The Randomized Freeway Stent Study: Drug-Eluting Balloons Outperform Standard Balloon Angioplasty for Postdilatation of Nitinol Stents in the SFA and ... View Full Text


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Article Info

DATE

2019-08-20

AUTHORS

Josef Tacke, Stephan Müller-Hülsbeck, Henrik Schröder, Johannes Lammer, Karl Schürmann, Walter Gross-Fengels, Roman Fischbach, Jochen Textor, Lothar Boguth, Christian Loewe, Hannes Häuser, Manfred Gschwendtner, Gunnar Tepe, Rembert Pogge von Strandmann, Stefanie Stahnke, Johannes Dambach, Klaus Hausegger

ABSTRACT

PURPOSE: The prospective randomized multicenter Freeway study evaluated the possible hemodynamic and clinical benefits of primary stent insertion followed by percutaneous transluminal angioplasty (PTA) with drug-eluting balloons (DEB) over post-stent insertion PTA with standard balloons in the treatment of symptomatic femoropopliteal arteriosclerotic lesions. METHODS: In total, 204 patients in 13 centers in Germany and Austria were enrolled and randomized to primary stenting followed by either FREEWAY™ drug-eluting balloon or standard PTA balloon angioplasty. The primary endpoint was the rate of clinically driven target lesion revascularization (TLR) at 6 months; the secondary endpoints include TLR rate at 12 months and primary patency, shift in Rutherford classification, ankle-brachial index (ABI) and major adverse events (MAE) at 6 and 12 months. Lesion characteristics and vessel patency were analyzed by an independent and blinded corelab. RESULTS: At 6-month and 12-month follow-up, TLR rate was lower in the DEB arm compared to standard PTA but did not reach statistical significance (4.1% vs. 9.0% p = 0.234 and 7.9% vs. 17.7% p = 0.064, respectively). Primary patency was significantly better for patients treated with the DEB at 6 months (90.3% vs. 69.8% p = 0.001) and 12 months (77.4% vs. 61.0% p = 0.027). Improvement in Rutherford classifications was likewise significantly better for patients in the DEB group at 6 (94.9% vs. 84.3% p = 0.027) and 12 months (95.5% vs. 79.9% p = 0.003). The percentage of patients with an improved ABI of 1.0-1.2 was significantly higher in the DEB group compared to the PTA group at 6 months (55.3% vs. 35.3%; p = 0.015) but without significant difference at 12 months (48.2% vs. 32.9%; p = 0.055). At 6 months, rate of major adverse events (MAE) was 1% in both arms, and at 12 months 2.2% for the DEB and 3.8% for the PTA group. CONCLUSION: The Freeway Stent Study shows that the usage of DEB as a restenosis prophylaxis seems to be safe and feasible. The 12-month follow-up results give a clear sign in favor of the DEB group. More... »

