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


Ontology type: schema:ScholarlyArticle      Open Access: True


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

PurposeThe 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.MethodsIn 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.ResultsAt 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.ConclusionThe 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": "PurposeThe 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.MethodsIn 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\u2013brachial 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.ResultsAt 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\u20131.2 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.ConclusionThe 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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