D COBEST PRESENT STRONG EVIDENCE FOR V12 AS CHOICE OF ... · Seven-year approach evolution of the aortoiliac occlusive disease endovascular treatment CS 13 BMS 9 Retrospective Study

THE 15-YEAR 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, FCS, FRACS

Clinical Associate Professor – Vascular Surgery

Biostatistic for PIVAR

University of Western Australia, Perth

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

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 BMS

i. High technical success rates

ii. Low morbidity

iii. High rates of patency for TASC A / TASC B

iv. Improvement in functional outcome for the individual patient

Advanced stenting: CERAB +/- Chimneys

i. High rates of patency for TASC A / TASC B

ii. Improvement in functional outcome for the individual patient

Non-intervention treatment: comprehensive BMT (DAPT / lipid Rx / others)

What is the evidence for Iliac Stenting?

•Registries

•Retrospective 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

study by forcing cohorts to be more alike

•Randomized controlled trials: are still the gold standard

•Meta-analysis and systematic review: will boost RCT results.

Surgical vs Endovascular Treatments

PTA vs Surgery

• 157 iliac lesions treated with either PTA or surgery

Wilson et al J Vasc Surg 1989; 9: 1-9

• No significant difference between PTA & surgery for death, amputations or loss of patency at 3 years

• No significant difference in the hemodynamic (ABI) result of a successful procedure between the 2 groups

3 year Follow-up Data

Bar graph of the 3-year event -free survival of PTA Vs surgery for iliac lesions

Baseline Post-treatment 3 year

PTA 0.50 ± 0.01 0.78 ± 0.04 0.80 ± 0.07

Surgery 0.50 ± 0.02 0.82 ± 0.03 0.78 ± 0.05

Ankle Brachial Index in Randomized Iliac Lesions

Conclusion: PTA had similar early and long-term results

compared with bypass surgery

Wilson et al J Vasc Surg 1989; 9: 1-9

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

Systematic / Meta-analysis Review

• Bosch 1997: meta-analysis of studies between 1990-1997: Stent placement lowered risk of long term failure by 39%.

• Wei Ye 2011: Early and late outcomes of percutaneous treatment of TransAtlantic Inter-Society Consensus class C and D

aorto-iliac lesions, meta-analysis review. This study demonstrates that outcomes of endovascular treatment for

TASC C and TASC D aortoiliac lesions were acceptable with a better patency rate for primary stenting compared

with selective stenting.

• Bekken JA 2018, (J Cardiovasc Surg (Torino). 2018 Feb;59(1):14-25). The use of covered stents in aortoiliac obstructions:

a systematic review and meta-analysis. High-quality 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 patency rates (due

to heterogeneity of TASC data reporting in the different publications).

• We are conducting a comprehensive Meta-analysis review off relevant publications on AIOD: 2007 – 2019 (The first

Advanta V12 stent was implanted in 2003 - 15 years of experience)

Meta analysis Methodology / Results

Records identified through database searchingPubMed, Embase,

PsychINFO, Medline(n = 3518)

Additional records identified through other sources

- Grey literature, cross referencing(n = 20)

Records after duplicates removed(n = 2077)

Records screened(n = 83)

Records excluded(n = 27)

Full-text articles assessed for eligibility

(n = 56)

Full-text articles excluded with reasons

(n = 21)

Studies included in the final review on iliac

artery stenting(n = 35)

FINAL REVIEW OF ALL STUDIES (N ≤ 16)

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

First Author Title N Type of studyStent type

Iliac artery

segmentTASC

Technicalsuccess

rate1yr patency 3yr patency

5yrpatency

Wiesinger et al 2005

PTFE-covered self-expanding nitinol stents for the treatment of severe iliac and femoral artery stenoses and occlusions: final results from a prospective study

60Prospective non

randomisedCS CIA/EIA n/a 99% 90.7% n/a n/a

Bosiers et al 2007

Flemish experience using the Advanta V12 stent-graft for the treatment of iliac artery occlusive disease

91Prospective non

randomisedCS CIA/EIA A-D 100% 91% n/a n/a

Sabri et al 2010Outcomes of covered kissing stent placement compared with bare metal stent placement in the treatment of atherosclerotic occlusive disease at the aortic bifurcation

26 CS

28 BMS

Retrospective

Study

CS

BMSAorta/CIA A-D 100%

CS 92%

BMS 78%

CS 92%

BMS 62%

at 2 years

n/a

Mwipatayi et al 2011, 2016

A comparison of covered vs bare expandable stents for the treatment of aortoiliac occlusive disease

CS 83

BMS 85RCT

CS

BMS

Aorta/CIA/

EIAB-D 100%

CS 88.5%

BMS 73.9%

CS 79.9%*

BMS 84.7%

CS 74.7%

BMS 62.9%

Grimme et al 2012

Midterm outcome of balloon-expandable polyterafluoroethylene-covered stents in the treatment of iliac artery chronic occlusive disease

