Patients treated with a paclitaxel-coated balloon saw greater survival, freedom from amputation and amputation-free survival through four-year follow-up after their initial femoropopliteal revascularization operation than those who received treatment using an uncoated device, researchers behind a propensity-matched retrospective review at University Hospitals Cleveland Medical Center, Ohio, found.
The study further demonstrated that freedom from target-lesion revascularization was higher in paclitaxel-treated patients through three-year follow-up.
These latest findings, presented by Alexander H. King, MS, of UH Cleveland’s division of vascular surgery and endovascular therapy, emerged during a session on peripheral arterial disease (PAD) at the Eastern Vascular Society (EVS) virtual annual meeting (Oct. 7–Nov. 18).
They relate to previous data showing that the IN.PACT Admiral DCB demonstrated a significant advantage in overall survival, amputation-free survival and target-lesion revascularization (TLR) after femoropopliteal artery treatment through four-year follow-up when compared to uncoated balloons in a head-to-head comparison between two discrete paclitaxel-coated devices. That arm of the research was presented a month previously at the Midwestern Vascular Surgical Society (MVSS) virtual annual meeting (Sept. 9–12). King et al told the gathering that the other DCB studied, the Lutonix (BD Bard), showed a less clear advantage in major outcomes compared to uncoated balloons.
At EVS, King elaborated on the research team’s single institution study of 1,419 femoropopliteal revascularization patients (treated from 2010–2019) as it pertained to four-year outcomes between those who received angioplasty with paclitaxel (using either the IN.PACT Admiral or the Lutonix) versus those treated via the same procedure without the drug (n=830 vs. 594).
Additionally, adjunctive stenting was used in 26.1%, atherectomy in 17.3%, and a combination of both in 3.6%. Atherectomy was more common in the paclitaxel group, while angioplasty as a standalone procedure and bare metal stent placement were more common among the uncoated device group.
The investigators compared the four-year outcome measures of all-cause mortality, freedom from major amputation, amputation-free survival and TLR.
After propensity matching, the two cohorts—paclitaxel-coated device recipients and uncoated balloon patients—each contained 529. The investigators found four-year survival rates were superior in the paclitaxel group at 62.1% compared to 51.8% with a plain balloon (p=0.04).
On multivariate analysis age, critical limb-threatening ischemia (CLTI), chronic kidney disease (CKD), hyperlipidemia, diabetes and chronic obstructive pulmonary disease (COPD) were all associated with mortality through four years. “Importantly, paclitaxel use was not a significant factor on multivariate analysis,” King said.
Freedom from major amputation rates were 91.3% among the patients treated with a paclitaxel-coated device and 85.5% in those undergoing a revascularization procedure with an uncoated balloon. Factors related to increased risk of amputation were CLTI and CKD, King explained, and paclitaxel use was a protective factor against amputation (hazard ratio [HR] 0.53; p=0.003).
In terms of amputation-free survival, “there was a clear benefit for patients treated with paclitaxel” at a rate of 59.3% vs. 46.4% in the uncoated device group, he said.
Many factors were found to be significant on multivariate analysis, with the highest for either amputation or death standard risk factors such as advanced age, CLTI and CKD. Paclitaxel was identified as protective with a HR of 0.72 (p=0.002).
And while TLR rates at four years were similar between the two groups (paclitaxel: 73.6%; uncoated: 71%), “paclitaxel patients had a similar advantage at one, two and three years after the initial operation.”
The authors acknowledged study limitations such as its retrospective, non-randomized, single institution nature; that the choice of balloon came at the discretion of individual physicians; and that paclitaxel was used in combination with other therapies.
King concluded: “Despite our limitations, in this propensity-matched cohort of paclitaxel vs. non-paclitaxel treatment of femoropopliteal occlusive disease, a reduction in mortality, amputation and combined amputation or death through four-year follow-up was observed after the use of paclitaxel-coated devices. Further adequately-powered prospective studies are certainly warranted to identify possible factors associated with the discrepancy between clinical trial and population-based data.”
Further explaining the findings, King told Vascular Specialist: “By propensity matching, we were able to compare two very similar cohorts, which helps offset potential confounding variables in different patient populations. The matched analysis coupled with a multivariate analysis helps identify if paclitaxel is actually a factor in outcome after lower-extremity revascularization. Our data found that in fact paclitaxel was associated with increased survival, amputation-free survival and freedom from major amputation, even after propensity matching.”