Popliteal artery: to stent or not to stent?

Popliteal artery: to stent or not to stent? Karl-Ludwig Schulte Vascular Center Berlin Ev. Hospital Königin Elisabeth St. Gertrauden Hospital University Hospital Charité, CC11 Humboldt-University Berlin www.vascular-center-berlin.com www.gefaesszentrum-berlin.de

Fempop Dynamic Zones Fempop Dynamic Zones

Challenges of SFA treatment SFA anatomy & mechanics During hip flexion and knee bending, the SFA and popliteal arteries demonstrated axial compression and bending, with most of the bending occurring behind the knee. Biomechanical forces in the femoropopliteal segment. - H.B. Smouse et all; Endovascular Today; 2005, June, pp: 1-6

Knee extension Knee extension Knee flexion Knee flexion Hinge Points

Results of Balloon fempop-angioplasty Patients (n) Lesion Length F/U Primary Patency Matsi PJ et al., 1995 Stanley B et al., 1996 Krankenberg H et al., 2002 Jämsén TS et al., 2002 107 7.2 cm 2 years 51 % 176 > 10 cm 2 years 46 % 58 22 cm 1 year 44 % 173 5.2 cm 1 year 46 % Weighted average: 47 %

12 Months Restenosis vs. Lesion Lenght: Data from Controlled Trials Binary Restenosis @ 12 Months (%) Length of the Lesion (cm)

Risk of stent fracture Illustration showing how adjacent stents separated by bare artery may shift out of plane during joint bending Smouse HB, Endovascular Today 2005 Smouse HB, Endovascular Today 2005

Spot-Stenting??

Typical fempop-stents (very flexible) Luminexx Novoflex aspire Hyperion Conformexx Samba LifeStent Smart Absolute SUPERA Protege Everflex Zilver PTX Astron Pulsar MISAGO Epic etc. etc. etc. etc.

2 Studies on hold: - POBA vs. Stent-PTA (Life-Stent) - POBA vs. Stent-PTA (Everflex-Stent)

Typical Fem-pop Stents (very flexible) Luminexx Novoflex aspire Hyperion Conformexx Samba LifeStent Smart Absolute SUPERA Protege Everflex Zilver PTX Astron MISAGO Epic etc. etc. etc. etc.

Drug eluting devices: stents (DES) and balloons (DEB)

MISAGO Stent New Generation Nitinol Stent with a unique stent design & RX Delivery System 035 Rapid-Exchange Delivery System

MISAGO 2 Patient Population Patients with documented symptomatic occlusion and/or > 70 % stenosis of SFA or popliteal artery in one or both legs 1 lesion/leg Primary Endpoint Absence of clinically driven target lesion revascularization (TLR) at 6 and 12 months post procedure

MISAGO 2 - TLR Per Subgroups 6 months FUP 12 months FUP Popliteal artery 5.3 8.8 Total occlusions 3.5 11.3 Lesions > 7 cm 3.6 12.6 TASC C or D 3.3 9.9 Overall population 3.1 10.4

MISAGO 2 Primary Patency - When compared with new DES (European results) 100 95 97,2 93 ZILVER PTX Misago 90 85 86,2 87,6 80 6 months 12 months Primary patency defined as stenosis < 50 % (defined as PSVR < 2.4) or freedom of TLR

Viabahn covered stents

Problems with fempop-stenting Restenosis

NEJM, 2008 NEJM, 2008

Late Lumen Loss at 6, 12 or 24 Months or Before 1st TLR (Primary Endpoint)

THUNDER: Late Lumen Loss Subgroups

Clinical programs: SFA ongoing and planned Study name Design DEB name and availibilty PI Current status INPACT SFA I POBA vs. DEB IN.PACT Admiral, CE marked, available Tepe Recruiting Freeride POBA vs. DEB FREEWAY 035, EUROCOR, no CE mark, not available Schulte Announced, not started Freeway Stent Study Stent assisted DEB vs. Stent assisted POBA FREEWAY, EUROCOR, CE marked, available Tacke Recruiting Pacuba I ISR DEB vs. PTA FREEWAY, EUROCOR, CE marked, available Lammer Recruiting

