Infratibial Management SES DES BMS Are there Statistical

Infratibial Management: SES, DES, BMS Are there Statistical Differences in Outcomes? Michael H. Wholey, MD, MBA San Antonio, TX 2/28/2011 2: 55 PM

Financial Disclosures I have no significant disclosures in this field. This definitely has off-label discussion.

Infrapopliteal Disease One of the most difficult and hostile regions to treat Why? Small vessel diameter Poor distal runoff High rate of restenosis, dissection Lesion Types to treat Location Multiple Occlusions

Popliteal Medial Inferior Geniculate Tibioperoneal Trunk Posterior Tibial Peroneal Anterior Tibial

Anterior Tibial Peroneal Posterior Tibial Commun. Br. of Peroneal Dorsalis Pedis Lat. Tarsal Medial & Lateral Plantar Arcuate

Compared to SFA Intervention Different Patient Population Patients with CLI are typically elderly with multiple co-morbidities and limited life expectancy Therefore, a procedure, which is minimally invasive with reduced morbidity and mortality but lesser long-term patency, may be more appropriate than a more invasive procedure with better long-term patency. Different Goals: Clinical success is superior to angiographic patency, because once healing has occurred, should the artery restenose or occlude, collateral flow can be sufficient to preserve tissue integrity if there is no further injury.

Infrapopliteal Lesion Types for Treatment Single, Focal Lesion (rare) 10 -20% Multiple, Diffuse Lesions 80 -90% • Occlusive Disease

Symptoms of PAD Asymptomatic Claudication Critical Limb Ischemia -Rest Pain -Tissue Loss ---Ulceration ---Gangrene Acute Limb Ischemia Amputation

Symptoms of PAD Asymptomatic Claudication Critical Limb Ischemia -Rest Pain -Tissue Loss ---Ulceration ---Gangrene Acute Limb Ischemia Amputation

Choosing the Device Based on Lesion Characteristics in the Infratibial Vessels First Choice of Intervention Balloon Angioplasty (PTA) Conventional Cutting Balloons Coming: Drug Eluting Balloons

Treatment Modalities Angioplasty Balloons 0. 014” Based Invatec Amphirion (MDT) e. V 3 Nano. Cross Cordis Savvy/Sleek Cook Abbot Vascular Drug Eluting Balloons Sizes: 1. 2 to 4 mm with lengths 4 to 22 cm

PTA

PTA of Distal Ant Tibial You are not going to make mayonnaise out of vinegar

What do you do if PTA Fails? High Grade Residual Stenosis Dissection Embolic Debris Dissection of Ant Tibial

Avoid thinking: that will never happen to me.

Infrapopliteal Vessels DES/BMS trifurcation. OK Need Self. Expandable 3 -D CTA of lower leg

Historical: Distal Posterior Tibial Stent After overnight infusion of Urokinase 120, 000 units/hr 0. 010 -0. 014” Crossit Wire 2 mm BSX Velocity stent

Historical: Distal Posterior Tibial Stent Patency: 1 month After overnight infusion of Urokinase 120, 000 units/hr 0. 010 -0. 014” Crossit Wire 2 mm BSX Velocity stent

Which stent in the infrapopliteal? Balloon Mounted Drug Eluting Self. Expandable Abbot Vascular Xience Cordis BSX Taxus Bare Metal Stent • Easily Deliverable • In Stock Bioabsorbable Cook Abbot Absorb Stent Guidant

DES Coronary Stents for Infrapopliteal 2. 75 x 12 mm Taxus stent

Coronary BMS and DES for Infrapopliteal Lesions? Benefits Vessel diameter similarities Immediate availability of existing materials for new indication Drawback Size Diameter 2 -3. 0 mm Lengths 1 -3 mm 0. 014” Rx Radiopacity

Coronary balloon-expandable DES Pre-op Post-op 2 x Cypher stent 22 Bosiers et al. J Cardvasc Surg 2006; 47(2): 171 -6. 6 months follow-up

Single Center DES & BMS Results Author Stent Type Peeters, Bosiers BMS Euro. Intervention 2007 Siablis Euro. Intervention 2006 62. 8 @12 M 89. 3 @12 M 65 40. 5 @12 M 100 @12 M 24 42 83. 7 @ 6 M 95. 0 @ 6 M 30 62 97 @ 7. 7 M 100 @ 7. 7 M 29 66 86. 4 @ 12 M 96. 0 @ 12 M 30 30 100 @ 6 M - BMS DES J Endovasc Ther 2007 Scheinert 62 29 Cardiovasc Interv Radiol 2006 Siablis Limb Salvage BMS Cardiovasc Interv Radiol 2006 Commeau Vessel No Primary Patency 50 J Endovasc Ther 2007 Rand Pts No DES

Single Center DES & BMS Results Author Stent Type Peeters, Bosiers Pts No Vessel No Primary Patency BMS Primary Patency 62 50 BMS Siablis appears better with 29 65 DES BMS Rand Limb Salvage Euro. Intervention 2007 62. 8 @12 M 89. 3 @12 M J Endovasc Ther 2007 40. 5 @12 M 100 @12 M Cardiovasc Interv Radiol 2006 Commeau 24 Euro. Intervention 2006 95. 0 @ 6 M 30 62 97 @ 7. 7 M 100 @ 7. 7 M 29 66 86. 4 @ 12 M 96. 0 @ 12 M 30 30 100 @ 6 M - DES J Endovasc Ther 2007 Scheinert 83. 7 @ 6 M DES Cardiovasc Interv Radiol 2006 Siablis 42 DES

