Key result
Adding PCSK9 inhibitors to statins increases fibrous cap thickness by ~25 μm versus placebo.
Why the study?
Do PCSK9 inhibitors improve coronary plaque phenotype and burden compared with placebo in patients on concomitant statin therapy?
Meta-Analysis (n=1,678)
Do PCSK9 inhibitors improve coronary plaque phenotype and burden compared with placebo in patients on concomitant statin therapy?
Mean Difference: 24.72 (95% CI 6.58–42.87)
p-value: p=0.008
Adding PCSK9 inhibitors to statin therapy significantly improves coronary plaque stability by increasing fibrous cap thickness and reducing atheroma volume.
Background Proprotein convertase subtilisin kexin type 9 inhibitors (PCSK9i) significantly reduce low-density lipoprotein cholesterol (LDL-C) levels and cardiovascular events. However, evidence regarding their effects on coronary plaque composition and morphology remains insufficiently characterised. Purpose To evaluate the effect of PCSK9i on coronary plaque phenotype and burden compared with placebo. Methods A comprehensive literature search was conducted across PubMed, Embase, and Cochrane until February 2025 to identify randomised controlled trials (RCTs) of PCSK9i versus placebo on coronary plaque characteristics using intravascular imaging and optic coherence tomography. All patients included in the studies were receiving concomitant statin therapy. A random-effects model was employed to pool mean differences (MDs) with their 95% confidence intervals (CIs). Heterogeneity was assessed using the I² statistic. R version 4.4.2 and TSA version 0.9.5.10 beta were used for statistical analyses. Results Our analysis included 6 RCTs comprising 1,678 patients, of whom 847 (50,4%) were randomised to PCSK9i. Mean age ranged from 56.7 to 61.3 years, and 1,246 (74.5%) were male. Treatment with PCSK9i increased the minimum fibrous cap thickness (FCT) (MD 24.72 μm; 95% CI 6.58 μm to 42.87 μm; P = 0.008; Figure 1A) when compared with placebo. Moreover, there was a significant reduction in the PAV (MD -1.08%; 95% CI -1.29% to -0.87%; P < 0.001; Figure 1B). TSA indicates that the observed effect in the endpoints of minimum FCT and PAV regression can be deemed conclusive, with a low risk of type 1 error. Conclusions This meta-analysis of RCTs demonstrates that adding PCSK9 inhibitors to statin therapy significantly reduces percent atheroma volume and increases minimum fibrous cap thickness.
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Oliveira et al. (2025) conducted a meta-analysis in coronary plaque (n=1,678). PCSK9 inhibitors vs. placebo was evaluated on minimum fibrous cap thickness (FCT) (MD 24.72 μm, 95% CI 6.58 to 42.87, p=0.008). Adding PCSK9 inhibitors to statin therapy significantly increased minimum fibrous cap thickness (MD 24.72 μm; P=0.008) and reduced percent atheroma volume (MD -1.08%; P<0.001) compared with placebo.
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