Long-term Safety of Stellarex DCB Across Two ILLUMENATE RCTs: 5-Year Results from a Patient-Level Meta-Analysis

In a late-breaking session at ISET 2022, William A. Gray, MD, Chief of Cardiovascular Services at Main Line Health and Co-director of the Lankenau Heart Institute in Wynnewood, PA, presented the 5-year results from a patient-level meta-analysis of long-term safety of the Stellarex drug-coated balloon (DCB) (Philips). This DCB was designed to limit drug dose and drug loss while ensuring high drug delivery and deliverability along with clinical performance.

Stellarex DCB has been extensively evaluated in 7 above-the-knee (ATK) studies, and in ILLUMENATE trials consistently met its primary safety/efficacy endpoints. In a meta-analysis of 2 ILLUMENATE trials, ILLUMENATE EU RCT and ILLUMENATE Pivotal, data were pooled to compare mortality through 5 years between Stellarex DCB and the PTA (control) cohorts. “Both of these trials have been published and the primary endpoints were met,” Dr. Gray said. “They were robust in their totality, with 600 patients with similar design and very similar rigor.”

The analysis of the pooled data showed no difference in survival or crude all-cause mortality between PTA and DCB through 5 years. “Stellarex DCB continues to consistently demonstrate no difference in mortality compared with the PTA cohort year-over-year through 5 years,” Dr. Gray explained, both within individual RCTs and pooled analysis.

“This patient-level meta-analysis represents the highest level of evidence to determine long-term mortality of a single DCB with high homogeneity and no difference in mortality, and no evidence of paclitaxel, either by exposure or dose, as a predictor of mortality,” Dr. Gray concluded. This independent meta-analysis confirms and reinforces the consistent and durable long-term safety profile of low-dose Stellarex in a 5-year dataset. The 4-year dataset was published in early January 2022, and the 5-year dataset is currently in process for publication.