Alirocumab improves coronary plaque burden in asymptomatic patients with FH
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Key takeaways:
- Alirocumab plus high-intensity statin therapy improved coronary plaque burden in patients with familial hypercholesterolemia and no atherosclerotic CVD.
- Coronary plaque characteristics were also improved.
PCSK9 inhibition with alirocumab, on top of high-intensity statin therapy, resulted in significant coronary plaque regression among patients with familial hypercholesterolemia and no clinical atherosclerotic CVD, researchers reported.
The results of the phase 4, open-label, multicenter, single-arm ARCHITECT study were published in Circulation.
Data were derived from Pérez de Isla L, et al. Circulation. 2023;doi:10.1161/CIRCULATIONAHA.122.062557.
“Despite the use of statins and other lipid-lowering therapies, patients with familial hypercholesterolemia continue to have a high prevalence of ASCVD. PCSK9 inhibitors have shown a significant reduction in lipid levels in these patients,” Leopoldo Pérez de Isla, PhD, of the cardiology department at Clinico San Carlos University Hospital in Madrid, and colleagues wrote. “The aim of the ARCHITECT study ... was to assess the changes in coronary plaque burden and its characteristics of intensive lipid-lowering therapies with alirocumab by quantification and characterization of atherosclerotic plaque throughout the coronary tree on the basis of analysis of coronary CTA in asymptomatic subjects with familial hypercholesterolemia receiving optimized and stable treatment with maximum tolerated statin dose with or without ezetimibe.”
The ARCHITECT study enrolled 104 patients with familial hypercholesterolemia (FH) and no clinical ASCVD taking subcutaneous alirocumab 150 mg (Praluent, Sanofi/Regeneron) every 14 days on top of high-intensity statin therapy for 78 weeks (median age, 53.3 years; 52% women; 86% on ezetimibe). Participants underwent coronary CTA at baseline and again at 78 weeks.
The primary outcome was change in coronary plaque burden at 78 weeks.
The median LDL level in the cohort was 138.9 mg/dL at baseline and 45 mg/dL at 78-week follow-up (P < .001), translating to a change in coronary plaque burden of 34.6% at entry to 30.4% at follow-up (P < .001).
The researchers also observed a significant increase in the proportion of calcified plaque (0.3%; P < .001) and mainly fibrous plaque (6.2%; P < .001) as well as a decrease in fibrofatty plaque (–3.9%; P < .001) and necrotic plaque (–0.6%; P < .001).
“The findings of our study suggest that vulnerable plaques might regress and be stabilized in patients with FH. This should further motivate both patients and health care professionals to strive for early implementation of the most effective lipid-lowering regimens to lower their high risk of future cardiovascular events,” the researchers wrote. “We still do not have a long enough follow-up of these patients to draw conclusions, but we must consider the parallelism that exists in other population groups between the effect of alirocumab and evolocumab (Repatha, Amgen) on coronary plaques (regression) and the reduction in clinical events. Therefore, we believe that we can anticipate a clinical benefit in the future follow-up of these patients.”
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