THE 15-YEAR EVOLUTION OF COVERED STENT: CHOOSING THE BEST STENT FOR AORTOILIAC ARTERY DISEASE.

Transcription

1 THE 15YEAR EVOLUTION OF COVERED STENT: CHOOSING THE BEST STENT FOR AORTOILIAC ARTERY DISEASE. DOES COBEST PRESENT STRONG EVIDENCE FOR V12 AS CHOICE OF COVERED STENT? B. PATRICE MWIPATAYI MMed, MClinED, F, FRA Clinical Associate Professor Vascular Surgery Biostatistic for PIVAR University of Western Australia, Perth

2 Disclosure Speaker name:...bibombe PATRICE MWIPATAYI I have the following potential conflicts of interest to report: Receipt of grants/research support: Biotronik, Medtronic, Getinge Maquet Receipt of honoraria and travel support Participation in a company sponsored speakers bureau Employment in industry Shareholder in a healthcare company Owner of a healthcare company I do not have any potential conflict of interest

3 Treatment Options for AIOD What are the optimal treatment options? Open bypass surgery: ABF / AFF Bypass Surgery Endovascular interventions Angioplasty +/ stenting Stenting: covered stents vs i. High technical success rates ii. Low morbidity iii. High rates of for TASC A / TASC B iv. Improvement in functional outcome for the individual patient Advanced stenting: CERAB +/ Chimneys i. High rates of for TASC A / TASC B ii. Improvement in functional outcome for the individual patient Nonintervention treatment: comprehensive BMT (DAPT / lipid Rx / others)

4 What is the evidence for Iliac Stenting? Registries cohort studies: important in understanding differences in ever changing treatment options and defining which RCTs are needed ** Propensity score analysis and Treatment effect analysis : adds value to a retrospective comparison by forcing cohorts to be more alike Randomized controlled trials: are still the gold standard Metaanalysis and systematic review: will boost RCT results.

5 Surgical vs Endovascular Treatments PTA vs Surgery 157 iliac lesions treated with either PTA or surgery No significant difference between PTA & surgery for death, amputations or loss of at 3 years No significant difference in the hemodynamic (ABI) result of a successful procedure between the 2 groups Wilson et al J Vasc Surg 1989; 9: 19

6 3 year Followup Data Baseline Posttreatment 3 year PTA 0.50 ± ± ± 0.07 Surgery 0.50 ± ± ± 0.05 Ankle Brachial Index in Randomized Iliac Lesions Conclusion: PTA had similar early and longterm results compared with bypass surgery Bar graph of the 3year event free survival of PTA Vs surgery for iliac lesions Wilson et al J Vasc Surg 1989; 9: 19

7 Iliac Disease: What type of SES? (CRISP )

8 Systematic / Metaanalysis Review Bosch 1997: metaanalysis of studies between : Stent placement lowered risk of long term failure by 39%. Wei Ye 2011: Early and late outcomes of percutaneous treatment of TransAtlantic InterSociety Consensus class C and D aortoiliac lesions, metaanalysis review. This demonstrates that outcomes of endovascular treatment for TASC C and TASC D aorto iliac lesions were acceptable with a better rate for primary stenting compared with selective stenting. Bekken JA 2018, (J Cardiovasc Surg (Torino) Feb;59(1):1425). The use of covered stents in aortoiliac obstructions: a systematic review and metaanalysis. Highquality evidence supporting the use of covered stents for aortoiliac occlusive arterial disease is limited. The use of covered stents in TASC C and D lesions may improve rates (due to heterogeneity of TASC data reporting in the different publications). We are conducting a comprehensive Metaanalysis review off relevant publications on AIOD: (The first Advanta V12 stent was implanted in years of experience)

9 Meta analysis Methodology / Results Records identified through database searching PubMed, Embase, PsychINFO, Medline (n = 3518) Additional records identified through other sources Grey literature, cross referencing (n = 20) Records screened (n = 83) Fulltext articles assessed for eligibility (n = 56) Records after duplicates removed (n = 2077) Records excluded (n = 27) Fulltext articles excluded with reasons (n = 21) 1. Forest Plot will be used 2. Heterogeneity of data to be managed by using treatment effect. 3. Robust logistic regression to compare data obtained. 4. Propensity score analysis matching Studies included in the final review on iliac artery stenting (n = 35) FINAL REVIEW OF ALL STUDIES (N 16)

