The Randomized Freeway Stent Study: Drug-Eluting Balloons Outperform Standard Balloon Angioplasty for Postdilatation of Nitinol Stents in the SFA and PI Segment

Journal Article · Fri Nov 15 04:00:00 EST 2019 · Cardiovascular and Interventional Radiology

DOI:https://doi.org/10.1007/S00270-019-02309-3· OSTI ID:22970447

Tacke, Josef ^[1]; Müller-Hülsbeck, Stephan ^[2]; Schröder, Henrik ^[3]; Lammer, Johannes ^[4]; Schürmann, Karl ^[5]; Gross-Fengels, Walter ^[6]; Fischbach, Roman ^[7]; Textor, Jochen ^[8]; Boguth, Lothar ^[9]; Loewe, Christian ^[4]; Häuser, Hannes ^[10]; others, and

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1. Klinikum Passau, Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie (Germany)
2. Radiologie, Diakonissenkrankenhaus Flensburg (Germany)
3. Neuroradiologie & Zentrum für Minimal Invasive Therapie am Jüdischen Krankenhaus Berlin, Jüdisches Krankenhaus Berlin, Gemeinschaftspraxis für Radiologie (Germany)
4. Medizinische Universität Wien, Kardiovaskuläre und Interventionelle Radiologie (Austria)
5. Institut für Diagnostische und Interventionelle Radiologie St.-Johannes-Hospital Dortmund (Germany)
6. Asklepios Klinik Harburg, Radiologie und Nuklearmedizin (Germany)
7. Asklepios Klinik Altona, Radiologie, Neuroradiologie und Nuklearmedizin (Germany)
8. St. Elisabeth/St. Petrus/St. Johannes gGmbH, Abteilung für Radiologie Gemeinschaftskrankenhaus Bonn (Germany)
9. Klinikum Idar-Oberstein GmbH, Institut für Diagnostische und Interventionelle Radiologie (Germany)
10. Klinikum St. Elisabeth Straubing GmbH, Klinik für Diagnostische und Interventionelle Radiologie (Germany)

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.

• OSTI ID: 22970447
• Journal Information: Cardiovascular and Interventional Radiology, Journal Name: Cardiovascular and Interventional Radiology Journal Issue: 11 Vol. 42; ISSN 0174-1551; ISSN CAIRDG
• Country of Publication: United States
• Language: English

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