Hybrid Heparin-Bonded Nitinol and eptfe Stent in the treatment of popliteal artery occlusion: mid- term follow-up results.

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1 Hybrid Heparin-Bonded Nitinol and eptfe Stent in the treatment of popliteal artery occlusion: mid- term follow-up results. Wronski J. 1), 2) 3), Wilczynski M 1), Gembal P 1), Milik K 1), Dec St 1), Grybos M 1) 1) Department of Vascular Surgery, Regional Hospital Mielec, Poland, 2) Department of Vascular Surgery, District Hospital Lublin, Poland 3) Department of Vascular Surgery and Angiology, Medical University, Lublin, Poland

2 Disclosure Speaker name: Jacek Wronski I do not have any potential conflict of interest

3 Valji K. Radiology Key Chapter 8 Origin of study Endovascular treatment of the femoro-popliteal segment is increasingly employed for treatment in patients suffering from PAD Self-expanding nitinol stents implanted to the popliteal artery have demonstrated high percentage of in-stent restenosis, stent occlusions and stent fractures

4 Tigris,Gore, technical data

5 Tigris,Gore, technical data

6 Aim of study The evaluation a 12 -months patency of the hybrid heparin-bonded nitinol and eptfe stent (Tigris, Gore) for treatment of atherosclerotic popliteal artery occlusion in a prospective, single center, analysis.

7 Study population Enrollment period January May 2015 No. of consecutive patients treated by TIGRIS implantation No. of patients included to the study 49 Intermitted claudications or CLI ( Rutherford category) 3,4 ± 0,9 Average lesions lenght of occluded arteries 85 9,38 cm ( 2,5-30 cm) CTO 86% ( 42/49) TASC categories: TASC A 10% ( 5/49 ) TASC B 41% ( 20/49 ) TASC C 24,5% ( 12/49 ) TASC D 24,5% ( 12/49 ) Exclusion criteria No. of patients Lack of follow-up 19 Concomittant other stents implantations 17

8 Patient demographics Variable Age 70,2±10,56 Male gender 92% ( 45/49) Diabetes mellitus 22% ( 11/49) Cerebral ischemia 10% ( 5/49 ) Cardiac disease 12% ( 6/49) Renal disease 4% ( 2/49 )

9 Baseline lesions characteristics Anatomical lesion location Distal SFA to P1 30,6 % ( 15/49) Pop P1 14,3% ( 7/49) Pop P2 4% ( 2/49) Pop P3 2% ( 1/49) Pop P1-P2 22,5% ( 11/49) Pop P2-P3 12,2% ( 6/49) Pop P1-P3 14,3% ( 7/49)

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11 Results ( 12-months follow-up overall/occluded popliteal group): Primary patency ( PP ) 68,5%/ 73,3% Freedom from Target Lesion Revascularisation ( TLR ) 81,6% ( 41/49)/ 86,7% Postoperated Rutherford category ( mean) 1,0±0,9 Change in Rutherford category pre/postop. ( mean) 2,4±1,0 Stent s fractures 0,0%

12 Results Overall the primary patency rates after 1,3,6 and 12 months were 98,0%, 93,8%, 87,5% and 68,5% respectivelly, in CTOs in the popliteal segment rate after 6 and 12 months was 93,3% and 73,3% respectivelly

13 Results Overall freedom from TLR after 1,3,6 and 12 months was 98,0%, 95,9%, 91,7% and 83,1% respectivelly, in patients with CTOs in popliteal segment after 6 and 12 months was 93,3% and 86,7% respectivelly

14 Comparision with other studies Study Type of study No. of patients/ occlusions CTO(%) in whole group Average lesions lenght ( mm) Hybrid Heparin-Bonded Nitinol and eptfe Stent in the treatment of popliteal artery occlusion: midterm follow-up results. Prospective single center analysis n=49/ 42 Twelve-month experience with Gore Tigris Vascular stent in the superficial femoral and popliteal arteries. Piorkowski M et all. J Cardiovasc Surg 2015; 1: Retrospective single center analysis Use of a new Hybrid Heparin- Bonded Nitinol Ring Stent in the popliteal artery procedural and mid-term clinical and anatomical outcomes. Parthipun A et all. Cardiovascular Intervent Radiol. 2015; 4: Prospective singler center analysis n=32/2 n=48 / legs 50/occl. 37 Tigris Trial data Laird J Viva, September 2016, USA Oral presentation ( VascularNews) Prospective randomised multicenter study n=197/ 83 86% 5% 74,0% 42,1% 119,1±67,0 / 93,8 ( ) Primary patency 68,5% / 73,3% Freedom from TLR 61,6%/ 86,7% 43,1±26 114,2±36,9 107,6±68,6 85,5±6,0% 69,5±6,0% 63% nd 86,1±5,9% nd

15 Conclusion Implantation of hybrid-heparin bonded nitinol and eptfe stent (GORE TIGRIS Vascular Stent) alleviated the need to perform revascularization in most patients with CTOs in popliteal segment, a lesion that previously had limited treatment options available.

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17 Hybrid Heparin-Bonded Nitinol and eptfe Stent in the treatment of popliteal artery occlusion: mid- term follow-up results. Wronski J. 1), 2) 3), Wilczynski M 1), Gembal P 1), Milik K 1), Dec St 1), Grybos M 1) 1) Department of Vascular Surgery, Regional Hospital Mielec, Poland, 2) Department of Vascular Surgery, District Hospital Lublin, Poland 3) Department of Vascular Surgery and Angiology, Medical University, Lublin, Poland