Paclitaxel-coated balloon does not confer elevated mortality risk at 5 years
In a patient-level meta-analysis of two pivotal trials of a paclitaxel-coated balloon, the paclitaxel-coated balloon was not associated with elevated risk for mortality in patients with peripheral artery disease at 5 years.
As Healio previously reported, a summary-level meta-analysis of pivotal trials of paclitaxel-coated devices published in December 2018 found elevated mortality risk associated with the devices compared with controls at 2 and 5 years in patients with PAD. Debate over the safety of the devices has continued since then.
At the International Symposium on Endovascular Therapy, William A. Gray, MD, chief of cardiovascular services at Main Line Health and co-director of the Lankenau Heart Institute in Wynnewood, Pennsylvania, presented 5-year results of a patient-level meta-analysis of the ILLUMENATE European Randomized Clinical Trial (EU RCT) and ILLUMENTATE Pivotal trials of the paclitaxel-coated balloon (PCB; Stellarex, Philips), which is designed to elute paclitaxel at a low dose, compared with percutaneous transluminal angioplasty. Both trials met their primary endpoints and showed the PCB was safe and effective compared with PTA, Gray said.
The pooled cohort included 589 patients (median age, 68 years; 65% men), of whom more than 90% had vital status information available, and the I2 was 0%, Gray said.
“This was an individual patient-level meta-analysis, which is the highest quality of meta-analyses, and it was done by a third party,” Gray said during the presentation. “It was a prespecified systematic assessment of mortality as a primary endpoint.”
At 5 years, the survival rate in both groups was 80.4% (log-rank P = .7754), Gray said during the presentation. He said there was also no difference in crude rates of all-cause mortality at 5 years (PCB, 25.2%; PTA, 24.8%; P > .9999).
In a multivariate model, paclitaxel exposure was not a predictor of mortality (HR = 1.149; 95% CI, 0.761-1.734; P = .5085), nor was paclitaxel dose (HR = 1.027; 95% CI, 0.959-1.1; P = .4423), Gray said, noting the predictors of mortality were age, renal insufficiency, lesion length and reference vessel diameter.
“The Stellarex drug-coated balloon continues to consistently demonstrate no difference in mortality compared to the PTA cohort year over year through 5 years, both within individual randomized controlled trials and pooled analyses,” Gray said during the presentation. “This patient-level meta-analysis represents the highest level of evidence to determine long-term mortality in a single DCB, with high homogeneity and no difference in mortality.”
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Gray WA, et al. Late-Breaking Data and Hot Topics. Presented at: International Symposium on Endovascular Therapy; Jan. 16-19, 2022; Hollywood, Florida (hybrid meeting).