10 COVERED STENT STUDIES First Author Title N Type of Wiesinger et al 2005 PTFEcovered selfexpanding nitinol stents for the treatment of severe iliac and femoral artery stenoses and occlusions: final results from a prospective 60 Prospective non randomised Stent type Iliac artery segment TASC Technical success rate 1yr 3yr 5yr CIA/EIA 99% 90.7% Bosiers et al 2007 Flemish experience using the Advanta V12 stentgraft for the treatment of iliac artery occlusive disease 91 Prospective non randomised CIA/EIA AD 100% 91% Sabri et al 2010 Outcomes of covered kissing stent placement compared with bare metal stent placement in the treatment of atherosclerotic occlusive disease at the aortic bifurcation Aorta/CIA AD 100% 92% 78% 92% 62% at 2 years Mwipatayi et al 2011, 2016 A comparison of covered vs bare expandable stents for the treatment of aortoiliac occlusive disease RCT Aorta/CIA/ EIA BD 100% 88.5% 73.9% 79.9%* 84.7% 74.7% 62.9% Grimme et al 2012 Humpheries et al 2014 Midterm outcome of balloonexpandable polyterafluoroethylenecovered stents in the treatment of iliac artery chronic occlusive disease Outcomes of covered versus baremetal balloonexpandable stents for aortoiliac occlusive disease CIA/EIA AD 99% 83.6% (91.4%) CIA/EIA AD 100% 85% (96%) 92% (99%) 79.7% (85.9%) At 2 years 72% (92%) 89% (98%) 63.4% (67.4%) At 4 years Tewksbury et al 2015 Outcomes of covered expandable stents for the treatment of TASC D aortoiliac occlusive lesions 30 Aorta/CIA D 100% 90% 79% At 2 years Piazza et al 2015 Outcomes of polytetrafluoroethylenecovered stent versus bare metal stent in the primary treatment of severe iliac artery obstructive lesions CIA/EIA C,D 99% 93% 80% At 2 years Kasemi et al 2016 Sevenyear approach evolution of the aortoiliac occlusive disease endovascular treatment 13 9 CIA/EIA D 100% 95.2% (combined) 90.5% (combined) Piazza et al 2017 Outcomes of self expanding PTFE covered stent versus bare metal stent for chronic iliac artery occlusion in matched cohorts using propensity score modelling ) + propensity score analyses CIA/EIA C,D 98% 88% 54%

11 First Author Title N Type of Stent type Iliac artery segment TASC Technical success rate 1yr 3yr 5yr Wiesinger et al 2005 PTFEcovered selfexpanding nitinol stents for the treatment of severe iliac and femoral artery stenoses and occlusions: final results from a prospective 60 Prospective non randomised CIA/EIA 99% 90.7% Bosiers et al 2007 Flemish experience using the Advanta V12 stentgraft for the treatment of iliac artery occlusive disease 91 Prospective non randomised CIA/EIA AD 100% 91% Sabri et al 2010 Outcomes of covered kissing stent placement compared with bare metal stent placement in the treatment of atherosclerotic occlusive disease at the aortic bifurcation Aorta/CI A AD 100% 92% 78% 92% 62% at 2 years Mwipatayi et al 2011, 2016 A comparison of covered vs bare expandable stents for the treatment of aortoiliac occlusive disease RCT Aorta/CIA /EIA BD 100% 88.5% 73.9% 79.9%* 84.7% 74.7% 62.9% Grimme et al 2012 Midterm outcome of balloonexpandable polyterafluoroethylenecovered stents in the treatment of iliac artery chronic occlusive disease 115 CIA/EIA AD 99% 83.6% (91.4%) 79.7% (85.9%) At 2 years 63.4% (67.4%) At 4 years Humpheries et al 2014 Outcomes of covered versus baremetal balloonexpandable stents for aortoiliac occlusive disease CIA/EIA AD 100% 85% (96%) 92% (99%) 72% (92%) 89% (98%) Tewksbury et al 2015 Outcomes of covered expandable stents for the treatment of TASC D aortoiliac occlusive lesions 30 Aorta/CIA D 100% 90% 79% At 2 years Piazza et al 2015 Outcomes of polytetrafluoroethylenecovered stent versus bare metal stent in the primary treatment of severe iliac artery obstructive lesions CIA/EIA C,D 99% 93% 80% At 2 years Kasemi et al 2016 Sevenyear approach evolution of the aortoiliac occlusive disease endovascular treatment 13 9 CIA/EIA D 100% 95.2% (combined) 90.5% (combined) Piazza et al 2017 Outcomes of self expanding PTFE covered stent versus bare metal stent for chronic iliac artery occlusion in matched cohorts using propensity score modelling (47 each group after propensity matching) + propensity score analyses CIA/EIA C,D 98% 88% 54%

12 First Author Title N Type of Stent type Iliac artery segment TASC Technical success rate 1yr 3yr 5yr Wiesinger et al 2005 PTFEcovered selfexpanding nitinol stents for the treatment of severe iliac and femoral artery stenoses and occlusions: final results from a prospective 60 Prospective non randomised CIA/EIA 99% 90.7% Bosiers et al 2007 Flemish experience using the Advanta V12 stentgraft for the treatment of iliac artery occlusive disease 91 Prospective non randomised CIA/EIA AD 100% 91% Sabri et al 2010 Outcomes of covered kissing stent placement compared with bare metal stent placement in the treatment of atherosclerotic occlusive disease at the aortic bifurcation Aorta/CIA AD 100% 92% 78% 92% 62% at 2 years Mwipatayi et al 2011, 2016 A comparison of covered vs bare expandable stents for the treatment of aortoiliac occlusive disease RCT Aorta/CI A/EIA BD 100% 88.5% 73.9% 79.9%* 84.7% 74.7% 62.9% Grimme et al 2012 Midterm outcome of balloonexpandable polyterafluoroethylenecovered stents in the treatment of iliac artery chronic occlusive disease 115 CIA/EIA AD 99% 83.6% (91.4%) 79.7% (85.9%) At 2 years 63.4% (67.4%) At 4 years Humpheries et al 2014 Outcomes of covered versus baremetal balloonexpandable stents for aortoiliac occlusive disease CIA/EIA AD 100% 85% (96%) 92% (99%) 72% (92%) 89% (98%) Tewksbury et al 2015 Outcomes of covered expandable stents for the treatment of TASC D aortoiliac occlusive lesions 30 Aorta/CIA D 100% 90% 79% At 2 years Piazza et al 2015 Outcomes of polytetrafluoroethylenecovered stent versus bare metal stent in the primary treatment of severe iliac artery obstructive lesions CIA/EIA C,D 99% 93% 80% At 2 years Kasemi et al 2016 Sevenyear approach evolution of the aortoiliac occlusive disease endovascular treatment 13 9 CIA/EIA D 100% 95.2% (combined) 90.5% (combined) Piazza et al 2017 Outcomes of self expanding PTFE covered stent versus bare metal stent for chronic iliac artery occlusion in matched cohorts using propensity score modelling (47 each group after propensity matching) + propensity score analyses CIA/EIA C,D 98% 88% 54%

