Efficacy and safety of a novel paclitaxel-nano-coated balloon for femoropopliteal angioplasty: one-year results of the EffPac trial

Autor: Ulf Teichgräber, Thomas Lehmann, René Aschenbach, Dierk Scheinert, Thomas Zeller, Klaus Brechtel, Erwin Blessing, Michael Lichtenberg, Sebastian Sixt, Steffen Brucks, Ulrich Beschorner, Christof Tobias Klumb, Markus Thieme, Peter von Flotow, Britta Heilmeier, Christian Erbel, Michael Werk, Vicenç Riambau, Andreas Wienke
Rok vydání: 2019
Předmět:
Zdroj: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 15(18)
ISSN: 1969-6213
Popis: AIMS Although paclitaxel drug-coated balloon (DCB) angioplasty is an established endovascular treatment for peripheral artery disease, restenosis remains a major concern. Thus, we compared a novel paclitaxel-coated DCB with nano-coating technology with uncoated plain old balloon angioplasty (POBA). METHODS AND RESULTS This multicentre trial randomly assigned 171 patients with stenotic and occlusive lesions of the femoropopliteal artery to angioplasty with a novel DCB or uncoated POBA. The primary endpoint, late lumen loss at six months, was 0.92 mm lower in the DCB group (95% CI: -1.36 to -0.49 mm, p
Databáze: OpenAIRE