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Evolocumab in patients with multivessel coronary disease after acute myocardial infarction: A target trial emulation
Jinying Zhou1, Xiaoning Guo1, Wei Gao1
1Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China; State Key Laboratory of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, China.
Insights
Early evolocumab (a PCSK9 inhibitor) use in acute myocardial infarction patients with non-culprit lesions significantly reduced early major adverse cardiac events (MACE) within 30 days, offering a new treatment strategy.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Pharmacology
Background:
- Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors like evolocumab promote plaque regression in acute myocardial infarction (AMI).
- Clinical benefits of PCSK9 inhibitors for non-culprit intermediate lesions deferred from revascularization in AMI patients remain unclear.
- This study investigates the impact of early evolocumab initiation on outcomes in this specific patient subgroup.
Purpose of the Study:
- To evaluate the efficacy of early evolocumab initiation in reducing major adverse cardiac events (MACE) in patients with AMI and deferred non-culprit intermediate lesions.
- To assess the 2-year clinical outcomes associated with early versus standard care for these patients.
Main Methods:
- Target trial emulation using a multicenter registry of AMI patients (Shanghai, 2021-2022).
- Inclusion criteria: successful culprit-vessel revascularization with at least one deferred non-culprit intermediate lesion.
- Intervention: evolocumab initiation during index hospitalization vs. standard care. Primary outcome: MACE at 2 years. Statistical analysis: Cox regression, propensity score matching (PSM), and inverse probability of treatment weighting (IPTW).
Main Results:
- 1862 patients (4034 lesions) were analyzed; 174 received evolocumab, 1688 received standard care.
- The evolocumab group had a higher baseline cardiovascular risk and elevated LDL-C (126.8 vs. 87.8 mg/dL).
- Over 2 years, MACE occurred in 5.9% of evolocumab-treated lesions vs. 11.9% in controls. A landmark analysis at 30 days showed a significant MACE risk reduction with evolocumab (HR 0.35; 95% CI 0.16-0.74).
Conclusions:
- Early initiation of evolocumab in AMI patients with deferred non-culprit lesions significantly reduces early MACE.
- The observed benefit is primarily driven by reductions in MACE within 30 days post-discharge.
- Findings support considering early PCSK9 inhibitor therapy in select AMI patients with non-culprit lesions.
Background And Aims:
The proprotein convertase subtilisin/kexin type 9 inhibitors, i.e. evolocumab, promote coronary plaque regression in patients with acute myocardial infarction (AMI). However, its clinical benefit for non-culprit intermediate lesions deferred for revascularization remains uncertain. This study evaluated whether early evolocumab initiation improves outcomes in this specific population.
Methods:
Using target trial emulation to a multicenter registry of AMI patients in Shanghai (2021-2022), this study enrolled patients with successful culprit-vessel revascularization but ≥1 deferred non-culprit intermediate lesion. The intervention was evolocumab initiation during index hospitalization versus standard care alone. The primary outcome was a major adverse cardiac event (MACE) at 2 years. Treatment effects were estimated using the multivariable-adjusted Cox regression model, propensity score matching (PSM) and inverse probability of treatment weighting (IPTW) to adjust for confounding.
Results:
Among 1862 eligible patients (4034 lesions), 174 received evolocumab and 1688 did not. The evolocumab group exhibited a higher baseline cardiovascular risk profile, including elevated LDL-C (126.8 vs. 87.8 mg/dL; p < 0.001). Over 2 years, MACE occurred in 5.9% of evolocumab-treated lesions compared with 11.9% in controls. While the hazard ratio (HR) for the full 2-year period was 0.72 (95% CI 0.48-1.09), a landmark analysis at 30 days demonstrated a significant reduction in MACE risk (HR 0.35; 95% CI 0.16-0.74). Results were consistent across PSM and IPTW adjustments.
Conclusions:
In AMI patients with deferred non-culprit lesions, early initiation of evolocumab was associated with a significant reduction in early MACE, driven by benefits within 30 days post-discharge.
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