November 7, 2020

4-Year DCB Mortality Across ILLUMENATE RCTs

Presented by Sean Lyden, MD

The Stellarex (Philips) drug-coated balloon (DCB) is a unique low-dose 2mcg/dl paclitaxel-coated balloon using polyethylene glycol as an excipient. The Stellarex DCB has been studied in 7 above-the-knee popliteal studies in over 2900 patients treated with independent clinical event committee for adverse event adjudications.

The ILLUMENATE EU RCT and ILLUMENATE pivotal randomized trials were pooled to compare mortality through 4 years between Stellarex DCB and the PTA (control) cohorts. An independent, 3rd party was used to make a systematic assessment of mortality data from these 2 trials at 4 years. We set a pre-specified pooled data analysis of patients treated with Stellarex DCB for ATK lesions with a test for homogeneity (I2 = 0%). 419 subjects were treated with DCB and 170 received PTA. The only pooled baseline characteristic differences in subjects were: the PTA arm was 2 years older, and the DCB arm had 8% more smokers.

There was no difference in survival between Stellarex DCB and PTA through 4 years, 85.7% vs 85.6% respectively. The was no difference in all-cause, cardiovascular or non-cardiovascular mortality. This confirms the safety of Stellarex at 4 years.

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