Safety and efficacy of gadofosveset-enhanced MR angiography for evaluation of pedal arterial disease: multicenter comparative phase 3 study.

Abstract

The purpose of this study was to evaluate the safety and efficacy of gadofosveset, a gadolinium-based albumin-binding MRI contrast agent, in patients with pedal arterial disease. A total of 185 adult patients with known or suspected pedal arterial disease were randomized in a group receiving 0.03 mmol/kg and a group receiving 0.05 mmol/kg of gadofosveset for MR angiography of the pedal arteries. Gadofosveset-enhanced and unenhanced time-of-flight MR angiograms were compared with conventional angiograms, the standard of reference, for the presence of vascular stenosis. All patients underwent drug safety analysis. For each of three blinded readers, the specificity (21-35%) of gadofosveset-enhanced MR angiography was a statistically significant (p < 0.010) improvement over that of unenhanced MR angiography in the detection of clinically significant (> 50%) stenosis. The sensitivities of the two techniques were similar. For all blinded readers of MR angiograms, sensitivity, specificity, and accuracy were higher with use of the 0.03-mmol/kg dose of gadofosveset than with the 0.05-mmol/kg dose. In the 0.03-mmol/kg group, 28% of patients reported a total of 50 adverse events, 96% of which were reported as mild or moderate. In the 0.05-mmol/kg group, 28% of patients reported a total of 55 adverse events, 98% of which were reported as mild or moderate. No patients died; one patient left the study because of myocardial infarction considered unrelated to the study drug. Because of markedly better efficacy than no contrast agent and a minimal and transient side-effect profile, 0.03 mmol/kg of gadofosveset was found safe and effective for MR angiography of patients with pedal arterial disease.