Imaging RCT · JAMA 2022
PACMAN-AMI trial
Effect of Alirocumab Added to High-Intensity Statin Therapy on Coronary Atherosclerosis in Patients With Acute Myocardial Infarction: The PACMAN-AMI Randomized Clinical Trial.
The bottom line
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.
Plaque regression / favourable changeUS status: US-approved
At a glance
- Medicine
- Biweekly subcutaneous alirocumab (150 mg; n=148) added to high-intensity statin therapy (rosuvastatin, 20 mg), initiated less than 24 hours after urgent PCI of the culprit lesion, for 52 weeks
- Compared with
- Placebo (n=152) added to high-intensity statin therapy (rosuvastatin, 20 mg)
- People
- 300
- Who took part
- Patients undergoing percutaneous coronary intervention for acute myocardial infarction at 9 academic European hospitals (mean [SD] age, 58.5 [9.7] years; 56 [18.7%] women; mean [SD] LDL-C level, 152.4 [33.8] mg/dL)
- Design
- double-blind, placebo-controlled, randomized clinical trial
- Follow-up
- 52 weeks
- Main question
- Change in IVUS-derived percent atheroma volume from baseline to week 52
Main result
Mean change in percent atheroma volume was -2.13% with alirocumab vs -0.92% with placebo (difference, -1.21% [95% CI, -1.78% to -0.65%], P < .001)
Effect on LDL cholesterol
''
Other results
Mean change in maximum lipid core burden index within 4 mm was -79.42 with alirocumab vs -37.60 with placebo (difference, -41.24 [95% CI, -70.71 to -11.77]; P = .006). Mean change in minimal fibrous cap thickness was 62.67 μm with alirocumab vs 33.19 μm with placebo (difference, 29.65 μm [95% CI, 11.75-47.55]; P = .001)
Safety
Adverse events occurred in 70.7% of patients treated with alirocumab vs 72.8% of patients receiving placebo
In the trial's own words
“At 52 weeks, mean change in percent atheroma volume was -2.13% with alirocumab vs -0.92% with placebo (difference, -1.21% [95% CI, -1.78% to -0.65%], P < .001).”
Quoted from the abstract of JAMA 2022, checked word for word against PubMed. PubMed 35368058 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Evolocumab (Repatha) and alirocumab (Praluent)
Common questions
What did the PACMAN-AMI trial find?
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.
Who was in PACMAN-AMI?
300 people. Patients undergoing percutaneous coronary intervention for acute myocardial infarction at 9 academic European hospitals (mean [SD] age, 58.5 [9.7] years; 56 [18.7%] women; mean [SD] LDL-C level, 152.4 [33.8] mg/dL).
What was PACMAN-AMI's main result?
Mean change in percent atheroma volume was -2.13% with alirocumab vs -0.92% with placebo (difference, -1.21% [95% CI, -1.78% to -0.65%], P < .001)
How much did LDL cholesterol change in PACMAN-AMI?
''
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.
- HUYGENS (2022)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.
- 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.
Get your LDL treated to a goal
Preval Health's protocols follow trials like this one. Licensed clinicians set your goal, prescribe and recheck until you reach it.
Get startedEducation only, not medical advice. Results describe the people in this trial and can differ for you. Talk with your clinician before starting or stopping any medicine. Back to all 106 trials.