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Review
. 2024 Oct 4;76(1):135.
doi: 10.1186/s43044-024-00567-2.

Safety and efficacy of PCSK9 inhibitors and effect on coronary plaque phenotype in statin-treated patients following acute coronary syndrome: a systematic review and meta-analysis

Dennis Ievan Hakim #  1 , Faqrizal Ria Qhabibi #  2   3 , Muhammad Yusuf  1 , Nasim Amar  1 , Indra Prasetya  4 , Ade Meidian Ambari  5
Affiliations
Review

Safety and efficacy of PCSK9 inhibitors and effect on coronary plaque phenotype in statin-treated patients following acute coronary syndrome: a systematic review and meta-analysis

Dennis Ievan Hakim et al. Egypt Heart J. .

Abstract

Background: Acute coronary syndrome continues to be a significant cardiovascular issue. Statins are commonly acknowledged as medications that reduce LDL-C levels and stabilize plaques. Nevertheless, their efficacy is limited. Presently, PCSK9 inhibitors are suggested to be advantageous in patients who are already receiving statin treatment. The study seeks to assess the safety and effectiveness of PCSK9 inhibitors in individuals who have been treated with statins after experiencing acute coronary syndrome (ACS), as well as investigate the impact on the characteristics of coronary plaque.

Methods: Articles were identified from PubMed, Cochrane Central Register of Controlled Trials, and ProQuest. Our analysis comprised trials and observational studies that compared the plaque phenotype, lipid profile, and safety outcomes between PCSK9 inhibitors and a control group in patients with acute coronary syndrome who were already being treated with statins. The random-effect model was used to measure the pooled effect, which was presented in terms of mean difference, standardized mean difference, and risk ratio.

Results: Acquired 12 studies that fulfilled our criteria. The addition of PCSK9 inhibitors ameliorates the plaque phenotype significantly in terms of percent atheroma volume (P = 0.02), total atheroma volume (P < 0.010), fibrous cap thickness (P < 0.00001), lipid arc (P < 0.00001), quantitative flow ratio (P = 0.003), and diameter of stenosis (P = 0.0003) but not in lipid/lesion length (P = 0.17). The administration of PCSK9 inhibitors led to a considerable improvement in all lipid profiles (P < 0.00001). Regarding safety analysis, there is no substantial disparity in the likelihood of non-serious side events (RR 1.21; P = 0.2), however, a significant reduction in the risk of serious adverse effects (RR 0.77; P = 0.04) in the PCSK9 inhibitor group.

Conclusions: The addition of PCSK9 inhibitors compared to statin-only treatment led to a majority of patients experiencing significant benefits in terms of safety and efficacy following ACS.

Keywords: Acute coronary syndrome; Atherosclerosis; LDL-C; Proprotein convertase subtilisin/kexin type 9; Statin.

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Conflict of interest statement

All authors and contributors (DIH, FRQ, MY, NA, IP, AMA) to the study declare no conflict of interest.

Figures

Fig. 1
Fig. 1
Diagram of study selection using PRISMA flowchart
Fig. 2
Fig. 2
Quality assessment of the risk of bias assessment of 9 controlled trials and 3 observational studies (cohort)
Fig. 3
Fig. 3
Forest plots illustrate the effects of PCSK9 additions in statin-treated ACS patients on plaque phenotype between baseline and follow-up. (A: Percent Atheroma Volume (PAV); B: Total Atheroma Volume (TAV); C: Fibrous Cap Thickness (FCT); D: Lipid Arc (LA); E: Quantitative Flow Ration (QFR); F: Diameter of Stenosis (DoS); G: Lipid/Lesion Length)
Fig. 4
Fig. 4
Forest plot of lipid profile amelioration in comparing between population with PCSK9 inhibitor and statin vs. population with statin medication only
Fig. 5
Fig. 5
Forest plots illustrate the effects of PCSK9 additions in statin-treated ACS patients on adverse effects. (A: Non-Serious Adverse Effects; B: Serious Adverse Effects)
Fig. 6
Fig. 6
Forest plot of leave-one-out method for sensitivity analysis
See this image and copyright information in PMC

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