Five-Year Independent Patient-Level Mortality Analysis of the Pooled ILLUMENATE Pivotal and EU Randomized Controlled Trials.

Background: There is a need to evaluate the latest information regarding a potential late safety signal in patients treated with paclitaxel-coated devices for peripheral artery disease. We evaluated the 5-year all-cause mortality rate of the Stellarex drug-coated balloon (DCB) compared with percutaneous transluminal angioplasty (PTA). Methods: An independent third-party performed a patient-level meta-analysis of the pooled ILLUMENATE Pivotal and EU randomized controlled trials. The primary outcome was time to death. Kaplan-Meier estimates of all-cause mortality were compared with the log-rank test. Predictors of mortality were assessed with Cox proportional hazard modeling. A blinded clinical events committee adjudicated all serious adverse events (including death). The follow-up was 60 months. Results: A total of 589 patients were followed for a median of 4.9 years (IQR, 4.8, 5.1 years); 419 were randomized to Stellarex DCB and 170 to PTA. Vital status was obtained for 93.8%. The 5-year Kaplan-Meier estimates of freedom from all-cause death were 80.4% (95% 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, Conclusions: There was no difference in all-cause mortality between the Stellarex DCB and PTA through the final 5-year follow-up window of 2 ILLUMENATE randomized controlled trials. These long-term data build on the previously reported safety of the Stellarex DCB for treating symptomatic femoropopliteal peripheral artery disease.