Konstantinos Katsanos, MSc, MD, PhD, EBIR. Consultant Interventional Radiologist Guy's and St.Thomas' Hospitals, NHS Foundation Trust
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1 Konstantinos Katsanos, MSc, MD, PhD, EBIR Consultant Interventional Radiologist Guy's and St.Thomas' Hospitals, NHS Foundation Trust King's Health Partners, London, United Kingdom
2 Nothing to declare
3 Anatomy Attributes (lesion location, morphology, length, etc) Device Attributes (scaffolding, anti- restenosis, costs, etc) Individualised Treatments (Customised therapies) Evidence-Based Medicine (EBM-MDM)
4 PTA Artherectomy Cutting Balloon Scoring Balloon Cryoplasty Brachytherapy (b,g) Laser Nitinol Stent Drug Eluting Stent Covered Stentt Drug Eluting Balloon...a fight for Sisyphos?
5 1% 8% 14% 36% 11% 27% 1% ~ 50% long occlusions (>10cm) ~ 30% three-vessel occlusive lesions ~ 50% at least one patent distal foot vessel L Graziani et al. Eur J Vasc Endovasc Surg 2007
6
7 Safety and immediate success Limb salvage / Amputation-free survival Primary patency / Vascular restenosis Event-free survival or sustained clinical improvement = no death, no major amputation, no repeat procedures Cost-benefit analysis Karnabatidis D et al. J Endovasc Ther 2009 Beard JD, Rutherford Lecture. J Vasc Surg 2008
8 Animal studies (Scheller B. et al. Circulation 2004 & Huang et al. Circulation 2011)
9 Paclitaxel Interferes with cell division at the M phase, after DNA synthesis has occurred. Cells are in an abnormal state with twice the normal DNA content, which leads to cell death by apoptosis ABT-578 Rapamycin Everolimus Growth Factor mtor Replicati ion prep Interfere with cell growth at the G1/S transition, before DNA synthesis has occurred. Cells return to the resting phase (G0) without dying and can reenter the cell cycle later again Mitosis Protein synthesis. G 0 Cell prepares for mitosis DNA synthesis
10 Non-randomized studies Low-volume single-center studies Single-arm cohort series (no control) Retrospective analyses Multicenter randomized trials YUKON-BTX, DESTINY, ACHLLES Siablis D, et al. J Endovasc Ther 2005 Bosiers M, et al. J Cardiovasc Surg (Torino) 2006 Scheinert D, et al. Eurointervention 2006 Commeau P, et al. Catheter Cardiovasc Interv 2006 Siablis D, et al. J Endovasc Ther 2007 Siablis D et al. J Vasc Interv Radiol 2007
11 Prospective, randomized, multicenter, double-blind trial in Germany Polymer-free sirolimus-eluting l stent t versus placebo-coated bare metal stent t 161 patients with IC or CLI Lesion length 31+/-9mm (1.3 stents/lesion, range 1-3) Rastan et al. YUKON BTX 1 year results European Heart Journal 2011
12 Multicenter European RCT Company sponsored (ABBOTT) Xience V everolimus-eluting stent versus Multi-link Vision bare metal stent 140 patients with CLI (154 lesions) Lesion length 15.9 vs 18.9mm (3-40mm) Bosiers et al. DESTINY 1 year results Journal of Vascular Surgery 2012
13 Multicenter European RCT Company sponsored (CORDIS) CYPHER sirolimus-eluting stent versus plain balloon angioplasty 200 patients with IC or CLI Lesion length 27+/-21mm (1.8 stents/lesion) Scheinert D et al. JACC 2012 in press
14 Vessel restenosis >50% Pooled 95% CIs Relative Risk Reduction 52% 31 66% Absolute Risk Difference 21% ( 31) ( 12)% Number Needed to Treat dd Katsanos K et al. Meta analysis of Infrapopliteal DES CVIR 2013
