Preliminary results from eight patients within the 12-month follow-up window of the PACIFIER trial showed significantly lower target lesion revacularisation was needed for patients in the drug-eluting balloon group vs the percutaneous transluminal angioplasty group. Similarly six-month follow-up from FREEWAY demonstrated a lower target lesion revascularisation rate after Freeway drug-eluting balloon and stent than after plain old balloon angioplasty and stent.
Michael Werk, Berlin, Germany, presented the preliminary 12-month results of the PACIFIER study, which is a randomised, multicentre trial that evaluated the prevention of restenosis with paclitaxel-coated angioplasty balloons in stenosis or occlusion of femoropopliteal arteries. Werk said that the In.Pact Pacific device (Medtronic) significantly reduced neointimal hyperplasia and restenosis rates compared with standard percutaneous transluminal angioplasty in claudicants.
He added that the six-month outcomes had shown that the drug-eluting balloon was associated with a 0.01mm late lumen loss compared with 0.65mm for standard percutaneous transluminal angioplasty (p=0.0014) – of the randomised controlled trials so far for drug eluting balloons, this is the best result for late lumen loss.
Concluding, Werk said that the final 12-month clinical results were awaited and, so far, no coating-related adverse events had been noted. He said: “PACIFIER confirms and reinforces the role of drug-eluting balloons as already seen from previous similar trials.”
Presenting the six-month results of the FREEWAY study, Stephan Duda, Berlin, Germany, said the study is investigating the inhibition of restenosis by stenting and angioplasty with a paclitaxel-eluting balloon (Freeway, Eurocor) postdilatation compared with stenting and angioplasty with plain balloon postdilatation in the treatment of superficial femoral artery or PI-segment lesions.
The multicentre, open, prospective randomised trial will enrol 200 patients with stenotic or occluded de novo lesions at 15 German and Austrian centres.
The primary endpoint is the rate of clinically driven target lesion revascularisation at six months. Forty six patients have reached six months of follow-up. Duda showed cases of lesions treated with the device. The preliminary results, he said, demonstrated a low target lesion revascularisation rate of 8.3% after Freeway drug-eluting balloon and stent vs. 14% after plain old balloon angioplasty and stent at six months of follow-up.