115Retrospective

StudyCS CIA/EIA A-D 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 bare-metal balloon-expandable stents for aortoiliac occlusive disease

CS 64

BMS 190

Retrospective

Study

CS

BMSCIA/EIA A-D 100%

CS 85% (96%)

BMS 92%

(99%)

CS 72%

(92%)

BMS 89%

(98%)

n/a

Tewksbury et al 2015

Outcomes of covered expandable stents for the treatment of TASC D aorto-iliac occlusive lesions

30Retrospective

StudyCS Aorta/CIA D 100% 90%

79%

At 2 yearsn/a

Piazza et al 2015Outcomes of polytetrafluoroethylene-covered stent versus bare metal stent in the primary treatment of severe iliac artery obstructive lesions

CS 82

BMS 85

Retrospective

Study

CS

BMSCIA/EIA C,D 99% n/a

CS 93%

BMS 80%

At 2 years

n/a

Kasemi et al 2016

Seven-year approach evolution of the aortoiliac occlusive disease endovascular treatment

CS 13

BMS 9

Retrospective

Study

CS

BMSCIA/EIA D 100%

95.2%(combined)

90.5%(combined)

n/a

Piazza et al 2017Outcomes of self expanding PTFE covered stent versus bare metal stent for chronic iliac artery occlusion in matched cohorts using propensity score modelling

CS 78

BMS 50)

Retrospective

Study +

propensity score

analyses

CS


CS 88%

BMS 54%n/a

COVERED STENT STUDIES


Iliac artery

segmentTASC

Technicalsuccess


5yrpatency



60Prospective non


Bosiers et al 2007


91Prospective non


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

26 CS

28 BMS

Retrospective

Study

CS

BMS

Aorta/CI

AA-D 100%

CS 92%

BMS 78%

CS 92%

BMS 62%

at 2 years

n/a

Mwipatayi et al 2011, 2016

A comparison of covered vs bare expandable stents for the treatment of aortoiliac occlusive disease

CS 83

BMS 85RCT

CS

BMS

Aorta/CIA

/EIAB-D 100%

CS 88.5%

BMS 73.9%

CS 79.9%*

BMS 84.7%

CS 74.7%

BMS 62.9%

Grimme et al 2012


115Retrospective


79.7%

(85.9%)

At 2 years

63.4%

(67.4%)

At 4 years



CS 64

BMS 190

Retrospective

Study

CS

BMSCIA/EIA A-D 100%

CS 85% (96%)

BMS 92%

(99%)

CS 72%

(92%)

BMS 89%

(98%)

n/a



30Retrospective


79%

At 2 yearsn/a

Piazza et al 2015

Outcomes of polytetrafluoroethylene-covered stent versus bare metal stent in the primary treatment of severe iliac artery obstructive lesions

CS 82

BMS 85

Retrospective

Study

CS


CS 93%

BMS 80%

At 2 years

n/a

Kasemi et al 2016


CS 13

BMS 9

Retrospective

Study

CS

BMSCIA/EIA D 100%

95.2%(combined)

90.5%(combined)

n/a

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

CS 78

BMS 50

(47 each

group after

propensity

matching)

Retrospective

Study +

propensity score

analyses

CS


CS 88%

BMS 54%n/a


Iliac artery

segmentTASC

Technicalsuccess


5yrpatency



60Prospective non


Bosiers et al 2007


91Prospective non


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

26 CS

28 BMS

Retrospective

Study

CS


CS 92%

BMS 78%

CS 92%

BMS 62%

at 2 years

n/a

Mwipatayi et

al 2011, 2016

A comparison of covered vs bare expandable stents for

the treatment of aortoiliac occlusive disease

CS 83

BMS 85RCT

CS

BMS

Aorta/CI

A/EIAB-D 100%

CS 88.5%

BMS 73.9%

CS 79.9%*

BMS

84.7%

CS 74.7%

BMS

62.9%

Grimme et al 2012


115Retrospective


79.7%

(85.9%)

At 2 years

63.4%

(67.4%)

At 4 years



CS 64

BMS 190

Retrospective

Study

CS

BMSCIA/EIA A-D 100%

CS 85% (96%)

BMS 92%

(99%)

CS 72%

(92%)

BMS 89%

(98%)

n/a



30Retrospective


79%

At 2 yearsn/a

Piazza et al 2015


CS 82

BMS 85

Retrospective

Study

CS


CS 93%

BMS 80%

At 2 years

n/a

Kasemi et al 2016


CS 13

BMS 9

Retrospective

Study

CS

BMSCIA/EIA D 100%

95.2%(combined)