13 First Author Title N Type of Stent type Iliac artery segment TASC Technical success rate 1yr 3yr 5yr Wiesinger et al 2005 PTFEcovered selfexpanding nitinol stents for the treatment of severe iliac and femoral artery stenoses and occlusions: final results from a prospective 60 Prospective non randomised CIA/EIA 99% 90.7% Bosiers et al 2007 Flemish experience using the Advanta V12 stentgraft for the treatment of iliac artery occlusive disease 91 Prospective non randomised CIA/EIA AD 100% 91% Sabri et al 2010 Outcomes of covered kissing stent placement compared with bare metal stent placement in the treatment of atherosclerotic occlusive disease at the aortic bifurcation Aorta/CIA AD 100% 92% 78% 92% 62% at 2 years Mwipatayi et al 2011, 2016 A comparison of covered vs bare expandable stents for the treatment of aortoiliac occlusive disease RCT Aorta/CIA /EIA BD 100% 88.5% 73.9% 79.9%* 84.7% 74.7% 62.9% Grimme et al 2012 Midterm outcome of balloonexpandable polyterafluoroethylenecovered stents in the treatment of iliac artery chronic occlusive disease 115 CIA/EIA AD 99% 83.6% (91.4%) 79.7% (85.9%) At 2 years 63.4% (67.4%) At 4 years Humpheries et al 2014 Outcomes of covered versus baremetal balloonexpandable stents for aortoiliac occlusive disease CIA/EIA AD 100% 85% (96%) 92% (99%) 72% (92%) 89% (98%) Tewksbury et al 2015 Outcomes of covered expandable stents for the treatment of TASC D aortoiliac occlusive lesions 30 Aorta/CIA D 100% 90% 79% At 2 years Piazza et al 2015 Outcomes of polytetrafluoroethylenecovered stent versus bare metal stent in the primary treatment of severe iliac artery obstructive lesions CIA/EIA C,D 99% 93% 80% At 2 years Kasemi et al 2016 Sevenyear approach evolution of the aortoiliac occlusive disease endovascular treatment 13 9 CIA/EIA D 100% 95.2% (combined) 90.5% (combined) Piazza et al 2017 Outcomes of self expanding PTFE covered stent versus bare metal stent for chronic iliac artery occlusion in matched cohorts using propensity score modelling (47 each group after propensity matching) + propensity score analyses CIA/EIA C,D 98% 88% 54%

14 First Author Title N Type of Stent type Iliac artery segment TASC Technical success rate 1yr 3yr 5yr Wiesinger et al 2005 PTFEcovered selfexpanding nitinol stents for the treatment of severe iliac and femoral artery stenoses and occlusions: final results from a prospective 60 Prospective non randomised CIA/EIA 99% 90.7% Bosiers et al 2007 Flemish experience using the Advanta V12 stentgraft for the treatment of iliac artery occlusive disease 91 Prospective non randomised CIA/EIA AD 100% 91% Sabri et al 2010 Outcomes of covered kissing stent placement compared with bare metal stent placement in the treatment of atherosclerotic occlusive disease at the aortic bifurcation Aorta/CIA AD 100% 92% 78% 92% 62% at 2 years Mwipatayi et al 2011, 2016 A comparison of covered vs bare expandable stents for the treatment of aortoiliac occlusive disease RCT Aorta/CIA /EIA BD 100% 88.5% 73.9% 79.9%* 84.7% 74.7% 62.9% Grimme et al 2012 Midterm outcome of balloonexpandable polyterafluoroethylenecovered stents in the treatment of iliac artery chronic occlusive disease 115 CIA/EIA AD 99% 83.6% (91.4%) 79.7% (85.9%) At 2 years 63.4% (67.4%) At 4 years Humpheries et al 2014 Outcomes of covered versus baremetal balloonexpandable stents for aortoiliac occlusive disease CIA/EIA AD 100% 85% (96%) 92% (99%) 72% (92%) 89% (98%) Tewksbury et al 2015 Outcomes of covered expandable stents for the treatment of TASC D aortoiliac occlusive lesions 30 Aorta/CIA D 100% 90% 79% At 2 years Piazza et al 2015 Outcomes of polytetrafluoroethylenecovered stent versus bare metal stent in the primary treatment of severe iliac artery obstructive lesions CIA/EIA C,D 99% 93% 80% At 2 years Kasemi et al 2016 Sevenyear approach evolution of the aortoiliac occlusive disease endovascular treatment 13 9 CIA/EIA D 100% 95.2% (combined) 90.5% (combined) Piazza et al 2017 Outcomes of self expanding PTFE covered stent versus bare metal stent for chronic iliac artery occlusion in matched cohorts using propensity score modelling (47 each group after propensity matching) + propensity score analyses CIA/EIA C,D 98% 88% 54%

