In the DCB Era, How Do I Choose To Use a Stent? When to Stent and What Devices to Use in the SFA Disclosures No financial disclosures. Cameron M. Akbari, MD, MBA, FACS Site Director, Vascular Surgery Medstar Georgetown University Hospital Washington, DC Lower Extremity Endovascular Interventions: More Options than Ever POBA Stenting, Covered Stents Thrombectomy Lysis Laser Atherectomy Atherectomy Subintimal Angioplasty Cryoplasty DES, DEB CTO Devices MOST, IF NOT ALL, ARE SUCCESSFUL Primary Patency Assisted Patency Freedom from TLR/TVR Limb Salvage Defining Success Symptom Improvement Scale Freedom from Change in Rutherford Scale 1
In the DCB Era, How Do I Choose To Use a Stent? When to Stent and What Devices to Use in the SFA 1. Where are we in the DCB Era?* * in the U.S. Average lesion length 7.5 cm Small numbers enrolled DCB shown to be safe, effective in TASC A, B lesions, even with dissections post PTA. DCB: THUNDER Trial 5 Year TLR NEJM 2008 DCB: LEVANT Trial DCB: LEVANT Trial: 1 Year Primary Patency LUTONIX DCB vs STANDARD PTA Average lesion length 6.5 cm Almost all TASC A and B Only 20% of lesions were CTO s PRIMARY EFFICACY ENDPOINT: Freedom from binary restenosis AND Freedom from TLR 2
Primary Patency Kaplan-Meier DCB for Long SFA Lesions:INPACT Leipzig Registry Free from Primary Patency Event (%) 100 90 80 70 60 50 40 30 20 10 Lutonix DCB (N) 291 Standard PTA (N) 146 0 Survival % Time Lutonix DCB Standard PTA P-value 365 days 73.5% 56.8% 0.001 0 1 2 3 4 5 6 7 8 9 10 11 12 13 Months from Randomization Date 261 116 DCB PTA 179 69 1 Year Freedom from TLR 260 patient prosepctive registry Average lesion length > 20 cm Provisional Stenting 23% Borrowed from Dr. Thomas Zeller When to Stent in the DCB Era in 2015? TASC A AND B LESIONS Predilatation of the SFA-lesion with Standard PTA, or Following Atherectomy and Standard PTA Where are we in the DCB Era? In case of severe dissection Good result Stent DCB Additional Stent if necessary 1. In infancy, especially for TASC C and D Lesions 2. Stenting is still an important part of the SFA endovascular treatment strategy 3
Considerations Not all stents created equal Calcification Location Length Size of recipient vessel ISR/Stent occlusion Need for adjunctive pharmacotherapy (DAPT) Considerations Special Situations Considerations Drug Eluting Stent Zilver PTX Outstanding Long-Term Data (most stent trials reporting 1-2 year patency rates) 4
DES 3-Year Freedom from TLR Zilver PTX vs. Standard Care 5-year Primary Patency (PSVR < 2.0) Zilver PTX vs. Standard Care 83.7% 70.2% Zilver PTX 240patients Optimal PTA + Bare Zilver 139 patients 3-year TLR Group Rate Reduction Zilver PTX 16.3% Optimal PTA + 29.8% 45% Provisional Bare Zilver p < 0.01 log-rank 66.4% 43.4% Zilver PTX Optimal PTA + BMS p < 0.01 log-rank 5-year Primary Patency (PSVR < 2.0) Provisional Zilver PTX vs. BMS Provisional 72.4% Zilver PTX 53.0% Provisional BMS p = 0.03 log-rank Considerations Calcification Location Length Size of recipient vessel ISR/Stent occlusion Need for adjunctive pharmacotherapy (DAPT) 5
Supera Interwoven Stent Highest radial strength of any self expanding stent Highest compression reistance Physiologically flexible/ conformable Kink and crush resistant Fracture proof 6
Supera Interwoven Stent SUPERB Trial 7