15 Limb amputations tti Pooled 95% CIs Relative Risk Reduction 40% ( 13) 68% Absolute Risk Difference 4% ( 9) (+1)% Number Needed to Treat dd n/a n/a Katsanos K et al. Meta analysis of Infrapopliteal DES CVIR 2013
16 Target tlesion revascularization Pooled 95% CIs Relative Risk Reduction 55% 27 72% Absolute Risk Difference 12% ( 19) ( 5)% Number Needed to Treat dd Katsanos K et al. Meta analysis of Infrapopliteal DES CVIR 2013
17 Event free survival Pooled 95% CIs Relative Risk Increase 26% 10 44% Absolute Risk Difference 15% 7 23% Number Needed to Treat dd Katsanos K et al. Meta analysis of Infrapopliteal DES CVIR 2013
18 Wound dhealing Pooled 95% CIs Relative Risk Increase 29% 2 62% Absolute Risk Difference 17% 2 32% Number Needed to Treat dd Katsanos K et al. Meta analysis of Infrapopliteal DES CVIR 2013
19 Sum up Level I-A evidence for olimus-eluting stents for FOCAL infrapopliteal l lesions DES inhibit restenosis & reduce TLR DES improve wound healing & increase event-free survival
20 CLI case study: long metal jacket Baseline Post angioplasty Stenting
21 2 year 2 year p follow up
22 Optical lcoherence Tomography 6 months 2 years
23 Lesion length of 3 RCTs Katsanos K et al. Meta analysis of Infrapopliteal DES CVIR 2013
24 R.Ferraresi EuroPCR 2011
25
26 Study type Prospective single center, single arm, investigator initiated study Objective Assess IN.PACT Amphirion efficacy for the treatment of long BTK lesions occlusions Population Symptomatic patients with CLI or severe claudication Eligibility At least one lesion BTK 80 mm Primary Endpoint 3 month restenosis rate Nr of patients 104 / 109 limbs
27 DEB (angio subgroup) #patients/ limbs 74 / 79 Male gender 51 (68.9%) mean age (y) diabetics 54 (73%) Renal insuff. 34 (45.9%) RC 3 16 (20.3%) RC 4 14 (17.7%) RC 5 49 (62%) RC 6 0 (0%) avg lesion length mm Tot occlusions 61.9% DEB (angio subgroup) 3m Ang. FU Restenosis (>50%) 27.4% Full-segment Resten. 10% Restenosis Length 64 mm 12m Clinical FU Deaths 16.3% Limb Salvage 95.6% Clinical Improvement 91.2% Compl. wound healing 74.2% TLR 17.3%
28 DEB PTA* DEB PTA* (angio subgroup) (historical group) (angio subgroup) (historical group) # patients / limbs 74 / / 62 Male gender 51 (68.9%) 38 (65.5%) mean age (y) diabetics 54 (73%) 52 (89.7%) Renal insuff. 34 (45.9%) 30 (51.7%) RC 3 16 (20.3%) 0 (0%) RC 4 14 (17.7%) 7%) 16 (25.8%) RC 5 49 (62%) 46 (74.2%) RC 6 0(0%) 0(0%) avg lesion length mm mm Restenosis (>50%) Full-segment Resten. Restenosis Length 3m Angiographic FU 27.4% 69% 10% 56% 64 mm 155 mm 12m Clinical FU 15m Clinical FU Deaths 16.3% 10.5% Limb Salvage 95.6% 100% Clinical Improvement (1) 91.2% 76.5% Tot occlusions 61.9% 64.9% Compl. wound healing 74.2% 78.6% TLR 17.3% 50%
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32 BTK algorithm Focal Lesions DES Level I A Long DCB? Lesions Level II B
33 Infrapopliteal drug-eluting stents inhibit restenosis and reduce repeat procedures Infrapopliteal drug-eluting stents significantly improve overall patient event-free survival
34 Infrapopliteal drug-eluting stents are indicated for spot stenting of focal belowthe-knee lesions or as bail-out Infrapopliteal drug-eluting balloons might have a role for long lesions to avoid permanent metal scaffolds
35 Thank You
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