Two studies of PCB show no excess mortality signal at 5 years
At 5 years, there was no link between a paclitaxel-coated balloon and excess mortality compared with percutaneous transluminal angioplasty in two studies of patients with peripheral artery disease.
The data, from the ILLUMENATE European Randomized Clinical Trial (EU RCT) and ILLUMENATE Pivotal RCT of the paclitaxel-coated balloon (PCB; Stellarex, Philips), were presented by Marianne Brodmann, MD, substitute head of the division of angiology at Medical University Graz, Austria, at the virtual Leipzig Interventional Course.
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. The paper sparked concern over the devices and led to further mortality studies, many of which have not shown a mortality signal from the devices.
ILLUMENATE EU RCT had 294 patients (PCB group: mean age, 67 years; 28% women; PTA group: mean age, 69 years; 32% women) and ILLUMENATE Pivotal had 300 patients (PCB group: mean age, 68 years; 44% women; PTA group: mean age, 70 years; 36% women).
Compared with the ILLUMENATE EU RCT cohort, the ILLUMENATE Pivotal cohort had more patients with severe calcium, diabetes, prior coronary revascularization, obesity and renal insufficiency, Brodmann said during a presentation.
At 5 years, mortality data were available for 93.2% of the ILLUMENATE EU RCT cohort and 91% of the ILLUMENATE Pivotal cohort, she said.
In ILLUMENATE EU RCT, the 5-year mortality rates were 19.3% in the PCB group and 19.4% in the PTA group (P = .989), whereas in ILLUMENATE Pivotal, the 5-year mortality rates were 21.2% in the PCB group and 20.2% in the PTA group (P = .853), she said.
In both trials, Brodmann said, the 5-year survival curves overlapped (log-rank P = .995 in ILLUMENATE EU RCT; log-rank P = .907 in ILLUMENATE Pivotal).
“The ILLUMENATE RCTs present the strongest long-term safety data from an individual drug-coated balloon,” Brodmann said during the presentation. “Following the recent findings from SWEDEPAD and Voyager, these data further reinforce not only the long-term safety of the Stellarex drug-coated balloon, but DCBs as a class.”
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Brodmann M, et al. Late-breaking trial session: New data and innovative concepts for the treatment of femoral arteries – part 1. Presented at: Leipzig Interventional Course; Jan. 25-29, 2021 (virtual meeting).