4/8/19 STENTING OF SFA AND POPLITEAL DISEASE DRUG ELUTING, COVERED AND BIOMEMETIC STENTS. WHAT I USE AND WHY DONALD L JACOBS, MD CHIEF , DIVISION OF VASCULAR SURGERY UNIVERSITY OF COLORADO DENVER SFA and popliteal environment is dynamic Nitinol Stents in the Femoropopliteal Artery: A Mechanical Perspective on Material, Design, and Performance Maleckis K, et al. Ann Biomed Eng. 2018 May;46(5):684-704 1
4/8/19 Standard nitinol stents • Low radial force • Variable conformability • Low crush resitance • Frequent fractures in complex anatomy/locations • Acceptable patency in short, proximal and mid SFA lesions • Good results in non calcified iliacs Newer generation of standard nitinol stents • Spiral design improves flexibility/conformability • Fewer fractures than first gen nitinol • Still with low radial strength and low crush resistance • Swirling flow pattern design in some with purported patency benefit 2
4/8/19 DRUG ELUTING STENTS • Zilver PTX (Cook) • High patency with good long term data in non complex lesions • A first generation nitinol stent • Short term drug elution pattern • Mechanical limitations override drug benefit in complex lesions/locations • Paclitaxel concerns • Eluvia (Boston Sci) • Second generation spiral cut nitinol stent • Improved mechanical properties and low fracture rate • Sirolimus coated with longer elution profile • 1 year FU with excellent patency • Increase in diameter of vessel to larger than the stent in a few cases Woven Nitinol stents • High crush resistance • Flexible • Only stent that will not kink • No fractures • Deployment technique challenging, particularly in complex lesions • High patency in complex and calcified lesions, and lesions that involve the popliteal 3
4/8/19 Covered nitinol stent • Good radial force • Covers collaterals • Easy to deploy • Outflow vessel stenosis like PTFE • Heparin bonded bypass • Covers complex disease • Neointimal reaction at the interface • No instent stenosis of flow out of the PTFE • Very low to no fractures • Mode of failure is acute thrombosis • Can cause worsening of ischemia • Useful in treating compared to pre implant stenosis/occlusion in larger • Loss of collaterals diameter vessels • Propagation of thrombus to distal • Excellent tool for bailout in vessels perforations Representative trial data 19 Trial N Lesion(cm) Patency(12mo) PSVR SMART Control Stroll 250 7.7 80% 2.0 LifeStent Resilient 134 7.1 81% 2.5 Everflex Durability II 287 8.9 77% 2.0 Innova SuperNOVA 299 9.3 74% 2.4 Zilver PTX Zilver RCT 241 5.5 83% 2.0 Supera Superb 264 7.8 91% 2.0 Viabahn Viastar 72 19 71% 2.5 4
4/8/19 Propensity matched patient outcomes of midterm femoral-popliteal interventions Woven Nitinol Woven Nitinol Stents Stents Drug Coated Bare Nitinol Balloons Stents 368 propensity matched pairs 254 propensity matched pairs Steiner S, et al J Endovasc Ther 23(2): 347-355 April, 2016 Comparison of Fem-Pop Drug-Eluting Stent with Bare-Metal Stents A Systematic Review and Meta-Analysis • 9 studies with 776 patients • No statistically significant difference between the DES and BMS • Late lumen loss at 6 months • Binary restenosis at 6, 12, and 24 months • (OR = 0.44, P = 0.20;OR = 0.75, P = 0.74; and OR = 0.62, P = 0.36; respectively) • Primary patency rate at 6, 12, and 24 months • (OR = 1.18, P = 0.73; OR = 1.43, P = 0.70; OR = 1.25, P = 0.68, respectively) • Freedom from TLR at 12 months • (OR = 1.13, P = 0.79) • Sensitivity analysis showed sig benefit of DES over BMS in binary restenosis at 6 month • (OR = 0.22, P = 0.008) Ding Y , et al. Ann Vasc Surg. 2018 Jul;50:96-105 5
4/8/19 Simplified stent selection • Simple, non distal SFA or popliteal, non calcified lesions • Does not matter much what you use • Long lesions, more distal lesions, popliteal involvement, calcified, or CTO more than 10-15 cm • Woven nitinol • Covered stent • Large diameter(> 8 mm on IVUS of CTA or by medial calcification estimate) • Covered stent My algorithm for SFA • Short non-calcified • Medium/long non-calcified SFA • Primay POBA • POBA with DCB • PTA w/ DCB if small vessel • Provisional stenting with woven nitinol • Provisional stenting with std nitinol • Medium/long calcified SFA • Short calcified SFA • Primary woven nitinol • Primary POBA • Atherectomy/PTA with DCB if small vessel • Provisional stenting with woven nitinol 6
4/8/19 My alogorithm for popliteal • Short non calcified • Long femoral/popliteal calcified or CTO • Atherectomy/DCB • Provisional stenting with woven • POBA nitinol • High propensity for provisional stenting with woven nitinol • Short calcified • Atherectomy/DCB if embolic protection feasible • DCB if EPD not feasible • Provisional stenting with woven nitinol Balloon technique is critical whether stenting or not • Appropriate diameter and length balloon • Nominal/full pressure inflation • Prolonged inflation • Progressive pressure and/or increase diameter if needed • Rare to not use final balloon diameter of less than 5 in SFA or popliteal • Repeat as needed! 7
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