A Data-driven Therapeutic Algorithm For Choosing Among Currently Available Tools For SFA Intervention

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1 A Data-driven Therapeutic Algorithm For Choosing Among Currently Available Tools For SFA Intervention William A. Gray MD Director of Endovascular Services Associate Professor of Clinical Medicine Columbia University Medical Center The Cardiovascular Research Foundation

2 Dissapointing results for non-nitinol nitinol stents Results of the first generation self-expanding expanding stents (WallStent & Strecker stent) in the SFA FU Lesion length Primary Patency Van Der Zaag et al EJVES 2004 Conroy et al J Vasc Int Radiol 2000 Gordon et al Arch Surg 2001 Cheng et al Ann Vasc Surg M 24M 12M 24M 5-15 cm 43% mean 13.5 cm 36% mean 14.5 cm 55% mean 16 cm 35% 1

3 TASC classifications of SFA lesions

4 Levels of evidence Source: US Preventive Services Task Force Level I Level IIa Level IIb Level IIc Level III well-designed, prospective, randomized, controlled trials well-designed, prospective, non-randomized, controlled trials well-designed, prospective, non-randomized, non-controlled cohort or case-control control analytic studies retrospective, non-randomized, non-controlled multiple time series expert opinions, based on clinical experience, descriptive studies or reports of expert committees 3

5 Summary of non-randomized trial results Levels IIa, IIb, IIc Reference stent lesion length prim patency name Jahnke 2002 IntraCoil % Wiesinger 2005 Covered SMART % Henry 1996 VascuCoil < 4 89 % Sabeti 2004 any 5 75 % Lugmayr 2002 Symphony < 6 87 % Lenti 2007 aspire unk 64 % Schillinger 2001 any % Fischer 2006 Hemobahn/Viabahn % Jahnke 2003 Hemobahn % Schlager 2005 any % Lammer 2000 Hemobahn % Cheng 2001 any % Daenens 2005 Hemobahn % Cheng 2003 any % Bray 2005 Hemobahn % Biamino 2002 SMART % 4

6 WL Gore Hemobahn vs. Study description: Single-center experience as part of a US prospective, randomized, controlled, multi-center study Balloon angioplasty vs. Hemobahn (Gore) eptfe-covered endoprosthesis placement Inclusion period: Jun 1998 Dec 1999 Saxon et al. J Vasc Interv Radiol 2003;14:

7 WL Gore Hemobahn vs. Randomization scheme 28 patients Randomization (n = 13) Hemobahn (n = 15) Saxon et al. J Vasc Interv Radiol 2003;14:

8 WL Gore Hemobahn vs. Lesion information Hemobahn Average lesion length 6.32cm ( ) 7.41cm ( ) TASC A 1 0 TASC B 8 5 TASC C 3 6 TASC D 1 4 Saxon et al. J Vasc Interv Radiol 2003;14:

9 WL Gore Hemobahn vs. 87% 23% Saxon et al. J Vasc Interv Radiol 2003;14:

10 WL Gore Hemobahn vs. Conclusions for medium length lesions Patency rates after Hemobahn implantation were significantly better than those after balloon angioplasty Clinical success rate was significantly higher in the Hemobahn group Saxon et al. J Vasc Interv Radiol 2003;14:

11 Absolute stent vs. Prospective, randomized, controlled, single-center Balloon angioplasty vs. nitinol stent implantation Inclusion period: Jun 2003 Aug 2004 Schillinger et al. NEJM 2006;354:

12 Absolute stent vs. Randomization scheme on treatment basis 104 patients Randomization (n = 53) Stent (n = 51) Crossover due to insufficient result (n = 17 [32%]) Schillinger et al. NEJM 2006;354:

13 Absolute stent vs. Randomization scheme on treatment basis 104 patients Randomization (n = 53) Stent (n = 51) Crossover due to insufficient result (n = 17 [32%]) (n = 36) on treatment Stent (n = 68) Schillinger et al. NEJM 2006;354:

14 Absolute stent vs. Lesion information Nitinol stent Average lesion length 9.2cm (±6.4)( 10.1cm (±7.5)( Occlusions 19% (±10)( 17% (±10)( Schillinger et al. NEJM 2006;354:

15 Absolute stent vs. intention to treat on treatment % p=0.05 (significant) 66 % % p=0.03 (significant) 75 % 10 0 (30/53) Stent (39/51) 10 0 (18/36) Stent (51/68) Schillinger et al. NEJM 2006;354:

16 Absolute stent vs. Based on intention to treat principle After 6 months After 12 months % p=0.01 (significant) % % 30 p=0.06 (not significant) % (29/53) Stent (38/51) 10 0 (19/52) Stent (31/49) Schillinger et al. NEJM 2006;354:

17 Absolute stent vs. Conclusion for medium length lesions Angiography showed significantly better restenosis enosis rates for the stent group at 6 months Duplex sonography confirmed significantly better restenosis rates at 12 months Clinical worsening was rare in either group Reintervention rates were similar in both groups Schillinger et al. NEJM 2006;354:

