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Effect of evolocumab in patients with chronic limb threatening ischemia (Evol-CLI study)
Ashwat S Dhillon1, Jorge Caro2, Jongkyu Choi2
1Division of Cardiovascular Medicine, Samaritan Health Services, Corvallis, OR, USA.
Insights
Evolocumab significantly reduced LDL cholesterol and improved vascular function in patients with chronic limb-threatening ischemia (CLTI) after revascularization. This treatment showed no adverse effects on wound healing, suggesting a potential benefit for cardiovascular and limb health.
Area of Science:
- Cardiovascular Medicine
- Vascular Biology
- Pharmacology
Background:
- Chronic limb-threatening ischemia (CLTI) poses a high risk for major adverse cardiac and limb events (MACLE).
- Evolocumab has demonstrated benefits in peripheral arterial disease (PAD) patients, including reduced MACLE and improved vascular parameters.
- This study focuses on the additive effects of evolocumab in CLTI patients undergoing revascularization and maximal lipid-lowering therapy.
Purpose of the Study:
- To evaluate the efficacy of adding evolocumab to maximally tolerated statin therapy in CLTI patients post-revascularization.
- To assess the impact of evolocumab on low-density lipoprotein cholesterol (LDL-C) levels.
- To investigate the effects of evolocumab on vascular function markers like flow-mediated dilation (FMD) and carotid intima-media thickness (IMT).
Main Methods:
- A double-blind, prospective, randomized, single-center, placebo-controlled study.
- Monthly administration of evolocumab or placebo for 6 months in CLTI patients on maximally tolerated statin therapy.
- Primary endpoint: LDL-C reduction at 6 months; Secondary endpoints: FMD and carotid IMT changes.
Main Results:
- Evolocumab significantly reduced LDL-C levels at 3 and 6 months compared to baseline (p=0.017).
- Placebo group showed no significant change in LDL-C.
- Evolocumab treatment led to improved brachial artery FMD and reduced carotid IMT at 6 months.
- No negative impact on wound healing was observed.
Conclusions:
- Evolocumab, when added to maximally tolerated statin therapy, effectively lowers LDL-C in CLTI patients.
- The addition of evolocumab improved vascular function (FMD) and reduced atherosclerosis markers (IMT).
- No adverse effects on wound healing were noted, indicating a favorable safety profile in this patient group.
Background:
Chronic limb-threatening ischemia (CLTI) is associated with increased risk of major adverse cardiac and limb events (MACLE). In patients with peripheral arterial disease (PAD), evolocumab is associated with decreased MACLE, improved maximal walking time, increased vascular flow-mediated dilation (FMD), and decreased carotid intima-media thickness (IMT). We investigated the additive effect of evolocumab in patients with CLTI on maximally tolerated lipid lowering therapy after an index revascularization for non-healing wounds.
Methods:
This double-blind, prospective, randomized, single-center, placebo-controlled study investigated the effect of monthly evolocumab for 6 months compared to placebo in patients with CLTI, with recent revascularization, and on maximally tolerated statin therapy. The primary endpoint was the reduction of low-density lipoprotein cholesterol (LDL-C) at 6 months of therapy. Secondary endpoints included evaluation of FMD and carotid IMT.
Results:
N = 13 in the evolocumab arm and N = 14 in the placebo arm. The evolocumab arm had a lower mean LDL-C level at 3 months and 6 months compared to baseline (mean 82 mg/dL at baseline, 26 mg/dL at 3 months, and 34 mg/dL at 6 months, p = 0.017). The placebo arm had no significant difference in LDL-C at 3 and 6 months compared to baseline. Treatment with evolocumab resulted in increased FMD of the brachial artery and decrease in carotid IMT at 6 months. There was no deleterious effect on wound healing.
Conclusion:
Evolocumab was associated with a decrease in LDL-C, decreased carotid IMT, and improved FMD in CLTI patients who were on evolocumab therapy in addition to maximally tolerated statin. There was no adverse effect on wound healing with further reduction in LDL-C.
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