COMPLEX SFA INTERVENTIONS:Gilles Soulez, MD, MScProfessor of RadiologyAcademic Chair dpt of Radiology, Nuclear Medicineand Radiation OncologyCHUM-University of Montreal
Introduction• Lot of technological evolution in theendovascular management of SFA disease– 3rd and 4th generation of nitinol stents– Covered and DE stents– DEB– Atherectomy– Re-entry devices– Bioabsorbable vascular scaffold• Need first to focus on the clinical indication
SFA Patency vs. Mean Lesion Length• Historically, there’s been a direct relationship between lesion lengthand patency rate in SFA trialsFAST(Luminexx)FACT(Conformexx)RESILIENT(LifeStent)Astron(Biotronik)DURABILITY(Everflex)Vienna(Absolute)Super SL(SMART)VIBRANT(BMS arm)01020304050607080901000.00 5.00 10.00 15.00 20.00 25.00 30.00PatencyRate(12mo)Mean Lesion Length (cm)DURABILITY 200(Everflex)Leipzig SFA Registry(SUPERA)CWZ(SUPERA)
Long-term clinical impact ?• RESILIENT 36 MONTHS– Survival• 90% vs. 91.7%, p = 0.71– Major adverse events• 75.2% vs. 75.2%, p = 0.98– target lesion revascularization• stent group (75.5%)• angioplasty group (41.8%), p<0.0001.– No difference in QOL at 2 and 3 years based upon the SF-8questionnaire and WIQ.– Significant improvement in quality of life for both treatmentgroups compared to baseline at all study time intervals.Laird et al JEVT 2012
Primary versus optional stentingSchillinger, Meet 2008
When shoud we perform primarystenting?• Our practice– More than 90% stenting overall !– Primary stenting• Lesion length more than 4cm• CTO• Recurrence post angioplasty– Provisional• Single stenosis less than 4 cm
Stent Fractures – what we know today• Major stent fractures (types 3 and 4) areclearly linked to reocclusion• Different nitinol stent designs havedifferent fracture rates and types• Fractures ↑ with Length of lesion andnumber of overlapping stents• Elongation of the stent during deploymentpredisposes to severe stent fracture
SUPERA Stent (IDEV)• Nitinol woven design• High radial strength (4X) (especially if Ca++)• High flexibility (kink resistant)• High resistance to fractures
Covered stent• Patency not different fromabove the knee syntheticbypass• Potential indications– No venous conduit– Long lesion > 20cm– Large arteries 6mm and more– Not too calcified– In stent stenosis ?Mc Quade K et al. J Vasc Surg 2010;53:584-90
Limitations• Short stent 8cm• Need to overlap several stents for long lesions• Cost• Positive clinical impact required to justify thecost• DEB for ISR good alternative ?
Indication of DES ?• ISR (drug coated balloon is an alternative)• Patient at high risk for restenosis by IH– Small arteries– Poor run-off– History of IH– Recurrence post-angioplasty– Long lesions• Calcified lesions ?
Drug eluting balloon• Potential advantage– Stent can be optional– Significant drug transfer to the wall and drugeffect– ISR• Potential limitation– No stent or vascular scaffold
DEB• Paclitaxel combined with acarrier– Iopromide, Ultravist, BTHC, urea• Drug remains in arterial wall forweeks• Effectively inhibits neointimalproliferation