PAGES

1513-1521

Journal

Author Affiliations

  • Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie, Klinikum Passau, Innstraße 76, 94036 Passau, Germany
  • Radiologie, Diakonissenkrankenhaus Flensburg, Knuthstraße 1, 24939 Flensburg, Germany
  • Jüdisches Krankenhaus Berlin, Gemeinschaftspraxis für Radiologie, Neuroradiologie & Zentrum für Minimal Invasive Therapie am Jüdischen Krankenhaus Berlin, Heinz-Galinski-Str. 1, 13347 Berlin, Germany
  • Kardiovaskuläre und Interventionelle Radiologie, Medizinische Universität Wien, Währinger Gürtel 18-20, 1090 Vienna, Austria
  • Institut für Diagnostische und Interventionelle Radiologie St.-Johannes-Hospital Dortmund, Johannesstraße 9-17, 44137 Dortmund, Germany
  • Radiologie und Nuklearmedizin, Asklepios Klinik Harburg, Eißendorfer Pferdeweg 52, 21075 Hamburg, Germany
  • Radiologie, Neuroradiologie und Nuklearmedizin, Asklepios Klinik Altona, Paul-Ehrlich-Str. 1, 22763 Hamburg, Germany
  • Abteilung für Radiologie Gemeinschaftskrankenhaus Bonn, St. Elisabeth/St. Petrus/St. Johannes gGmbH, Bonner Talweg 4-6, 53113 Bonn, Germany
  • Institut für Diagnostische und Interventionelle Radiologie, Klinikum Idar-Oberstein GmbH, Dr.-Ottmar-Kohler Str. 2, 55743 Idar-Oberstein, Germany
  • Klinik für Diagnostische und Interventionelle Radiologie, Klinikum St. Elisabeth Straubing GmbH, St.-Elisabeth-Str. 23, 94315 Straubing, Germany
  • Institut für Diagnostische und Interventionelle Radiologie, KH Elisabethinen Linz, Fadingerstrasse 1, 4010 Linz, Austria
  • Radiologie, Klinikum Rosenheim, Pettenkoferstr. 10, 83022 Rosenheim, Germany
  • Eurocor Tech GmbH, In den Dauen 6a, 53117 Bonn, Germany
  • Institut für Diagnostische und Interventionelle Radiologie, Klinikum Klagenfurt am Wörthersee, Feschnigstraße 11, 9020 Klagenfurt, Austria
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1007/s00270-019-02309-3

    DOI

    http://dx.doi.org/10.1007/s00270-019-02309-3

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1120435644

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/31432220


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        "description": "PURPOSE: The prospective randomized multicenter Freeway study evaluated the possible hemodynamic and clinical benefits of primary stent insertion followed by percutaneous transluminal angioplasty (PTA) with drug-eluting balloons (DEB) over post-stent insertion PTA with standard balloons in the treatment of symptomatic femoropopliteal arteriosclerotic lesions.\nMETHODS: In total, 204 patients in 13 centers in Germany and Austria were enrolled and randomized to primary stenting followed by either FREEWAY\u2122 drug-eluting balloon or standard PTA balloon angioplasty. The primary endpoint was the rate of clinically driven target lesion revascularization (TLR) at 6\u00a0months; the secondary endpoints include TLR rate at 12\u00a0months and primary patency, shift in Rutherford classification, ankle-brachial index (ABI) and major adverse events (MAE) at 6 and 12\u00a0months. Lesion characteristics and vessel patency were analyzed by an independent and blinded corelab.\nRESULTS: At 6-month and 12-month follow-up, TLR rate was lower in the DEB arm compared to standard PTA but did not reach statistical significance (4.1% vs. 9.0% p\u2009=\u20090.234 and 7.9% vs. 17.7% p\u2009=\u20090.064, respectively). Primary patency was significantly better for patients treated with the DEB at 6\u00a0months (90.3% vs. 69.8% p\u2009=\u20090.001) and 12\u00a0months (77.4% vs. 61.0% p\u2009=\u20090.027). Improvement in Rutherford classifications was likewise significantly better for patients in the DEB group at 6 (94.9% vs. 84.3% p\u2009=\u20090.027) and 12\u00a0months (95.5% vs. 79.9% p\u2009=\u20090.003). The percentage of patients with an improved ABI of 1.0-1.2 was significantly higher in the DEB group compared to the PTA group at 6\u00a0months (55.3% vs. 35.3%; p\u2009=\u20090.015) but without significant difference at 12\u00a0months (48.2% vs. 32.9%; p\u2009=\u20090.055). At 6\u00a0months, rate of major adverse events (MAE) was 1% in both arms, and at 12\u00a0months 2.2% for the DEB and 3.8% for the PTA group.\nCONCLUSION: The Freeway Stent Study shows that the usage of DEB as a restenosis prophylaxis seems to be safe and feasible. The 12-month follow-up results give a clear sign in favor of the DEB group.", 
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