Pooled analysis shows no 4-year mortality risk with low-dose PCB
In a pooled analysis of two randomized controlled trials of a low-dose paclitaxel-coated balloon to treat peripheral artery disease, there was no mortality difference between the paclitaxel-coated balloon and an uncoated balloon at 4 years.
As Healio previously reported, a summary-level meta-analysis published in December 2018 showed that patients treated with paclitaxel-coated devices had higher rates of long-term mortality than controls. An FDA analysis found similar results, and the agency has recommended restricting paclitaxel-coated device use to patients in whom the benefits greatly outweigh the risks. Most subsequent retrospective and prospective analyses have found no mortality signal.
At the virtual VIVA 20, Sean Lyden, MD, chairman of the department of vascular surgery at Cleveland Clinic’s Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute, presented a pooled analysis of mortality data from two randomized controlled trials of a low-dose paclitaxel-coated balloon (PCB; Stellarex, Philips) vs. percutaneous transluminal angioplasty. The ILLUMENATE EU randomized controlled trial and the ILLUMENATE Pivotal IDE trial included a combined 589 patients (PCB group, median age, 67 years; 54% men; PTA group, median age, 69 years; 65% men).
The analysis included patient-level data and “represents a robust methodology,” Lyden said during the presentation.
At 4 years, Lyden said, the survival rates were almost identical between the groups (PCB, 85.7%; PTA, 85.6%; log-rank P = .864).
There were also no differences between the groups in CV death (P = .91) and non-CV death (P = .803), he said.
Among those in the PCB cohort, the most common cause of death was cancer/neoplasm (28%), with cardiac disorders accounting for 25% and vascular disorders accounting for 7%, Lyden said, noting the cause of death was undetermined in 21%.
“The 4-year data confirm the safety profile of the Stellarex [drug-coated balloon] ... and this independent patient-level meta-analysis continues to show rigorous, consistent, long-term data of the low-dose Stellarex DCB,” Lyden said.
In a discussion after the presentation, Misti Malone, PhD, chief of the peripheral interventional devices branch of the FDA’s Center for Devices and Radiological Health, said: “There’s an expectation that a lot of these results will be published soon in peer-reviewed literature, and as this information becomes available, we do look at [it] often. When we have sufficient information ... I can’t say when, I don’t have my magic ball, we will ... update our communication.”
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Lyden S, et al. Late-breaking clinical trials. Presented at: VIVA 20; Nov. 6-8, 2020 (virtual meeting).
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