Objective:

To evaluate the influence of intensively lowering LDL-C via PCSK9 inhibitors on global coagulability and clinical safety, particularly regarding bleeding risk, in post-PCI ACS patients treated with dual antiplatelet therapy.

Approach:

Key Findings:

• Clinically relevant bleeding incidence was 6.7% in the Low LDL-C group and 5.0% in the Non-Low LDL-C group, indicating no significant difference in overall bleeding risk (log-rank P = 0.72).
• Global coagulability and specific platelet reactivity parameters remained stable with no significant intergroup differences (all P > 0.05).
• Major adverse cardiovascular events (MACE) occurred in 6.7% of the Low LDL-C group and 13.3% of the Non-Low LDL-C group (HR 0.48, log-rank P = 0.22).

Interpretation:

Achieving LDL-C levels ≤0.78 mmol/L in ACS patients treated with PCSK9 inhibitors and DAPT did not increase bleeding risk or significantly alter coagulability and platelet reactivity, suggesting that such treatment strategies may be safe in this high-risk population.

Limitations:

• The non-inferiority analysis was underpowered due to a sparse number of overall bleeding events (n = 7), which limits the reliability of the safety findings.
• Findings are descriptive and exploratory, lacking definitive conclusions that could guide clinical practice.

Conclusion:

These findings support the clinical safety of achieving ultra-low LDL-C levels in high-risk ACS patients treated with PCSK9 inhibitors and DAPT.

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