The IN.PACT Admiral drug-coated balloon (DCB) demonstrated a significant advantage in overall survival, amputation-free survival and target-lesion revascularization after femoropopliteal artery treatment through four-year follow-up when compared to uncoated balloons, a single-institution, retrospective review that tackled a head-to-head comparison between two discrete paclitaxel-coated devices found.
Furthermore, the Lutonix DCB (BD Bard) showed a less clear advantage in major outcomes compared to uncoated balloons. Meanwhile, between paclitaxel balloons, the IN.PACT Admiral (Medtronic) was found to be advantageous over Lutonix only in the arena of amputation-free survival.
The findings were delivered Sept. 9 in a talk entitled, “Clinical outcomes differ after femoropopliteal artery treatment between individual paclitaxel-coated balloons,” presented by Alexander H. King, MS, from the division of vascular surgery and endovascular therapy, at University Hospitals Cleveland Medical Center, Ohio, during the Midwestern Vascular Surgical Society (MVSS) virtual annual meeting (Sept. 9–12), which selected the study as the winner of the Emerick Szilagyi Award for clinical research.
With three paclitaxel-coated balloons currently approved for use by the Food and Drug Administration (FDA) observed King, along with UH Cleveland colleagues he set out to compare outcomes between the two: “Available DCBs employ different paclitaxel composition, dose and excipient,” he explained. “DCBs decrease restenosis compared to uncoated balloons, but have not been compared to each other. Our aim was to compare outcomes in patients treated with two discrete DCBs”—further noting there has been no prior head-to-head comparisons between paclitaxel-coated devices.
Some 1,419 patients who had undergone femoropopliteal artery percutaneous revascularization from 2010–2019 were analyzed to determine how use of the two devices impacts on survival, amputation rates and need for reintervention.
The patients were placed in one of three groups: 41.6% were treated with an uncoated balloon, with 58.4% receiving a DCB. Of the latter, 60.6% were assigned the IN.PACT Admiral and 39.4% the Lutonix. Primary outcomes included all-cause mortality, freedom from major amputation, amputation-free survival and freedom from target-lesion revascularization, which were compared using Kaplan Meier analysis. Multivariable logistic progression was also deployed.
Further, adjunctive stenting was used in 26% of patients, atherectomy in 17%, and a combination of both in 3.6%, King explained. In the paclitaxel group, atherectomy was more common, while among those who received an uncoated balloon, angioplasty as a standalone procedure and bare-metal stent placement were more common.
The results showed a four-year survival rate of 64.1% among those given the IN.PACT Admiral device, 60.6% in patients treated with the Lutonix DCB, and 51% in those who received an uncoated device. Rates of freedom from major amputation were 93.2% for the IN.PACT Admiral, 88.9% for the Lutonix and 85.8% for the uncoated group.
“Again the IN.PACT Admiral showed superiority over a non-coated balloon but there was not a significant difference between the two DCBs,” noted King.
“Amputation-free survival showed differences across all balloon types,” continued. “IN.PACT showed rates of amputation-free survival of 64.3%, Lutonix 57.5% and non-coated 46.6%. All three were significantly different from each other on Kaplan Meier analysis.”
In terms of freedom from target-lesion revascularization, IN.PACT was found to have an advantage over non-coated balloons. However, no differences between the two paclitaxel-coated balloons were observed. Four-year rates were 75.4% for the IN.PACT Admiral, 72.3% for the Lutonix and 71.5% for non-coated devices.
King detailed the investigation’s limitations. “This study was limited by the retrospective, nonrandomization of the design,” he said. “Additionally, the choice of balloon was left up to physician discretion and may therefore be subject to inherent biases. Paclitaxel was often used in conjunction with other therapies. The possible effects of those adjunctive therapies cannot be ruled out.”
King added that despite the noted limitations, the research team was able to conclude that individual DCBs may not yield equivalent outcomes, but that “through four-year follow-up, the IN.PACT Admiral showed a clear advantage over uncoated balloons, while Lutonix had a less clear advantage. Further studies are certainly needed to determine the ideal paclitaxel composition, dose and excipient.”