PCSK9 Inhibitors "Fast Track" Use Versus "Stepwise" Lipid-Lowering Therapy in Patients with Acute Coronary Syndrome: A Retrospective Single-Center Study in a "Real-World" Population

Abstract

Background: The "fast track" addition (within 48 h) of proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) to the optimized oral lipid-lowering therapy (LLT) during hospitalization for acute coronary syndrome (ACS) has been shown to rapidly achieve the low-density lipoprotein cholesterol (LDL-C) therapeutic targets. However, so far, its efficacy in real-world settings remains understudied. Methods: We retrospectively analyzed 128 ACS patients treated at our center, comparing "PCSK9i fast track" use within 48 h to standard "stepwise" LLT. Lipid levels and incidence of major adverse cardiovascular events (MACEs) were evaluated at 30 and 180 days. Results: The "PCSK9i fast track" group achieved significantly lower LDL-C levels at 30 days (41.5 ± 27.5 vs. 85.6 ± 35.9 mg/dL, p < 0.001) and 180 days (29.6 ± 21.0 vs. 59.0 ± 32.4 mg/dL, p < 0.001). Recommended LDL-C targets (<55 mg/dL) were met by 88.3% of the "PCSK9i fast track" group at 180 days, compared with 61.9% of controls (p < 0.001). No significant differences in MACEs were observed between groups. No adverse effects from PCSK9i use were noted. Conclusions: The "PCSK9i fast track" strategy was safe and effective in achieving LDL-C targets more rapidly than conventional approaches in real-world ACS patients.

Keywords: LDL-C; PCSK9i; acute cardiovascular syndrome; dyslipidemia; “fast track” strategy.

Figure 1

Flow diagram of the study. AIFA, Agenzia Italiana del Farmaco; FT, fast track; LDL-C, low-density lipoprotein cholesterol; LLT, lipid-lowering therapy; NFT, non-fast track; non-HDL, non-high-density lipoprotein; TC, total cholesterol; TG, triglycerides.

Figure 2

Comparison of lipid values between the “PCSK9i FT” and “PCSK9i NFT” groups at 30 days and 180 days. Total cholesterol, low-density lipoprotein cholesterol, triglycerides, and non-high-density lipoprotein cholesterol values were significantly lower (p < 0.05) in the “PCSK9i FT” group compared with the “PCSK9i NFT” group (p < 0.05), both at 30 days (A) and 180 days (B) of follow-up. FT, fast track; LDL-C, low-density lipoprotein cholesterol; NFT, non-fast track; non-HDL, non-high-density lipoprotein cholesterol; TC, total cholesterol; TG, triglycerides.

Figure 3

Difference in the mean percentage change of LDL-C from baseline to follow-up and between the “PCSK9i NFT” and “PCSK9i FT” groups at 30 and at 180 days. At 30 days of follow-up, the difference in the mean percentage change of LDL-C from baseline to follow-up (Δ LDL-C) was −101.1% in the “PCSK9i FT” group versus −36.6% in the “PCSK9i NFT” group (p-value < 0.001), whereas at 180 days the difference in the mean percentage change of LDL-C from baseline to follow-up (Δ LDL-C) was −129.0% in the “PCSK9i FT” group versus −72.7% in the “PCSK9i NFT” group (p-value < 0.001). FT, fast track; LDL-C, low-density lipoprotein cholesterol; NFT, non-fast track. * p < 0.001 versus baseline; ^§ p < 0.001 versus the “PCSK9i NFT” group.

Figure 4

Percentages of patients that reached the recommended LDL-C target (<55 mg/dL) in the “PCSK9i NFT” and “PCSK9i FT” groups at 30 days and 180 days. The percentage of patients in the “PCSK9i FT” group that reached the recommended LDL-C target (<55 mg/dL) at 30 days was 73.8% versus 23.8% in the “PCSK9i NFT” group, whereas the percentage of patients in the “PCSK9i FT” group that reached the recommended LDL-C target (<55 mg/dL) at 180 days was 88.3% versus 61.9% in the “PCSK9i NFT” group. FT, fast track; LDL-C, low-density lipoprotein cholesterol; NFT, non-fast track. ^§ p < 0.001 versus the “PCSK9i NFT” group.