BK lesions-What’s the best strategy now and in the future Rabih A. Chaer, MD, MSc Associate Professor of Surgery Division of Vascular Surgery VAM 2013 PG course. PVD:Endovascular treatments of the lower extremity

DISCLOSURES • Nothing to disclose

Outline • Case planning/Access • Crossing techniques

• Intervention

Case planning/Access

Case planning/ Access • Preprocedural evaluation – History/Physical exam – Doppler/duplex – CTA

Case planning/ Access • Antegrade access preferred – More pushability

– Avoid hostile bifurcation – 4-5 Fr sheath

• Retrograde contralateral access most common – Need full support with long sheath down to the popliteal artery • Brachial access – Feasible

– Limitations

Lesion Crossing

Crossing • Extra support – Sheaths, support catheters

• Wires: hi torque, extra support, tip load – 0.35. floppy glidewire – 0.18 v18, Connect wire – 0.14 PT2, Winn, Confianza Pro, Command

Crossing CTO • Crosser device • Truepath device

• Laser step by step technique • Outback re-entry • Frontrunner • Viance crossing catheter • Enteer re-entry system

Retrograde Pedal Approach • Feasible • Safe

• An option for high risk patient with failed antegrade recanalization

Scheinert, et al JEVT 2008 Manzi et al. Jl Cardiovasc Surg 2009

Retrograde Approach. Indications • Flush SFA or tibial occlusion • Distal popliteal occlusion extending into the origin of the tibial vessels • Failed antegrade recanalization

93 yo woman with toe gangrene

Follow up • Toe pressure 0-->65 mmHg • Healed Toe amp

• Independent, ambulatory with a walker.

Interventions

Balloon Angioplasty

Cryoplasty Balloon Angioplasty

Cutting Balloon Angioplasty Angioplasty & Stent

Angiojet Thrombectomy

DES

1. PTA

AT occlusion Peroneal stenosis

Persistent wound 6 months re-occlusion

Tibial Interventions and Wound Healing • 123 limbs treated with a tibial with or without multilevel endovascular intervention (83% tissue loss) • 41% had complete healing (mean time to healing of 10.7±7.4 months. • 39% of patients treated for tissue loss had improvement in their wounds (mean FU 4.4±4.8 months)

• Extended patency is needed for wound healing

TIBIAL RESTENOSIS IS NOT BENIGN IN CLI

Results: CLI Limbs 235

Tibial restenosis 96 (41%) Asymptomatic 10 (10%)

Rest pain 15 (16%)

Primary Patent 129 (59%)

Persistent wound 30 (32%)

New/Worsened wounds 41 (42%)

Results:

Tibial Restenosis 96 Secondary TAEI 42 (44%)

Major Amputation 26 (27%)

Open BP 20 (21%)

Observation 8 (12%)

Restenosis-rate after angioplasty of extensive infrapopliteal arterial disease is high and occurs early after treatment

2. Recent Atherectomy Reports Author

Device

N (patients)

Adjunctive Rx

Primary Limb patency/TL Salvage R

Zeller 2011

SH

476

NA

87% 6mo

McKinsey 2008

SH

275

Talon 2006

SH

728

21%PTA, 6%stent

80%@12mo TLR freedom

Safian 2009 OASIS

DB360

124

39%PTA, 2.5%stent

61%@12mo

Zeller 2009

Jetstream

172

Stoner 2007

Laser

40

75%PTA

Laird 2006

Laser

145

96%PTA, 45%stent

Laird 2002 PELA

Laser

251

100%PTA, 42%stent

53%@18mo

92%@18mo

100%

TLR 26%@12mo 44%@12mo

55% in CLI 92%@6mo

51%@12mo

Tibial debulking in CLI • RCT: short and 1-year outcomes, 50 patients, Diamondback 360° Orbital Atherectomy System +PTA vs. PTA alone

• No amputations in either group @ 1 year • Freedom from TLR 93.3% vs. 80.0% (p = 0.14)

J Endovasc Ther. 2012 Aug;19(4):480-8

CLI, tibial disease. Laser assisted PTA vs. PTA • 80 patients: 47 PTA, 42 Laser. • Three-year AFS significantly improved with CELA (95.2%) versus TBA (89.4%; P=.0165).

