Skip to main content

Table 2 Diagnostic criteria for VTE

From: CATCH: a randomised clinical trial comparing long-term tinzaparin versus warfarin for treatment of acute venous thromboembolism in cancer patients

  VTE before randomisation Recurrent VTE after randomisation
Symptomatic VTE • All patients must have diagnostic imaging performed of both legs and the lungs in order to determine baseline presence or absence of DVT or PE. • Standard objective imaging is required to diagnose recurrent VTE. If there are symptoms from the leg(s) AND lungs, objective imaging is required for both sites.
• Diagnostic imaging results for DVT: • Diagnostic imaging results for recurrent DVT:
 - A non-compressible venous segment of the proximal deep veins in the legs, including iliac, femoral and popliteal veins.  - A non-compressible venous segment of the deep veins (proximal and/or distal) in the legs that had normal compression at baseline.
 - An intraluminal filling defect on venography, CT scan or MR venography of the proximal deep veins in the leg.  - A new or extension of 5 cm or greater of intraluminal filling defect on venography, CT scan or MR venography of the deep veins in the leg, including inferior vena cava.
• Diagnostic imaging results for PE:  - An extension of non-visualisation of the deep veins of the leg in the presence of a sudden cut-off on venography, CT scan or MR venography.
 - An intraluminal filling defect on CT pulmonary angiography. • Diagnostic imaging results for recurrent PE:
 - A perfusion defect of at least 75% of a segment with a local normal ventilation result (mismatch defect) on ventilation-perfusion lung scintigraphy (high-probability scan).  - A new or extension of an existing intraluminal filling defect on CT pulmonary angiography.
 - A non-high, non-diagnostic ventilation-perfusion lung scan with confirmed DVT.  - A new sudden cut-off of vessels more than 2.5 mm in diameter on CT pulmonary angiography.
   - A new perfusion defect of at least 75% of a segment with a local normal ventilation result (mismatch defect) on ventilation-perfusion lung scintigraphy (high-probability scan).
 - A non-high, non-diagnostic ventilation-perfusion lung scan with confirmed DVT.
• Diagnostic criteria for fatal PE:
 - Objective testing as above associated with death.
 - Autopsy finding of PE contributing to death.
 - Sudden and unexplained death within the 6-month study period which cannot be attributed to a documented cause and for which PE is the most probable cause.
Incidental VTE • Not valid as an inclusion criterion. • Incidental PE or DVT are defined as thrombi that were reported during imaging testing performed for reasons other than for suspected PE or DVT.
• Diagnosis of incidental VTE during the required baseline imaging represents the baseline status. • The same diagnostic imaging criteria for recurrent DVT or PE apply to confirming the presence of an incidental DVT or PE.
• Incidental DVT is only included as an outcome if located in the popliteal or more proximal leg veins.
• Incidental PE is only included as an outcome if located in segmental or more proximal pulmonary arteries.
   • In patients with incidental PE involving subsegmental pulmonary arteries only, a compression ultrasound showing a new DVT is necessary to confirm a recurrent thrombotic event.