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

Abstract

Objective The Effect of Lipid Modification on Peripheral Artery Disease after Endovascular Intervention Trial (ELIMIT), a prospective double-blind randomized study, was designed to determine the effects of triple-drug lipid modification therapy versus mono-therapy over 24 months on the progression of atherosclerosis in the distal superficial femoral artery (SFA), as assessed by 3.0T magnetic resonance imaging (MRI). Methods A total of 102 patients were randomized to either mono-therapy with simvastatin (40 mg daily) or triple-therapy with simvastatin (40 mg daily), extended-release niacin (1500 mg daily), and ezetimibe (10 mg 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.

Magnetic resonance imaging-based computational modelling of blood flow and nanomedicine deposition in patients with peripheral arterial disease

“…ELIMIT was a double-blind and double-placebo-controlled trial in PAD patients with the goal of studying the efficacy of intensive lipid-modifying triple therapy (simvastatin, ezetimibe and extended-release niacin) versus standard lipid-modifying mono-therapy (simvastatin) on the progression of atherosclerosis in the SFA as quantified by high-resolution MRI. The main findings of ELIMIT have been reported previously [30]. Briefly, patients underwent MRI of the distal SFA at baseline, six months, 12 months and 24 months with a 3.0 T system (Signa Excite; GE Healthcare, Milwaukee, WI, USA) using a unilateral phased array coil with a FOV of 8 cm (along the z-axis) and 12 cm (in-plane x-and y-axes; Pathway Biomedical, Inc.).…”

“…21 . Serial MRI scans were carefully coregistered across follow-up visits using anatomical landmarks (artery, vein and muscle) [30]. Velocity profiles over the cardiac cycle were obtained at each location using the luminal crosssectional areas (region of interest (ROI)), the mean signal intensity of the ROIs and the VENC factor.…”

“…The geometries for the current analysis were extracted from proton-density-weighted (PDW) fast spinecho scans. Sequence parameters of the PDW scans were described previously [30]. ELIMIT participants were also imaged using gated two-dimensional PC sequences, acquired at select locations within the corresponding PDW volumes-typically proximally and distally to SFA lesions.…”

“…The MRI data used in this analysis were obtained from the Effect of Lipid Modification on Peripheral Artery Disease after Endovascular Intervention Trial (ELIMIT) [30]. ELIMIT was a double-blind and double-placebo-controlled trial in PAD patients with the goal of studying the efficacy of intensive lipid-modifying triple therapy (simvastatin, ezetimibe and extended-release niacin) versus standard lipid-modifying mono-therapy (simvastatin) on the progression of atherosclerosis in the SFA as quantified by high-resolution MRI.…”

“…However, the study of atherosclerosis in lower extremity vessels, including the superficial femoral artery (SFA), presents various MRI challenges, due to potential involuntary muscle twitching causing motion artefacts, vessel calibre and tortuosity [30]. Although recent advances in coil technology allow full coverage of the SFA, sampling a large enough field of view (FOV) remains challenging in the domain of high-resolution plaque imaging.…”