Heavily calcified SFA lesions do not avoid the use of 4 F systems Maria Schoder Division of Cardiovascular and Interventional Radiology Medical University of Vienna Bulgarian Endovascular Course 2011

CTA 90-year old lady History of CABP x3 chronic heart insufficiency chronic renal insufficiency hyperlipidemia femoropopliteal PTA (rigth side) 12 years ago Symptoms Intermittend claudication on both sides Fontaine stage IIb

 Subintimal recanalization  Antegrade access  Subintimal recanalization pushability

severe calcifications Identical findings on the left side

ABI improved from below of 0.4 to right 0.85 left 0.79 Worsening of the walking distance after 6 month

6 F device (Absolute) Pulsar-18

after re-PTA

Dick P et al. Catheter Cardiovasc Interv 2009;74:1090-5 ASTRON Trial  Prospektive, randomized, multicenter trial  Astron Pulsar vs PTA and optional stenting  Study entry  intermittend claudication and CLI (Rutherford class 3-5)  lesion length 30-200 mm  at least one tibioperoneal run-off vessel SES- Sirolimus eluting stent  Primary endpoint  occurrence of restenosis within 6 month (> 50% lumen diameter reduction)  Secondary endpoints (at 3, 6 and 12 months)  Binary restenosis, walking distance, amputation and death, ABI

ASTRON Trial Lesion-characteristics- ITT Astron Pulsar n=34 PTA n=39 P Length of target lesion, mm 82 65 0.022 Occlusions, % 38 39 0.98 Procedural data Astron Pulsar PTA P Cross-over access, % 88 92 0.55 Stents used, % 100 26 (bail-out) <0.001 Length of treated segment, mm 98 71 0.011

ASTRON Trial – Results Conclusion: primary stenting using the Astron Nitinol stent improved morphological and clinical outcome compared to PTA with optional stenting

Patency and lesion length for randomized stent studies Level I Evidence FAST RESILIENT ASTRON Trial ABSOLUTE Design Stent vs PTA Mean lesion length (cm) 4.5 6.2 8,4 10.1 12-month primary patency (%) 67 vs 62 81,3 vs 36,7 66 vs 39 63 vs 36 P p=0.38 p<0.0001 p<0.05 p=0.01 Primary stenting vs PTA; Astron prim stenting vs PTA+optional stenting Astron results intention to treat TASC II A and B lesions Stent fracture rates were reported in 2% to 12%

ASTRON PULSAR Nitinol stent in the femoropopliteal sector AcÍn F et al. Técnicas Endovasculares 2010;13:3203-11 ASTRON PULSAR Nitinol stent in the femoropopliteal sector  prospective, non-randomized registry  bail-out procedure after failed PTA  intermittend claudication and CLI (69%)  total mean lesion length 52 mm − mean stenosis length 31 mm − mean occlusion length 67 mm Bail-out:> 30% reststenosis, dissection  Primary endpoints  primary patency (< 50% ISR, PSVR < 2.5 ) and fracture rate

 Target lesion revascularization 14%  Clinical success 61% AcÍn F et al. Técnicas Endovasculares 2010;13:3203-11 77.5% Freedom from binary restenosis 68% Primary patency Bail-out:> 30% reststenosis, dissection. Kaplan Meyer analysis revealed a 24months…..  No stent fracture  Target lesion revascularization 14%  Clinical success 61%  Limb salvage at 24 months 73.7%

Performance characteristics of self-expanding Nitinol stents Schmidt W et al. Fortschr Rröntgenstr 2011;183:818-25 7/80 mm stent systems Bending stiffness of stents in crimped and expanded conditions  highest flexibility Trackability of stent system (mean track force F)  best trackability

The radial force of the expanded stent Schmidt W et al. Fortschr Rröntgenstr 2011;183:818-25 Radial force during stent expansion as a function of stent diameter (5 and 6 mm) The radial force of the expanded stent is essential for holding the lesion widely open It is not finally clear wether a high, moderate or low radial force will result in higher patency rates

Conclusion Primary patency rates after stenting in long SFA lesion are significantly better compared to PTA alone Astron-Trial shows comparable results to 6F systems Radial force of the Astron stent family seems to be high enough even for treatment of heavily calcified lesions 4F systems  lower crossing profile  lower access site complications  cost effectiveness - no closure device - earlier ambulation

Active investigational study  4-EVER Trial; M. Bosiers, Belgium  enrollment of 120 pts completet  Rutherford-category 2-4  De novo, re-stenotic and re-occluded lesions  length up to 200 mm; treatable with 1 stent  at least one-vessel-runoff Acute and interim results will be presented at LINC 2012 Safety and efficacy studies on the way. Bioflex estimated enrollement 396 Pts. ClinicalTrials.gov

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