90.5%(combined)

n/a

Piazza et al 2017


CS 78

BMS 50

(47 each

group after

propensity

matching)

Retrospective

Study +

propensity score

analyses

CS


CS 88%

BMS 54%n/a


Iliac artery

segmentTASC

Technicalsuccess


5yrpatency



60Prospective non


Bosiers et al 2007


91Prospective non


Sabri et al 2010




26 CS

28 BMS

Retrospective

Study

CS


CS 92%

BMS 78%

CS 92%

BMS 62%

at 2 years

n/a

Mwipatayi et al

2011, 2016

A comparison of covered vs bare expandable stents for the treatment

of aortoiliac occlusive disease

CS 83

BMS 85RCT

CS

BMS

Aorta/CIA

/EIAB-D 100%

CS 88.5%

BMS 73.9%

CS 79.9%*

BMS 84.7%

CS 74.7%

BMS 62.9%

Grimme et al

2012

Midterm outcome of balloon-expandable

polyterafluoroethylene-covered stents in the treatment

of iliac artery chronic occlusive disease

115Retrospective

StudyCS CIA/EIA A-D 99%

83.6%

(91.4%)

79.7%

(85.9%)

At 2 years

63.4%

(67.4%)

At 4 years



CS 64

BMS 190

Retrospective

Study

CS

BMSCIA/EIA A-D 100%

CS 85% (96%)

BMS 92%

(99%)

CS 72%

(92%)

BMS 89%

(98%)

n/a



30Retrospective


79%

At 2 yearsn/a

Piazza et al 2015


CS 82

BMS 85

Retrospective

Study

CS


CS 93%

BMS 80%

At 2 years

n/a

Kasemi et al 2016


CS 13

BMS 9

Retrospective

Study

CS

BMSCIA/EIA D 100%

95.2%(combined)

90.5%(combined)

n/a

Piazza et al 2017


CS 78

BMS 50

(47 each

group after

propensity

matching)

Retrospective

Study +

propensity score

analyses

CS


CS 88%

BMS 54%n/a


Iliac artery

segmentTASC

Technicalsuccess


5yrpatency



60Prospective non


Bosiers et al 2007


91Prospective non


Sabri et al 2010




26 CS

28 BMS

Retrospective

Study

CS


CS 92%

BMS 78%

CS 92%

BMS 62%

at 2 years

n/a

Mwipatayi et al

2011, 2016

A comparison of covered vs bare expandable stents for the treatment

of aortoiliac occlusive disease

CS 83

BMS 85RCT

CS

BMS

Aorta/CIA

/EIAB-D 100%

CS 88.5%

BMS 73.9%

CS 79.9%*

BMS 84.7%

CS 74.7%

BMS 62.9%

Grimme et al

2012

Midterm outcome of balloon-expandable polyterafluoroethylene-

covered stents in the treatment of iliac artery chronic occlusive

disease

115Retrospective


79.7%

(85.9%)

At 2 years

63.4%

(67.4%)

At 4 years

Humpheries

et al 2014

Outcomes of covered versus bare-metal balloon-

expandable stents for aortoiliac occlusive disease

CS 64

BMS

190

Retrospective

Study

CS

BMSCIA/EIA A-D 100%

CS 85%

(96%)

BMS 92%

(99%)

CS 72%

(92%)

BMS 89%

(98%)

n/a



30Retrospective


79%

At 2 yearsn/a

Piazza et al 2015


CS 82

BMS 85

Retrospective

Study

CS


CS 93%

BMS 80%

At 2 years

n/a

Kasemi et al 2016


CS 13

BMS 9

Retrospective

Study

CS

BMSCIA/EIA D 100%

95.2%(combined)

90.5%(combined)

n/a

Piazza et al 2017


CS 78

BMS 50

(47 each

group after

propensity

matching)

Retrospective

Study +

propensity score

analyses

CS


CS 88%

BMS 54%n/a


Iliac artery

segmentTASC

Technicalsuccess


5yrpatency

Park et al 2005Stent placement for chronic iliac arterial occlusive disease: the results of 10 years experience in a single instiution

249Retrospective

studyBMS CIA/EIA n/a 98% n/a 87% 83%

Yilmaz et al 2006Aortoiliac kissing stents: long-term results and analysis of risk factors affecting patency

68Retrospective

studyBMS CIA A-C 100% 76% 63% 63%

Leville et al 2006Endovascular management of iliac artery occlusions: extending treatment to TransAtlantic Inter-Society Consensus class C and D patients

92Retrospective

studyBMS CIA/EIA B-D 95% n/a 76% n/a

De Roeck et al 2006

Long-term results of primary stenting for long and complex iliac artery occlusions

