MEET M. Bosiers K. Deloose P. Peeters. SFA stenting in 2009 : The good and the ugly What factors influence patency?
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1 MEET 2009 SFA stenting in 2009 : The good and the ugly What factors influence patency? M. Bosiers K. Deloose P. Peeters 1
2 TASC II 2007 vs TASC 2000 Type A Type B Type C Type D 2000 < 3 cm 3-5 cm < 3 cm < 3 cm 3-5 cm < 3-5 cm < 3-5 cm > 5 cm cm 5 cm 5 cm 5 cm 5 cm 15 cm > 15 cm > 20 cm Norgren L et al, EJVES 2007;33:S1-S75 endovascular surgery 2
3 TASC II 2007 endstage! Recent LEVEL-I I studies with current generation stents support endovascular strategy for TASC A&B New investigational stents might further expand endovascular possibilities towards TASC C&D 3
4 1/ TASC A Fast trial Prospective, randomized, controlled PTA vs. Luminexx nitinol stent (Bard) Endpoints = Duplex based patency PTA alone Stent Luminexx Intention to treat On treatment Lesion length 4.5cm 4.5cm Occlusions 25% 37% 1Y patency (duplex) 61% 68% NS Krankenberg et al, Circulation 2007;116:
5 1/ TASC A Fact trial Prospective, non-randomized, control = FAST Conformexx nitinol stent (Bard) Endpoints = Duplex based patency PTA alone Stent Luminexx Stent Conformexx Intention to treat On treatment Lesion length 4.5cm 4.5cm 5.9cm Occlusions 25% 37% 35.5% 1Y patency (duplex) 61% 68% 77% NS Zeller et al, J Endovasc Ther 2008;15:
6 1/ TASC A Is this the right stent for the SFA? longitudinally oriented bridges between the struts stent fractures 12M data Stent Fracture Primary Patency Smart (Cordis) Smart 26.9% 78% Self-X 29.2% 60% Luminexx 53.3% 27% Luminexx (Bard) Scheinert D. et al, JACC
7 1/ TASC A FESTO database STENT FRACTURES CLINICAL IMPORTANCE Scheinert D. et al, JACC
8 2/ TASC B Improved design improved results Reorientation stent bridges First generation stent design Stent rings connected with longitudinally oriented bridges Latest generation stent design Stent rings connected with helically oriented bridges Improved adaption to torsion Astron Pulsar 8
9 2/ TASC B Astron trial Prospective, randomized, controlled PTA+optional stenting vs. primary stenting (Astron - Biotronik) Endpoints = Duplex based patency PTA + optional stenting Primary stenting Intention to treat On treatment - - Lesion length 8.4 cm 1Y patency (duplex) 39% 66% p<.05 Schillinger et al, unpublished presented at EURO-PCR
10 2/ TASC B Absolute Vienna trial Prospective, randomized, controlled PTA vs. Absolute nitinol stent (Abbott Vascular) Endpoints = Duplex based patency + Stent fractures PTA +/- stent Stent Intention to treat On treatment Lesion length 12.7cm 13.2cm 2Y patency (duplex) 31% 54% p<.05 2Y fracture rate - 2% Schillinger et al, N Engl J Med 2006;354: , Circulation
11 2/ TASC B Resilient Trial Prospective, randomized, controlled PTA vs. triple helix nitinol Lifestent (Edwards - Bard) Endpoints = Duplex based patency + Stent fractures PTA alone Stent Intention to treat On treatment - - Lesion length 6.4cm 7.1cm 12M patency (duplex) 38% 80% p< M freedom from TLR 43% 80% p< M fracture rate - 3.8% Scheinert et al, unpublished presented at LINC
12 2/ TASC B Need for long stents SIROCCO I & II : stent overlap increases fracture risk Stent SIROCCO I (max 3 stents) 19% 31% SIROCCO II (max 2 stents) 9% 11% 12
![2% [ 5/38 ] more stents higher fracture rate Lesion length: 8-16 cm 42.](/docs-images/82/86255665/images/13-1.jpg "4% [ 14/33 ] Lesion length: >16 cm 52.0% [ 26/50 ] Scheinert D.")
