Imaging RCT · JACC Cardiovasc Imaging 2022
HUYGENS trial
Effect of Evolocumab on Coronary Plaque Phenotype and Burden in Statin-Treated Patients Following Myocardial Infarction.
The bottom line
Adding evolocumab to statin therapy after NSTEMI led to greater regression and stabilization of coronary plaque on imaging (thicker fibrous caps, smaller lipid cores, less plaque burden) compared with placebo.
Plaque regression / favourable changeUS status: US-approved
At a glance
- Medicine
- Monthly evolocumab 420 mg plus statin
- Compared with
- Placebo (on background statin)
- People
- 161
- Who took part
- Patients with non-ST-segment elevation myocardial infarction, on statin therapy; age 60.5 ± 9.6 years; 28.6% women; baseline LDL-C 141.3 ± 33.1 mg/dL
- Design
- Randomized, (implied double-blind), placebo-controlled imaging trial
- Follow-up
- 52 weeks
- Main question
- Change in minimum fibrous cap thickness and maximum lipid arc throughout the imaged arterial segment (OCT)
Main result
Evolocumab vs placebo: minimum fibrous cap thickness +42.7 vs +21.5 μm (P = 0.015); maximum lipid arc -57.5° vs -31.4° (P = 0.04)
Effect on LDL cholesterol
Evolocumab group achieved LDL-C 28.1 mg/dL vs 87.2 mg/dL with placebo; P < 0.001
Other results
Greater regression of percent atheroma volume was observed with evolocumab compared with placebo (-2.29% ± 0.47% vs -0.61% ± 0.46%; P = 0.009). Groups did not differ regarding changes in microchannels or calcium.
Safety
Safety and tolerability were evaluated (no specific adverse event data reported in abstract).
In the trial's own words
“The evolocumab group demonstrated a greater increase in minimum fibrous cap thickness (+42.7 vs +21.5 μm; P = 0.015) and decrease in maximum lipid arc (-57.5o vs. -31.4o; P = 0.04) and macrophage index (-3.17 vs -1.45 mm; P = 0.04) throughout the arterial segment.”
Quoted from the abstract of JACC Cardiovasc Imaging 2022, checked word for word against PubMed. PubMed 35431172 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Evolocumab (Repatha) and alirocumab (Praluent)
Common questions
What did the HUYGENS trial find?
Adding evolocumab to statin therapy after NSTEMI led to greater regression and stabilization of coronary plaque on imaging (thicker fibrous caps, smaller lipid cores, less plaque burden) compared with placebo.
Who was in HUYGENS?
161 people. Patients with non-ST-segment elevation myocardial infarction, on statin therapy; age 60.5 ± 9.6 years; 28.6% women; baseline LDL-C 141.3 ± 33.1 mg/dL.
What was HUYGENS's main result?
Evolocumab vs placebo: minimum fibrous cap thickness +42.7 vs +21.5 μm (P = 0.015); maximum lipid arc -57.5° vs -31.4° (P = 0.04)
How much did LDL cholesterol change in HUYGENS?
Evolocumab group achieved LDL-C 28.1 mg/dL vs 87.2 mg/dL with placebo; P < 0.001
Related trials
- FOURIER-OLE (2022)Long-term evolocumab treatment after FOURIER maintained very low LDL-C with a persistently favorable safety profile over more than 8 years, and earlier initiation of evolocumab was associated with fewer cardiovascular events, including cardiovascular death, compared with delayed treatment start.
- PACMAN-AMI (2022)Adding alirocumab to high-intensity statin therapy after acute MI led to significantly greater regression of coronary plaque burden, lipid content, and thickening of fibrous caps over 52 weeks, with similar adverse event rates to placebo.
- LIBerate-HeFH (2023)In patients with heterozygous familial hypercholesterolaemia needing more LDL-C lowering, adding monthly subcutaneous lerodalcibep to therapy produced a large, highly significant LDL-C reduction versus placebo over 24 weeks with a safety profile similar to placebo aside from mild injection site reactions.
- MK-0616 phase 2b (2023)In this phase 2b trial, the oral PCSK9 inhibitor MK-0616 produced large, dose-dependent LDL-C reductions compared with placebo and was well tolerated over 8 weeks of treatment plus 8 weeks of follow-up.
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