A long-term real-world experience with Stellarex (Philips) drug-coated balloons (DCB) in the periphery strengthens the mass of recent evidence largely acquitting it and other paclitaxel-coated devices of any special mortality hazard.
A 4-year analysis based on the ILLUMENATE Global postmarket registry suggested that the DCB was safe and effective in a broad population of patients with often complex femoropopliteal lesions, fewer than one-third of whom required stents on a provisional basis.
Their target-limb amputation rate was only 0.8% and all-cause mortality was 8.1%, “very low for a cardiovascular patient group with claudication,” said Andrew Holden, MB, ChB, Auckland City Hospital, New Zealand, reporting the results during TCT Connect, the virtual edition of Transcatheter Cardiovascular Therapeutics (TCT) 2020.
The findings were consistent across prospectively defined subgroups by sex, diabetes, and target-lesion length, as well as the broader ILLUMENATE trial experience encompassing more than 2000 patients, he said.
And they impressed observers at TCT Connect, who called for an end to any stigma against paclitaxel-coated devices in peripheral vascular disease (PAD) and for tighter focus on randomized trials to refine their selection and targeted use.
As chronicled at length by theheart.org | Medscape Cardiology, a controversial meta-analysis published in December 2018 upended clinical trials looking at paclitaxel-coated devices for PAD revascularization by tying them to an almost 70% jump in relative risk (RR) for mortality at 2 years and a 93% RR increase at 5 years.
The findings led to a warning letter regarding the alleged risk from the US Food and Drug Administration (FDA), followed by a comprehensive public analysis by the agency and its independent advisors in June 2019, which acknowledged the existence of a safety signal.
Four months later, the FDA approved two sizes of the Stellarex for de novo and restenotic lesions in the superficial femoral and popliteal arteries. They joined other Stellarex DCBs and paclitaxel-coated peripheral devices already on the market, all of which account for the safety signal in their labeling.
“The mortality at 4 years is strikingly low. Normally, in a population like this, we would expect it to be at least 10% to 20% at 4 years,” Peter A. Schneider, MD, University of California, San Francisco, said as an observer of ILLUMENATE-Global at a media briefing.
“So, far from a doubling of mortality risk with paclitaxel, actually this appears to be less than what we would expect for a population like this.”
At the same press conference, Robert Lookstein, MD, MHCDL, said the findings represent “just really spectacular data in a real world subset — high degrees of severe calcification, high preponderance of diabetics. I think this just further reinforces the broad consensus among vascular specialists that DCB has really become the go-to therapy for patients with lifestyle-limiting claudication.”
ILLUMENATE-Global “is just another valuable contribution to the literature suggesting that this Stellarex balloon is a safe and effective technology in a real-world population,” said Lookstein, Ichan School of Medicine at Mount Sinai, New York City.
“I think right now, many of us are