• Three-year freedom from TER improved with CELA (92.9%) versus 78.7% TBA (P=.026). • Non randomized

• Almost ½ patients required tibial stents in either group • Subintimal technique only used with PTA Sultan S et al. Vascular and Endovascular Surgery 2013,47(3) 179-191

3. Drug Eluting Technology

3. Drug Eluting Technology

at 3 months: restenosis in 27.4% (19.1% had restenosis of more than 50%, and 8.3% were totally occluded)

DEBATE BTK study • Diabetic patients with CLI: paclitaxel-eluting balloon (In.Pact Amphirion, Medtronic Invatec) vs. uncoated balloon (Amphirion Deep, Medtronic Invatec) • 51 patients, 1 yr follow up • Restenosis: 27% vs. 63% (P = .01) • Reocclusion: 44% vs 19% (P = .02) • No major amputations in either group Liistro F, Angiolil P, Grottil S et al (2011) Drug eluting balloon for below the knee angioplasty evaluation: the DEBATE BTK study.

DEB. Summary • Paclitaxel eluting • Seem to lower the incidence of restenosis or reocclusion • IN.PACT DEEP (ongoing but not recruiting)

• EURO CANAL (POBA vs. Cotavance)

DES • Common drugs include either-limus type agent (everolimus, sirolimus) or paclitaxel. • Work on different phases of the cell cycle.

TINY trial: Primary patency of 85% at 12 months Freedom from TLR 91%

YUKON trial • 161 patients, RCT • Sirolimus eluting stent vs. BMS

• CLI and claudication • The 1-year primary patency rates for the sirolimus-eluting stent and BMS groups were 80.6 and 55.6 %, respectively (p = 0.004) Zeller et al. J Am Coll Cardiol. 2012 Aug 14;60(7):587-91.

Other trials • BELOW trial – RCT, 60 patients. – DES, BMS, PTA: lower restenosis with DES Tepe G, Scmehl J, Heller S et al (2010) Drug eluting stents versus PTA with GP IIb/IIIa blockade below the knee in patients with current ulcers: the BELOW study. J Cardiovasc Surg (Torino) 51:203–212

• PADI study (Netherlands)

– Ongoing CLI trial, infrapopliteal occlusive disease – PTA vs. paclitaxel eluting stent Martens JM, Knippenberg B, Vos JA et al (2009) Update on PADI trial: percutaneous transluminal angioplasty and drug eluting stents for infrapopliteal lesions in critical limb ischemia. J Vasc Surg 50:687–690

ACHILLES trial • RCT, 200 patients: cypher DES vs. PTA • At 12 months: significantly increased binary restenosis rate with PTA 41.9 vs. 22.4 % (p = 0.019) in the DES group • Wound healing had a trend toward improved healing rates in the DES group (61.7 vs. 41.3 %, p = 0.06)

Scheinert D et al. J Am Coll Cardiol 2012;60:2290–5.

DES. Summary • Consistent benefit in terms of patency compared to PTA or BMS • Potential clinical benefit in terms of wound healing and limb salvage • DES designed for the calf vs. the coronaries

• Multiple stent typically needed for more extensive lesions • Cost, questionable ICER for DES Katsanos KN, Diamantopoulos A, Spiliopoulos S et al (2011) Cost-effectiveness analysis of infrapopliteal drug-eluting stents for critical limb ischemia treatment. CIRSE Munich

BIOABSORBABLE stents/BVS • Combine mechanical prevention of vessel recoil, anti-proliferative agent, no permanent implant that could trigger restenosis • First generation: Magnesium-alloy bioabsorbable stent (Biotronik AG): 117 patients with CLI. Stent vs. PTA • 6 months: angiographic patency lower with BVS (31.8 vs. 58.0 %, p = 0.013)

• No improvement in long-term patency over PTA Bosiers M, AMS INSIGHT Investigators (2009) AMS INSIGHT—absorbable metal stent implantation for treatment of below-the-knee critical limb ischemia: 6-month analysis. Cardiovasc Intervent Radiol 32:424–435

ABSROB trial • Newer generation: Polylactide stent, everolimus eluting • ABSORB BTK (Esprit BVS) terminated

• Coronary data: bioresorption at 2 years • Low MACE at 4 years: 3.4%. No stent thrombosis.

• ABSORB II coronary RCT: currently recruiting in the US: XIENCE vs. Everolimus eluting stent Dudek D, Onuma Y, Ormiston JA, Thuesen L, Miquel-Hebert K, Serruys PW. Four-year clinical follow-up of the ABSORB everolimus-eluting bioresorbable vascular scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention. 2012 Jan;7(9):1060-1.

DURABILITY • Tibial interventions are not durable – Women – Diabetic patients – Renal failure patients

• High rate of limb loss with Restenosis in the setting of tissue loss

BTK interventions. Best Strategy • USA: PTA! With strict surveillance – Debulking ± DEB?

• Drug eluting technology seems to improve durability but is not perfect – DEB, DES – BVS? – Proven limb clinical outcomes need to be demonstrated in clinical trials • Improved medical therapy • Cilostazol, statins, antiplatelets

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