At the LINC congress (Leipzig, Germany, 23–26 January), Dierk Scheinert, Park Hospital Leipzig, Germany, presented the details of a new randomised controlled trial that will evaluate a drug-eluting stent vs. paclitaxel-eluting balloons for the treatment of symptomatic femoropopliteal artery disease.
The objective of the Real PTX study is to assess the performance of the Zilver PTX drug-eluting stent (Cook Medical) in comparison to paclitaxel-eluting balloon (In.Pact Admiral, Medtronic) in the treatment of symptomatic peripheral arterial disease of the femoropopliteal artery in a head-to-head comparison.
The trial will include 150 patients at up to seven sites in Germany and Belgium. Patient enrolment will be stratified in three groups of 50 patients according to lesion length: ≤10cm, >10cm and ≤20cm, >20cm and ≤30cm. Patients will be randomised 1:1 within each group to treatment with either Zilver PTX or drug-eluting balloons. All analyses with be done by an independent corelab for duplex and angiography.
The primary endpoint of the study is one-year primary patency rate, defined as absence of binary restenosis (Duplex PSVR>2.4) or re-occlusion, and absence of clinically driven target lesion revascularisation. The secondary endpoints, which will be assessed at six, 12 and 24 months, are major adverse events, all-cause death, target vessel revascularisation, clinically-driven target lesion revascularisation, major target limb amputation, sustained clinical improvement, binary restenosis (PSVR>2.4) of the target lesion, walking capacity assessment and procedural success.
Scheinert showed delegates images of one of the Zilver PTX cases that entered the study. The patient had partially stenosed and partially occluded lesions and was randomised to group 2 (lesions up to 20cm). The results after the implantation of two Zilver PTX 6cm stents were successful. He also showed delegates a case from the drug-eluting balloon group, of a patient with a stenotic lesion and severe calcification. “The drug-eluting balloon achieved a very nice result without any stent implantation even in such calcified artery. It will be very interesting to see which of the two treatments will perform better,” he said.
Scheinert said, in conclusion, that enrolment is ongoing, with 25 (16.7%) patients enrolled by the time of the presentation. End of enrolment is planned for the second quarter of this year, and the first results are anticipated in the third or fourth quarter of 2014, he said.
Read the full article in Vascular News CX Special Edition in March/April 2013.