Long-term effectiveness and safety of femoropopliteal drug-coated balloon angioplasty : : 5-year results of the randomized controlled EffPac trial

Abstract: Purpose

This study aimed to assess 5-year effectiveness and safety of femoropopliteal angioplasty with the Luminor® 35 drug-coated balloon (DCB).
Materials and Methods

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.
Results

Kaplan–Meier curves at 5 years demonstrate a primary patency of 61.4% after DCB angioplasty and 53.5% after POBA (log-rank p = 0.040) with a decreasing difference throughout the observation period. Freedom from TLR was 82.1% and 73.7%, respectively (log-rank p = 0.050). Incidence of primary clinical improvement was similar between groups (61% DCB vs. 64% POBA, p = 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 p = 0.34).
Conclusions

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)

Angaben zum Objekt

• Standort: Deutsche Nationalbibliothek Frankfurt am Main
• Umfang: Online-Ressource
• Sprache: Englisch
• Anmerkungen: CardioVascular and interventional radiology. - 45, 12 (2022) , 1774-1783, ISSN: 1432-086X

Beteiligte, Orts- und Zeitangaben

• Ereignis: Veröffentlichung
• (wo): Freiburg
• (wer): Universität
• (wann): 2022
• Urheber: Teichgräber, Ulf ; Lehmann, Thomas ; Ingwersen, Maja ; Aschenbach, René ; Zeller, Thomas ; Brechtel, Klaus Franz Martin ; Blessing, Erwin ; Lichtenberg, Michael Klaus William ; Flotow, Peter von ; Heilmeier, Britta ; Sixt, Sebastian ; Brucks, Steffen ; Erbel, Christian ; Beschorner, Ulrich ; Werk, Michael ; Riambau, Vicente ; Wienke, Andreas ; Klumb, Christof Tobias ; Thieme, Marcus ; Scheinert, Dierk Wolfgang

Weitere Informationen

• DOI: 10.1007/s00270-022-03265-1
• URN: urn:nbn:de:bsz:25-freidok-2299803
• Rechteinformation: Open Access; Der Zugriff auf das Objekt ist unbeschränkt möglich.
• Letzte Aktualisierung: 25.03.2025, 13:45 MEZ