When Not To Use A Bare Metal When Not To Use A Covered .

When not to use a bare metal –when not to use a covered stentfor iliac stenotic lesionsMichel ReijnenRijnstate Hospital ArnhemThe Netherlands

DisclosureSpeaker name:MMPJ ReijnenI have the following potential conflicts of interest to report:X ConsultingEmployment in industryStockholder of a healthcare companyOwner of a healthcare companyOther(s)I do not have any potential conflict of interest

Endovascular treatment of the iliac arteryDilemma: Angioplasty or stenting Self-expanding or balloon-expandable stents Covered stents or bare metal stents Common iliac artery versus the external iliacartery

DIST trial“There were no substantial differences in technical resultsand clinical outcome of the two treatment strategies bothat short-term and long-term follow-up”“Selective stenting should be the treatment of choice”Stenosis in 92% of patients

STAG trial

TASC C and D lesions Meta analysis including 958 patients: Technical success 1-yr primary patency Technical success 1-yr primary patencyTASC C93.7%89.6%Primary94.2%92.1%TASC D90.1%87.3%Selective88.0%82.9% Long-term patency rates better for primary stentingYe W. et al. Early and late outcomes of percutaneous treatment of TransAtlantic Inter-Society Consensus class Cand D aorto-iliac lesions. J Vasc Surg 2011 Jun;53(6):1728-37.

Endovascular approach of iliacartery occlusive disease 5-years patency of iliac stenting Overall complication rate69-83%2-24%– Major complication rate– Emboli Lesions with increased risk:– Heavily calcified– Excentric– Ulcerative plaque3-4%0-9%

When to use a covered stent?;theoretical advantages Likely to reduce the incidence ofin-stent re-stenosis Focal edge stenosis: incidence independent of lesion length Easier to treat compared to diffuse ISR May reduce the risk on embolization May reduce the risk of an eventual rupture

Why using Advanta V12 covered stents?Due to specific characteristics: low profile double ePTFE layer easy and accurate deployment radial force dog-bone type inflation of balloon diameter adaptiveness

Cobest trial: covered versus BMS iniliac artery occlusive disease Prospective, multi-center, randomized, controlledtrial Covered stents versus bare-metal stents in iliacartery occlusive disease Included patients: 125 Included limbs:168 Follow-up at 1, 6, 12 and 18 monthsMwipatayi BP, Thomas S, Wong J, Temple SE, Vijayan V, Jackson M, Burrows SA; Covered Versus Balloon Expandable Stent Trial(COBEST) Co-investigatorsA comparison of covered vs bare expandable stents for the treatment of aortoiliac occlusive disease. JVasc Surg. 2011 Dec;54(6):1561-70.

Cobest trial: covered versus BMS iniliac artery occlusive diseasePrimary endpoints Rate of binary restenosis Freedom from stent occlusion at 18 monthsSecondary endpoints Stent patency TASC B, C and D Amputations above the ankle ABI changes from baselineMwipatayi BP, Thomas S, Wong J, Temple SE, Vijayan V, Jackson M, Burrows SA; Covered Versus Balloon Expandable Stent Trial(COBEST) Co-investigatorsA comparison of covered vs bare expandable stents for the treatment of aortoiliac occlusive disease. JVasc Surg. 2011 Dec;54(6):1561-70.

Cobest trial: covered versus BMS iniliac artery occlusive disease TASC B: Similar patency TASC C and D: Less binary re-stenosis Less occlusions Less re-interventions in thecovered stent group(p 0.006 at 12 months)Mwipatayi BP, Thomas S, Wong J, Temple SE, Vijayan V, Jackson M, Burrows SA; Covered Versus Balloon Expandable Stent Trial(COBEST) Co-investigatorsA comparison of covered vs bare expandable stents for the treatment of aortoiliac occlusive disease. JVasc Surg. 2011 Dec;54(6):1561-70.

Property of Bram Fioole, Maasstad Hospital, The Netherlands

Discover trial 68/174 patients randomised Completion of enrollment is scheduled for July 2016Property of Bram Fioole, Maasstad Hospital, The Netherlands

Covered stents in iliac artery occlusivedisease: mid-term outcome 115 Advanta V12 stents in 87 patients Primary procedures (n 69)– 1-year patency89%– 4-years patency72% Secondary procedures (n 46)– 1-year patency78%– 4-years patency53% Primary patency significantly higher in theprimary treatment group (p 0.05)Grimme FAB, Spithoven JH, Zeebregts CJ, Scharn DM, Reijnen MMPJ. Mid-term outcome of balloon expandablepolytetrafluoroethylene covered stents in the treatment of iliac artery chronic occlusive disease. J Endovasc Ther. 2012Dec;19(6):797-804.

The kissing stent configuration Review of 951 patients Intermittent claudication TASC C or D Technical success rate Complication rate Primary patency 12 months 24 months 36 months72.8 %50 %98.2 %11 %88.8 %78.9 %68.5 %Groot Jebbink E, Holewijn S, Slump CH, Lardenoye JW, Reijnen MM. Systematic review of results of kissing stents in thetreatment of aortoiliac occlusive disease. Submitted.

Kissing covered stentsNon-randomized comparison of 26 patients with kissing coveredstents and 28 patients with kissing bare stentsSabri SS. et al. J Vasc Interv Radiol 2010;21:995-1003.

Kissing covered stents Advanta V12 covered stents: Increased clinical improvement(p .05) Superior patency at 24 months(92% vs. 62%, p .05)Sabri SS. et al. J Vasc Interv Radiol 2010;21:995-1003.

Kissing covered stentsMidterm outcome Retrospective analysis 73 consecutive kissing stent procedures TASC-2 A B C Dn 22n 24n 3n-24including 10 patients after previous stentingincluding 15 patients after previous stenting1 year4 years Primary patency87.2%69.1% Secondary patency87.2%72.7% The freedom from re-intervention at four years: 76.5%Grimme FAB, Spithoven H, Zeebregts CJ, Scharn DM, Reijnen MM. Endovascular treatment of occlusive lesions in the aorticbifurcation with kissing polytetrafluoroethylene covered stents. Submitted.

Conclusions Endovascular treatment seem to be justified for allTASC categories Angioplasty and bare metal stenting are treatment ofchoice in less complex lesions and covered stents inmore extensive disease As re-do procedures perform worse the initialtreatment strategy is crucial Critical issues include cost-efficacy and thedevelopment of techniques for extensive aorto-iliacocclusive disease

CERAB for extensive aorto-iliacocclusive disease

CERAB for extensive aorto-iliacocclusive disease Median follow-up 12 months Primary patency 6 months12 months18 months92%87%87% Secondary patency 6 months12 months18 months98%95%95% Limb salvage 100%

When not to use a bare metal –when not to use a covered stentfor iliac stenotic lesionsMichel ReijnenRijnstate Hospital ArnhemThe Netherlands

covered stent group (p 0.006 at 12 months) Mwipatayi BP, Thomas S, Wong J, Temple SE, Vijayan V, Jackson M, Burrows SA; Covered Versus Balloon Expandable Stent Trial (COBEST) Co-investigatorsA comparison of covered vs bare expandable stents for the treatment of aortoiliac