Effects of Early Alirocumab Plus Statin Therapy on Lipid Control and Vascular Endothelial Function After PCI in Patients With Coronary Artery Disease

Q: What are the key findings of this study?

Early alirocumab plus statin therapy after PCI achieved greater 8-week LDL-C reduction (to 1.120 vs 1.435 mmol/L, P=0.001) and FMD improvement (to 6.95% vs 6.3%, P=0.013) than statin monotherapy.

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Coronary artery disease undergoing percutaneous coronary intervention (PCI) (n=62). Intervention: Alirocumab plus statin therapy vs. Statin monotherapy (lipid-lowering regimen without a PCSK9 inhibitor). Primary outcome: Low-density lipoprotein cholesterol (LDL-C, mmol/L) at 8 weeks (co-primary with brachial artery FMD) (p=0.001).

Q: What does this research mean for the field?

Early initiation of alirocumab combined with statin therapy after percutaneous coronary intervention results in greater reductions in atherogenic lipid levels and improves vascular endothelial function compared to statin monotherapy. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Yixiong Qiao; Jiewen Lei; Yuwen Cao; Junbo Wei; Wenkun Bai; Junhong Zhou; Junxia Wu; Yongguang Li

doi:10.21203/rs.3.rs-11185127/v1

October 23, 2026Open Access

Effects of Early Alirocumab Plus Statin Therapy on Lipid Control and Vascular Endothelial Function After PCI in Patients With Coronary Artery Disease

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Key result

Alirocumab plus statin after PCI linked to greater LDL-C reduction and improved FMD vs statin alone.

P=0.001
n=62

Why the study?

This study aimed to compare the effects of early alirocumab injection plus statin therapy versus statin monotherapy on lipid control, vascular function, and short-term laboratory safety at 8 weeks after PCI in patients with coronary artery disease.

Does early alirocumab plus statin therapy improve LDL-C reduction and brachial artery flow-mediated dilation compared to statin monotherapy at 8 weeks in patients with coronary artery disease undergoing PCI?

Study Design

Type

Cohort (n=62)

Blinding

Open-label

Multicenter

No

Structured PICO

Does early alirocumab plus statin therapy improve LDL-C reduction and brachial artery flow-mediated dilation compared to statin monotherapy at 8 weeks in patients with coronary artery disease undergoing PCI?

P

Population

62 Chinese adults (mean age ~64.7 years, 27.4% female) with a first diagnosis of coronary artery disease undergoing PCI and <2 weeks of prior statin exposure, followed for 8 weeks.

E

Exposure

Subcutaneous alirocumab 75 mg or 150 mg every 2 weeks added to conventional lipid-lowering therapy (statin therapy) for 8 weeks (n=22)

C

Comparator

Conventional lipid-lowering regimen (statin monotherapy without a PCSK9 inhibitor) for 8 weeks (n=40); both groups received concomitant cardiovascular medications including antiplatelet agents, cholesterol absorption inhibitors, RAAS inhibitors, and beta-blockers per routine clinical care

O

Outcome

Change in low-density lipoprotein cholesterol (LDL-C) and brachial artery flow-mediated dilation (FMD, assessed in a 22-patient subgroup) from baseline to 8 weekssurrogate

Main Result

Absolute Event Rate: 1.12% vs 1.435%

p-value: p=0.001

In patients with coronary artery disease undergoing PCI, early initiation of alirocumab plus statin therapy achieved significantly greater 8-week reductions in atherogenic lipids (LDL-C, total cholesterol, ApoB) and was associated with improved endothelial function (FMD) and short-term laboratory safety compared with statin therapy alone.

