Or is the ivolution stent a better alternative? EVOLUTION 12-month data
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1 Or is the ivolution stent a better alternative? EVOLUTION 12-month data Dr. Marc Bosiers LINC 2018, Leipzig
2 Conflict of interest 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) V I do not have any potential conflict of interest FMRP - LINC
3 12-month Primary Patency (%) Results with in the SFA TASC A & B 12 months Primary Patency at 12 months = +/- 78% Stent 1. FAST 2. FACT 3. RESILIENT 4. DURABILITY 5. ASTRON 6. VIENNA 7. 4EVER Lesion length (cm) FMRP - LINC
4 Stent design Affects TOO LOW >50% residual stenosis Impossible to open the lesion Residual stenosis FMRP - LINC
5 Stent Design Affects TOO HIGH Chronic stentvessel irritation Intimal Hyperplasia FMRP - LINC
6 Stent Design Affects Example: 8 mm stent mm mm mm Stent Stent HIGH OVERSIZING Stent Zhao HQ et. al. Cardiovasc Intervent Radiol Jul;32(4): FMRP - LINC
7 Stent Design Affects Even when oversizing low rates of COF, due to the flat expansion curve BIOTRONIK Pulsar-35 7/150 (1-3) Expansion Abbott Absolute Pro (LL) 7/150 (4-6) Expansion normalized radial force [N/mm] BARD Lifestent FlexStar (XL) 7/150 (7-9) Expansion ev3 EverFlex Plus 7/150 (13-15) Expansion Cordis Smart(er) CONTROL 7/150 (10-12) Expansion ivascular Terumo ivolution Misago 7/150 (16-18) Expansion stent diameter [mm] FMRP - LINC
8 Stent Design Affects Bent Leg: vessel diameter range: mm : 6mm stent implant 100N 60N 5,02 40N Expansion force increases with decreasing diameter Illustration is artist s rendition. 2,98 Flat expansion force 5,02 FMRP - LINC
9 Stent Design Affects Bent Leg: vessel diameter range: mm : 6mm stent implant 5,02 40N 30N Expansion force increases with decreasing diameter Illustration is artist s rendition. 2,98 Flat expansion force 5,02 20N FMRP - LINC
10 ivolution Stent Design FMRP - LINC
11 Evolution study A Prospective, non-randomized, multi center study investigating the Efficacy of the Self- Expanding ivolution nitinol stent for treatment of femoropopliteal lesions FMRP - LINC
12 Study design Study Objective: To evaluate the short-term (up to 12 months) outcome of treatment by means of the self-expanding ivolution nitinol stent in symptomatic (RF 2-4) femoropopliteal stenotic or occlusive lesions Primary Endpoint: Primary Patency at 12Months, defined as freedom from >50% restenosis at 12months as indicated by an independently verified duplex ultrasound PSVR <2.5 in the target vessel with no reintervention. FMRP - LINC
13 Participating centers BELGIUM M. Bosiers, K. Deloose, J. Callaert - AZ Sint-Blasius, Dendermonde P. Peeters, J. Verbist - Imelda Hospital, Bonheiden L. Maene, R. Beelen - OLV, Aalst K. Keirse - RZ Heilig Hart, Tienen FMRP - LINC
14 Inclusion criteria EVOLUTION 120 out of 120 patients enrolled (100%) Rutherford classification from 2 to 4 Main inclusion criteria De novo lesion in the femoropopliteal arteries, suitable for endovascular therapy Total target lesion length 150mm FMRP - LINC
15 Study overview Timeline proc disch 1 M 6 M 12 M Medication Physical examination Rutherford ABI Core Lab Ultrasound Duplex Ultrasound FMRP - LINC
16 Patient Demographics N = 120 Male (%) 86 (71.67%) Age (min max; ±SD) ( ; ±10.68) Rutherford Classification Nicotine abuse (%) 76 (63.33%) Hypertension (%) 87 (72.50%) Diabetes mellitus (%) 26 (21.67%) Renal insufficiency (%) 19 (15.83%) Hypercholesterolemia (%) 66 (55.00%) Obesity (%) 31 (25.83%) 76 RF 2 RF 3 RF 4 FMRP - LINC
17 Procedural characteristics N = 120 Procedure time (min-max ; ±SD) min ( ; ±15.74) Scopy time (min max; ±SD) min ( ; ±8.11) Contrast (min max; ±SD) ml ( ; ±34.08) Cross-over performed (%) 105 (87.50%) Inflow Lesion (%) 18 (15.00%) Outflow lesion (%) 22 (18.33%) FMRP - LINC
18 Lesion Characteristics N = 120 Lesion length (min max; ±SD) mm ( ; ±44.68) Pre-op Ref Vessel Diameter (min max; ±SD) 5.63 mm ( ; ±0.58) 1 study stent implanted (%) 112 (93.33%) 2 study stents implanted (%) 8 (6.67%) Occlusion (%) 48 (40.00%) Calcified lesion (%) 86 (71.67%) FMRP - LINC
19 12-month Primary Patency 86.30% FMRP - LINC
20 12-month Freedom from TLR 88.00% FMRP - LINC
21 12-month Rutherford evolution FMRP - LINC
22 12-month Primary Patency (%) Results with in the SFA TASC A & B Primary 12 months Stent 1. FAST 2. FACT 3. RESILIENT 4. DURABILITY 5. ASTRON 6. VIENNA 7. 4EVER Evolution Lesion length (cm) FMRP - LINC
23 Conclusion Final results show that the ivolution stent is a very effective treatment for femoropopliteal TASC A&B lesions FMRP - LINC
24 Or is the ivolution stent a better alternative? EVOLUTION 12-month data Dr. Marc Bosiers LINC 2018, Leipzig
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