Abdominal and iliac arterial stenoses: comparative double-blinded randomized study of diagnostic accuracy of 3D MR angiography with gadodiamide or gadopentetate dimeglumine. - Université de Bretagne Occidentale Access content directly
Journal Articles Radiology Year : 2006

Abdominal and iliac arterial stenoses: comparative double-blinded randomized study of diagnostic accuracy of 3D MR angiography with gadodiamide or gadopentetate dimeglumine.

Frank P Boudghene
  • Function : Author
Hans J Brambs
  • Function : Author
Montserrat Bret-Zurita
  • Function : Author
Jose L Caniego
  • Function : Author
Richard A Coulden
  • Function : Author
Hans B Gehl
  • Function : Author
Renate Hammerstingl
  • Function : Author
Armin Huber
  • Function : Author
Ramiro J Mendez
  • Function : Author
Joerg W Oestmann
  • Function : Author
Jesus C Pueyo
  • Function : Author
Siegfried Thurnher
  • Function : Author
Dominik Weishaupt
  • Function : Author
Thomas Jahnke
  • Function : Author

Abstract

PURPOSE: To prospectively evaluate accuracy of gadolinium-enhanced three-dimensional (3D) magnetic resonance (MR) angiography with gadodiamide and gadopentetate dimeglumine (0.1 mmol/kg), with intraarterial DSA as reference standard, for imaging abdominal and iliac arterial stenoses. MATERIALS AND METHODS: The study was approved by all institutional review boards; informed consent was obtained from each subject before procedures. Two hundred forty-seven subjects were included; 240 received either contrast agent and were available for safety analysis; 222 were available for accuracy analysis. Enhanced 3D MR angiography and DSA were performed; image data were evaluated in a double-blinded randomized study. Stenoses were classified as not relevant (<50% stenosis) or relevant (> or =50%). For detection of main stenosis, accuracy with enhanced 3D MR angiography compared with that with DSA was determined. RESULTS: The difference in accuracy for imaging with gadodiamide and gadopentetate was 3.6%. Noninferiority was inferred because the lower bound of the exact two-sided 95% confidence interval was -10.1 and was above the noninferiority margin (-15%). Accuracy for detection of the main stenosis was low, 56.4% for gadodiamide and 52.8% for gadopentetate group. Subgroup analysis with exclusion of inferior mesenteric artery and internal iliac arteries and the most false-positive stenosis classifications yielded better results: 76.6% and 71.6%, respectively. Sensitivity, specificity, and negative and positive predictive values did not differ substantially between study groups. In the main analysis, values were 44%, 96%, 35%, and 97% for gadodiamide and 44%, 83%, 30%, and 90% for gadopentetate, respectively. In the subgroup analysis, values were 66%, 95%, 61%, and 96% for gadodiamide and 63%, 86%, 58%, and 88% for gadopentetate, respectively. CONCLUSION: Noninferiority of gadodiamide versus gadopentetate was verified based on the primary end point, which was accuracy for detection of the main stenosis with enhanced 3D MR angiography compared with DSA.
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Dates and versions

hal-00689041 , version 1 (19-04-2012)

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Philipp J Schaefer, Frank P Boudghene, Hans J Brambs, Montserrat Bret-Zurita, Jose L Caniego, et al.. Abdominal and iliac arterial stenoses: comparative double-blinded randomized study of diagnostic accuracy of 3D MR angiography with gadodiamide or gadopentetate dimeglumine.. Radiology, 2006, 238 (3), pp.827-40. ⟨10.1148/radiol.2383041769⟩. ⟨hal-00689041⟩
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