Research article
Alirocumab and Coronary Atherosclerosis in Asymptomatic Patients with Familial Hypercholesterolemia: The ARCHITECT Study
- Single-arm clinical trial
- phase IV
- open-label
- multicentre
Authors' conclusion
Treatment with alirocumab in addition to high-intensity statin therapy resulted in significant regression of coronary plaque burden and plaque stabilization on coronary computed tomographic angiography over 78 weeks in these groups of patients with familial hypercholesterolemia without clinical atherosclerotic cardiovascular disease.
Study context
- Population
- Asymptomatic patients with familial hypercholesterolemia without clinical atherosclerotic CVD, on maximum tolerated statin dose with or without ezetimibe104 completed
- Comparison
- Alirocumab added to high-intensity statin therapy, 78 weeks vs baseline
- Outcome
- Change in coronary plaque burden and characteristics on coronary CT angiography
- Follow-up
- 78 weeks
Main finding
As reported in the abstract
Coronary plaque burden
P < 0.001
- Increase in calcified plaque proportion
- +0.3%; P<0.001
- Increase in mainly fibrous plaque proportion
- +6.2%; P<0.001
- Decrease in fibro-fatty plaque percentage
- −3.9%; P<0.001
- Decrease in necrotic plaque percentage
- −0.6%; P<0.001
Further findings
LDL-C · 78 weeks
P < 0.001
Original publication
Alirocumab and Coronary Atherosclerosis in Asymptomatic Patients with Familial Hypercholesterolemia: The ARCHITECT Study. Circulation. Published 3 April 2023. doi:10.1161/circulationaha.122.062557
Summarised from the published abstract; every number is checked against it