SFA and popliteal environment is dynamic Nitinol Stents in the - - PDF document

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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

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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

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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

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Covered nitinol stent

• Good radial force
• Easy to deploy
• Heparin bonded
• Covers complex disease
• No instent stenosis
• Very low to no fractures
• Useful in treating

stenosis/occlusion in larger diameter vessels

• Excellent tool for bailout in

perforations

• Covers collaterals
• Outflow vessel stenosis like PTFE

bypass

• Neointimal reaction at the interface
• f flow out of the PTFE
• Mode of failure is acute thrombosis
• Can cause worsening of ischemia

compared to pre implant

• Loss of collaterals
• Propagation of thrombus to distal

vessels

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

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Propensity matched patient outcomes of midterm femoral-popliteal interventions

Woven Nitinol Stents Drug Coated Balloons 368 propensity matched pairs Woven Nitinol Stents 254 propensity matched pairs Bare Nitinol Stents

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

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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,
• r 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
• Primay POBA
• PTA w/ DCB if small vessel
• Provisional stenting with std

nitinol

• Short calcified SFA
• Primary POBA
• Atherectomy/PTA with DCB if

small vessel

• Provisional stenting with woven

nitinol

• Medium/long non-calcified SFA
• POBA with DCB
• Provisional stenting with woven

nitinol

• Medium/long calcified SFA
• Primary woven nitinol

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My alogorithm for popliteal

• Short non calcified
• Atherectomy/DCB
• Provisional stenting with woven

nitinol

• Short calcified
• Atherectomy/DCB if embolic

protection feasible

• DCB if EPD not feasible
• Provisional stenting with woven

nitinol

• Long femoral/popliteal

calcified or CTO

• POBA
• High propensity for provisional

stenting with woven nitinol

Balloon technique is critical whether stenting

• r 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!

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