A review of data from recent randomized controlled trials concludes that there is no significant statistical difference in long-term mortality between patients who were treated for femoropopliteal peripheral artery disease (PAD) with drug-coated balloons (DCBs) and stents vs. uncoated balloon angioplasty (PTA). The research was presented on Sept. 28 at TCT 2019 and simultaneously published in JACC: Cardiovascular Interventions.

Kenneth Ouriel, MD, et al., reviewed data from the LEVANT 1, LEVANT 2 and LEVANT Japan trials after a recent meta-analysis based on data from heterogenous trials and summary-level data found increased mortality among patients treated with paclitaxel-coated balloons and stents.

Researchers evaluated 1,093 DCB and 250 PTAs. Based on the aggregate dataset from the LEVANT trials using patient-level data, the hazard rate (HR) for mortality was 1.01 at five years. There was no clustering of causes of death or adverse events within any category and no dose-response relationships. The studies are a subset of 3,095 patients treated for femoropopliteal PAD with the Lutronix DCB or with uncoated balloon angioplasty.

Survival rates were higher in patients who underwent paclitaxel or non-paclitaxel reinterventions compared with those who did not. Baseline factors that predicted mortality, with no differences between treatment arms, included age (HR, 1.03/year; p<0.0001), prior treatment of target lesion (HR,1.67; p=0.022), arrhythmia (HR, 1.65, p=0.031) and diabetes (HR, 1.18; p=0.047).

"An analysis of individual patient-level data from the full LEVANT dataset … demonstrated no increase in mortality with the use of DCB," the authors concluded. "While a numerical increase in mortality was observed in the LEVANT-2 DCB randomized treatment arm compared to the [uncoated balloon angioplasty] arm, the difference was not statistically significant."

The review of the data can be used to evaluate Lutronix DCBs and form a basis for the design of future studies of paclitaxel devices as well as other lower extremity interventional devices, according to the study authors.

In a related editorial comment, Krishna J. Rocha-Singh, MD, FACC, and Sue Duval, PhD, add that "it will take considerable time, funding and collaboration, both across industry members, professional societies and regulators, for all the proposals to accrue a sufficient cohort size to detect a safety signal of paclitaxel drug-coated devices for the treatment of peripheral artery disease."

Keywords: TCT19, Transcatheter Cardiovascular Therapeutics, Femoral Artery, Angioplasty, Percutaneous Coronary Intervention, Angiography

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