BASELINE CHARACTERISTICS OF PARTICIPANTS ENROLLED IN VICTORION-INCEPTION: A RANDOMIZED STUDY OF INCLISIRAN VS. USUAL CARE IN PATIENTS WITH RECENT HOSPITALIZATION FOR AN ACUTE CORONARY SYNDROME

Abstract

Therapeutic Area

CVD Prevention – Primary and Secondary

Background

Patients with recent acute coronary syndrome (ACS) are at high risk for recurrent atherosclerotic cardiovascular disease (ASCVD) events. Lowering low-density lipoprotein cholesterol (LDL-C) to <70 mg/mL can reduce this risk; thus, lipid-lowering therapy (LLT), including non-statin therapy, should be intensified within 4–6 weeks of ACS. Despite this recommendation, few patients achieve LDL-C <70 mg/dL after an ACS event. When added to maximally tolerated statin therapy, inclisiran lowered LDL-C by an additional ∼50% in patients with ASCVD in prior trials, but those with ACS within 3 months of screening were excluded.

Methods

VICTORION-INCEPTION (NCT04873934) is an ongoing, Phase 3b, US, randomized, parallel-group, open-label, multicenter trial in patients with recent ACS. Eligible patients were screened within 5 weeks of hospital discharge and had LDL¬ C ≥70 mg/mL (or non-high-density lipoprotein cholesterol [HDL-C] ≥100 mg/dL) either on statin therapy or with statin intolerance. Patients were randomized 1:1 to inclisiran 284 mg (equivalent to 300 mg inclisiran sodium) on Days 0, 90, and 270 plus usual care or usual care alone (standard of care per treating physician). This interim analysis describes patient demographics and clinical characteristics.

Results

Through February 5, 2024, 788 patients were screened across 40 sites, of whom 400 were eligible and randomized: median age 61 years, 29.3% female, 12.3% Black or African American, and 14.3% Hispanic or Latino. The most common index ACS event (93%) was myocardial infarction (MI); 22% of patients had a prior MI. The median time from discharge to randomization was 34 days (Q1–Q3: 26–43). At baseline, median calculated LDL-C was 84.0 mg/dL (Q1–Q3: 71.0–103.0), non-HDL-C was 107.0 mg/dL (Q1–Q3: 93.0–129.0), and 95.5% of patients were receiving LLT (any statin therapy [alone or combination]: 93.3%; any high-intensity statin therapy: 81.3%; combination therapy [statin plus non-statin LLT]: 9.0%). Demographic and baseline characteristics are comparable between treatment arms (Table).

Conclusions

VICTORION-INCEPTION evaluates the LDL-C lowering effect of implementing a systematic LDL-C management pathway including inclisiran in patients with a recent ACS. The enrolled study population is reflective of real-world US clinical practice.