Inclisiran plus usual care in recent acute coronary syndrome significantly increased LDL-C <70 mg/dL attainment at Day 330 compared to usual care alone (66.7% vs 28.1%; OR 5.42, 97.5% CI 3.29-8.91).
RCT (n=400)
Open-label
1:1
Yes
Does inclisiran plus usual care improve LDL-C goal attainment and lower LDL-C in patients with recent acute coronary syndrome compared to usual care alone?
Early initiation of inclisiran plus usual care in patients with recent acute coronary syndrome significantly improves rapid and sustained attainment of guideline-directed LDL-C goals compared to usual care alone.
Effect estimate: OR 5.42 (95% CI 3.29-8.91)
Absolute Event Rate: 66.7% vs 28.1%
p-value: p=<0.001
Background The low‐density lipoprotein cholesterol (LDL‐C)‐lowering effect of inclisiran, a proprotein convertase subtilisin/kexin type 9‐targeting small interfering RNA, has not been established in patients with recent acute coronary syndrome. Methods VICTORION‐INCEPTION, a 330‐day, phase 3b, open‐label, multicenter trial, designed to mimic clinical practice, randomized 400 eligible participants (discharged following acute coronary syndrome ≤5 weeks of screening, with LDL‐C ≥70 mg/dL or non–high‐density lipoprotein cholesterol ≥100 mg/dL, receiving statin therapy or statin intolerant) 1:1 to inclisiran sodium 300 mg (284 mg inclisiran equivalent; Days 0, 90, 270) + usual care, or usual care (clinician‐directed LDL‐C management). Coprimary end points at Day 330 were LDL‐C <70 mg/dL attainment and LDL‐C percentage change from baseline. Results At Day 90, inclisiran + usual care led to greater LDL‐C goal attainment and lowering versus usual care (<70 mg/dL: 74.6% versus 26.6%, odds ratio OR, 10.84 97.5% CI, 6.13–19.16; <55 mg/dL: 63.2% versus 8.5%, OR, 26.58 95% CI, 14.14–49.98; percentage change from baseline: −48.9% versus 2.2%); this was sustained to Day 330 (<70 mg/dL: 66.7% versus 28.1%, OR, 5.42 97.5% CI, 3.29–8.91, P <0.001; <55 mg/dL: 54.2% versus 13.6%, OR, 8.24 95% CI, 4.97–13.65; percentage change: −46.9% difference 97.5% CI, −55.4 to −38.5; P <0.001). Participants with ≥1 adverse events were comparable (inclisiran + usual care, 58.6%; usual care, 53.3%). Conclusions VICTORION‐INCEPTION was the first inclisiran trial in participants with recent acute coronary syndrome. Early inclisiran initiation with usual care resulted in rapid, sustained attainment of guideline‐directed LDL‐C goals and was well tolerated. Registration URL: https://clinicaltrials.gov ; Unique identifier: NCT04873934.
Knowlton et al. (Thu,) conducted a rct in Recent acute coronary syndrome (n=400). Inclisiran sodium plus usual care vs. Usual care was evaluated on LDL-C <70 mg/dL attainment at Day 330 (OR 5.42, 95% CI 3.29-8.91, p=<0.001). Inclisiran plus usual care in recent acute coronary syndrome significantly increased LDL-C <70 mg/dL attainment at Day 330 compared to usual care alone (66.7% vs 28.1%; OR 5.42, 97.5% CI 3.29-8.91).