Gunnar Tepe1, Özlem Gögebakan2, Ulf Redlich3, Jörg Tautenhahn3, Jens Ricke4, Zuhir Halloul4, Dirk-Roelfs Meyer5, Matthias Waliszewski6, Beatrix Schnorr7, Thomas Zeller8, Stefan Müller-Hülsbeck9, Ilka Ott10, Thomas Albrecht2. 1. Department of Radiology, RoMed Klinikum Rosenheim, Pettenkoferstr. 10, 83022, Rosenheim, Germany. gunnar.tepe@ro-med.de. 2. Department of Radiology and Interventional Radiology, Vivantes Hospital Berlin Neukölln, Berlin, Germany. 3. Departments of Radiology and Vascular Surgery, Klinikum Magdeburg, Magdeburg, Germany. 4. Departments of Radiology and Vascular Surgery, University Hospital Magdeburg, Magdeburg, Germany. 5. Department of Diagnostic and Interventional Radiology, Hubertus Hospital, Berlin, Germany. 6. Medical Scientific Affairs, B. Braun Melsungen AG, Berlin, Germany. 7. Charité Universitätsmedizin, Berlin, Germany. 8. University Heart Center Bad Krozingen, Bad Krozingen, Germany. 9. Diakonissenanstalt zu Flensburg, Flensburg, Germany. 10. Heart Center Munich, Munich, Germany.
Abstract
OBJECTIVES: Based on a novel paclitaxel-resveratrol drug matrix, the safety and efficacy to inhibit intimal hyperplasia were studied in symptomatic claudicants with morphologically challenging lesions. BACKGROUND: The treatment of peripheral artery occlusive disease (PAOD) with percutaneous transluminal angioplasty is limited by occurrence of vessel recoil and neointimal hyperplasia. Drug-coated balloons (DCB) deliver drugs to the arterial wall to potentially reduce the restenosis rate. A number of paclitaxel-coated balloon technologies are available to treat peripheral lesions. METHODS: In this randomized controlled trial, a total of 153 patients with symptomatic PAOD in femoro-popliteal lesions were randomized either to DCB or plain old balloon angioplasty (POBA). RESULTS: The mean lesion length was 13.2 ± 10.4 cm with target lesion total occlusions in 26.1% of all patients (40/153). The primary endpoint of in-lesion late lumen loss (LLL) at 6 months was significantly reduced in the DCB group as compared to the POBA group (0.35 mm CI [0.19; 0.79 mm] vs. 0.72 mm CI [0.68; 1.22 mm], p = 0.006). At 12 months, the TLR rate in the DCB group was significantly lower as compared to the POBA group (17.8 vs. 37.7% p = 0.008). The censored walking distance increase suggests a benefit for patients who underwent DCB angioplasty as compared to the standard POBA treatment (12 months 165 ± 105 vs. 94 ± 136 m, p = 0.012). CONCLUSION: The use of paclitaxel-resveratrol-matrix-coated peripheral balloon angioplasty as compared to POBA was associated with significantly reduced in-lesion LLL and reduced TLR rates. ClinicalTrials.gov identifier NCT01970579.
RCT Entities:
OBJECTIVES: Based on a novel paclitaxel-resveratrol drug matrix, the safety and efficacy to inhibit intimal hyperplasia were studied in symptomatic claudicants with morphologically challenging lesions. BACKGROUND: The treatment of peripheral artery occlusive disease (PAOD) with percutaneous transluminal angioplasty is limited by occurrence of vessel recoil and neointimal hyperplasia. Drug-coated balloons (DCB) deliver drugs to the arterial wall to potentially reduce the restenosis rate. A number of paclitaxel-coated balloon technologies are available to treat peripheral lesions. METHODS: In this randomized controlled trial, a total of 153 patients with symptomatic PAOD in femoro-popliteal lesions were randomized either to DCB or plain old balloon angioplasty (POBA). RESULTS: The mean lesion length was 13.2 ± 10.4 cm with target lesion total occlusions in 26.1% of all patients (40/153). The primary endpoint of in-lesion late lumen loss (LLL) at 6 months was significantly reduced in the DCB group as compared to the POBA group (0.35 mm CI [0.19; 0.79 mm] vs. 0.72 mm CI [0.68; 1.22 mm], p = 0.006). At 12 months, the TLR rate in the DCB group was significantly lower as compared to the POBA group (17.8 vs. 37.7% p = 0.008). The censored walking distance increase suggests a benefit for patients who underwent DCB angioplasty as compared to the standard POBA treatment (12 months 165 ± 105 vs. 94 ± 136 m, p = 0.012). CONCLUSION: The use of paclitaxel-resveratrol-matrix-coated peripheral balloon angioplasty as compared to POBA was associated with significantly reduced in-lesion LLL and reduced TLR rates. ClinicalTrials.gov identifier NCT01970579.
Authors: Gunnar Tepe; Thomas Zeller; Matej Moscovic; Jean-Marc Corpataux; Johnny Kent Christensen; Koen Keirse; Giovanni Nano; Henrik Schroeder; Christoph A Binkert; Marianne Brodmann Journal: J Endovasc Ther Date: 2020-01-28 Impact factor: 3.487
Authors: Gary M Ansel; Marianne Brodmann; Koen Keirse; Antonio Micari; Michael R Jaff; Krishna Rocha-Singh; Eric J Fernandez; Hong Wang; Thomas Zeller Journal: J Endovasc Ther Date: 2018-10-03 Impact factor: 3.487
Authors: Gunnar Tepe; Thomas Zeller; Matej Moscovic; Jean-Marc Corpataux; Johnny Kent Christensen; Koen Keirse; Giovanni Nano; Henrik Schroeder; Christoph A Binkert; Marianne Brodmann Journal: Cardiovasc Intervent Radiol Date: 2020-10-20 Impact factor: 2.740