Objectives: This trial assessed diagnostic accuracy of contrast-enhanced magnetic resonance angiography (MRA) with meglumine gadoterate (Gd-DOTA) at 3 Tesla (T) over unenhanced MRA at 3 T in non-coronary arterial diseases by comparing their accuracy with that of the gold standard, x-ray angiography.
Methods: Ninety-two patients with suspected non-coronary arterial disease underwent in fixed sequence unenhanced time-of flight (TOF) MRA, contrast-enhanced MRA using a Gd-DOTA bolus (intravenous bolus 0.1 mmol/kg) and x-ray angiography.
Results: Eighty-four patients (71 male, 13 female; median age 64.5 years) were included in an intent-to-treat efficacy analysis. Targeted vascular areas were aorto-iliac, calf, carotid, femoral, popliteal and renal. Within-patient accuracy was significantly higher with contrast-enhanced MRA using Gd-DOTA than with unenhanced MRA (p = 0.0003). There was 84.4 +/- 17.5% agreement between contrast-enhanced MRA (Gd-DOTA) and x-ray angiography, compared with 76.8 +/- 20.4% between non-enhanced MRA and x-ray angiography. Sensitivity and specificity were also better with Gd-DOTA compared with non-enhanced MRA at the segment level. Duration of the MRA procedure was 3.5 times shorter with Gd-DOTA compared with non-enhanced MRA. Six patients reported six mild or moderate adverse events. No serious adverse events occurred.
Conclusions: Contrast-enhanced MRA using Gd-DOTA at 3 T was superior to unenhanced TOF MRA in the vascular territories investigated.