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

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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, P = .7754). There was no difference in all-cause mortality when stratified by paclitaxel dose terciles. Predictors of mortality included renal insufficiency, reference vessel diameter, age, and lesion length, but not paclitaxel dose nor paclitaxel exposure. 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.

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