The ZILVERPASS study a randomized study comparing ZILVER PTX stenting with Bypass in femoropopliteal lesions Preliminary report

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1 The ZILVERPASS study a randomized study comparing ZILVER PTX stenting with Bypass in femoropopliteal lesions Preliminary report G. Biro, M. Bosiers on behalf of ZILVERPASS Study Group

2 Disclosure Speaker name: G Biro... 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

3 Bypass is the golden standard First Author/Yr Type of Study Study Population Primary patency Hines/2010 Retrospective 27 patients with TASC D lesions above- and below-knee venous FP bypass bypass 12 months: 73.2% McQuade/2009 Prospective, randomized eptfe/nitinol stent graft vs AKpopliteal bypass with synthetic material 86 patients/100 limbs 50 limbs: stent graft 50 limbs: bypass with Dacron graft or eptfe 12-month: Stent-graft: 72% Bypass: 77% Kedora/2007 Prosepctive,Randomized Viabahn stent grafts vs prosthetic femoro-(above-knee) popliteal bypass 86 patients with femoro-popliteal artery occlusive disease 50 limbs treated with angio and stent 50 limbs treated with bypass with synthetic Dacron or PTFE grafts 12-month: Stent: 73.5% Bypass: 74.2% Jensen/2007 Prospective, Randomized: PTFE and Dacron for above the knee femoropopliteal bypass 427 patients with chronic lower limb ischemia with bypass for suprageniculate bypass: 205 with PTFE and 208 with Dacron 12-month: Dacron: ~78% PTFE: ~70% Berglund/2005 Retrospective comparison: autologous saphenous vein grafts to PTFE grafts 499 patients undergoing bypassfor CLI or claudication: -139 with vein graft -360 with eptfe Vein, claudication: ~87% eptfe, claudication: ~75% Erstellt von: Eva Schuster MPOE_MI_PräsentationMaster2007ppt_100819

4 Zilver PTX in de novo long lesions (>15cm) Freedom from TLR after 1 y 85.4% Bosiers M. et al, J Cardiovasc Surg, 2013;54(1):

5 ZILVERPASS study The Cook Zilver PTX drug-eluting stent versus bypass surgery for the treatment of femoropopliteal TASC C&D lesions.

6 ZILVERPASS study A prospective, randomized, multi-center study 1:1 randomization 220 patients 4 countries 13 clinical centers Zilver PTX Surgical bypass

7 Study Time Line screen disch 24 M Patient informed consent In- / exclusion criteria check Medical / clinical history Medication Physical examination Rutherford ABI Regular Angiography Regular Duplex Ultrasound Core Lab Duplex Ultrasound Adverse Events

8 Inclusion criteria 1. Patient presenting with lifestyle-limiting claudication, rest pain or minor tissue loss (Rutherford Clinical Category 2 to 5) 2. Stenotic or occlusive de novo lesion located in the above knee femoropopliteal arteries, suitable for endovascular therapy and for bypass surgery. 3. Total target lesion length is at least 150mm. Exclusion criteria 1. Any planned surgical intervention/procedure within 30 days of the study procedure. 2. Major distal amputation (above the transmetatarsal) in the study or non-study limb

9 Primary Endpoints Primary patency at 12 months, defined as: ZILVER PTX Absence of binary restenosis or occlusion within treated lesion* Without TLR within 12 months BYPASS Absence of binary restenosis or occlusion at proximal and distal anastomoses and over the entire length of the bypass graft* Without clinically driven reintervention to restore flow in the bypass. Based on CFDU measuring a PSV ratio <2,4 Shrikhande, G.V. et al. Ann Vasc Surg. 2011; 25:

10 Patient Demographics and Risk Factors Data on full cohort 220 pts ZILVER PTX N = 113 BYPASS N = 107 Male Gender 69% 75.7% Age Claudication 70.8% 55.1% CLI 29.2% 44.9% Smoking history 69% 80.4% Hypertension 65.5% 81.3% Diabetes Mellitus 27.5% 31.8% Coronary Artery Disease Cerebrovascular Disease 23.% 29.9% 7.1% 5.6% Renal Insufficiency 9.7% 12.1% Obesity 8.9% 18.7% Hypercholesterolemia 50.4% 65.4%

11 Lesion Characteristics Occlusion 94% in both groups Lesion Length more than 240 mm Prox. vessel diameter 5.8mm in average Data on full cohort 220 pts Procedure Characteristics Procedural time and hospital stay significant shorter in Zilver PTX Group

12 12-month Primary Patency [150 pts] Zilver PTX : % BYPASS : 64.90% Primary Patency, defined as absence of binary restenosis in both groups Baseline 30 days 6MFU 12MFU D365 12MFU D395 ZILVER PTX BYPASS Tar % Tar %

13 12-month Secondary Patency [150 pts] Zilver PTX : % BYPASS : 95.60% ZILVER PTX BYPASS Baseline 30 days 6MFU 12MFU D365 12MFU D395 Tar % Tar %

14 12-month freedom from TLR [150 pts] Zilver PTX : % BYPASS : 73.00% Baseline 30 days 6MFU 12MFU D365 12MFU D395 ZILVER PTX BYPASS Tar % Tar %

15 Conclusion Preliminary results in 150 patients show at least a non-inferiority of Zilver PTX versus prosthetic bypass surgery ATK. Patency analysis in these study cohorts are based on objective CFDU PSVR assessments Zilver PTX is obtaining comparable primary patencies, also in long and complex SFA lesions Final evaluation of the study is still running

16 NN Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical University of Munich