1	Infrapopliteal Stenting 2006 The „Leipzig Experience“ & a Global Review of DES & BMS Andrej Schmidt, MD and Dierk Scheinert, MD Department of Medicine I / Angiology Park Hospital Leipzig, Germany Division of Angiology University of Leipzig – Heart Center Germany
2	Balloon-Angioplasty of Infrapopliteal Arteries in Critical Limb Ischemia 60 pat., 72 limbs, 12-24 Mo F/U Lesion-length 3.8 ± 3.0 cm
3	PTA in Critical Limb Ischemia
4	Infrapopliteal Lesions in Claudicants
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9	Stents for Revascularisation of Infrapopliteal Arteries
10	Stents for Revascularisation of Infrapopliteal Arteries
11	PTA + Stenting of Infrapop. Lesions
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13	Diffuse Lesions in Diabetes-Patients
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15	"Passive coatings" Passive coatings Active coatings Bioabsorbable stents
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17	"Patients and lesions:" Patients and lesions: Patients with CLI (Rutherford 4,5) Single or multiple highgrade stenoses (>70%) Or occlusions Max: 3 lesions, 3cm
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22	"Multicentric," Multicentric, prospective, randomized 6 European centers 100 patients (50 PTA, 50 Carbostent (Sorin)) Rutherford 4 and 5 Target lesion <45mm, max. 3 lesions Primary endpoint: Angiographic late lumen loss at 9 months
23	"BEST-BTK" BEST-BTK First in Man experience with the Biotronik absorbablE metal StenT Below The Knee Dual center, prospective, non randomized analysis of the safety & performance of the Lekton Mg (Biotronik) AMS in endovascular infrapopliteal procedures
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25	Drug-Eluting Stents Below the Knee
26	FK506-Eluting Stents Below the Knee
27	Ceramic – Coating (ALO)
28	Tacrolimus (FK506)
29	Inhibition of SMC and EC
30	FK506 + Ceramic-Coating: Case 1
31	FK506 + Ceramic-Coating: Case 1
32	FK506 + Ceramic-Coating: Case 2
33	FK506 + Ceramic-Coating: Case 2
34	FK506-Eluting Stents; Results
35	Active Coatings Sirolimus-eluting balloon-expandable stent – CYPHER select^TM (Cordis) Two phases: Proof of concept: Comparative pilot study Mid-term efficacy: Cypher registry Cypher is CE-marked for BTK-indication Cypher is not approved in the US for BTK
36	"Symptomatic PAOD Rutherford 3 to..." Symptomatic PAOD Rutherford 3 to 5 Single infrapopliteal lesions Lesion length up to 30 mm Reference vessel diameter 3.0 to 3.5 mm Max. 1 stent / patient
37	"30 patients:" 30 patients: Sirolimus-eluting stent Cypher select (Cordis) 30 patients: Bare-metal stent Sonic (Cordis) (3,5/33 mm-stents)
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41	Follow-up Example - Cypher Stent
42	SES (Cypher) vs. BMS – Pilot Study Summary According to the angiographic follow-up the use of sirolimus-eluting stents was associated with a significantly reduced in-stent-reobstruction rate (0% vs 56%). Adverse clinical events (amputation and TLR) could be significantly reduced using sirolimus-eluting stents.
43	SES (Cypher) vs. BMS
44	Cypher – BTK Registry Study Objective To assess the mid-term safety and efficacy of Sirolimus-eluting balloon-expandable stents for symptomatic focal infrapopliteal obstructions.
45	Cypher – BTK Registry Study Design Prospective, non-randomized, monocentric registry Investigator initiated, no industry support
46	Cypher – BTK Registry Study Endpoints Clinical and Safety Endpoints Death Major amputation (above the metatarsal level) Target lesion revascularization (TLR) Bypass surgery
47	Cypher – BTK Registry Baseline Angiographic Data
48	Cypher – BTK Registry Study Design
49	Cypher – BTK Registry Study Design
50	Cypher – BTK Registry Angiographic Follow-up
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55	"Patient with moderate claudiaction refused..." Patient with moderate claudiaction refused re-intervention 1 months later acute ischemia with occlusion of the popliteal artery and the Cypher stent Successfully treated with thrombolysis and SFA-stenting
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58	Cypher – BTK Registry Angiographic Follow-up
59	Conclusions Sirolimus-eluting stents are safe and effective for treatment of focal infrapopliteal obstructions. These results need to be validated in a randomized, multicentric trial.