18 vs. Lumunexx Stent Prospective, randomized, controlled Balloon angioplasty vs. Luminexx nitinol stent Femoral Artery Stenting Trial SFA lesions between 1 and 10cm in length Only 1 stent per treated lesion Krankenberg H et al. Circulation 2007;116; ;

19 vs. Lumunexx Stent Randomization scheme on treatment basis 244 patients Randomization (n = 121) Stent (n = 123) Crossover due to insufficient result (n = 13 [11%]) Krankenberg H et al. Circulation 2007;116; ;

20 vs. Lumunexx Stent Randomization scheme on treatment basis 244 patients Randomization (n = 121) Stent (n = 123) Crossover due to insufficient result (n = 13 [11%]) (n = 108) on treatment Stent (n = 136) Krankenberg H et al. Circulation 2007;116; ;

21 vs. Lumunexx Stent Lesion information: short to medium length lesions Luminexx stent Average lesion length 44.5mm 45.2mm not signifcant Occlusions 25% 37% not signifcant Krankenberg H et al. Circulation 2007;116; ;

22 vs. Lumunexx Stent intention to treat on treatment % 68.3 % % 67 % p=0.377 (not significant) p=0.554 (not significant) (62/101) Stent (69/101) 10 0 (56/90) Stent (75/112) Krankenberg H et al. Circulation 2007;116; ;

23 vs. Lumunexx Stent Conclusion The Femoral Artery Stenting Trial failed to demonstrate the superiority of the Luminexx nitinol stent over stand-alone alone in the treatment of patients with superficial femoral artery (SFA) lesions 1-10cm 10cm in length Krankenberg. TCT 2006

24 SIROCCO I & II: SES vs. BMS Double-blind, blind, randomized, prospective (sirolimus( vs. bare stent) SIROlimus Coated Cordis SMART Nitinol Self-expanding expanding stent for the treatment of Obstuctive SFA disease Phase 1: 36 patients max 3 stents >70% stenosis >7cm to <20cm occlusion >4cm to <20cm Phase 2: 57 patients max 2 stents lesion length >7cm to <14.5cm occlusion >4cm to <14.5cm

25 SIROCCO I & II Baseline Lesion Characteristics Sirolimus (n=29) Control (n=28) P- value Thrombus (%) Moderate/Severe Calcification (%) Total Occlusion (%) Lesion Length (mm) 86.5 ± ± Reference Vessel Diameter (mm) 4.92 ± ± Pre Percent Diameter Stenosis (%) 95.8 ± ±

26 SIROCCO I & II Duplex 24-month Slower Eluting (n=5) Fast Eluting (n=11) Control (n=17) Binary Restenosis Rate %(n) 40.0 (2) 44.4 (4) 47.1 (8) Total Occlusion %(n) (1) Total Restenosis/Occlusions %(n) 40.0 (2) 44.4 (4) 52.9 (9) Target Lesion Revascularization %(n) (1) 5.8 (1)

27 SIROCCO I & II 24-month Pooled SR SIROCCO I-II (n=16) Control SIROCCO I-II (n=14) p value Minimum Lumen Diameter 2.15mm 2.15mm Stent Mean Diameter 3.42mm 3.35mm In-stent restenosis - unreadable - patent 3 (18.8%) 9 (56.3%) 2 (14.3%) 8 (57.1%) % and <70% 4 (25.0%) 2 (14.3%) - 70% and <100% - 1 (7.1%) - occlusion - 1 (7.1%)

28 SIROCCO I & II: conclusions Fractures associated with Multiple stents Longer stented lengths Frequently adjacent to the overlaps (not in the overlap areas themselves) No relationship between fracture and restenosis Sirolimus-eluting stents are safe for SFA treatment Excellent results with bare SMART stent In-stent binary restenosis rate : 24 months (angiographically) Duda et al. Cx

29 Zilver PTX: PES vs. BMS Randomized Study (480 pts) Phase 1: 60 patients lesions < 7 cm, up to 1 stent per limb enrollment complete Phase 2: 420 patients Lesions < 14 cm, up to 2 stents per limb Currently enrolling Registry Study (760 pts) Up to 4 Zilver PTX stents per patient Currently enrolling: more than 700 patients enrolled/approximately 2500 stents implanted

30 PTX: Baseline angiographic data Lesion Length (cm) Randomized Study (Phase 1) (N = 33 lesions) 3.6 ± 2.0 (range 1 to 7) ZPTX (N = 29 lesions) 4.1± 3.1 (range 1 to 10) Registry Study ZPTX (N = 91 lesions) 10 ± 8.1 (range 1 to 33) Proximal RVD (mm) 5.2 ± ± ± 0.8 Distal RVD (mm) 5.3 ± ± ± 0.8 MLD in lesion (mm) 1.3 ± ± ± 0.7 % Diameter Stenosis 76 ± ± ± 12

31 Zilver PTX: 6-month 6 effectiveness Study Freedom from TLR Phase 1 of the randomized study 52% [17/33] No failure 100% [17/17] acute failure BMS Zilver 75% [6/8] acute failure PTX Zilver 100% [8/8] 48%[16/33] Zilver PTX 90% [26/29] Registry Zilver PTX 90% [82/91]

32 RESILIENT: LifeStent vs. n=20 + LifeStent Phase I: 6 sites Only Control Arm n=69 n=20 roll-in + LifeStent n=206 randomly allocated 1 : 2 Phase II: 24 sites + LifeStent Test Arm n=137 Biamino G, Katzen BT, Laird J. The RESILIENT Trial: 12-mos. results. Leipzig Interventional Course. Leipzig, Germany, 2008.

