Eurocor unveiled interim results of the ongoing Freeway Stent Study on 17 January 2013 at IROS (Interventionell Radiologische Olbert Symposium), Berlin, Germany. The study was presented during the Free Paper Session 2 by Josef Tacke, Klinikum Passau, Germany. The multicentre, open, prospective randomised trial investigates the prevention of restenosis by drug-eluting balloon dilatation (Freeway) after stenting with a nitinol stent versus dilatation with standard balloon angioplasty after stenting with a nitinol stent in the treatment of superficial femoral artery or popliteal artery lesions.
The trend shows a very low target lesion revascularisation rate of 2.5%, whereas the second group of 39 patients that have been treated with the nitinol stent and angioplasty are showing a target lesion revascularisation rate of 10.2 %. Also a higher rate of primary patency for the drug-eluting balloon arm compared to the angioplasty arm (86.1% vs. 75.7%, respectively) has been found. These findings are reflected in a significant better clinical outcome regarding Rutherford classification (0.25±0.66 vs. 0.69±0.97, respectively; p=0.02).
The randomised, prospective clinical study is being conducted in 15 European sites to investigate the rate of clinically driven target lesion revascularisation. Two hundred patients suffering from de novo lesions that need to be stented are enrolled and are randomised in a 1:1 ratio. Both groups will be treated with nitinol stent implantation following postdilatation with a drug-eluting balloon (Freeway DEB) or a standard balloon angioplasty, randomized in a 1:1 ratio. The primary endpoint is the rate of clinically driven target lesion revascularisation at six months. After six and 12 months, the patients will undergo a duplex follow-up or an angiographic follow-up (a clinical follow-up at 12 months will finalise the study). The analysis is performed by an independent core lab.
Currently 111 patients have been enrolled, whereof a six-month follow-up is now available for 79 patients – 40 of them have been treated with a nitinol stent and a drug-eluting balloon.
Tacke commented: “In-stent restenosis is a serious problem in the superficial femoral artery and popliteal segment. Drug-eluting balloons might be an option to prevent restenosis at an early stage for patients that need to be stented. The interim results are very promising and we are looking forward to the final results of the study.”
“The trend so far shows a good and safe performance of our drug-eluting balloon Freeway. Especially the already significant outcome regarding the Rutherford classification is good news. We trust that our drug-eluting balloon technology platform used in the Freeway stent study will offer treatment options and significant therapeutic advantages for the patients,” said Rembert Pogge von Strandmann, director Clinical Department, Eurocor.