2-YEAR DATA SUPERA POPLITEAL REAL WORLD

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1 2-YEAR DATA SUPERA POPLITEAL REAL WORLD Enrique M. San Norberto. Angiology and Vascular Surgery. Valladolid University Hospital. Valladolid. Spain.

2 Disclosure Speaker name: ENRIQUE M. SAN NORBERTO I have the following potential conflicts of interest to report: Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Travel grant from Abbott.

3 INTRODUCTION 40% of endovascular interventions are done in FP segment. PTA: early vessel recoil and neointimal proliferation. Limitations of standard self-expanding nitinol stents: - In-stent restenosis. - Fractures. - Biomechanical forces over the knee joint. Vasculomimetic stent (Supera stent, Abbott Vascular).

4 MATERIAL AND METHODS Nonrandomized prospective study. Valladolid University Hospital, Spain. Test the efficacy of Supera stent for stenotic popliteal lesions.. INCLUSION CRITERIA Atherosclerotic lesions in popliteal artery Rutherford stage 3-6 At least 24-months follow-up EXCLUSION CRITERIA Contraindication for antiplatelet or anticoagulation therapies Aneurysm of the SFA or PA Acute thrombus Unsalvageable limb Very limited life-expectancy

5 MATERIAL AND METHODS Supera implantation: after primary PTA. - Severe residual stenosis. - Flow-limiting dissection. - Elastic recoil. 46 patients / 50 limbs. Data: - Demographics. - Risk factors. - Angiograms. - Postoperative ABI. - Duplex ( months). - Plain radiographic studies.

6 MATERIAL AND METHODS PRIMARY ENDPOINT Primary stent patency 1-2 years. SECONDARY ENDPOINTS Primary assisted / Secondary patency. Mortality / Amputation rate. Clinical status / ABI measurements. Stent fractures / Implantation defects.

7 MATERIAL AND METHODS Occlusion 22 (42%) Stenosis 28 (56%) Lesion lenght (mm) Degree of calcification No calcification 7 (14%) Mild calcification 15 (30%) Moderate calcification 12 (4%) Severe calcification 20 (40%) Location P1 4 (8%) P2 14 (28%) P3 32 (64%) Runoff vessels 0 2 (4%) 1 21 (42%) 2 18 (36%) 3 14 (28%) TASC II A 3 (6%) B 5 (10%) C 10 (20%) D 32 (64%) 46 patients (36 men, 10 women). November 2013-February Age 74.4 years (37-92). 78.3% hypertensive. 52.2% hyperlipidemic. 43.5% tissue loss.

8 MATERIAL AND METHODS Ankle-brachial index Before After Stents (n=74) 1 32 (64%) 2 11 (22%) 3 7 (14%) Stent diameter (n=72) 4 7 (9.7%) 5 55 (76.4%) 6 12 (16.7%) Hybrid procedure 11 (22%) Femoral thromboendarterectomy 3 (6%) Digital amputation 5 (10%) Transmetatarsal amputation 3 (6%) Multistage endovascular procedure Iliac 0 (0%) Femoral 38 (76%) Popliteal 17 (34%) Technical success 100%. In-hospital adverse events: - 2 pseudoaneurysms. - 4 minor access site hematomas. 3 patients required major amputation at 2, 4 and 5 months follow-up. Distal 12 (24%)

9 RESULTS 1-YEAR

10 RESULTS 2-YEARS

11 RESULTS Cases with implantation defects at the moment of implantation 35 (70%) Nominal lenght 18 (36%) Moderate longitudinal compression 15 (30%) Moderate elongation (10-20%) 21 (42%) Severe elongation (20-40%) 13 (26%) Invagination 7 (14%)

