probability, Perfusion Imaging
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