J Am Heart Assoc. 2026 Apr 22:e047923. doi: 10.1161/JAHA.125.047923. Online ahead of print.
ABSTRACT
BACKGROUND: Combining PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors with statins significantly lowers low-density lipoprotein cholesterol and reduces cardiovascular events in patients with coronary heart disease versus statins alone. However, it remains unclear which monotherapy offers greater cardiovascular benefit.
METHODS: This prospective non-randomized real-world observational cohort study enrolled coronary heart disease inpatients from July 2020 to March 2024. Patients received either alirocumab (75 mg/2 weeks) or statins (atorvastatin 20 mg/day or rosuvastatin 10 mg/day). The primary outcome was a composite of cardiovascular death, myocardial infarction, stroke, heart failure hospitalization, or coronary revascularization. Cox proportional hazards models and restricted mean survival time analyses were used.
RESULTS: Among 1165 analyzed patients, 215 received PCSK9 inhibitors and 950 received statins. After 1 month, low-density lipoprotein cholesterol reduction was greater in the PCSK9 inhibitor group (from 2.57 to 0.75 mmol/L) than in the statin group (from 2.29 to 1.40 mmol/L; P<0.001). However, this difference was not significant at 12 months (1.44 versus 1.52 mmol/L; P=0.058). Multivariate Cox regression analysis revealed an adjusted hazard ratio of 0.74 (95% confidence interval, 0.49-1.12; P=0.152) for the primary outcome with statins versus PCSK9 inhibitors. The restricted mean survival time was 26.11 months for the PCSK9 inhibitor group and 26.48 months for the statin group. The results were consistent across key subgroups. No serious adverse events occurred during the follow-up.
CONCLUSIONS: PCSK9 inhibitor monotherapy showed no statistically significant difference from statin monotherapy in long-term lipid-lowering efficacy or cardiovascular risk reduction, suggesting it may be an effective alternative for secondary prevention in coronary heart disease.
PMID:42017316 | DOI:10.1161/JAHA.125.047923
