Does stent design influence the results of SFA stenting?
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1 LINC 2015, Leipzig A.Z. Sint-Blasius, Dendermonde Marc Bosiers Koen Deloose Joren Callaert Imelda Hospital, Bonheiden Patrick Peeters Jürgen Verbist OLV Hospital, Aalst Does stent design influence the results of SFA stenting? Lieven Maene Roel Beelen R.Z. Heilig Hart, Tienen Koen Keirse Bart Joos Koen Deloose, MD 1
2 Disclosure slide I have the following potential conflicts of interest to report: Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest 2
3 Stent design related factors Flexibility Axial Compression Resistance Torsion Resistance Chronic Outward Force (COF) Radial Resistive Force (RRF) Crush Resistance (CR) Fractures Physical irritation Collapse Endothelial trauma/neo-intimal hyperplasia RESTENOSIS 3
4 Supera VMI Abbott Vascular Superb,Supera 500 Leipzig exp, Auroraa, CWS, Tucson Tigris Gore & Associates Retrospective study Tigris IDE Study Biomimics 3D Veryan Medical MIMICS study 4
5 Supera VMI Abbott Vascular Superb,Supera 500 Leipzig exp, Auroraa, CWS, Tucson 6 stable closed-ends interwoven nitinol wires Extreme flexibility & kink resistance Low chronic outward force High crush resistance & radial resistive force Dedicated preparation & delivery technique Deflection (mm) Supera VMI s Greater than 4x Compression resistance Standard Nitinol Stents 5
6 Supera VMI Abbott Vascular Superb,Supera 500 Leipzig exp, Auroraa, CWS, Tucson Mean patency of BMS : 75% Mean patency of BMS : 60% Pacanowski et al. LINC 2013, Leipzig, Germany 6
7 TIGRIS Gore & Associates Retrospective study Tigris IDE Study Helical single nitinol wire spiral frame Heparin coated eptfe bridges High flexibility Elongation-axial compression resistance ++ 7
8 TIGRIS Gore & Associates Retrospective study Retrospective analysis of 40 SFA lesions, mean lesion length 62.3mm Procedural success (%) 100 ABI 12 m > P< Rutherford 12 m 3.0 > 1.0 P< Primary patency@12m (%)
9 TIGRIS Gore & Associates Tigris US IDE Trial Prospective, multicenter, 3:1 randomized SFA trial, Tigris (Gore ) vs Lifestent (Bard ) 36 clinical sites (US EU) ; 274 inclusions (197 Tigris 70 Lifestent) Mean lesion length : 10.7 cm (Tigris) cm (Lifestent) Results summer
10 BioMimics 3D Veryan Medical Mimics study Unique 3 dimensional helical centerline geometry short & long spiral oriented connectors Promotes Swirling flow shear stress Enables coil-spring shortening Reduces risk of stent compression Zeller T, VIVA 2014, Las Vegas, US With the courtesy of Veryan Medical 10
11 BioMimics 3D Veryan Medical Mimics study Prospective, randomized multicenter controlled trial 8 German centers, PI T. Zeller 2:1 randomization Mean lesion length (mm) : BMS Biomimics 3D p < 0.7 Zeller T, VIVA 2014, Las Vegas, US 11
12 BioMimics 3D Veryan Medical Mimics study Prospective, randomized multicenter controlled trial BioMimics 3D BMS p 1 yr primary patency yr primary patency (%) yr free CD-TLR (%) yr free CD-TLR (%) Stent # 0 na Zeller T, VIVA 2014, Las Vegas, US 12
![Durability I Supera Viastar Supera LL [1] Dake MD et al. Circ Cardiovasc Interv. 2011; [2] Scheinert D LINC 2013; [3] Laird JR et al.](/docs-images/72/66496503/images/13-1.jpg "Circ Cardiovasc Interv. 2010; [4] Cordis SMART Control IFU 100000000922.1; [5] Matsumura JS J Vasc Surg. 2013;; [6] Bosiers M J Endovasc Ther.")
13 Does stent design influence the results? 1 yr ppr 1 yr CD-TLR mean LL 22,6 85,5% 80,4% 86% 78% 9,9 6,2 6,6 9,0% Zilver PTX Complete SE Tigris Biomimics Resilient Stroll Durability II Durability I Supera Viastar Supera LL [1] Dake MD et al. Circ Cardiovasc Interv. 2011; [2] Scheinert D LINC 2013; [3] Laird JR et al. Circ Cardiovasc Interv. 2010; [4] Cordis SMART Control IFU ; [5] Matsumura JS J Vasc Surg. 2013;; [6] Bosiers M J Endovasc Ther. 2009; [7] Lammer J et al. J Am Coll Cardiol With the courtesy of Medtronic Academia of medical education 13
14 Conclusion Stent design related factors as flexibility, axial compression and torsion resistance, COF, RRF and CR are important to avoid fractures, collapse and restenosis Supera, Tigris and Biomimics 3D are perfect examples of the latest generation nitinol stents Especially in long challenging lesions, adapted designs might play a role in improving outcome results 14
15 LINC 2015, Leipzig A.Z. Sint-Blasius, Dendermonde Marc Bosiers Koen Deloose Joren Callaert Imelda Hospital, Bonheiden Patrick Peeters Jürgen Verbist OLV Hospital, Aalst Does stent design influence the results of SFA stenting? Lieven Maene Roel Beelen R.Z. Heilig Hart, Tienen Koen Keirse Bart Joos Koen Deloose, MD 15
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