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
