title: Heparin-bonded stent-graft for the treatment of TASC II C and D femoropopliteal lesions: the Viabahn-25 cm trial.
abstract: 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.
authors.affiliation: 1 Department Angiology, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
authors.forename: Patrick
authors.initials: P
authors.lastname: Peeters
authors.forename: Marc
authors.initials: M
authors.lastname: Bosiers
authors.forename: Johannes
authors.initials: J
authors.lastname: Lammer
authors.forename: Klaus
authors.initials: K
authors.lastname: Brechtel
authors.forename: Dierk
authors.initials: D
authors.lastname: Scheinert
authors.forename: Aljoscha
authors.initials: A
authors.lastname: Rastan
authors.forename: Elias
authors.initials: E
authors.lastname: Noory
authors.forename: Ulrich
authors.initials: U
authors.lastname: Beschorner
mesh_terms: D000368:Aged; D055109:Ankle Brachial Index; D000925:Anticoagulants / Q000008:administration & dosage*; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D020099:Coated Materials, Biocompatible; D003251:Constriction, Pathologic; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D005060:Europe; D005260:Female; D005263:Femoral Artery / Q000503:physiopathology / Q000601:surgery*; D006493:Heparin / Q000008:administration & dosage*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D011150:Popliteal Artery / Q000503:physiopathology / Q000601:surgery*; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D011474:Prosthesis Design; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
chemical_list: D000925:Anticoagulants; D020099:Coated Materials, Biocompatible; D006493:Heparin
keywords: angioplasty; covered stent; heparin bonding; occlusion; patency; peripheral artery disease; polytetrafluoroethylene; stenosis; stent-graft; superficial femoral artery