1. V.CHERVENKOFF, M.TSENOV VASCULAR SURGERY CLINIC TOKUDA HOSPITAL SOFIA

2. NOW WHAT? We’ve successfully crossed a lesion AngioplastyAtherectomyStent POBA DCB BMS DES

3. POBA vs Stent

4. RESILIENT TRIAL – LIFESTENT VS PTA IN FEMOROPOPLITEAL LESIONS POBA vs Stent

5. POBA is clearly the less efficient treatment modality in terms of durability Possible explanations:  Dissection  Elastic recoil and calcification  Vessel wall trauma

6. WHY DCB? DCB vs BMS POBA – 95% technical success rate, but up to 80% restenosis at 1 year Drug eluting therapy shows advantages in the coronary circulation Single dose exposure leads to prolongated inhibition of cellular proliferation Paclitaxel selectively inhibits VSMC, not endothelial cells Decreases intimal hyperplasia Positive wall remodelling

7. WHY DCB? DCB vs BMS Strong evidence from 5 RCTs that DCB are superior to POBA in AFS Dissected lesions treated with DCB alone without stenting have favorable restenotic results (Gunnar Tepe Euro PCR 2011) DCB without stenting have never been prospectively compared to DCB with spot stenting DCBs were so far tested only for rather benign lesions of the SFA with lower need of bail- out stenting (4-9% stenting in DCB group compared to up to 22% in control group) DCB have never been compared to bare nitinol stents in the SFA at all

8. DES BMS are superior to PTA alone in AFS, but are still limited by restenosis with 12m patency rates of 60-80% DCB shows promising and superior to POBA results in AFS Dual therapy : mechanical support and drug therapy (paclitaxel) Several RCTs in the SFA segment – Zilver PTX, SIROCCO, STRIDES

9. 3Y PRIMARY PATENCY DES VS PTA DES

10. 3Y PRIMARY PATENCY DES VS BMS DES

11. DES are superior to BMS and POBA in terms of durability REAL PTX study investigating DES (Zilver PTX) vs paclitaxel coated balloon for the treatment of symptomatic de-novo SFA lesions – results still pending Promising technology

12. POINT OF VIEW OF THE SURGEON THE NON-STENT ZONES Bending/kinking External compression Possible anasthomosis sites Large vessel ostia preservation (deep femoral artery)

13. STENTS IN THE SFA Foreign material Changes wall mechanics Stops positive remodeling Chronic wall injury -> restenosis Brake May cover collaterals Get in the way of re-intervention Scaffolding Excellent mechanical support Good radial force Indications:  Acute recoil  Excessive calcification  Flow limiting dissection

14. FACTORS ASSOCIATED WITH RESTENOSIS STENTS IN THE SFA Lesion length 1 Diabetes 2 CRF Occlusions 3 Calcification 4 Poor runoff Elevated CRP 1.Norgren et al. Eur J Vas Endovasc Surg 33, S1-S75: 2007. 2.DeRubertis et al. J Vasc Surg 2008;47:101-108. 3.Lida et al. Cath and Cardiovasc Interven 2011 Oct 1;78(4):611-7. 4. Cioppa et al. CV Revasc. Med. 2012 Jul-Aug:219-23. ISR @1y according to location (Virmani, ESVB 2007)

15. OVERSIZING Possible solutions Self-expanding stents are usually oversized to assure wall apposition Oversizing leads to chronic outward force on the vessel wall This leads to chronic stent-vessel irritation ©2013 Abbott. All rights reserved. AP2938022-OUS Rev. A  If possible – avoid excessive oversizing  New stent designs – gradual and reduced chronic outward force

16. NEW STENT DESIGNS Possible solutions IDEV SUPERA PSS  Six pair of closed end interwoven nitinol wires with a closed cell geometry  Coaxial catheter delivery  Designed for SFA and the popliteal artery GORE TIGRIS  Dual component design  Single wire nitinol stent inteconnected by a biocompatible ePTFE structure  The interconnected structure has a heparin-bonded structure CORDIS S.M.A.R.T. Stent  Each ring is connected by 6 alternating bridges – longitudinal stability  Each circumferential ring contains 36 struts – radial force and scaffolding

17. COVERED STENTS Possible solutions Block the inflammatory response of the vessel wall, caused by the stent No plaque protrusion through the mesh Proven superiority in other vascular pools (iliac arteries) VIBRANT study showed no superiority over BNS Different restenosis pattern – focal edge stenosis => advantage in longer lesions RELINE RCT Viabahn vs PTA – promising results TLR 79 vs 29 %

18. BIORESORBABLE STENTS Possible solutions The mechanical support at the treatment site is temporary needed Provide excellent lumen, then reabsorb completely in the body Nothing is left behind but the native vessel  No chronic inflammatory response  Possible late vascular wall remodeling  Easier re-intervention More data needed (ESPIRIT I)

19. ATHERECTOMY AND DEB Possible solutions Mechanically recanalize the vessel without overstretch Better drug uptake after removing the mechanical barrier Preserve the native vessel, no metal left behind Intraluminal recanalization needed Promising early experience (30 pt. single center study TLR 10%, PP 90% at 12 months) 1 DEFINITIVE AR study – enrollment finished, ongoing 1.Cioppa A et al. Cardiovasc. Revasc. Medicine 2012

20. Conclusion Despite the development of new modalities, for now stents remain a treatment of choice for the majority of SFA lesions DCB plus provisional spot stenting gains popularity, and is the preferred option for most situations Atherectomy and DCB, and BVS showed encouraging early results, but RCT data is still missing