Supera Durability: Importance of Correct Sizing and Vessel Prep Considerations Calcification Location Length Size of recipient vessel ISR/Stent occlusion Need for adjunctive pharmacotherapy (DAPT) Binary restenosis @ 12 months (%) SFA LESION LENGTH and PATENCY: 12 months restenosis vs. lesion length PTA + provisional stent Stent Lesion length (cm) RESILIENT FAST FAST RESILIENT Data from randomised trials ASTRON FACT ABSOLUTE SUPER SL DurabilityABSOLUTE SMART ASTRON SUPERA SFA Zilver PTX: 12-Month Primary Patency (PSVR < 2.0) in Longer Lesions Average Lesion Length 20 cm 80% CTO 86.1% Zilver PTX 70.5% Zilver Flex 8
Supera: Long Lesions Covered Stents: Gore VIPER Clinical Study Gore VIPER Clinical Study Data: 73% primary patency and 92% secondary patency at 1-year Prospective, multi-center 119 limbs at 12 sites Primary patency by duplex (peak systolic velocity ratio (PSVR) < 2.5) Average lesion length 19 cm 56 % Chronic Total Occlusions Primary Patency Per-Protocol Analysis * Patency advantage with GORE VIABAHN Endoprosthesis amplified in lesions 20 cm. When treating lesions at the same TASC II level, BMS were 2.71 times more likely to lose patency. Considerations Calcification Location Length Size of recipient vessel ISR/Stent occlusion Need for adjunctive pharmacotherapy (DAPT) 9
Stenting: Length Matters, But So Does Vessel Diameter Avoid Oversizing Any Stent Deleterious Effects of Chronic Outforce on the Vessel Wall Recent Clinical Studies: Gore VIPER Clinical Study Gore VIPER Clinical Study Data: 11 Device Sizing Patency improved when device not oversized > 20% proximally Device Diameter Patency independent of device diameter (5, 6, 7 mm devices utilized, p = 0.22) Lesion Length Patency independent of lesion length (lesions > 20 cm versus 20 cm, p = 0.51) 2013 W. L. Gore & Associates, Inc. 11. J Vasc Interv Radiol. 2013;24(2):165-173. (RP1598) Considerations Not all stents created equal Calcification Location ISR/Stent occlusion RELINE: Viabahn vs. PTA for SFA ISR Multi-center, RCT of Viabahn (N=39) vs. PTA (N=44) in 83 pts. Key Inclusion Criteria Rutherford class 2-5 ABI 0.8 Key Angiographic Inclusion Criteria restenotic or reoccluded lesion located in an SFA stent total target lesion length between 4-27 cm (comprising in-stent restenosis and adjacent stenotic disease) Deloose, LINC 2015 10
100% 75% 50% 25% 0% RELINE: 1& 2 yr. Primary Patency Viabahn PTA 75% p<0.001 58% p<0.001 28% 12% 1 year 2 year (DUS PSVR 2.5) Deloose, LINC 2015 11
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Covered Stents: Caveats Crossing large collaterals, especially at the distal aspect of occluded BMS Need healthy vessel at proximal and distal edge If not, consider adding BMS at the edge Edge restenosis Conclusions Generic, short lesion, post dissection, healthy vessel, good runoff Probably any stent will do well. Conclusions Zilver PTX: Provisional Stenting, SFA or proximal popliteal without severe calcification, able to tolerate DAPT for at least 60 days, vessel size > 5 mm Can justify use for long lesions (20 cm) Consider use as a top-hat for Viabahn Conclusions Supera: Provisional Stenting, SFA or Popliteal with severe calcification Crossing the knee joint Nonostial vessel size > 4.5 mm Can justify use for long lesions (20 cm) 13
Conclusions Gore Viabahn: In Stent Occlusion (consider in conjunction with laser atherectomy), Healthy vessel above and below In Stent Restenosis* Long Lesions vessel size > 4.4 mm Extensive Disruption following SubintimalAngioplasty * May also consider atherectomy plus DCB Conclusions Vessel Diameter < 4.5 mm Zilver (5 mm) for ostial lesions Smart Flex (5 mm) for nonostial Conclusions Disadvantaged Runoff Zilver PTX? Supera? Thank You 14