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

Objective: 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.

Subjects And Methods: 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.

Results: 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.

Conclusion: 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.