15 BARE METAL STENT STUDIES First Author Title N Type of Stent type Iliac artery segment TASC Technical success rate 1yr 3yr 5yr Park et al 2005 Stent placement for chronic iliac arterial occlusive disease: the results of 10 years experience in a single instiution 249 CIA/EIA 98% 87% 83% Yilmaz et al 2006 Aortoiliac kissing stents: longterm results and analysis of risk factors affecting 68 CIA AC 100% 76% 63% 63% Leville et al 2006 Endovascular management of iliac artery occlusions: extending treatment to TransAtlantic InterSociety Consensus class C and D patients 92 CIA/EIA BD 95% 76% De Roeck et al 2006 Longterm results of primary stenting for long and complex iliac artery occlusions 38 CIA/EIA BD 97.4% 94% 89% 77% AbuRahama et al 2007 iliac stenting versus transluminal angioplasty with selective stenting 149 CIA/EIA AD 100% 98% 87% 77% Chang et al 2008 Longterm results of combined common femoral endarterectomy and iliac stenting/stent grafting for occlusive disease 193 CIA/EIA CD 98% 60% Carreira et al 2008 Longterm followup of Symphony nitinol stents in iliac arteriosclerosis obliterans 31 Prospective CIA/EIA 100% 83% 75% Gandini et al 2008 Percutaneous treatment in iliac artery occlusion: longterm results 138 CIA/EIA 99% 90% 85% Kashyap et al 2008 The management of severe aortoiliac occlusive disease: endovascular therapy rivals open reconstruction 127 CIA/EIA BD 100% 74% Koziumi et al CIA/EIA AD 100% 94% 88% 82% Higashuria et al 2009 Prevalence, factors and clinical impact of selfexpanding stent fractures following iliac artery stenting 216 CIA/EIA AD 95% 93% 91% Maurel et al 2009 Endovascular treatment of external iliac artery stenoses for claudication with systematic stenting 90 Prospective EIA AD 100% 97% 84%

16 First Author Title N Type of Stent type Iliac artery segment TASC Technical success rate 1yr 3yr 5yr Kondo et al 2010 stent placement for iliac artery chronic total occlusions 114 CIA/EIA 100% 8991% at 2 years Ozkan et al 2010 Technique, complication and longterm outcome for endovascular treatment of iliac artery occlusion 127 CIA/EIA BD 92% 63% Stockx et al 2010 Express LD vascular stent in the treatment of iliac artery lesions: 24 month results from the MELODIE trial 163 Prospective CIA/EIA AD 98% 89% 87.8% at 2 years Ichihashi et al 2011 Longterm outcomes for sytematic primary stent placement in complex iliac artery occlusive disease classified according to TASCII 533 CIA/EIA AD 99% 9095% 8891% 8388% Soga et al 2012 Contemporary outcomes after endovascular treatment for aortoiliac artery disease 2601 Aorta/CIA/ EIA AD 97.6% 92.5% 82.6% 77.5% Kordecki et al 2012 Assessment of effectiveness of endovascular treatment of common and external iliac artery stenosis/occlusion using selfexpanding Jaguar SM stents 95 Prospective CIA/EIA AD 100% 84% 76% at 2 years Bosiers et al 2013 BRAVISSIMO: 12month results from a large scale prospective trial 147 Prospective CIA/EIA AD 93.1% Clair et al CIA/EIA AD 98% 94.4% BechterHughl et al 2014 The influence of gender on rates after iliac artery stenting 404 CIA/EIA AD % % % % Burket et al 2016 Twelvemonth results of the nitinol astron stent in iliac artery lesions 161 Prospective CIA/EIA AC 95% 89.8% Krankenberg et al 2017 Selfexpanding versus balloonexpandable stents for iliac artery occlusive disease 660 Randomized prospective trial CIA/EIA AC % SE 94.5% BE 87.0%

