Primary results of the VICTORION-NOVEL (LDL-C management Program in atherosclerotic cardiovascular disease patients with elevated LDL-C) lipid optimization multicenter implementation trial.

BACKGROUND

Many patients with atherosclerotic cardiovascular disease (ASCVD) have suboptimal longitudinal low-density-lipoprotein cholesterol (LDL-C) control. New system-level implementation strategies are needed to improve lipid optimization among high-risk adults.

METHODS

VICTORION-NOVEL was a prospective, multicenter implementation trial including 66 clinicians across ambulatory practices at 6 sites in the United States (9/5/2023-8/31/2024). Adults ≥18 years with established ASCVD, statin therapy and LDL-C ≥ 70 mg/dl were included. The intervention combined online dashboard for lipid management-related performance, peer-to-peer discussion calls and optional clinician resources and educational modules. Primary outcome was the probability of experiencing a composite endpoint defined as 1) achieving LDL-C < 70 mg/dl, 2) achieving ≥20% reduction in LDL-C, or 3) experiencing intensification of lipid lowering therapy (LLT) within 1 year.

RESULTS

Overall, 1097 patients (364 at 3 intervention sites, 733 at 3 usual care sites) were included (mean age 68, 45% women). At 1-year, similar proportion of patients (intervention: 44.2%, control: 48.2%, p = 0.22) experienced the composite endpoint. However, a significant time-varying effect on the primary outcome was observed with no benefit or lipid optimization favoring the control sites in the initial period (baseline to day 49 and day 50-218) with potentially late beneficial effects emerging thereafter (adjusted HR 1.34; 95% CI 1.07-1.68). At 1-year, a higher proportion of intervention patients achieved LDL-C < 70 mg/dl than control patients (22.5% vs. 16.2%, p < 0.001).

CONCLUSIONS

The multi-faceted intervention was associated with a higher proportion of patients achieving LDL-C goals. The delayed emergence of benefit suggests that a lead-in period may be required for full effectiveness of similar system-level implementation efforts.