Clinical programs: SFA ongoing and planned Study name Design DEB name and availibilty PI Current status BIOLUX PI POBA vs. DEB Passeo-18 Lux Biotronik, no CE mark, not available Scheinert Recruiting RIVER POBA vs. DEB Cotovance, Bayer Medrad, no CE mark, not available Gray/Ansel Announced, not started Definitive AR DEB vs. Atherectomy/DE B Cotovance, Bayer Medrad, no CE mark, not available Tepe/Zeller Announced, not started Copa Cabana POBA vs. DEB in ISR Cotovance, Bayer Medrad, no CE mark, not available Tepe Announced, not started FAIR ISR DEB vs. PTA IN.PACT Admiral, Medtronic/Invatec CE marked, available Krankenberg Recruiting PACIFIER DEB vs. PTA DeNovo up to 40cm IN.PACT Admiral, Medtronic/Invatec CE marked, available Werk Recruiting

FREEWAY 035, femoropopliteal PTA balloon 0.035" OTW FREEWAY 014, infrapopliteal PTA balloon 0.014" OTW

FREERIDE STUDY Prospective, Randomized, Controlled, Multicentre, Open Study Release of Paclitaxel during PTA versus PTA alone for the treatment of de-novo occluded, stenotic or, reoccluded, restenotic superficial femoral (SFA) or popliteal arteries Principal Investigator: Prof. Dr. med. Karl-Ludwig Schulte Vascular Center Berlin / Dept. Internal Medicine Ev. Hospital Königin Elisabeth Herzberge, St. Gertrauden Hospital and CC11, Charité/Humboldt University Berlin, Germany

Objective and Study Design Comparison of Paclitaxel-Coated Balloon (FREEWAY) with POBA in the treatment of de-novo occluded, stenotic or, reoccluded, restenotic superficial femoral (SFA) or popliteal arteries. Prospective, randomized, multi-center, two-armed phase-iii study conducted mainly in Europe, but also in South- and North-America (Colombia, Canada). 280 patients: More patients (280) than in other studies and wide indication range Design: POBA versus FREEWAY 035

Primary and Secondary Endpoints Primary Endpoint: Rate of clinically driven target lesion revascularization (TLR) at 6 months * Secondary Endpoints: Technical success defined as the rate of successfully performed index procedures after wire passage Late lumen loss, i.e. the difference between the minimum lumen diameter after intervention and during the follow-up at 6 determined by angiography Clinical success defined as technical success without the occurrence of serious adverse events during procedure Ankle-Brachial Index improvement of 0.1 (ABI before procedure compared with ABI at discharge and at 6, 12 (and 24) months Primary and secondary patency rate defined as < 50 % diameter reduction and peak systolic velocity < 2.4 at 6, 12 (and 24) months Change in WIQ i.e. walking impairment questionnaire from pre-intervention to 6, 12 (and 24) months follow-up improvement of walking distance before procedure compared with walking distance at discharge and at 6 and 12 months (if Treadmill test is available) Rate of minor and major complications at 6 and 12 (and 24) months Change in Rutherford classification grades of chronic limb ischemia from preintervention to 6, 12 (and 24) months follow-up. Rate of clinically driven target lesion revascularization (TLR) at 12 (and 24) months * Assessed by an independent, blinded Core-Lab

Flowchart 280 patients August 2011 August 2012 Randomization 1 : 1 ratio GROUP A POBA GROUP B FREEWAY 0.35 6 and 12-month Duplex follow-up 6 month angiographic follow-up (subgroup)

K.K., male, 56 yrs. Rest pain right leg (Rutherford 4, Fontaine III) Risk factors: Smoking, Hypertension, LDL-C Therapy: ASS, ACE- Inhibitor, Statin

4x60 PTA, 4x30 Dior (2)

Popliteal artery: to stent or not to stent? Karl-Ludwig Schulte Vascular Center Berlin Thank you for your attention Ev. Hospital Königin Elisabeth St. Gertrauden Hospital University Hospital Charité, CC11 Humboldt-University Berlin www.vascular-center-berlin.com www.gefaesszentrum-berlin.de