38Retrospective

studyBMS CIA/EIA B-D 97.4% 94% 89% 77%

AbuRahama et al 2007

Primary iliac stenting versus transluminal angioplasty with selectivestenting

149Retrospective

studyBMS CIA/EIA A-D 100% 98% 87% 77%

Chang et al 2008Long-term results of combined common femoral endarterectomy and iliac stenting/stent grafting for occlusive disease

193Retrospective

studyBMS CIA/EIA C-D 98% n/a n/a 60%

Carreira et al 2008

Long-term follow-up of Symphony nitinol stents in iliac arteriosclerosis obliterans

31 Prospective study BMS CIA/EIA n/a 100% n/a 83% 75%

Gandini et al 2008

Percutaneous treatment in iliac artery occlusion: long-term results 138Retrospective


Kashyap et al 2008

The management of severe aortoiliac occlusive disease: endovascular therapy rivals open reconstruction

127Retrospective


Koziumi et al 2009

296Retrospective


Higashuria et al 2009

Prevalence, factors and clinical impact of self-expanding stent fractures following iliac artery stenting

216Retrospective

studyBMS CIA/EIA A-D 95% n/a 93% 91%

Maurel et al 2009

Endovascular treatment of external iliac artery stenoses for claudication with systematic stenting

90 Prospective study BMS EIA A-D 100% 97% 84% n/a

BARE METAL STENT STUDIES


Iliac artery

segmentTASC

Technicalsuccess


5yrpatency

Kondo et al 2010 Primary stent placement for iliac artery chronic total occlusions 114Retrospective

studyBMS CIA/EIA n/a 100% n/a

89-91%

at 2 yearsn/a

Ozkan et al 2010Technique, complication and long-term outcome for endovascular treatment of iliac artery occlusion

127Retrospective

studyBMS CIA/EIA B-D 92% n/a n/a 63%

Stockx et al 2010Express LD vascular stent in the treatment of iliac artery lesions: 24-month results from the MELODIE trial

163 Prospective study BMS CIA/EIA A-D 98% 89%87.8%

at 2 yearsn/a

Ichihashi et al 2011

Long-term outcomes for sytematic primary stent placement in complex iliac artery occlusive disease classified according to TASC-II

533Retrospective

studyBMS CIA/EIA A-D 99% 90-95% 88-91% 83-88%

Soga et al 2012Contemporary outcomes after endovascular treatment for aorto-iliac artery disease

2601Retrospective

studyBMS

Aorta/CIA/

EIAA-D 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 self-expanding Jaguar SM stents

95 Prospective study BMS CIA/EIA A-D 100% 84%76%

at 2 yearsn/a

Bosiers et al 2013

BRAVISSIMO: 12-month results from a large scale prospective trial 147 Prospective study BMS CIA/EIA A-D n/a 93.1% n/a n/a

Clair et al 2014 125Retrospective

studyBMS CIA/EIA A-D 98% 94.4% n/a n/a

Bechter-Hughl et al 2014

The influence of gender on patency rates after iliac artery stenting 404Retrospective

studyBMS CIA/EIA A-D

97.7 –

99.3%89.9-90.3% 71.5-77.2% 60.2-63.6%

Burket et al 2016 Twelve-month results of the nitinol astron stent in iliac artery lesions 161 Prospective study BMS CIA/EIA A-C 95% 89.8% n/a n/a

Krankenberg et al 2017

Self-expanding versus balloon-expandable stents for iliac artery occlusive disease

660Randomized

prospective trialBMS CIA/EIA A-C

96.5 -

98.4%

SE 94.5%

BE 87.0%n/a n/a


Iliac artery

segmentTASC

Technicalsuccess


5yrpatency


249Retrospective


Yilmaz et al 2006

Aortoiliac kissing stents: long-term results and analysis of risk factors affecting patency

68Retrospective

studyBMS CIA A-C 100% 76% 63% 63%

Leville et al 2006

Endovascular management of iliac artery occlusions: extending treatment to TransAtlantic Inter-Society Consensus class C and D patients

92Retrospective


De Roeck et al 2006


38Retrospective


AbuRahamaet al 2007

Primary iliac stenting versus transluminal angioplasty with selective stenting

149Retrospective


Chang et al 2008

Long-term results of combined common femoral endarterectomy and iliac stenting/stent grafting for occlusive disease

193Retrospective


Carreira et al 2008


31Prospective


Gandini et al 2008



Kashyap et al 2008

The management of severe aortoiliac occlusive disease: endovascular therapy rivals open reconstruction

127Retrospective


Koziumi et al 2009

296 BMS CIA/EIA A-D 94% 88% 82%



216Retrospective

studyBMS CIA/EIA A-D n/a 93% 91%

Maurel et al 2009


90Prospective

studyBMS EIA A-D 100% 97% 84% n/a


Iliac artery

segmentTASC

Technicalsuccess


5yrpatency


249Retrospective


Yilmaz et al 2006

Aortoiliac kissing stents: long-term results and analysis of risk factors affecting patency

