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
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 aorto- iliac 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
BMSCIA/EIA C,D 98% n/a
CS 88%
BMS 54%n/a
COVERED STENT STUDIES
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 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
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 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
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 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
BMSCIA/EIA C,D 98% n/a
CS 88%
BMS 54%n/a
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 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
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/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
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 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
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 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
BMSCIA/EIA C,D 98% n/a
CS 88%
BMS 54%n/a
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 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
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 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
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 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
BMSCIA/EIA C,D 98% n/a
CS 88%
BMS 54%n/a
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 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
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 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
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 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
BMSCIA/EIA C,D 98% n/a
CS 88%
BMS 54%n/a
First Author Title N Type of studyStent type
Iliac artery
segmentTASC
Technicalsuccess
rate1yr patency 3yr patency
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
studyBMS CIA/EIA n/a 99% n/a 90% 85%
Kashyap et al 2008
The management of severe aortoiliac occlusive disease: endovascular therapy rivals open reconstruction
127Retrospective
studyBMS CIA/EIA B-D 100% n/a 74% n/a
Koziumi et al 2009
296Retrospective
studyBMS CIA/EIA A-D 100% 94% 88% 82%
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
First Author Title N Type of studyStent type
Iliac artery
segmentTASC
Technicalsuccess
rate1yr patency 3yr patency
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
First Author Title N Type of studyStent type
Iliac artery
segmentTASC
Technicalsuccess
rate1yr patency 3yr patency
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 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
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%
AbuRahamaet al 2007
Primary iliac stenting versus transluminal angioplasty with selective stenting
149Retrospective
studyBMS CIA/EIA A-D 100% 98% 87% 77%
Chang et al 2008
Long-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
31Prospective
studyBMS CIA/EIA n/a 100% n/a 83% 75%
Gandini et al 2008
Percutaneous treatment in iliac artery occlusion: long-term results 138Retrospective
studyBMS CIA/EIA n/a 99% n/a 90% 85%
Kashyap et al 2008
The management of severe aortoiliac occlusive disease: endovascular therapy rivals open reconstruction
127Retrospective
studyBMS CIA/EIA B-D 100% n/a 74% n/a
Koziumi et al 2009
296 BMS CIA/EIA A-D 94% 88% 82%
Higashuria et al 2009
Prevalence, factors and clinical impact of self-expanding stent fractures following iliac artery stenting
216Retrospective
studyBMS CIA/EIA A-D n/a 93% 91%
Maurel et al 2009
Endovascular treatment of external iliac artery stenoses for claudication with systematic stenting
90Prospective
studyBMS EIA A-D 100% 97% 84% n/a
First Author Title N Type of studyStent type
Iliac artery
segmentTASC
Technicalsuccess
rate1yr patency 3yr patency
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 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
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 selective
stenting149
Retrospective
studyBMS CIA/EIA A-D 100% 98% 87% 77%
Chang et al 2008
Long-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
31Prospective
studyBMS CIA/EIA n/a 100% n/a 83% 75%
Gandini et al 2008
Percutaneous treatment in iliac artery occlusion: long-term results 138Retrospective
studyBMS CIA/EIA n/a 99% n/a 90% 85%
Kashyap et al
2008
The management of severe aortoiliac occlusive disease:
endovascular therapy rivals open reconstruction127
Retrospective
studyBMS CIA/EIA B-D 100% n/a 74% n/a
Koziumi et al 2009
296 BMS CIA/EIA A-D 94% 88% 82%
Higashuria et al 2009
Prevalence, factors and clinical impact of self-expanding stent fractures following iliac artery stenting
216Retrospective
studyBMS CIA/EIA A-D n/a 93% 91%
Maurel et al 2009
Endovascular treatment of external iliac artery stenoses for claudication with systematic stenting
90Prospective
studyBMS EIA A-D 100% 97% 84% n/a
First Author Title N Type of studyStent type
Iliac artery
segmentTASC
