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Teichgräber, Ulf; Lehmann, Thomas; Ingwersen, Maja; Aschenbach, René; Zeller, Thomas; Brechtel, Klaus; Blessing, Erwin; Lichtenberg, Michael; von Flotow, Peter; Heilmeier, Britta; Sixt, Sebastian; Brucks, Steffen; Erbel, Christian; Beschorner, Ulrich; Werk, Michael; Riambau, Vicenç; Wienke, Andreas; Klumb, Christof; Thieme, Markus; Scheinert, Dierk

Long-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac Trial

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  • Media type: E-Article
  • Title: Long-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac Trial
  • Contributor: Teichgräber, Ulf; Lehmann, Thomas; Ingwersen, Maja; Aschenbach, René; Zeller, Thomas; Brechtel, Klaus; Blessing, Erwin; Lichtenberg, Michael; von Flotow, Peter; Heilmeier, Britta; Sixt, Sebastian; Brucks, Steffen; Erbel, Christian; Beschorner, Ulrich; Werk, Michael; Riambau, Vicenç; Wienke, Andreas; Klumb, Christof; Thieme, Markus; Scheinert, Dierk
  • imprint: Springer Science and Business Media LLC, 2022
  • Published in: CardioVascular and Interventional Radiology
  • Language: English
  • DOI: 10.1007/s00270-022-03265-1
  • ISSN: 0174-1551; 1432-086X
  • Origination:
  • Footnote:
  • Description: <jats:title>Abstract</jats:title><jats:sec><jats:title>Purpose</jats:title><jats:p>This study aimed to assess 5-year effectiveness and safety of femoropopliteal angioplasty with the Luminor® 35 drug-coated balloon (DCB).</jats:p></jats:sec><jats:sec><jats:title>Materials and Methods</jats:title><jats:p>The EffPac trial was a prospective, multicenter, randomized controlled trial that enrolled 171 patients of Rutherford category 2 to 4 with medium length femoropopliteal lesions. Patients were allocated 1:1 to either Luminor® 35 DCB angioplasty or plain old balloon angioplasty (POBA). Assessment at 5 years included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), clinical improvement, and target limb amputation. Long-term vital status was ascertained in 97.1% of the participants.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p><jats:italic>Kaplan</jats:italic>–Meier curves at 5 years demonstrate a primary patency of 61.4% after DCB angioplasty and 53.5% after POBA (log-rank<jats:italic>p</jats:italic> = 0.040) with a decreasing difference throughout the observation period. Freedom from TLR was 82.1% and 73.7%, respectively (log-rank<jats:italic>p</jats:italic> = 0.050). Incidence of primary clinical improvement was similar between groups (61% DCB vs. 64% POBA,<jats:italic>p</jats:italic> = 0.94). Major target limb amputation was necessary in one POBA-group participant. Freedom from all-cause death at 5 years was 88.5% after DCB and 86.0% after POBA (log-rank<jats:italic>p</jats:italic> = 0.34).</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Primary patency after femoropopliteal DCB angioplasty remained superior to POBA throughout 5 years, however, with decreasing difference. Clinical improvement, freedom from TLR, and all-cause mortality were similar between groups over the long term. (Effectiveness of Paclitaxel-Coated Luminor® Balloon Catheter Versus Uncoated Balloon Catheter in the Superficial Femoral Artery [EffPac]; NCT02540018).</jats:p></jats:sec>