Paclitaxel-coated balloon does not confer elevated 5-year mortality risk

February 07, 2022

2 minute read


Gray WA, et al. Breaking news and hot topics. Presented at: International Symposium on Endovascular Therapy; January 16-19, 2022; Hollywood, Florida (hybrid meeting).

Disclosures: The study was funded by Philips. Gray claims to be a consultant for Boston Scientific, Medtronic, Philips and Surmodics.

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In a patient-level meta-analysis of two pivotal trials of a paclitaxel-coated balloon, the paclitaxel-coated balloon was not associated with an elevated risk of mortality in patients with peripheral arterial disease at 5 years.

As Healio previously reported, a summary meta-analysis of pivotal trials of paclitaxel-coated devices published in December 2018 revealed an elevated mortality risk associated with devices compared to controls at 2 and 5 years in patients with of AOMI. The debate over device security has continued ever since.

Graphical representation of the data presented in the article
Data are from Gray WA, et al. Breaking news and hot topics. Presented at: International Symposium on Endovascular Therapy; January 16-19, 2022; Hollywood, Florida (hybrid meeting).

At the International Symposium on Endovascular Therapy, William A. Gray, MD, the Chief of Cardiovascular Services at Main Line Health and Co-Director of the Lankenau Heart Institute in Wynnewood, Pennsylvania, presented the 5-year results of a patient-level meta-analysis of the European ILLUMENATE Randomized Clinical Trial (EU RCT) and ILLUMENTATE pivotal trials of paclitaxel-coated balloon (PCB; Stellarex, Philips), designed to elute low-dose paclitaxel, versus percutaneous transluminal angioplasty. Both trials met their primary endpoints and showed PCB to be safe and effective compared to PTA, Gray said.

The pooled cohort comprised 589 patients (median age, 68 years; 65% male), over 90% of whom had information on vital status, and I2 was 0%, Gray said.

William A. Gray

“This was an individual patient-level meta-analysis, which is the highest quality of meta-analyses, and it was performed by a third party,” Gray said during the presentation. “This was a pre-specified systematic assessment of mortality as the primary endpoint.”

At 5 years, the survival rate in both groups was 80.4% (log-rank P = 0.7754), Gray said during the presentation. He said there was also no difference in crude 5-year all-cause mortality rates (PCB, 25.2%; PTA, 24.8%; P > .9999).

In a multivariate model, exposure to paclitaxel was not a predictor of mortality (HR=1.149; 95% CI, 0.761-1.734; P = 0.5085), nor the dose of paclitaxel (HR = 1.027; 95% CI, 0.959-1.1; P = 0.4423), said Gray, noting that predictors of mortality were age, renal impairment, lesion length and reference vessel diameter.

“The Stellarex drug-coated balloon continues to demonstrate no difference in mortality compared to the PTA cohort year-over-year at 5 years, in both individual randomized controlled trials and pooled analyses,” said Gray during the presentation. “This patient-level meta-analysis represents the highest level of evidence for determining long-term mortality in a single DCB, with high homogeneity and no difference in mortality.”