Technicalsuccess
rate1yr patency 3yr patency
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
First Author Title N Type of studyStent type
Iliac artery
segmentTASC
Technicalsuccess
rate1yr patency 3yr patency
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%
-
• Stents deployed as well above aortic bifurcation
Mwipatayi RCTCOBEST: The Covered vs Balloon-Expandable Trial
Total: 168CS: 83BMS: 85
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%
• Stents deployed as well above aortic bifurcation
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
Total: 254CS: 64BMS: 190
CLI14% CS35% BMSClaudication73% CS58% BMS
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
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%
-
• Stents deployed as well above aortic bifurcation• Gender – no difference
Mwipatayi RCTCOBEST: The Covered vs Balloon-Expandable Trial
Total: 168CS: 83BMS: 85
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%
• Stents deployed as well above aortic bifurcation
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
Total: 254CS: 64BMS: 190
CLI14% CS35% BMSClaudication73% CS58% BMS
Primary Patency,Assisted PP
Secondary patency
1 yr: 85%3 yr: 72%5 yr: -
92%89%
-
• Gender – no difference
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 – DAPTFirst 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• DAPT
Sabri RetrospectiveRegistry
Total: 54CS: 26BMS: 28
Claudication81% CS75% BMS
Primary patency
1 yr: 92% 2 yr: 92% 5 yr: -
78%62%
-
• Stents deployed as well above aortic bifurcation• Gender – no difference• DAPT
Mwipatayi RCTCOBEST: The Covered vs Balloon-Expandable Trial
Total: 168CS: 83BMS: 85
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%
• Stents deployed as well above aortic bifurcation• Gender – no difference !!• DAPT
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
Total: 254CS: 64BMS: 190
CLI14% CS35% BMSClaudication73% CS58% BMS
Primary Patency,Assisted PP
Secondary patency
1 yr: 85%3 yr: 72%5 yr: -
92%89%
-
• Gender – no difference• DAPT
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%
--
• DAPT
Comparison of Six Studies –TASC ClassificationFirst 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• DAPT• TASC: less complex lesions
Sabri RetrospectiveRegistry
Total: 54CS: 26BMS: 28
Claudication81% CS75% BMS
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
Mwipatayi RCTCOBEST: The Covered vs Balloon-Expandable Trial
Total: 168CS: 83BMS: 85
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%
• Stents deployed as well above aortic bifurcation• DAPT• TASC: A-D, included sub-group analysis TASC C/D
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%
---
• TASC: A-D
Humpheries RetrospectiveRegistry
Total: 254CS: 64BMS: 190
CLI14% CS35% BMSClaudication73% CS58% BMS
Primary Patency,Assisted PP
Secondary patency
1 yr: 85%3 yr: 72%5 yr: -
92%89%
-
• Gender – no difference• DAPT• TASC: few complex lesions
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%
--
• DAPT• TASC: less complex lesions
Comparison of Six Studies – Impact of EIAFirst 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• DAPT• TASC: less complex lesions• Impact of EIA
Sabri RetrospectiveRegistry
Total: 54CS: 26BMS: 28
Claudication81% CS75% BMS
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
Mwipatayi RCTCOBEST: The Covered vs Balloon-Expandable Trial
Total: 168CS: 83BMS: 85
CLI35% CS17% BMSClaudication45% CS60% BMS
Rate of binary restenosis
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
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%
---
• TASC: A-D
Humpheries RetrospectiveRegistry
Total: 254CS: 64BMS: 190
CLI14% CS35% BMSClaudication73% CS58% BMS
Primary Patency,Assisted PP
Secondary patency
1 yr: 85%3 yr: 72%5 yr: -
92%89%
-
• Gender – no difference• DAPT• TASC: few complex lesions • Impact of EIA
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%
--
• DAPT• TASC: less complex lesions
Comparison of Six Studies – CIA Stent Size (≤ 7 mm)
First Author Type of Study NIndication for treatment
Primary Outcome Measure
Secondary 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
Total: 54CS: 26BMS: 28
Claudication81% CS75% BMS
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
Total: 168CS: 83BMS: 85
CLI35% CS17% BMSClaudication45% CS / 60% BMS
Rate of binary restenosis
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
Total: 254CS: 64BMS: 190
CLI14% CS35% BMSClaudication73% CS58% BMS
Primary Patency,Assisted PP
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
Cumulativeincidence of binary restenosis
PrimaryPatency
1 yr: -
2 yr: -5 yr: -
SE: 94.5%BE: 87.0%
--
• DAPT• TASC: less complex lesions
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)
• Technical success 100% in both groups
• Primary patency
• 1 year: 85% CS vs 92% BMS
• 3 year: 72% CS vs 89% BMS
• 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)
• Technical success 100% in both groups
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
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