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 |
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Rok vydání: | 2019 |
Předmět: |
medicine.medical_specialty
Time Factors Paclitaxel medicine.medical_treatment Urology 030204 cardiovascular system & hematology Balloon law.invention 03 medical and health sciences Peripheral Arterial Disease 0302 clinical medicine Randomized controlled trial Restenosis Coated Materials Biocompatible law Angioplasty medicine Clinical endpoint Humans Popliteal Artery 030212 general & internal medicine business.industry medicine.disease Clinical trial Femoral Artery medicine.anatomical_structure Treatment Outcome Relative risk Cardiology and Cardiovascular Medicine business Angioplasty Balloon Vascular Access Devices Artery |
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 |
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