68Retrospective

studyBMS CIA A-C 100% 76% 63% 63%

Leville et al 2006

Endovascular management of iliac artery occlusions: extending treatment to TransAtlantic Inter-Society Consensus class C and D patients

92Retrospective


De Roeck et al 2006


38Retrospective


AbuRahama et

al 2007

Primary iliac stenting versus transluminal angioplasty with selective

stenting149

Retrospective


Chang et al 2008

Long-term results of combined common femoral endarterectomy and iliac stenting/stent grafting for occlusive disease

193Retrospective


Carreira et al 2008


31Prospective


Gandini et al 2008



Kashyap et al

2008

The management of severe aortoiliac occlusive disease:

endovascular therapy rivals open reconstruction127

Retrospective


Koziumi et al 2009

296 BMS CIA/EIA A-D 94% 88% 82%



216Retrospective

studyBMS CIA/EIA A-D n/a 93% 91%

Maurel et al 2009


90Prospective

studyBMS EIA A-D 100% 97% 84% n/a


Iliac artery

segmentTASC

Technicalsuccess


5yrpatency

Kondo et al 2010 Primary stent placement for iliac artery chronic total occlusions 114Retrospective

studyBMS CIA/EIA n/a 100% n/a

89-91%

at 2 yearsn/a

Ozkan et al 2010Technique, complication and long-term outcome for endovascular

treatment of iliac artery occlusion127

Retrospective

studyBMS CIA/EIA B-D 92% n/a n/a 63%

Stockx et al 2010Express LD vascular stent in the treatment of iliac artery lesions: 24-

month results from the MELODIE trial163 Prospective study BMS CIA/EIA A-D 98% 89%

87.8%

at 2 yearsn/a

Ichihashi et al

2011

Long-term outcomes for sytematic primary stent placement in complex

iliac artery occlusive disease classified according to TASC-II533

Retrospective

studyBMS CIA/EIA A-D 99% 90-95% 88-91% 83-88%

Soga et al 2012Contemporary outcomes after endovascular treatment for aorto-iliac

artery disease2601

Retrospective

studyBMS

Aorta/CIA/

EIAA-D 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 self-expanding Jaguar SM

stents

95 Prospective study BMS CIA/EIA A-D 100% 84%76%

at 2 yearsn/a

Bosiers et al

2013BRAVISSIMO: 12-month results from a large scale prospective trial 147 Prospective study BMS CIA/EIA A-D n/a 93.1% n/a n/a

Clair et al 2014 125Retrospective

studyBMS CIA/EIA A-D 98% 94.4% n/a n/a

Bechter-Hughl et

al 2014The influence of gender on patency rates after iliac artery stenting 404

Retrospective

studyBMS CIA/EIA A-D

97.7 –

99.3%89.9-90.3% 71.5-77.2% 60.2-63.6%

Burket et al 2016 Twelve-month results of the nitinol astron stent in iliac artery lesions 161 Prospective study BMS CIA/EIA A-C 95% 89.8% n/a n/a

Krankenberg

et al 2017

Self-expanding versus balloon-expandable stents for iliac

artery occlusive disease660

Randomized

prospective

trial

BMS CIA/EIA A-C96.5 -

98.4%

SE 94.5%

BE 87.0%n/a n/a


Iliac artery

segmentTASC

Technicalsuccess


5yrpatency

Grimme et al 2015

First results of the covered endovascular reconstruction of the aortic bifurcation (CERAB) technique for aortoiliac occlusive disease

103Retrospective

studyCERAB EIA/IIA B-D 95.1% 87.3%

82.3%

at 2 yearsn/a

Taeymans et al 2018

Three-year outcome of the covered endovascular reconstruction of the aortic bifurcation techniques for aortoiliac occlusive disease

130Retrospective

studyCERAB EIA/IIA A-D 97% 86% 82% n/a

CERAB Studies

Comparison of Six Studies – Aorto-Iliac Occlusive DiseaseFirst Author Type of Study N Indication for

