Table 3.
PCSK9 inhibitors vs. Placebo/Statin in acute coronary syndrome
| Outcome | Comparison | Effect Estimate (95% CI) | Certainty of Evidence (GRADE) | Reasons for Downgrading/Upgrading |
|---|---|---|---|---|
| LDL-C reduction (mg/dL) | Evolocumab vs. Placebo | MD − 55.4 (–65.1 to − 45.7) | High | Consistent results across GLAGOV [18], EVOPACS [15], and others |
| Alirocumab vs. Placebo | MD − 49.1 (–58.3 to − 39.9) | High | Strong effects, minimal heterogeneity, PACMAN-AMI [22], ODYSSEY [19] | |
| Evolocumab vs. Statin alone | MD − 27.8 (–34.5 to − 21.1) | Moderate | Downgraded for indirectness (statin regimens varied) | |
| MACE incidence | Evolocumab vs. Placebo | OR 0.79 (0.68 to 0.92) | Moderate | Downgraded for imprecision in early-phase trials [14][16][17] |
| Alirocumab vs. Placebo | OR 0.85 (0.74 to 0.97) | Moderate | Downgraded for inconsistency (e.g., PACMAN-AMI vs. ODYSSEY) | |
| PCSK9i (class) vs. Statin alone | OR 0.84 (0.72 to 0.98) | Low | Downgraded for indirectness and moderate heterogeneity |