According to results from the PACIFIER (Paclitaxel-coated balloons in femoral indication to defeat restenosis) trial, led by Michael Werk, Martin Luther Hospital, Berlin, Germany, and published in Circulation: Cardiovascular Interventions, percutaneous transluminal angioplasty (PTA) with drug-eluting balloons (DEBs) is associated with significant reductions in late lumen loss and restenosis compared with angioplasty with uncoated balloons in patients with femoropopliteal artery disease.
In the study, 85 patients with femoropopliteal artery disease were randomised to receive percutaneous transluminal angioplasty with a paclitaxel-eluting balloon (41; IN.PACT Pacific, Medtronic) or angioplasty with an uncoated balloon (44; Pacific Xtreme, Medtronic). Six of these patients were re-randomised to receive additional treatment—five had a new femoropopliteal stenosis of the contralateral leg and one had a restenosis of the target lesion six months after the initial procedure. The patient with the restenosis was included twice because the restenosis developed after the primary endpoint was reached (late lumen loss at six months) and the restenosis was considered to be an identical target lesion. Therefore, there were a total of 91 randomised cases.
The primary endpoint of the study was late lumen loss at six months (assessed by quantitative angiography) and secondary endpoints were binary restenosis and Rutherford class change at six months, and target lesion revascularisation (TLR) plus major adverse clinical events (eg, death) at six and 12 months.
At six months, Werk et al observed from the quantitative angiography analysis, that drug-eluting balloons were associated with a significantly lower rate of late lumen loss compared with uncoated balloons: 0.01mm vs. 0.65mm, respectively (p=0.001). Also, there were fewer binary restonoses in the DEB group (8.6% for the DEB group vs. 32.4% for the uncoated balloon group; p=0.01). The authors reported that at the six month follow-up point, there were three cases of revascularisation in the drug-eluting balloon group compared with 10 cases of TLR (in nine patients) in the uncoated balloon group. They added that no additional cases of target lesion revascularisation for the drug-eluting balloon group were reported at the 12-month follow-up point compared with five additional cases in the uncoated balloon group.
Werk et al wrote that one of the implications of their study was that angioplasty with the IN.PACT Pacific DEB was “feasible and safe without extensive predilation” in femoropopliteal artery disease. They added the intervention also “significantly reduces restenosis entity and rates (ie, angiographic late lumen loss and binary restenosis) in comparison with state-of-the-art uncoated balloons. Such angiographic superiority translates into significant clinical benefits.”
The authors commented that angioplasty with stents (bare metal or drug-eluting stents) have been proposed as an alternative approach to standard angioplasty (with uncoated balloons) and have been shown to have “superior results”. However, Werk et al wrote that angioplasty plus stenting permanently changes the structure of the vessel and that “in-stent restensosis is more difficult to treat in non-stented segments”. They added: “Drug-coated balloons combine the advantages of local drug delivery (with ensuring inhibition of restenotic processes), but lacking any permanent implant typical of balloons.”
The PACIFIER trial, according to Werk et al, provides further evidence favouring the use of dug eluting balloons for femoropopliteal percutanous transluminal angioplasty.
They concluded: “This randomised clinical study of paciltaxel-coated balloon catheter in the femoropopliteal arteries confirms that potent inhibition of restenosis and reduction in target lesion revascularisation at one year. In agreement with previous studies, no coating-related adverse events were observed.”