Paclitaxel Balloon Angioplasty did not Increase Mortality in PAD

A new analysis of LEVANT studies data shows no difference in mortality between treated patients with paclitaxel-coated balloon angioplasty (DCB) for femoropopliteal peripheral artery disease (PAD) as well as patients treated with uncoated balloon angioplasty (PTA).
There has been no clustering of causes of death in any group and no dose-response associations have been identified, the researchers note.
Such results argue against a causal link between the use of paclitaxel-coated balloons in femoropopliteal disease and mortality, said the New York City study author Kenneth Ouriel, MD, MBA, Syntactx president and CEO.
Ouriel announced the findings of Transcatheter Cardiovascular Therapy (TCT) 2019, which were released simultaneously online in JACC on September 28: Cardiovascular Interventions.
Jury Still Out
The LEVANT research was conducted in response to results from a systematic review as well as meta-analysis published late last year, showing an increased long-term risk of death following treatment with paclitaxel-coated balloons and stents for PAD after the first year.
After reviewing 28 randomized controlled trials, Konstantinos Katsanos, MD, PhD, Patras University Hospital, Rion, Greece and colleagues stated that paclitaxel-based devices were linked with a 68% increase in the relative risk of all-cause death at 2 years and a 93% increase in the relative risk of non-coated devices at 5 years.
The meta-analysis sparked a federal investigation and flurry of new research by major device manufacturers, such as a new patient-level meta-analysis that found no association between mortality or paclitaxel exposure in treated patients with IN.PACT Admiral (Medtronic) DCB in two single-group and two randomized controlled trials.
No Survival Differences
In the current study, Ouriel and colleagues used separate patient-level data from the three LEVANT trials to assess mortality following DCB diagnosis of femoropopliteal disease. There were 1093 patients with DCB and 250 patients treated with PTA.