Yvonne Bausback1, Tim Wittig1, Andrej Schmidt1, Thomas Zeller2, Marc Bosiers3, Patrick Peeters4, Steffen Brucks5, Aaron E Lottes6, Dierk Scheinert1, Sabine Steiner7. 1. Division of Angiology, Department of Internal Medicine, Neurology and Dermatology, University Hospital Leipzig, Leipzig, Germany. 2. Department of Angiology, Universitäts-Herzzentrum Freiburg, Bad Krozingen, Germany. 3. Department of Vascular Surgery, AZ St.-Blasius, Dendermonde, Belgium. 4. Department of Cardiovascular Surgery, Imelda Hospital, Bonheiden, Belgium. 5. Angiologikum Hamburg, Hamburg, Germany. 6. Cook Research Incorporated, West Lafayette, Indiana. 7. Division of Angiology, Department of Internal Medicine, Neurology and Dermatology, University Hospital Leipzig, Leipzig, Germany. Electronic address: Sabine.Steiner@medizin.uni-leipzig.de.
Abstract
BACKGROUND: Randomized trials of drug-eluting stents (DES) and drug-coated balloons (DCB) for femoropopliteal interventions reported superior patency rates for both strategies compared to standard balloon angioplasty. To date, head-to-head comparisons are missing. OBJECTIVES: The authors sought to compare DES versus DCB for femoropopliteal lesions through 36 months. METHODS: Within a multicenter, randomized trial, 150 patients with symptomatic femoropopliteal disease were randomly assigned to primary DES implantation or DCB angioplasty with bailout stenting after stratification for lesion length (≤10 cm, >10 cm to ≤20 cm, and >20 cm to ≤30 cm). The primary effectiveness endpoint was primary patency at 12 months assessed by Kaplan-Meier. Secondary endpoints comprised major adverse events including death, major amputations, and clinically driven target lesion revascularization, and clinical outcomes. RESULTS: More than one-half of lesions were total occlusions, and the stenting rate was 25.3% in the DCB group. Kaplan-Meier estimates of primary patency were 79% and 80% for DES and DCB at 12 months (p = 0.96) but decreased to 54% and 38% through 36 months (p = 0.17), respectively. Freedom from clinically driven target lesion revascularization was >90% at 12 months but dropped to around 70% at 36 months in both groups. Overall, the mortality rate through 36 months was 7.3%, with 1 procedure-related death in the DCB group. Improvement of clinical outcomes was sustained through 36 months. CONCLUSIONS:Patency rates at 12 months suggest comparable effectiveness and safety of DES versus DCB plus bailout stenting in femoropopliteal interventions; a trend in favor of the DES was observed up to 36 months. (Randomized Evaluation of the Zilver PTX Stent vs. Paclitaxel-Eluting Balloons for Treatment of Symptomatic Peripheral Artery Disease of the Femoropopliteal Artery [REAL PTX]; NCT01728441).
RCT Entities:
BACKGROUND: Randomized trials of drug-eluting stents (DES) and drug-coated balloons (DCB) for femoropopliteal interventions reported superior patency rates for both strategies compared to standard balloon angioplasty. To date, head-to-head comparisons are missing. OBJECTIVES: The authors sought to compare DES versus DCB for femoropopliteal lesions through 36 months. METHODS: Within a multicenter, randomized trial, 150 patients with symptomatic femoropopliteal disease were randomly assigned to primary DES implantation or DCB angioplasty with bailout stenting after stratification for lesion length (≤10 cm, >10 cm to ≤20 cm, and >20 cm to ≤30 cm). The primary effectiveness endpoint was primary patency at 12 months assessed by Kaplan-Meier. Secondary endpoints comprised major adverse events including death, major amputations, and clinically driven target lesion revascularization, and clinical outcomes. RESULTS: More than one-half of lesions were total occlusions, and the stenting rate was 25.3% in the DCB group. Kaplan-Meier estimates of primary patency were 79% and 80% for DES and DCB at 12 months (p = 0.96) but decreased to 54% and 38% through 36 months (p = 0.17), respectively. Freedom from clinically driven target lesion revascularization was >90% at 12 months but dropped to around 70% at 36 months in both groups. Overall, the mortality rate through 36 months was 7.3%, with 1 procedure-related death in the DCB group. Improvement of clinical outcomes was sustained through 36 months. CONCLUSIONS: Patency rates at 12 months suggest comparable effectiveness and safety of DES versus DCB plus bailout stenting in femoropopliteal interventions; a trend in favor of the DES was observed up to 36 months. (Randomized Evaluation of the Zilver PTX Stent vs. Paclitaxel-Eluting Balloons for Treatment of Symptomatic Peripheral Artery Disease of the Femoropopliteal Artery [REAL PTX]; NCT01728441).
Authors: Ramya C Mosarla; Ehrin Armstrong; Yonatan Bitton-Faiwiszewski; Peter A Schneider; Eric A Secemsky Journal: J Soc Cardiovasc Angiogr Interv Date: 2022-08-20
Authors: Sabine Steiner; Andrej Schmidt; Thomas Zeller; Gunnar Tepe; Marcus Thieme; Lars Maiwald; Henrik Schröder; Wulf Euringer; Matthias Ulrich; Klaus Brechtel; Steffen Brucks; Erwin Blessing; Johannes Schuster; Ralf Langhoff; Sebastian Schellong; Norbert Weiss; Dierk Scheinert Journal: Eur Heart J Date: 2020-07-14 Impact factor: 29.983
Authors: William A Gray; Michael R Jaff; Sahil A Parikh; Gary M Ansel; Marianne Brodmann; Prakash Krishnan; Mahmood K Razavi; Frank Vermassen; Thomas Zeller; Roseann White; Kenneth Ouriel; Mark A Adelman; Sean P Lyden Journal: Circulation Date: 2019-09-30 Impact factor: 29.690