Heparin-Bonded Stent-Graft for the Treatment of TASC II C and D Femoropopliteal Lesions: The Viabahn-25 cm Trial

• Published in: Journal of endovascular therapy Vol. 21; no. 6; pp. 765 - 774
• Main Authors: Zeller, Thomas, Peeters, Patrick, Bosiers, Marc, Lammer, Johannes, Brechtel, Klaus, Scheinert, Dierk, Rastan, Aljoscha, Noory, Elias, Beschorner, Ulrich
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA SAGE Publications 01.12.2014; Allen Press Inc
• Subjects: Aged; Amputation; Angioplasty; Ankle Brachial Index; Anticoagulants - administration & dosage; Biomedical research; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation - adverse effects; Blood Vessel Prosthesis Implantation - instrumentation; Cardiovascular disease; Clinical trials; Coated Materials, Biocompatible; Constriction, Pathologic; Endovascular Procedures - adverse effects; Endovascular Procedures - instrumentation; Europe; FDA approval; Female; Femoral Artery - physiopathology; Femoral Artery - surgery; Heart surgery; Heparin - administration & dosage; Human subjects; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Mortality; Patients; Peripheral Arterial Disease - diagnosis; Peripheral Arterial Disease - physiopathology; Peripheral Arterial Disease - surgery; Popliteal Artery - physiopathology; Popliteal Artery - surgery; Postoperative Complications - etiology; Prospective Studies; Prosthesis Design; Stents; Studies; Thrombosis; Time Factors; Treatment Outcome; Vascular Patency; Europe; patency; peripheral artery disease; stent-graft; occlusion; superficial femoral artery; polytetrafluoroethylene; covered stent; heparin bonding; stenosis; angioplasty
• ISSN: 1526-6028; 1545-1550; 1545-1550
• DOI: 10.1583/14-4790R.1

Purpose: To confirm the performance and safety of the 25-cm Viabahn endoprosthesis with Propaten bioactive surface when used in the treatment of de novo and/or restenotic TransAtlantic Inter-Society Consensus II C and D lesions of the superficial femoral artery and proximal popliteal artery. Methods: The 25-cm Gore Viabahn Endoprosthesis study (ClinicalTrials.gov identifier NCT01263665) is a prospective, multicenter, single-arm study that enrolled 71 patients (50 men; mean age 66.7±8.34 years) with lifestyle-limiting claudication (Rutherford class 2 to 4) and lesions longer than 20 cm (mean length 26.5±5.31 cm, range 20–40). The majority of lesions (92.9%) were total occlusions. The primary performance outcome was post-deployment stent length within ±10% of the pre-deployment stent length determined angiographically by quantitative vascular analysis. The primary safety outcome was device- and procedure-related serious adverse events occurring within 30 days of the procedure. The patients underwent follow-up examinations at 1 month and 1 year. Results: The median follow-up was 12.3 months (mean 12.3±0.6). Nine (12.7%) patients discontinued the study due to different reasons including 2 bypass surgeries. Angiography was available in 60 patients to determine the primary performance outcome, which was met in all cases. Two (2.8%) patients experienced a procedure-/device-related adverse event (dissection) during the 30-day follow-up. Kaplan-Meier estimates for 1-year primary and secondary patency were 67.0% [95% confidence interval (CI) 53.5% to 77.3%] and 96.9% (95% CI 88.0% to 99.2%), respectively. Changes in ankle-brachial index and Rutherford category at 1 and 12 months each showed sustained improvement. Conclusion: This study confirms that the 25-cm Viabahn endoprosthesis acutely performs as intended and is safe when used as indicated in complex femoropopliteal lesions. One-year primary and secondary patency rates are satisfying and comparable to historical prosthetic bypass graft outcomes.