Limitations

Nonrandomized single-center observational design vulnerable to confounding by indication and baseline imbalances in LDL-C and concomitant medications
Small sample size with only 22 patients (9 in the alirocumab group) having paired vascular ultrasonography measurements
Multiple correlated vascular outcomes tested without multiplicity correction
Incomplete exposure records regarding statin intensity, exact alirocumab dosing, and adherence
Short 8-week follow-up duration precluding assessment of clinical events or long-term safety
Nonrandomized single-center design vulnerable to confounding by indication, particularly given baseline LDL-C and concomitant-medication imbalances
Small vascular ultrasonography subgroup (only 22 patients had paired vascular measurements, including 9 alirocumab-treated patients) with undocumented reasons for missing follow-up
Multiple correlated vascular outcomes tested without multiplicity correction, making false-positive nominal P values plausible
Very small 8-week changes in QIMT and stiffness indices may reflect measurement variability rather than structural remodeling
Exposure records do not fully specify statin intensity, alirocumab dosing, and adherence, and the short follow-up precludes conclusions about clinical events or long-term safety

Ask about this paper

Answers are grounded in this paper and cite their sources.

Implication

Supports early post-PCI combination therapy for LDL-C and FMD; hypothesis-generating and requires randomized confirmation before practice change.

Abstract

Objective To compare the effects of early treatment with alirocumab injection (brand name: Praluent) plus statin therapy versus statin monotherapy on lipid control, vascular function, and short-term laboratory safety at 8 weeks after percutaneous coronary intervention (PCI) in patients with coronary artery disease. Methods This single-center observational cohort study included 62 patients with coronary artery disease who underwent PCI. Based on the post-PCI lipid-lowering regimen, 22 patients received alirocumab plus statin therapy and 40 received a regimen without a PCSK9 inhibitor; follow-up was scheduled at 8 weeks. Lipid profiles and inflammatory and laboratory safety measures were compared between baseline and follow-up. Paired vascular ultrasonography was available in 22 patients (9 in the combination group and 13 in the comparison group), in whom brachial artery flow-mediated dilation (FMD), quantitative intima-media thickness (QIMT), and local carotid stiffness indices were evaluated. Results At 8 weeks, total cholesterol and LDL-C had decreased from baseline in both groups (all P < 0.001). The reductions in total cholesterol, LDL-C, and ApoB were greater in the combination group than in the comparison group, with between-group P values for change of < 0.001, 0.001, and 0.017, respectively. In the vascular subgroup, between-group differences were observed for changes in FMD, compliance coefficient, right QIMT, stiffness coefficient beta, and local PWV (P = 0.013, P = 0.008, P = 0.018, P = 0.012, and P = 0.038, respectively). ALT and AST decreased from baseline in the combination group (P = 0.030 and P = 0.002, respectively), while between-group differences in changes in creatinine and CK were not statistically significant (P = 0.373 and P = 0.335, respectively). Conclusion Compared with statin monotherapy, early alirocumab plus statin therapy after PCI achieved greater reductions in LDL-C, total cholesterol, and ApoB and was associated with favorable changes in FMD and selected measures of arterial elasticity. No consistent adverse changes in hepatic or renal function or muscle enzyme levels associated with alirocumab plus statin therapy were observed within 8 weeks.

Discussion

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Cite This Study

Qiao et al. (2026) conducted a cohort in Coronary artery disease undergoing percutaneous coronary intervention (PCI) (n=62). Alirocumab plus statin therapy vs. Statin monotherapy (lipid-lowering regimen without a PCSK9 inhibitor) was evaluated on Low-density lipoprotein cholesterol (LDL-C, mmol/L) at 8 weeks (co-primary with brachial artery FMD) (p=0.001). Early alirocumab plus statin therapy after PCI achieved greater 8-week LDL-C reduction (to 1.120 vs 1.435 mmol/L, P=0.001) and FMD improvement (to 6.95% vs 6.3%, P=0.013) than statin monotherapy.

synapsesocial.com/papers/6ae682a3e432e7a5c4ef3620 https://doi.org/10.21203/rs.3.rs-11185127/v1

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Effects of Early Alirocumab Plus Statin Therapy on Lipid Control and Vascular Endothelial Function After PCI in Patients With Coronary Artery Disease

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Effects of Early Alirocumab Plus Statin Therapy on Lipid Control and Vascular Endothelial Function After PCI in Patients With Coronary Artery Disease

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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