Long-Term Safety of Stellarex DCB Across Two ILLUMENATE Randomized Controlled Trials: 5-Year Results from a Patient-Level Meta-Analysis

Purpose: To assess the long-term 5-year safety of the Stellarex drug-coated balloon (DCB) compared with percutaneous transluminal angioplasty (PTA) for symptomatic femoropopliteal peripheral artery disease (PAD) in a patient-level meta-analysis of the ILLUMENATE randomized controlled trials (RCTs).

Materials and Methods: An independent third party performed a patient-level meta-analysis of the ILLUMENATE Pivotal and EU RCTs to assess the safety of the Stellarex DCB compared with PTA for the treatment of Rutherford 2 to 4 PAD. The primary outcome was time to death. Kaplan Meier (KM) estimates of all-cause mortality were compared with restricted mean survival time. Cox proportional hazard modeling was used to assess predictors of mortality. All serious events (including death) were adjudicated by a blinded clinical events committee. The follow-up period was 60 months.

Results: In total, 589 patients were included in the pooled ILLUMENATE dataset. The median follow-up period was 1806 days (interquartile range, 1768, 1852 days). Vital status was obtained for more than 90% of patients. The KM estimates of freedom from all-cause death at 5 years were 80.4% (95% confidence interval [CI], 76.7%–84.3%) in the Stellarex DCB arm versus 80.4% (95% CI, 74.3%–86.5%) in the PTA arm (log rank; P = 0.7754). There were no differences in adjudicated cause-specific deaths in patients treated with Stellarex DCB relative to PTA. Predictors of death included renal insufficiency (hazard ratio [HR], 2.363; 95% confidence interval [CI], 1.530–3.650), reference vessel diameter (HR, 1.244; 95% CI, 1.019–1.518), age (HR, 1.052; 95% CI, 1.031–1.074), and lesion length (HR, 1.005; 95% CI, 1.001–1.009). Neither paclitaxel dose (HR, 1.027; 95% CI, 0.959–1.100) nor exposure (HR, 1.149; 95% CI, 0.761–1.734) predicted mortality.

Conclusions: In the patient-level meta-analysis of the pooled ILLUMENATE Pivotal and EU RCTs, there was no difference in all-cause mortality between the Stellarex DCB and PTA throughout the full 5-year follow-up window. These data build on the consistent long-term safety profile of the Stellarex DCB for the treatment of patients with symptomatic PAD.