13 2/ TASC B FESTO database: Fracture rate ~ segment & lesion length longer lesions Average FU: 10.7 mos Lesion length (< 8 cm) 13.2% [ 5/38 ] more stents higher fracture rate Lesion length: 8-16 cm 42.4% [ 14/33 ] Lesion length: >16 cm 52.0% [ 26/50 ] Scheinert D. et al, JACC
14 2/ TASC B Long stents improved results Durability : Prospective, non-randomized, controlled Protégé Everflex stent (ev3) = FIRST TRIAL WITH LONG STENTS Endpoints = Duplex based patency + Stent fractures Stent Intention to treat - On treatment 151 Lesion length 9.6cm Single stent in 93% of cases 150mm stent in 47% of cases 12M patency (duplex) 72% 12M fracture rate 8% 15 cm Bosiers, Scheinert et al, presneted at VIVA
15 2/ TASC A & B Primary stenting Binary 12 months (%) PTA + provisional stent Stent ASTRON RESILIENT FAST FAST RESILIENT Data from randomised trials ABSOLUTE ABSOLUTE ASTRON Lesion length (cm) Schillinger et al, unpublished presented at EURO-PCR
16 3/ TASC C&D Will surgery be abandonded??? NO! Femoropopliteal venous bypass = GOLDEN STANDARD 16
17 3/ TASC C&D Will surgery be abandonded??? Primary patency results in patients with above-knee vein bypasses after 5 yrs AK-Prosth Prosth. AK-Venous above-knee PTFE vs. above-knee vein (n=1713) (n=580) 60.0% 81.1% Pereira et al. J Vasc Surg Sept 2006;44-3:
18 3/ TASC C&D Modified stents Durability 200 Prospective, non-randomized, controlled Protégé Everflex stent (ev3) of 200mm long Inclusion completed on 05-JUN-2009 Protégé Everflex (ev3) - up to 200mm in length 18
19 3/ TASC C&D Active coatings STRIDES Everolimus eluting Dynalink-E (Abbott Vascular) FIM: Non-randomized European trial (100 pat s ) Enrolled fempop lesions up to 17cm Results to be awaited L. Scwartz et al, presneted at EURO-PCR
20 3/ TASC C&D Active coatings ZILVER PTX Paclitaxel eluting ZILVER (Cook) Phase2: Non-randomized worldwide registry (1000 pat s ) Enrolled fempop lesions up to 28cm Follow-up through 2 years Currently available data 6-month follow-up for 684 patients (774 lesions) 12-month follow-up for 458 patients (529 lesions) 26% of these patients have lesions > 14 cm 20
21 3/ TASC C&D Active coatings ZILVER PTX Paclitaxel eluting ZILVER (Cook) Case example Full length occlusion right SFA treated with 4 ZILVER PTX stents 3x x
22 3/ TASC C&D Effectivness Freedom from TLR TLR defined as: Clinically driven re-intervention for 50% DS within treated segment (including ± 5 mm) 12 Months Overall Group Lesions 14 cm Lesions > 14 cm Patients Lesions Effectiveness: Freedom from TLR 88% 92% 77% ~ Primary 12 months of ± 70% 22
23 THE UGLY: SFA stenting is NOT perfect Problem of in-stent restenosis Intimal hyperplasia as an inflammatory reaction to the stent material time short long mid of procedure term Hoffman. Circulation, 1996 VSMC = vascular smooth muscle cell 23
24 Thrombolysis Example case Only for recent re-occlusions In case of insufficient result, additional procedure is performed 24
25 Regular PTA balloon Example case ) 25 no data found Apart from case descriptions
26 Cryoballoon Rationale Polarcath Peripheral dilatation System (BSCI) Simultaneous PTA & cooling plaque & vessel wall Weakening the plaque Reducing vessel wall recoil Inducing apoptosis 26
27 Cryoballoon Results for in-stent restenosis Karthik et al. Prospective, non-randomized trial between May 2004 and June inclusions no proven benefit for cryoplasty over PTA 100% angiographical success (<30% residual stenosis) 50% failure after 6 months 100% failure after 12 months Karthik et al. Eur J Vasc Endovasc Surg 33, (2007) 27
28 Cutting balloon Rationale Mechanism ~ atherotomy Peripheral Cutting Balloon (BSCI) AngioSculpt (AngioScore) 28
29 PTA vs Cutting balloon 6-months results for in-stent re-stenosis Prospective, controlled, randomized, single-center 39 consecutive patients Mean lesion length = 80mm (±70mm) 6-months results No proven benefit of cutting balloon over regular PTA PTA Cutting balloon (N=17) (N=22) PP 27% 35% ABI Walk dist 103m 117m Dick P et al, Radiology 2008 Jul;248(1):
30 Balloons failed for in-stent restenosis 30
31 Rotarex Zeller et al. Prospective, non-randomized, single-center study between Jul Feb recanalisations PP after 13 months : Does not work well for in-stent re-stenosis Native artery lesion : 67% Instent restenosis : 26% 31
32 SilverHawk Plaque Excision System Zeller et al. Prospective, single-center study between June 2002 and May 2004 Rutherford patients (100 limbs; )131 lesions De novo lesions : 45 Restenosis in a native artery : 43 In-stent restenosis : 43 Zeller et al. JACC 2006:
33 Event-free survival 18 months Seems to be better than PTA Zeller et al. JACC 2006:
34 DES-in-stent / Drug coated balloons 34
35 DES-in-stent Zilver PTX Overall Long Lesion Group De novo In-stent Restenosis (ISR) Overall Group 88% (n = 529) 93% (n = 372) 78% (n = 98) Freedom from TLR 12 Months Lesions 14 cm 92% (n = 405) 95% (n = 288) 82% (n = 65) Lesions > 14 cm Drug-eluting stents may be promising for the treatment of SFA in-stent restenosis 77% (n = 124) 85% (n = 79) 70% (n = 33) Occlusions 86% (n = 195) 92% (n = 103) 79% (n = 91) 35
36 DCB-in-stent THUNDER trial Subgroup analysis Tepe G et al. NEJM 2008;358: DCB may be promising for treating SFA in-stent re-stenosis - further investigation needed BUT : - small numbers
37 Conclusion TASC A & B TASC C & D Primary stenting Surgery, but DURABILITY-200?? ZILVER PTX?? In-stent restenosis is still the Achilles heel of SFA stenting Further investigation needed for promising techniques (SilverHawk, DES, DCB) 37
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