PACMAN-AMI
Trial question
What is the effect of adding alirocumab to high-intensity statin therapy in patients with acute MI?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
19.0% female
81.0% male
N = 300
300 patients (56 female, 244 male).
Inclusion criteria: adult patients undergoing PCI for acute MI.
Key exclusion criteria: left main or 3-vessel coronary artery disease; history of coronary artery bypass surgery; severe kidney dysfunction, liver disease, or known statin intolerance.
Interventions
N=148 alirocumab (subcutaneous dose of 150 mg biweekly).
N=152 placebo (subcutaneous administration of matching placebo biweekly).
Primary outcome
Reduction in atheroma volume at week 52
2.13%
0.92%
2.1 %
1.6 %
1.1 %
0.5 %
0.0 %
Alirocumab
Placebo
Significant
increase ▲
NNT = 82
Significantly greater reduction in atheroma volume at week 52 (2.13% vs. 0.92%; AD 1.21%, 95% CI 0.65 to 1.78).
Secondary outcomes
Significantly greater reduction in maximum lipid core burden index within 4 mm (79.42 vs. 37.6; AD 41.24 , 95% CI 11.77 to 70.71).
Significantly greater improvement in minimal fibrous cap thickness (62.67 um vs. 33.19 um; AD 29.65 um, 95% CI 11.75 to 47.55).
Safety outcomes
No significant difference in adverse events.
Conclusion
In adult patients undergoing PCI for acute MI, alirocumab was superior to placebo with respect to reduction in atheroma volume at week 52.
Reference
Lorenz Räber, Yasushi Ueki, Tatsuhiko Otsuka et al. Effect of Alirocumab Added to High-Intensity Statin Therapy on Coronary Atherosclerosis in Patients With Acute Myocardial Infarction The PACMAN-AMI Randomized Clinical Trial. JAMA. 2022 May 10;327(18):1771-1781.
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