treatmentPrimary Outcome Measure

Secondary Outcome Measure

Patency Rate Points of Interest

CS BMS

Gandini RetrospectiveRegistry

Total: 150BMS: 150

Primary patency

Secondary patency

1 yr: -2 yr: -5 yr: -

-90%85%

• Stents deployed as well above aortic bifurcation

Sabri RetrospectiveRegistry

Total: 54CS: 26BMS: 28

Claudication81% CS75% BMS

Primary patency

1 yr: 92% 2 yr: 92% 5 yr: -

78%62%

-


Mwipatayi RCTCOBEST: The Covered vs Balloon-Expandable Trial


CLI35% CS17% BMSClaudication45% CS60% BMS

Rate of binary restenosis

Stentpatency

1 yr: 95.1% 2 yr: 82.1% 5 yr: 74.7%

73.9%70.9%62.5%


Grimme Prospective Registry

Total: 115CS: 115

77% Claud17% CLI

Primary patency

Secondary patency

1 yr: 88.7% 2 yr: 86.4% 5 yr: 71.5%

---

Humpheries RetrospectiveRegistry



Primary Patency,Assisted PP

Secondary patency

1 yr: 85%3 yr: 72%5 yr: -

92%89%

-

Krakenberg RandomizedProspective Trial

Total: 660BMS: 660

BE: 320SE: 340

53% Claud 2% CLI

Cumulativeincidence of binary restenosis

Primary patency

1 yr: -

2 yr: -5 yr: -

SE: 94.5%BE: 87.0%

--

Comparison of Six Studies – GenderFirst Author Type of Study N Indication for




CS BMS


Total: 150BMS: 150

Primary patency

Secondary patency

1 yr: -2 yr: -5 yr: -

-90%85%





Primary patency

1 yr: 92% 2 yr: 92% 5 yr: -

78%62%

-

• Stents deployed as well above aortic bifurcation• Gender – no difference





Stentpatency

1 yr: 95.1% 2 yr: 82.1% 5 yr: 74.7%

73.9%70.9%62.5%



Total: 115CS: 115

77% Claud17% CLI

Primary patency

Secondary patency

1 yr: 88.7% 2 yr: 86.4% 5 yr: 71.5%

---





Secondary patency

1 yr: 85%3 yr: 72%5 yr: -

92%89%

-

• Gender – no difference


Total: 660BMS: 660

BE: 320SE: 340

53% Claud 2% CLI


Primary patency

1 yr: -

2 yr: -5 yr: -

SE: 94.5%BE: 87.0%

--

Comparison of Six Studies – DAPTFirst Author Type of Study N Indication for




CS BMS


Total: 150BMS: 150

Primary patency

Secondary patency

1 yr: -2 yr: -5 yr: -

-90%85%

• Stents deployed as well above aortic bifurcation• DAPT




Primary patency

1 yr: 92% 2 yr: 92% 5 yr: -

78%62%

-

• Stents deployed as well above aortic bifurcation• Gender – no difference• DAPT





Stentpatency

1 yr: 95.1% 2 yr: 82.1% 5 yr: 74.7%

73.9%70.9%62.5%

• Stents deployed as well above aortic bifurcation• Gender – no difference !!• DAPT


Total: 115CS: 115

77% Claud17% CLI

Primary patency

Secondary patency

1 yr: 88.7% 2 yr: 86.4% 5 yr: 71.5%

---





Secondary patency

1 yr: 85%3 yr: 72%5 yr: -

92%89%

-

• Gender – no difference• DAPT


Total: 660BMS: 660

BE: 320SE: 340

53% Claud 2% CLI


Primary patency

1 yr: -

2 yr: -5 yr: -

SE: 94.5%BE: 87.0%

--

• DAPT

Comparison of Six Studies –TASC ClassificationFirst Author Type of Study N Indication for




CS BMS


Total: 150BMS: 150

Primary patency

Secondary patency

1 yr: -2 yr: -5 yr: -

-90%85%

• Stents deployed as well above aortic bifurcation• DAPT• TASC: less complex lesions




Primary patency

1 yr: 92% 2 yr: 92% 5 yr: -

78%62%

-

• Stents deployed as well above aortic bifurcation• Gender – no difference• DAPT• TASC A-D





Stentpatency

1 yr: 95.1% 2 yr: 82.1% 5 yr: 74.7%

73.9%70.9%62.5%

• Stents deployed as well above aortic bifurcation• DAPT• TASC: A-D, included sub-group analysis TASC C/D


Total: 115CS: 115

77% Claud17% CLI

Primary patency

Secondary patency

1 yr: 88.7% 2 yr: 86.4% 5 yr: 71.5%

---

• TASC: A-D





Secondary patency

1 yr: 85%3 yr: 72%5 yr: -

92%89%

-

• Gender – no difference• DAPT• TASC: few complex lesions


Total: 660BMS: 660

BE: 320SE: 340

53% Claud 2% CLI


Primary patency

1 yr: -

2 yr: -5 yr: -

SE: 94.5%BE: 87.0%

--

• DAPT• TASC: less complex lesions

Comparison of Six Studies – Impact of EIAFirst Author Type of Study N Indication for




CS BMS


Total: 150BMS: 150

Primary patency Secondary patency

1 yr: -2 yr: -5 yr: -

-90%85%

• Stents deployed as well above aortic bifurcation• DAPT• TASC: less complex lesions• Impact of EIA




