The Effect of Lipid Modification on Peripheral Artery Disease after Endovascular Intervention Trial (ELIMIT)

Methods: A total of 102 patients were randomized to either mono-therapy with simvastatin (40mg daily) or triple-therapy with simvastatin (40mg daily), extended-release niacin (1500mg daily), and ezetimibe (10mg daily). MRI was performed at baseline and 6, 12, and 24 months. SFA wall, lumen, and total vessel volumes were quantified. MRI-derived SFA parameters and lipids were analyzed with multilevel models and nonparametric tests, respectively. Results: Baseline characteristics did not differ between mono and triple-therapy groups, except for ethnicity ( p=0.02). SFA wall, lumen, and total vessel volumes increased non-significantly for both groups between baseline and 24-months. Non-high-density lipoprotein cholesterol was significantly reduced at 12 months with triple-therapy compared with mono-therapy ( p=0.01). Conclusion: No significant differences were observed between mono-therapy using simvastatin and triple-therapy with simvastatin, extended-release niacin, and ezetimibe for 24-month changes in SFA wall, lumen, and total vessel volumes. Clinical Trial Registration Information: NCT00687076; Link: http://clinicaltrials.gov/ct2/show/. NCT00687076.