Angiographic and Clinical Outcomes After Treatment of Femoro-Popliteal Lesions with a Novel Paclitaxel-Matrix-Coated Balloon Catheter.

Autor: Tepe G; Department of Radiology, RoMed Klinikum Rosenheim, Pettenkoferstr. 10, 83022, Rosenheim, Germany. gunnar.tepe@ro-med.de., Gögebakan Ö; Department of Radiology and Interventional Radiology, Vivantes Hospital Berlin Neukölln, Berlin, Germany., Redlich U; Departments of Radiology and Vascular Surgery, Klinikum Magdeburg, Magdeburg, Germany., Tautenhahn J; Departments of Radiology and Vascular Surgery, Klinikum Magdeburg, Magdeburg, Germany., Ricke J; Departments of Radiology and Vascular Surgery, University Hospital Magdeburg, Magdeburg, Germany., Halloul Z; Departments of Radiology and Vascular Surgery, University Hospital Magdeburg, Magdeburg, Germany., Meyer DR; Department of Diagnostic and Interventional Radiology, Hubertus Hospital, Berlin, Germany., Waliszewski M; Medical Scientific Affairs, B. Braun Melsungen AG, Berlin, Germany., Schnorr B; Charité Universitätsmedizin, Berlin, Germany., Zeller T; University Heart Center Bad Krozingen, Bad Krozingen, Germany., Müller-Hülsbeck S; Diakonissenanstalt zu Flensburg, Flensburg, Germany., Ott I; Heart Center Munich, Munich, Germany., Albrecht T; Department of Radiology and Interventional Radiology, Vivantes Hospital Berlin Neukölln, Berlin, Germany.
Jazyk: angličtina
Zdroj: Cardiovascular and interventional radiology [Cardiovasc Intervent Radiol] 2017 Oct; Vol. 40 (10), pp. 1535-1544. Date of Electronic Publication: 2017 Jun 28.
DOI: 10.1007/s00270-017-1713-2
Abstrakt: 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.
Databáze: MEDLINE
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