Primary patency 1 yr: 92% 2 yr: 92% 5 yr: -

78%62%

-

• Stents deployed as well above aortic bifurcation• Gender – no difference• DAPT• TASC A-D• Impact of EIA





Stent patency 1 yr: 95.1% 2 yr: 82.1% 5 yr: 74.7%

73.9%70.9%62.5%

• Stents deployed as well above aortic bifurcation• DAPT• TASC: A-D, included sub-group analysis TASC C/D


Total: 115CS: 115

77% Claud17% CLI

Primary patency Secondary patency

1 yr: 88.7% 2 yr: 86.4% 5 yr: 71.5%

---

• TASC: A-D





Secondary patency

1 yr: 85%3 yr: 72%5 yr: -

92%89%

-

• Gender – no difference• DAPT• TASC: few complex lesions • Impact of EIA


Total: 660BMS: 660

BE: 320SE: 340

53% Claud 2% CLI


Primary patency

1 yr: -

2 yr: -5 yr: -

SE: 94.5%BE: 87.0%

--


Comparison of Six Studies – CIA Stent Size (≤ 7 mm)

First Author Type of Study NIndication for treatment

Primary Outcome Measure


Patency RatePoints of Interest

CS BMS

GandiniRetrospectiveRegistry

Total: 150BMS: 150

Primary patency

Secondary patency

1 yr: -2 yr: -5 yr: -

-90%85%

• Stents deployed as well above aortic bifurcation• DAPT• TASC: less complex lesions• Impact of EIA

SabriRetrospectiveRegistry



Primary patency

1 yr: 92% 2 yr: 92% 5 yr: -

78%62%

-

• Stents deployed as well above aortic bifurcation• Gender – no difference• DAPT• TASC: A-D• Impact of EIA• Small stent size

Mwipatayi

RCTCOBEST: The Covered vs Balloon-Expandable Trial


CLI35% CS17% BMSClaudication45% CS / 60% BMS


StentPatency

1 yr: 95.1% 2 yr: 82.1% 5 yr: 74.7%

73.9%70.9%62.5%

• Stents deployed as well above aortic bifurcation• DAPT• TASC: A-D, included sub-group analysis TASC C/D• Small stent size

GrimmeProspective Registry

Total: 115CS: 115

77% Claud17% CLI

Primary patency

Secondary Patency

1 yr: 88.7% 2 yr: 86.4% 5 yr: 71.5%

---

• TASC: A-D

HumpheriesRetrospectiveRegistry




Secondary patency

1 yr: 85%3 yr: 72%5 yr: -

92%89%

-

• Gender – no difference• DAPT• TASC: few complex lesions • Impact of EIA

KrakenbergRandomizedProspective Trial

Total: 660BMS: 660

BE: 320SE: 340

53% Claud 2% CLI


PrimaryPatency

1 yr: -

2 yr: -5 yr: -

SE: 94.5%BE: 87.0%

--


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.

• Retrospective review

• 54 patients: covered stents (n=26) vs BMS (n=28)

• Technical success 100% in both groups

• Major complications: 3 in CS and 2 in BMS

• Primary patency

• 1 year: 92% CS vs 78% BMS

• 2 year: 92% CS vs 62% BMS (p=0.023)

• CONCLUSION: The use of covered balloon-expandable kissing stents for atherosclerotic aortic bifurcation occlusive disease provides superior patency at 2 years as compared with balloon-expandable stents

• Why do BMS occlude at a higher rate when used in the kissing stent configuration compared with use in the iliac arteries?

• LIMITATIONS: non-randomised, single institution, retrospective

J Vasc Interv Radiol 2010; 21: 995-1003

Humpheries MD, Armstrong E, Laird J et al. Outcomes of covered versus bare-metal ballon expandable stents for aortoiliac occlusive disease.

• Retrospective study

• 254 iliac arteries: covered stents (n=37) vs BMS (n=125)


• Primary patency



• CONCLUSION: BMS had better patency compared with CS for treatment of AIOD.

• LIMITATIONS: non-randomised, single institution, retrospective, larger number of patients in

BMS group

J Vasc Surg 2014; 60: 337-344.

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 BMS (n=85)


COBEST: The Covered vs Balloon-expandable Trial- Short-term Results -

• Primary patency

• 1 year: 95.1% CS vs 73.9% BMS

• LIMITATIONS: different BMS stents, fewer TASC D lesions treated with BMS, DUS as principal

imaging tool

• CONCLUSION: COBEST demonstrates CS and BMS produce similar and acceptable results for TASC

B lesions. However, CS perform better for TASC C & D lesions in terms of patency

and clinical outcome.

J Vasc Surg 2011; 54: 561-570.

