Drug-coated Balloon Angioplasty of Femoropopliteal Lesions Maintained Superior Efficacy over Conventional Balloon: 2-year Results of the Randomized EffPac Trial
| Autor: | Dierk Scheinert, Andreas Wienke, Markus Thieme, M. Werk, Christof Klumb, Klaus Brechtel, Vicenç Riambau, Britta Heilmeier, Michael Lichtenberg, Steffen Brucks, Christian Erbel, Ulrich Beschorner, Sebastian Sixt, Erwin Blessing, René Aschenbach, Thomas Zeller, Ulf Teichgräber, Thomas Lehmann, Peter von Flotow |
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| Rok vydání: | 2020 |
| Předmět: |
Male
medicine.medical_specialty Drug coated balloon Paclitaxel medicine.medical_treatment Repeat revascularization Balloon 030218 nuclear medicine & medical imaging Peripheral Arterial Disease 03 medical and health sciences 0302 clinical medicine Coated Materials Biocompatible Restenosis Germany Angioplasty medicine Humans Popliteal Artery Single-Blind Method Radiology Nuclear Medicine and imaging Prospective Studies Vascular Patency Aged business.industry medicine.disease Surgery Femoral Artery Lower Extremity 030220 oncology & carcinogenesis Quality of Life Female business Angioplasty Balloon |
| Zdroj: | Radiology. 295:478-487 |
| ISSN: | 1527-1315 0033-8419 |
| DOI: | 10.1148/radiol.2020191619 |
| Popis: | Background Paclitaxel drug-coated balloon (DCB) catheter angioplasty is the preferred treatment for revascularization of femoropopliteal lesions in peripheral artery disease, but mortality is a safety concern. Purpose To assess 2-year efficacy and safety of DCB angioplasty compared with conventional balloon angioplasty (also known as plain old balloon angioplasty or POBA). Materials and Methods This prospective, multicenter, randomized controlled trial enrolled consecutive participants with symptomatic superficial femoral and/or popliteal artery disease at 11 German centers between September 2015 and December 2016. Participants underwent DCB angioplasty or conventional balloon angioplasty. Primary outcome of 6-month late lumen loss showed superiority of DCB angioplasty over conventional balloon angioplasty. Evaluation at 2 years included secondary outcomes of primary patency and target lesion revascularization (TLR) estimated with Kaplan-Meier analysis, clinical and hemodynamic improvement, quality of life, target limb amputation, and all-cause mortality. Results A total of 171 participants (mean age, 69 years ± 8; 111 men) were evaluated. At 2 years, primary patency was achieved in 90.2% (95% confidence interval [CI]: 80.4%, 95.2%) of DCB angioplasty and 62.7% (95% CI: 50.0%, 73.0%) of conventional balloon angioplasty participants ( |
| Databáze: | OpenAIRE |
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