33 RESILIENT: Bail-out lesion characteristics Lesion Length/patient (mm) 52.0 ± ± 44.3 p= p= ± 37.8 * = Visual Estimate + = t-test for Equality of Means Biamino G, Katzen BT, Laird J. The RESILIENT Trial: 12-mos. results. Leipzig Interventional Course. Leipzig, Germany, 2008.

34 RESILIENT Results:12-Month 100% 80% 86% 86% *Data from Kaplan-Meier Survival Analysis 80% 87% +LifeStent 72% 60% 40% p=.91 38% 46% 34% 20% p<.0001 p<.0001 p< % Freedom from MACE* Prim. Patency (duplex)* Freedom from TLR* Clinical success Biamino G, Katzen BT, Laird J. The RESILIENT Trial: 12-mos. results. Leipzig Interventional Course. Leipzig, Germany, 2008.

35 RESILIENT: behind the numbers Bail-out stenting (crossover) in the group occurred 40.2% (29/72) for: Major flow-limiting limiting dissection (38%) Residual stenosis >30% (62%) Confirmed as acceptable by Core Lab and CEC Procedural crossover to stenting in the group was defined as a TLR and counted as a primary endpoint and patency failure Biamino G, Katzen BT, Laird J. The RESILIENT Trial: 12-mos. results. Leipzig Interventional Course. Leipzig, Germany, 2008.

36 Clinical trial comparison using the reported rates of TLR STENT STENT ABSOLUTE VIENNA (12 mos., 10.1 cm) RESILIENT (12 mos., 7.1 cm) ZILVER PTX (6 mos., 4.1 cm)

37 Clinical trial comparison using the RESILIENT/ZILVER PTX definitions of TLR STENT STENT ABSOLUTE VIENNA (12 mos., 10.1 cm) RESILIENT (12 mos., 7.1 cm) ZILVER PTX (6 mos., 4.1 cm)

38 Clinical trial comparison using the ABSOLUTE/VIENNA definitions of TLR STENT STENT ABSOLUTE VIENNA (12 mos., 10.1 cm) RESILIENT (12 mos., 7.1 cm) ZILVER PTX (6 mos. 4.1 cm)

39 SFA Challenges: Data collection Data collection Endpoint definitions of success Anatomic Binary restenosis (>50%) Discrete vs. diffuse vs. volume definitions Clinical Walking distance ABI Quantifying (and understanding) restenosis Angiographic Duplex Intravascular ultrasound Time course defining durability of intervention Consistent and standardized reporting structure

40 Patient factors with unclear influence on interventional outcomes Inflow/Run-off off status Length of disease Vessel diameter Occlusion vs. stenosis Diabetic status Tobacco status Atheroma volume Calcification Gender

41 Procedural factors with unclear influence on interventional outcomes Stents Number Degree of overlap Compression or stretch during implant Significant oversizing or undersizing Adjunctive debulking

42 SFA: Design challenges This arterial territory response to intervention is poorly understood There are no large-scale data sets from which to establish design goals Such data was critical to the understanding of coronary stent behavior and the opportunity to improve the technology in a focused direction

43 Multi-Link Penta*, , 0.90mm Late Loss in Bare Metal Stents 6-mo Follow-Up ASCENT VISION PENTA REGISTRY DISTINCT NIRVANA VENUS VELVET 1 RAVEL Ctrl Bx VELOCITY,.0055, 0.80mm Multi-Link Vision*,.0032, 0.83mm NIR*,.0040", 0.80mm Bx VELOCITY,.0055, 0.97mm Bx VELOCITY,.0055, 0.70mm Multi-Link,.0022", 0.90mm QCA Late Loss (mm) BiodivYsio TM *,.0036, 0.80mm

44

45 Result of lack of outcome data Current efforts at designing successful devices which will have improved outcomes are at best estimates of the causal relationships In the typically small clinical trials testing in SFA therapies, these devices are subject to variation in subject/vessel characteristics

46 Conclusions Stents are better than (I think) for limited lesion length Long stents are worse than short stents Not all stent fractures are created equal FESTO results not borne out in later trials Alternative therapies (photodynamic, adventitial injection, adjunctive atherectomy,, etc.,) may be useful but as yet untested Drug-eluting balloon looks interesting in spite of lack of clear mechanism VIBRANT trial data will be interesting

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