COBEST: Baseline Lesion CharacteristicsV12 stent (n=83) Bare Stent (n=85) P value

Pre-Op Resting-ABI (side of lesion) – mean ± SEM

0.65±0.03 0.63±0.03 0.64

Pre-Op Duplex Scan 0.39

% Performed (n) 74.7 (62) 76.5 (65)

>50% Stenosis 87.1 81.5

Occlusion 12.9 18.5

Pre-Op Angiogram 0.03

% Performed (n) 80.7 (67) 85.9 (73)

TASC B 50.7 72.6

TASC C 34.3 20.5

TASC D 14.9 6.8

Runoff 0.15

% Performed (n) 89.1 (74) 85.9 (73)

0 0 1.4

1 12.2 5.5

2 20.3 21.9

3 23.0 37.0

4 44.6 34.2

COBEST: KM Curve of Adjusted Primary Patency

Time (Months) 0 12 24 36 48 60 72 84 96

Advanta V12 Stent (n. at risk) 83 74 52 47 35 28 17 5 2

Standard Error (%) - 2.95 4.54 4.54 4.93 5.84 5.84 7.27 7.27

BMS (n. at risk) 85 66 46 40 28 23 10 3 1

Standard Error (%) - 4.89 5.13 5.27 5.94 5.94 7.36 11.2 11.2

PP = 74.7%

PP = 62.9%

COBEST: KM Curve of Adjusted Patency for different TASC lesions

KM Curve of Adjusted Primary Patency

for TASC C/D Lesion

KM Curve of Adjusted Primary Patencyfor TASC B lesion

COBEST: Factors independently affecting primary patency based on multivariate logistic regression models

Variable Coefficients B SE Wald test HR (95% CI) P value

Type of stent used (Advanta V12 vs. BMS)

1.028 0.328 9.8382.797

(1.471–5.318)0.002

Rutherford stratification

9.122 80.786 11.0442.019

(1.278–3.191)0.026

Variable AUS (95% CI) SE P value

Type of stent used (Advanta V12 vs. BMS)

0.606 (0.511 – 0.700)

0.048 0.034

Rutherford stratification

0.634 (0.541 – 0.727)

0.048 0.007

ROC ANALYSES OF FACTORS AFFECTING PRIMARY PATENCY

Mwipatayi BP, Sharma S, Daneshmand A et al. Durability of the balloon-expandable covered versus bare-metal 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 BMS (n=57)

COBEST: The Covered vs Balloon-expandable Trial- Long-term Results -

• CONCLUSION: CS has an enduring patency advantage over BMS both in the short and long term. Patients who receive CS require fewer revascularisation procedures. Choice of stent did not affect the rate of major limb amputations.

• Primary patency

• 2 year: 82.1% CS vs 70.9% BMS

• 4 year: 79.9% CS vs 63.0% BMS

• 5 year: 74.7% CS vs 62.5% BMS

• LIMITATIONS: different BMS stents, not power for subgroup analysis (assumption), DUS as principal imaging tool

J Vasc Surg 2016; 64: 83-94.

Krakenberg H, Zeller T, Ingwersen M et al. Self-expanding versus balloon-expandable stents for iliac artery occlusive disease..

• Prospective, multicenter, block-randomized, non-blinded trial

• 660 patients – 660 iliac arteries: SE (n=340) vs BE (n=320)

BMS: Self-Expanding (SE) vs Balloon-Expanding (BE)- A Game Changer -

• Cumulative incidence of binary restenosis

• 1 year: 6.1% SE vs 14.9% BE p = 0.006

• Primary patency

• 1 year: 94.5% SE vs 87.0% BE p = 0.026

• Freedom from TLR

• 1 year: 97.2% SE vs 93.6% BE p = 0.042

• 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

J Am Coll Cardiol Intv 2017; 10: 1694-1704

BMS: Self-Expanding (SE) vs Balloon-Expanding (BE)

CONCLUSION: treatment of AIOD with SE led to ↓ incidence of restenosis at 12 months and was therefore provided superior primary patency than treatment with BE

Figure: Association of multiple variables with the incidence of binary restenosis at 12 months, based on logistic regression model

LIMITATIONS: non-blinded, no independent core lab. So, the interpretation of angiographic findings and DUS was left to the investigators , introducing a bias in result interpretation.

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

Take home message….

AIOD

TASC C/DTASC A/BAortic

Disease + Iliac

CS Angioplasty

+/- DCBBMS

CERAB vs Kissing

Stenting

BMS +/-CS

Dissection

Thank You

THE 15-YEAR 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, FCS, FRACS

Clinical Associate Professor – Vascular Surgery

University of Western Australia, Perth

Documents

D COBEST PRESENT STRONG EVIDENCE FOR V12 AS CHOICE OF ... · Seven-year approach evolution of the aortoiliac occlusive disease endovascular treatment CS 13 BMS 9 Retrospective Study