VICTORION-INCEPTION: EARLY AND SUSTAINED LDL-C GOAL ATTAINMENT WITH INCLISIRAN PLUS USUAL CARE IN PARTICIPANTS WITH RECENT ACUTE CORONARY SYNDROME

CVD Prevention – Primary and Secondary Guideline-directed low-density lipoprotein cholesterol (LDL-C) goals are not met by many patients with recent acute coronary syndrome (ACS). The 330-day, phase 3b, open-label VICTORION-INCEPTION (NCT04873934) trial was the first to evaluate LDL-C lowering and goal attainment with inclisiran in participants with recent ACS in a setting designed to mimic real-world practice. Participants (discharged from hospitalization for ACS ≤5 weeks before screening with LDL-C ≥70 mg/dL, or non–high-density lipoprotein cholesterol ≥100 mg/dL, receiving statin therapy or with statin intolerance) were randomized 1:1 to inclisiran (inclisiran sodium 300 mg [284 mg inclisiran equivalent] on Days 0, 90, and 270) + usual care or to usual care. We present analyses of LDL-C <70 mg/dL (coprimary endpoint) and <55 mg/dL (secondary endpoint) goal attainment at Day 330 by predefined and post hoc subgroups. Sustained goal attainment between time points was assessed post hoc. Of 400 randomized participants, 29.0% were female, 15.3% were non-White or multiple races, and 14.3% were Hispanic or Latine. Most participants had no history of statin intolerance (87.8%), and 82.0% were receiving high-intensity statin at baseline. The most frequent index ACS event was non–ST-segment elevation myocardial infarction (53.5%). Overall, significantly more participants receiving inclisiran + usual care achieved LDL-C goals at Day 90 vs usual care (<70 mg/dL: 74.6% vs 26.6%, odds ratio [OR]: 10.84 [97.5% confidence interval {CI}: 6.13-19.16], P <0.001; <55 mg/dL: 63.2% vs 8.5%, OR: 26.58 [95% CI: 14.14-49.98], P <0.001). Of participants at goal at Day 90, goal attainment was sustained to Day 330 in more participants receiving inclisiran + usual care vs usual care (<70 mg/dL: 75.3% vs 62.3%; <55 mg/dL: 68.5% vs 58.8%; Figure 1 ). Across subgroups, the proportion of participants with LDL-C <70 mg/dL or <55 mg/dL at Day 330 was consistently greater with inclisiran + usual care vs usual care ( Figure 2 ). In this analysis of participants with recent ACS in VICTORION-INCEPTION, treatment with inclisiran + usual care resulted in rapid and sustained LDL-C goal attainment compared with usual care. These findings highlight the potential role of inclisiran in enabling guideline-directed LDL-C goal attainment among patients with recent ACS.