Minimizing Burden, the effect of thin strut and low Chronic Outward Force SE stents Prof. Yong LIU The affiliated hospital of southwest medical university LINC AP 2018, Hong Kong 13-15 th March
Disclosure Speaker name: Prof. Yong LIU 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
BARE-METAL STENTS play a role as definitive or adjunctive treatment options SFA stents are proven as a standalone therapy STUDY DEVICE Av. Lesion Length. PP FTLR 4EVER 1 Pulsar-18 10.8 cm 73.4% 85.2% PEACE 2 Pulsar-18 11.2 cm 79.5% 81.0% RESILIENT 3 Lifestent 6.2 cm 81.3% 87.3% DURABILITY II 4 EverFlex 8.9 cm 77.2% N/A SUPERB 5 Supera 9.0 cm 84.7% N/A DURABILITY 6 EverFlex 9.6 cm 72.2% 79.1% Stents may complement DCB and are an alternative to DES DCB +/- Stent vs. DES Ability to spot stent rather than full metal burden associated with DES Provisional stent choice based on lesion type Crush resistance in Ca +++ Low COF for dissection 'tacking' 3 Source: BIOFLEX PEACE (interim). Lichtenberg M. Presented at LINC 2017. 1) 4EVER Bosiers M. JEVT 2013;20:746 756; 2) PEACE Lichtenberg M. JEVT, 2014, 21:373-380; 3) Laird JR, Katzen BT, Scheinert D, et al., Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve month results from the RESILIENT randomized trial. Circ Cardiovasc Interv. 2010;3:267-276; 4) Matsumura JS, Yamanouchi D, Goldstein JA, Pollock CW, Bosiers M, Schultz GA, Scheinert D, Rocha-Singh KJ. The United States StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By using the Protégé EverfLex NitInol STent SYstem II (DURABILITY II). J Vasc Surg. 2013 Jul;58(1):73-83.e1. doi: 10.1016/j.jvs.2012.12.066. Epub 2013 May 2. 5) Bosiers M, Torsello G, Gissler HM, et al., Nitinol stent implantation in long superficial femoral artery lesions: 12-months results of the DURABILITY I study. J Endovasc Ther. 2009;16:261-269.
Thin strut, low COF SE stents represent a promising clinical option as a standalone or combination solution Properties of an ideal SFA stent Low Chronic Outward Force (COF) High multidirectional flexibility Sufficient Radial Resisitive Force (RRF) Sufficient Crush Resistance (CR) Accurate deployment RRF (resistance to concentric compression) CR (resistance to eccentric compression) COF in summary Chronic force exerted by a nitinol stent on vessel wall COF depends on: Oversizing Stent material and design Irregularities in the lesion
BIOTRONIK Pulsar-18 SE Stent Pulsar-18 Specifications Pulsar-18 specifications 0.018 OTW Nitinol Stent Ø: 4.0-5.0-6.0-7.0 mm Strut thickness 140µm L: 30-40-60-80-100-120-150-170mm probio coated (Silicon Carbide) 4F Introducer Sheath compatible Thin Struts Low COF (Chronic Outward Force) Clinically Proven MCV00058006 REVA
Thin strut, low COF SE stents represent a promising clinical option as a standalone or combination solution Different Stents, different forces on the vessel Chronic Outward and Radial Resistive Force, length normalized [N/mm] RRF max COF max RRF min COF min Pulsar exhibits up to 50% less Chronic Outward Force than contemporary Drug-Eluting Stent platforms
Pulsar-18 has the thinnest struts and lowest outer surface area of all FDA approved SFA stents Source: 1. BIOTRONIK Data on file test report IIB(P)79/2016 2. Morton 2004, The influence of physical stent parameters upon restenosis A.C. Morton et al., Pathologie Biologie 52 (2004) 196 205 Calculated stent outer surface area (stents fully open) % 25 23,5 20 16,7 16,2 16,9 15 10 13,8 12,4 10,3 5 0 Entrust Innova LifeStent XL Zilver Flex Complete SE Supera Pulsar-18 Pulsar has the lowest metal to artery ratio (outer surface area ratio) of modern SE Stents Thinner struts have been shown to have a lower restenosis rate 2.
LifeStent Pulsar BMS Astron Pulsar Current Practice Could low-cof, thin strut stents be a good match for DCB? High COF Stents Stent oversizing Atherectomy & DCB Weaken/remove IEL Aneurysmal changes Vessel Injury Inflammatory response Aneurysms reported in 7% of DAART patients 1, 2 Vascular Mimetic Implant & DCB High metal-artery ratio Trapped PTX? (no washout) Low COF 90d Thin Struts Lower injury score vs. high COF stent 3 Less inflammation 3 Lower metal-artery ratio 3 90d Less risk of exacerbating cytotoxic effects of PTX? 1. K. Stavroulakis MD: Presented at LINC 2017 2. Stavroulakis K, Schwindt A, Torsello G, et al. J Endovasc Ther 2016; doi:10.1177/1526602816683933. 3. Funovic M. Correlation between chronic outward force (COF) and neointimal hyperplasia in self-expanding nitinol stents. Presented at LINC 2017
Pulsar-18 clinical results Short/med lesions Long lesions Popliteal Dissection Occlusion Low/Mod. Calcification High Calcification Adjunct to DCB Pulsar-18 PP (%) TLR (%) A.L.L. (cm) 11.6 7.1 24.5 18.2 11.2 16.4 8 8.2 Pulsar has demonstrated consistent clinical performance in several clinical studies. Results are consistent across a range of lesion lengths. 9 Source: BIOFLEX PEACE. Lichtenberg M. Presented at CIRSE 2017. 4EVER Bosiers M. JEVT 2013;20:746 756; PEACE Lichtenberg M. JEVT, 2014, 21:373-380; BERN registry Baumann F. JCS 2012:52;475-80; TASC D registrylichtenberg M. JCS 2013: 54; 433-9; "TASC D II" registry Lichtenberg M. Clin Med Insights 2014: 8; 37-42; 4F intervention" Sarkadi H, Eur J Vasc Endovasc Surg (2015) 49, 199-204. US Food and Drug Administration, Center for Devices and Radiological Health. FDA Summary of Safety and Effectiveness Data Astron Pulsar and Pulsar-18 Stent, P160025. www.fda.gov (accessed, May 5, 2017).,
Summary Bare-metal SE stents play an important role in SFA therapy as a proven standalone or adjunctive option Thin-strut, low COF Stents appear to reduce vessel injury and inflammatory response based on preclinical and clinical evidence. Thin strut, low COF stents as an adjunct to DCB may avoid exacerbation of vessel injury associated with a weakened internal elastic lamina SE stents must be uniquely clinically proven as standalone or adjuctive options- no class effect exists.
Minimizing Burden, the effect of thin strut and low Chronic Outward Force SE stents Prof. Yong LIU The affiliated hospital of southwest medical university LINC AP 2018, Hong Kong 13-15 th March