17 First Author Title N Type of Stent type Iliac artery segment TASC Technical success rate 1yr 3yr 5yr Park et al 2005 Stent placement for chronic iliac arterial occlusive disease: the results of 10 years experience in a single instiution 249 CIA/EIA 98% 87% 83% Yilmaz et al 2006 Aortoiliac kissing stents: longterm results and analysis of risk factors affecting 68 CIA AC 100% 76% 63% 63% Leville et al 2006 Endovascular management of iliac artery occlusions: extending treatment to TransAtlantic InterSociety Consensus class C and D patients 92 CIA/EIA BD 95% 76% De Roeck et al 2006 Longterm results of primary stenting for long and complex iliac artery occlusions 38 CIA/EIA BD 97.4% 94% 89% 77% AbuRahama et al 2007 iliac stenting versus transluminal angioplasty with selective stenting 149 CIA/EIA AD 100% 98% 87% 77% Chang et al 2008 Longterm results of combined common femoral endarterectomy and iliac stenting/stent grafting for occlusive disease 193 CIA/EIA CD 98% 60% Carreira et al 2008 Longterm followup of Symphony nitinol stents in iliac arteriosclerosis obliterans 31 Prospective CIA/EIA 100% 83% 75% Gandini et al 2008 Percutaneous treatment in iliac artery occlusion: longterm results 138 CIA/EIA 99% 90% 85% Kashyap et al 2008 The management of severe aortoiliac occlusive disease: endovascular therapy rivals open reconstruction 127 CIA/EIA BD 100% 74% Koziumi et al CIA/EIA AD 94% 88% 82% Higashuria et al 2009 Prevalence, factors and clinical impact of selfexpanding stent fractures following iliac artery stenting 216 CIA/EIA AD 93% 91% Maurel et al 2009 Endovascular treatment of external iliac artery stenoses for claudication with systematic stenting 90 Prospective EIA AD 100% 97% 84%

18 First Author Title N Type of Stent type Iliac artery segment TASC Technical success rate 1yr 3yr 5yr Park et al 2005 Stent placement for chronic iliac arterial occlusive disease: the results of 10 years experience in a single instiution 249 CIA/EIA 98% 87% 83% Yilmaz et al 2006 Aortoiliac kissing stents: longterm results and analysis of risk factors affecting 68 CIA AC 100% 76% 63% 63% Leville et al 2006 Endovascular management of iliac artery occlusions: extending treatment to TransAtlantic InterSociety Consensus class C and D patients 92 CIA/EIA BD 95% 76% De Roeck et al 2006 Longterm results of primary stenting for long and complex iliac artery occlusions 38 CIA/EIA BD 97.4% 94% 89% 77% AbuRahama et al 2007 iliac stenting versus transluminal angioplasty with selective stenting 149 CIA/EIA AD 100% 98% 87% 77% Chang et al 2008 Longterm results of combined common femoral endarterectomy and iliac stenting/stent grafting for occlusive disease 193 CIA/EIA CD 98% 60% Carreira et al 2008 Longterm followup of Symphony nitinol stents in iliac arteriosclerosis obliterans 31 Prospective CIA/EIA 100% 83% 75% Gandini et al 2008 Percutaneous treatment in iliac artery occlusion: longterm results 138 CIA/EIA 99% 90% 85% Kashyap et al 2008 The management of severe aortoiliac occlusive disease: endovascular therapy rivals open reconstruction 127 CIA/EIA BD 100% 74% Koziumi et al CIA/EIA AD 94% 88% 82% Higashuria et al 2009 Prevalence, factors and clinical impact of selfexpanding stent fractures following iliac artery stenting 216 CIA/EIA AD 93% 91% Maurel et al 2009 Endovascular treatment of external iliac artery stenoses for claudication with systematic stenting 90 Prospective EIA AD 100% 97% 84%

19 First Author Title N Type of Stent type Iliac artery segment TASC Technical success rate 1yr 3yr 5yr Kondo et al 2010 stent placement for iliac artery chronic total occlusions 114 CIA/EIA 100% 8991% at 2 years Ozkan et al 2010 Technique, complication and longterm outcome for endovascular treatment of iliac artery occlusion 127 CIA/EIA BD 92% 63% Stockx et al 2010 Express LD vascular stent in the treatment of iliac artery lesions: 24 month results from the MELODIE trial 163 Prospective CIA/EIA AD 98% 89% 87.8% at 2 years Ichihashi et al 2011 Longterm outcomes for sytematic primary stent placement in complex iliac artery occlusive disease classified according to TASCII 533 CIA/EIA AD 99% 9095% 8891% 8388% Soga et al 2012 Contemporary outcomes after endovascular treatment for aortoiliac artery disease 2601 Aorta/CIA/ EIA AD 97.6% 92.5% 82.6% 77.5% Kordecki et al 2012 Assessment of effectiveness of endovascular treatment of common and external iliac artery stenosis/occlusion using selfexpanding Jaguar SM stents 95 Prospective CIA/EIA AD 100% 84% 76% at 2 years Bosiers et al 2013 BRAVISSIMO: 12month results from a large scale prospective trial 147 Prospective CIA/EIA AD 93.1% Clair et al CIA/EIA AD 98% 94.4% BechterHughl et al 2014 The influence of gender on rates after iliac artery stenting 404 CIA/EIA AD % % % % Burket et al 2016 Twelvemonth results of the nitinol astron stent in iliac artery lesions 161 Prospective CIA/EIA AC 95% 89.8% Krankenberg et al 2017 Selfexpanding versus balloonexpandable stents for iliac artery occlusive disease 660 Randomized prospective trial CIA/EIA AC % SE 94.5% BE 87.0%

20 CERAB Studies First Author Title N Type of Stent type Iliac artery segment TASC Technical success rate 1yr 3yr 5yr Grimme et al 2015 First results of the covered endovascular reconstruction of the aortic bifurcation (CERAB) technique for aortoiliac occlusive disease 103 CERAB EIA/IIA BD 95.1% 87.3% 82.3% at 2 years Taeymans et al 2018 Threeyear outcome of the covered endovascular reconstruction of the aortic bifurcation techniques for aortoiliac occlusive disease 130 CERAB EIA/IIA AD 97% 86% 82%