Single Center DES & BMS Results Author Stent Type Peeters, Bosiers BMS Euro. Intervention 2007 Siablis J Endovasc Ther 2007 Rand Cardiovasc Interv Radiol 2006 Commeau Cardiovasc Interv Radiol 2006 Siablis Euro. Intervention 2006 Vessel No Primary Patency Limb Salvage 50 62 62. 8 @12 M 89. 3 @12 M 29 65 40. 5 @12 M 100 @12 M 83. 7 @ 6 M 95. 0 @ 6 M 97 @ 7. 7 M 100 @ 7. 7 M BMS No Difference 24 42 DES in Limb 30 Salvage 62 DES BMS J Endovasc Ther 2007 Scheinert Pts No 29 66 86. 4 @ 12 M 96. 0 @ 12 M 30 30 100 @ 6 M - DES

Destiny Trial The multicentre DESTINY trial compared the Xience V drug-eluting stent to Abbott’s bare metal stent, the Multi-link Vision, in 140 patients with claudication of the lower leg, with lesion lengths less than 40 mm. 12 -month results from DESTINY demonstrated that everolimus-eluting stent, Xience V had significantly better patency compared to the Multi-link Vision bare metal stent at 12 months (85. 2% Xience V versus 54. 4% Multi-link Vision; p=0. 0001). Leipzig Interventional Course (LINC) held in Leipzig, Germany Jan 2011

The Need for Dedicated BTK Stents Which platform: DES, BMS, Self-expandable Key Features Variable Lengths Low Profile (< 4 Fr Delivery) Minimal metal interface and strut surface Over the wire for pushability Radiopacity MR Compatibility

Dedicated balloon-expandable Cobalt-chromium stent : BTK-study Study design Infrapopliteal lesions in patients with CLI Primary stenting (Chromis) 50 CLI patients (Rutherford 4 -5) Lesion length 52. 2 mm (30. 0 -80. 0 Stent length 10 -76 mm, dia 2 -4 mm

CHROMIS BTK-study Proximal lesions 69 % Distal lesions 33. 3 %

CHROMIS BTK-study PROXIMAL LESIONS good indication for dedicated balloonexpandable stents Proximal lesions 69 % Distal lesions 33. 3 %

Stenting: Self Expandable 4 x 40 Xpert

Dedicated self-expanding BTK stent : XPERT BTK-study Study design Infrapopliteal lesions in patients with CLI Primary stenting Xpert nitinol stent March-November 2007 47 CLI patients (Rutherford 4 -5) 67 stents Lesion length 32. 4 mm (6. 0 -100. 0)

Dedicated self-expanding BMS case Pre-op Xpert placement Final angio

XPERT BTK-study 24 -MONTHS PRIMARY PATENCY RATE PP @12 M 76. 3% PP @24 M 54. 4% 34

XPERT BTK-study 24 -MONTHS PRIMARY PATENCY RATE Proximal Lesion 57% Distal Lesion 52% 35

XPERT BTK-study 24 -MONTHS LIMB SALVAGE RATE Proximal Lesion 95 % Distal 81 % 36

XPERT BTK-study 24 -MONTHS LIMB SALVAGE RATE Proximal Lesion 95 % Dedicated BTK selfexpandable with good outcomes 37 Distal 81 %

New Technologies

Self-Expanding Drug Eluting Stents Promising SFA/Popliteal Cook Zilver Results Cook Medical is reporting that an international study, involving 792 patients implanted with the company's paclitaxelcoated peripheral arterial stent, has demonstrated "that 82% of patients who were treated. . . were free from reintervention at 2 yr follow up. " 479 Patients: -83% primary patency after 12 mos. 75% primary patency after 24 mos

Bioabsorbable Stents Infrapopliteal Promising European PTCA Data Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) stent. The stent utilizes a poly-L-lactide polymer. Advantages: No long-term need for dual antiplatelet therapy Ability to restore normal vasomotion Potential for plaque regression Ability to decrease late stent thrombosis Late angiographic in-stent hyperplasia Not "permanently jail side branches”

(Early) Algorithm for BTK Interventions Short Focal Lesions Long Diffuse Lesions PTA If PTA Failure (Dissection, . . ) If Focal, Calcified and/or Proximal to Trifurcation If Diffuse or Located lower or mid- calf -DES (Balloon Mounted) -Nitinol Self Expandable

Future: New Technologies Bioabsorbable Self Expanding and Balloon Mounted Stents Drug Eluting Self-Expandable Stents

(Later? ) Algorithm for BTK Interventions Short Focal Lesions Long Diffuse Lesions If Focal, Calcified and/or Proximal to Trifurcation If Diffuse or Located lower or mid- calf -DES -Bioabsorbable Balloon Mounted -Nitinol Self Expandable -Drug Eluting -Bioabsorbable

Infrapopliteal Intervention Treatment of Trifurcation Disease