12 RESULTS Demographics / comorbidities n HR (95% CI) Female gender 4 (8%) 2.12 ( ) Age <75 years 21 (42%) 2.56 ( ) Smoking 23 (46%) 0.43 ( ) Hypertension 36 (72%) 1.11 ( ) Hyperlipidemia 24 (48%) 1.83 ( ) Diabetes mellitus 19 (38%) 1.57 ( ) Coronary artery disease 17 (34%) 0.57 ( ) Renal insufficiency 11 (22%) 1.31 ( ) Cerebrovascular disease 10 (20%) 1.03 ( ) COPD 3 (6%) 0.84 ( ) Lesion features Occlusion lesion 22 (42%) 0.93 ( ) Severe/moderate calcification 32 (64%) 1.12 ( ) Location P2 14 (28%) 1.32 ( ) Runoff vessel = 1 21 (42%) 0.96 ( ) TASC-II D 32 (64%) 3.11 ( ) Implantation defects 35 (70%) 1.21 ( ) Predictors for restenosis 1-year: - Age <75 years (p=0.023). - Female sex (p=0.032). - TASC-II D lesions (p=0.041).

13 RESULTS Demographics / comorbidities n HR (95% CI) Female gender 4 (8%) 1.13 ( ) Age <75 years 21 (42%) 2.41 ( ) Smoking 23 (46%) 0.32 ( ) Hypertension 36 (72%) 1.24 ( ) Hyperlipidemia 24 (48%) 1.54 ( ) Diabetes mellitus 19 (38%) 1.24 ( ) Coronary artery disease 17 (34%) 0.66 ( ) Renal insufficiency 11 (22%) 1.43 ( ) Cerebrovascular disease 10 (20%) 1.43 ( ) COPD 3 (6%) 0.99 ( ) Lesion features Occlusion lesion 22 (42%) 0.87 ( ) Severe/moderate calcification 32 (64%) 1.09 ( ) Location P2 14 (28%) 1.33 ( ) Runoff vessel = 1 21 (42%) 1.92 ( ) TASC-II D 32 (64%) 3.34 ( ) Implantation defects 35 (70%) 1.65 ( ) Predictors for restenosis 2-years: - Age <75 years (p=0.042). - TASC-II D lesions (p=0.047). NO implantation defects

14 DISCUSSION Year n P1 P2 P3 1-year Primary Patency 2-years Primary Patency Goltz et al % 68% - León et al % 6% 59% 79% - Scheinert et al % 47.5% 13.9% 87.7% - Werner et al % 43.4% 24.2% 83.3% - Chan et al % % 73% - George et al % % - Brescia et al % 83.1% Chan et al % % 81.4% 79.9% Present study % 28% 64% 90% 72.3%

15 STUDY LIMITS Single center experience. Number of patients. Lack of randomization. Longer follow-up is necessary.

16 CONCLUSIONS The implantation of vasculomimetic nitinol stents in popliteal artery is safe and effective, with encouraring patency rates and clinical results after 2-years follow-up. Predictors for re-stenosis are TASC-II type D lesions and age<75 years. No significant differences in patency at 2-years follow-up have been demonstrated in patients with implantation defects.

17 CONCLUSIONS The implantation of vasculomimetic nitinol stents in popliteal artery is safe and effective, with encouraring patency rates and clinical results after 2-years follow-up. Predictors for re-stenosis are TASC-II type D lesions and age<75 years. No significant differences in patency at 2-years follow-up have been demonstrated in patients with implantation defects.

18 CONCLUSIONS The implantation of vasculomimetic nitinol stents in popliteal artery is safe and effective, with encouraring patency rates and clinical results after 2-years follow-up. Predictors for re-stenosis are TASC-II type D lesions and age<75 years. No significant differences in patency at 2-years follow-up have been demonstrated in patients with implantation defects.

19 THANK YOU Enrique M. San Norberto García. Angiology and Vascular Surgery. Valladolid University Hospital. Valladolid. Spain.

20 2-YEAR DATA SUPERA POPLITEAL REAL WORLD Enrique M. San Norberto. Angiology and Vascular Surgery. Valladolid University Hospital. Valladolid. Spain.

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