21 Comparison of Six Studies AortoIliac Occlusive Disease First Author Type of N Indication for treatment Gandini Sabri Mwipatayi RCT COBEST: The Covered vs Balloon Expandable Trial Total: 150 : 150 Total: 54 : 26 : 28 Total: 168 : 83 : 85 Claudication 81% 75% CLI 35% 17% Claudication 45% 60% Outcome Measure Rate of binary restenosis Outcome Measure Stent Patency Rate 1 yr: 2 yr: 1 yr: 92% 2 yr: 92% 1 yr: 95.1% 2 yr: 82.1% 5 yr: 74.7% 90% 85% 78% 62% 73.9% 70.9% 62.5% Points of Interest Stents deployed as well above aortic bifurcation Stents deployed as well above aortic bifurcation Stents deployed as well above aortic bifurcation Grimme Prospective Total: 115 : % Claud 17% CLI 1 yr: 88.7% 2 yr: 86.4% 5 yr: 71.5% Humpheries Total: 254 : 64 : 190 CLI 14% 35% Claudication 73% 58% Patency, Assisted PP 1 yr: 85% 3 yr: 72% 92% 89% Krakenberg Randomized Prospective Trial Total: 660 : 660 BE: 320 SE: % Claud 2% CLI Cumulative incidence of binary restenosis 1 yr: 2 yr: SE: 94.5% BE: 87.0%

22 First Author Type of N Indication for treatment Gandini Sabri Mwipatayi RCT COBEST: The Covered vs Balloon Expandable Trial Total: 150 : 150 Total: 54 : 26 : 28 Total: 168 : 83 : 85 Comparison of Six Studies Gender Claudication 81% 75% CLI 35% 17% Claudication 45% 60% Outcome Measure Rate of binary restenosis Outcome Measure Stent Patency Rate 1 yr: 2 yr: 1 yr: 92% 2 yr: 92% 1 yr: 95.1% 2 yr: 82.1% 5 yr: 74.7% 90% 85% 78% 62% 73.9% 70.9% 62.5% Points of Interest Stents deployed as well above aortic bifurcation Stents deployed as well above aortic bifurcation Gender no difference Stents deployed as well above aortic bifurcation Grimme Prospective Total: 115 : % Claud 17% CLI 1 yr: 88.7% 2 yr: 86.4% 5 yr: 71.5% Humpheries Total: 254 : 64 : 190 CLI 14% 35% Claudication 73% 58% Patency, Assisted PP 1 yr: 85% 3 yr: 72% 92% 89% Gender no difference Krakenberg Randomized Prospective Trial Total: 660 : 660 BE: 320 SE: % Claud 2% CLI Cumulative incidence of binary restenosis 1 yr: 2 yr: SE: 94.5% BE: 87.0%

23 First Author Type of N Indication for treatment Gandini Sabri Mwipatayi RCT COBEST: The Covered vs Balloon Expandable Trial Total: 150 : 150 Total: 54 : 26 : 28 Total: 168 : 83 : 85 Comparison of Six Studies DAPT Claudication 81% 75% CLI 35% 17% Claudication 45% 60% Outcome Measure Rate of binary restenosis Outcome Measure Stent Patency Rate 1 yr: 2 yr: 1 yr: 92% 2 yr: 92% 1 yr: 95.1% 2 yr: 82.1% 5 yr: 74.7% 90% 85% 78% 62% 73.9% 70.9% 62.5% Points of Interest Stents deployed as well above aortic bifurcation DAPT Stents deployed as well above aortic bifurcation Gender no difference DAPT Stents deployed as well above aortic bifurcation Gender no difference!! DAPT Grimme Prospective Total: 115 : % Claud 17% CLI 1 yr: 88.7% 2 yr: 86.4% 5 yr: 71.5% Humpheries Total: 254 : 64 : 190 CLI 14% 35% Claudication 73% 58% Patency, Assisted PP 1 yr: 85% 3 yr: 72% 92% 89% Gender no difference DAPT Krakenberg Randomized Prospective Trial Total: 660 : 660 BE: 320 SE: % Claud 2% CLI Cumulative incidence of binary restenosis 1 yr: 2 yr: SE: 94.5% BE: 87.0% DAPT

24 Comparison of Six Studies TASC Classification First Author Type of N Indication for treatment Gandini Sabri Mwipatayi RCT COBEST: The Covered vs Balloon Expandable Trial Total: 150 : 150 Total: 54 : 26 : 28 Total: 168 : 83 : 85 Claudication 81% 75% CLI 35% 17% Claudication 45% 60% Outcome Measure Rate of binary restenosis Outcome Measure Stent Patency Rate 1 yr: 2 yr: 1 yr: 92% 2 yr: 92% 1 yr: 95.1% 2 yr: 82.1% 5 yr: 74.7% 90% 85% 78% 62% 73.9% 70.9% 62.5% Points of Interest Stents deployed as well above aortic bifurcation DAPT TASC: less complex lesions Stents deployed as well above aortic bifurcation Gender no difference DAPT TASC AD Stents deployed as well above aortic bifurcation DAPT TASC: AD, included subgroup analysis TASC C/D Grimme Prospective Total: 115 : % Claud 17% CLI 1 yr: 88.7% 2 yr: 86.4% 5 yr: 71.5% TASC: AD Humpheries Total: 254 : 64 : 190 CLI 14% 35% Claudication 73% 58% Patency, Assisted PP 1 yr: 85% 3 yr: 72% 92% 89% Gender no difference DAPT TASC: few complex lesions Krakenberg Randomized Prospective Trial Total: 660 : 660 BE: 320 SE: % Claud 2% CLI Cumulative incidence of binary restenosis 1 yr: 2 yr: SE: 94.5% BE: 87.0% DAPT TASC: less complex lesions

25 First Author Type of N Indication for treatment Gandini Sabri Mwipatayi RCT COBEST: The Covered vs Balloon Expandable Trial Total: 150 : 150 Total: 54 : 26 : 28 Total: 168 : 83 : 85 Comparison of Six Studies Impact of EIA Claudication 81% 75% CLI 35% 17% Claudication 45% 60% Outcome Measure Outcome Measure Patency Rate 1 yr: 2 yr: 1 yr: 92% 2 yr: 92% Rate of binary restenosis Stent 1 yr: 95.1% 2 yr: 82.1% 5 yr: 74.7% 90% 85% 78% 62% 73.9% 70.9% 62.5% Points of Interest Stents deployed as well above aortic bifurcation DAPT TASC: less complex lesions Impact of EIA Stents deployed as well above aortic bifurcation Gender no difference DAPT TASC AD Impact of EIA Stents deployed as well above aortic bifurcation DAPT TASC: AD, included subgroup analysis TASC C/D Grimme Prospective Total: 115 : % Claud 17% CLI 1 yr: 88.7% 2 yr: 86.4% 5 yr: 71.5% TASC: AD Humpheries Total: 254 : 64 : 190 CLI 14% 35% Claudication 73% 58% Patency, Assisted PP 1 yr: 85% 3 yr: 72% 92% 89% Gender no difference DAPT TASC: few complex lesions Impact of EIA Krakenberg Randomized Prospective Trial Total: 660 : 660 BE: 320 SE: % Claud 2% CLI Cumulative incidence of binary restenosis 1 yr: 2 yr: SE: 94.5% BE: 87.0% DAPT TASC: less complex lesions

26 First Author Type of N Gandini Sabri Mwipatayi Grimme Humpheries Krakenberg RCT COBEST: The Covered vs Balloon Expandable Trial Prospective Randomized Prospective Trial Total: 150 : 150 Total: 54 : 26 : 28 Total: 168 : 83 : 85 Total: 115 : 115 Total: 254 : 64 : 190 Total: 660 : 660 BE: 320 SE: 340 Comparison of Six Studies CIA Stent Size ( 7 mm) Indication for treatment Claudication 81% 75% CLI 35% 17% Claudication 45% / 60% 77% Claud 17% CLI CLI 14% 35% Claudication 73% 58% 53% Claud 2% CLI Outcome Measure Rate of binary restenosis Patency, Assisted PP Cumulative incidence of binary restenosis Outcome Measure Stent Patency Patency Patency Patency Rate 1 yr: 2 yr: 1 yr: 92% 2 yr: 92% 1 yr: 95.1% 2 yr: 82.1% 5 yr: 74.7% 1 yr: 88.7% 2 yr: 86.4% 5 yr: 71.5% 1 yr: 85% 3 yr: 72% 1 yr: 2 yr: 90% 85% 78% 62% 73.9% 70.9% 62.5% 92% 89% SE: 94.5% BE: 87.0% Points of Interest Stents deployed as well above aortic bifurcation DAPT TASC: less complex lesions Impact of EIA Stents deployed as well above aortic bifurcation Gender no difference DAPT TASC: AD Impact of EIA Small stent size Stents deployed as well above aortic bifurcation DAPT TASC: AD, included subgroup analysis TASC C/D Small stent size TASC: AD Gender no difference DAPT TASC: few complex lesions Impact of EIA DAPT TASC: less complex lesions

27 Sabri S, Choudri A, Orgera G et al. Outcomes of covered kissing stent placement compared with bare metal stent placement in the treatment of atherosclerotic occlusive disease at the aortic bifurcation. review 54 patients: covered stents (n=26) vs (n=28) Technical success 100% in both groups Major complications: 3 in and 2 in 1 year: 92% vs 78% 2 year: 92% vs 62% (p=0.023) CONCLUSION: The use of covered balloonexpandable kissing stents for atherosclerotic aortic bifurcation occlusive disease provides superior at 2 years as compared with balloonexpandable stents LIMITATIONS: nonrandomised, single institution, retrospective Why do occlude at a higher rate when used in the kissing stent configuration compared with use in the iliac arteries? J Vasc Interv Radiol 2010; 21:

28 Humpheries MD, Armstrong E, Laird J et al. Outcomes of covered versus baremetal ballon expandable stents for aortoiliac occlusive disease. 254 iliac arteries: covered stents (n=37) vs (n=125) Technical success 100% in both groups 1 year: 85% vs 92% 3 year: 72% vs 89% CONCLUSION: had better compared with for treatment of AIOD. LIMITATIONS: nonrandomised, single institution, retrospective, larger number of patients in group J Vasc Surg 2014; 60:

29 COBEST: The Covered vs Balloonexpandable Trial Shortterm Results Mwipatayi BP, Thomas S, Wong J et al. A comparison of covered vs bare expandable stents for the treatment of aortoiliac occlusive disease. Randomised controlled trial 125 patients 168 iliac arteries: covered stents (n=83) vs (n=85) Technical success 100% in both groups 1 year: 95.1% vs 73.9% CONCLUSION: COBEST demonstrates and produce similar and acceptable results for TASC B lesions. However, perform better for TASC C & D lesions in terms of and clinical outcome. LIMITATIONS: different stents, fewer TASC D lesions treated with, DUS as principal imaging tool J Vasc Surg 2011; 54:

30 COBEST: Baseline Lesion Characteristics V12 stent (n=83) Bare Stent (n=85) P value PreOp RestingABI (side of lesion) mean ± SEM 0.65± ± PreOp Duplex Scan 0.39 % Performed (n) 74.7 (62) 76.5 (65) >50% Stenosis Occlusion PreOp Angiogram 0.03 % Performed (n) 80.7 (67) 85.9 (73) TASC B TASC C TASC D Runoff 0.15 % Performed (n) 89.1 (74) 85.9 (73)

31 COBEST: KM Curve of Adjusted Patency PP = 74.7% PP = 62.9% Time (Months) Advanta V12 Stent (n. at risk) Standard Error (%) (n. at risk) Standard Error (%)

32 COBEST: KM Curve of Adjusted Patency for different TASC lesions KM Curve of Adjusted Patency for TASC B lesion KM Curve of Adjusted Patency for TASC C/D Lesion

33 COBEST: Factors independently affecting primary based on multivariate logistic regression models Variable Coefficients B SE Wald test HR (95% CI) P value Type of stent used (Advanta V12 vs. ) ( ) Rutherford stratification ( ) Variable AUS (95% CI) SE P value ROC ANALYSES OF FACTORS AFFECTING PRIMARY PATENCY Type of stent used (Advanta V12 vs. ) ( ) Rutherford stratification ( )

34 COBEST: The Covered vs Balloonexpandable Trial Longterm Results Mwipatayi BP, Sharma S, Daneshmand A et al. Durability of the balloonexpandable covered versus baremetal stents in the Covered versus Balloon Expandable Stent Trial for the treatment of aortoiliac occlusive disease. Randomised controlled trial For 5 year analysis 77 patients. 119 iliac arteries: covered stents (n=62) vs (n=57) 2 year: 82.1% vs 70.9% 4 year: 79.9% vs 63.0% 5 year: 74.7% vs 62.5% CONCLUSION: has an enduring advantage over both in the short and long term. Patients who receive require fewer revascularisation procedures. Choice of stent did not affect the rate of major limb amputations. LIMITATIONS: different stents, not power for subgroup analysis (assumption), DUS as principal imaging tool J Vasc Surg 2016; 64: 8394.

35 : SelfExpanding (SE) vs BalloonExpanding (BE) A Game Changer Krakenberg H, Zeller T, Ingwersen M et al. Selfexpanding versus balloonexpandable stents for iliac artery occlusive disease.. Prospective, multicenter, blockrandomized, nonblinded trial 660 patients 660 iliac arteries: SE (n=340) vs BE (n=320) Inclusion Criteria: Rutherford 1 to 4 70% stenosis or occlusion by DUS common or external iliac lesion of 10 to 200mm in length, not extending into the aorta or common femoral artery Cumulative incidence of binary restenosis 1 year: 6.1% SE vs 14.9% BE p = year: 94.5% SE vs 87.0% BE p = Freedom from TLR 1 year: 97.2% SE vs 93.6% BE p = J Am Coll Cardiol Intv 2017; 10:

36 : SelfExpanding (SE) vs BalloonExpanding (BE) Figure: Association of multiple variables with the incidence of binary restenosis at 12 months, based on logistic regression model CONCLUSION: treatment of AIOD with SE led to incidence of restenosis at 12 months and was therefore provided superior primary than treatment with BE LIMITATIONS: nonblinded, no independent core lab. So, the interpretation of angiographic findings and DUS was left to the investigators, introducing a bias in result interpretation.

37 CONCLUSIONS There are still many gaps in the area of AIOD treatment that need to be examined. All stents do not function the same way and the design of the stent can impact clinical outcomes Due to differences in stent design, covering technology and graft material, each covered stent requires proof of clinical efficacy The COBEST Trial provides clear clinical data of the superiority of Advanta V12 over bare metal stents for TASC C/D lesions (not enough powered!!!) However there is room for further studies as kissing stent vs CERAB for severe aortoiliac occlusive disease

38 Take home message. AIOD TASC A/B TASC C/D Aortic Disease + Iliac Angioplasty +/ DCB CERAB vs Kissing Stenting Dissection +/

39 Thank You

40 THE 15YEAR EVOLUTION OF COVERED STENT: CHOOSING THE BEST STENT FOR AORTOILIAC ARTERY DISEASE. DOES COBEST PRESENT STRONG EVIDENCE FOR V12 AS CHOICE OF COVERED STENT? B. PATRICE MWIPATAYI MMed, MClinED, F, FRA Clinical Associate Professor Vascular Surgery University of Western Australia, Perth