The BeGraft study : a physician-initiated study investigating the … · Modified TASC II TASC A...
Transcript of The BeGraft study : a physician-initiated study investigating the … · Modified TASC II TASC A...
The BeGraft study : a physician-initiatedstudy investigating the BeGraft peripheral
stentgraft in the iliac arteries :final 24-month results
Koen Deloose, MD
Head Vascular Surgery, AZ Sint Blasius,
Dendermonde, Belgium
2ID3 Medical – 2018 |
Disclosure slide
I have the following potential conflicts of interest to report:
Consulting: Medtronic, Spectranetics, Biotronik, Abbott, Bard
iVascular, Bentley, Cook, GE Healthcare, Terumo, Boston
Scientific, Contego Medical, B Braun
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
I do not have any potential conflict of interest
Speaker name: Koen Deloose, MD
3ID3 Medical – 2018 |
Is there a place/a need for stentgrafts in the iliac field?
4ID3 Medical – 2018 |
Is there a place/a need for stentgrafts in the iliac field?
5ID3 Medical – 2018 |
82.1%
53.0%
100% 87.0%
Chang et al. J Vasc Surg 2008;48:362-7 -
Are stentgrafts performing better in the iliac field?
0.00
0.25
0.50
0.75
1.00
24 18 16 11 Bare Stent Group
40 39 38 35 V12 Stent Group
Number at risk
1 6 12 18
Time (Months)
V12 Stent Bare Stent
Freedo
m f
rom
Bin
ary
Reste
no
sis
HR 0.136 (95% CI 0.042-0.442); p=0.0056
COBEST : Mwipatayi et al. J vasc Surg 2011;54:1561-70
Freedom from restenosisTASC C/D Group
6ID3 Medical – 2018 |
What about newer generations ?
Getinge Advanta V12 Bard Lifestream
Gore Viabahn BX InSitu Silene
Not CE marked
7ID3 Medical – 2018 |
What about newer generations ?
BeGraft (8x57mm)
Graft MaterialePTFE sleeve(203±25µm)
ePTFE film (110±10µm)
ePTFE ePTFE
Stent Material (Composition)
CoCr (L605) Stainless Steel Stainless Steel Stainless Steel
Stent Graft DesignSingle StentePTFE sleeve
clamped@stent ends
Film-Cast Encapsulation
Technology
Film-Cast Encapsulation
Technology
Film-Cast Encapsulation
Technology
SheathCompatibility
6F (8x57mm)7F
6F (6x22mm)7F
6F (7x37mm)7F (9x58mm)
8F
7F (8x59mm)8F
Guide Wire 0.035“ 0.035“ 0.035“ 0.035“
Crimped Profile 2.0 – 2.4mm 2.1 – 2.5mm n/a n/a
Advanta V12 LifeStream Viabahn BX
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Ideal combination crushresistance, low profile, flexibility
0,230,26
0,15
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0,05
0,10
0,15
0,20
0,25
0,30
ADVANTA V12(Ø10 x 59mm)
BeGraftPeripheral (Ø10
x 57mm)
BardLIFESTREAM
(Ø10 x 58mm)
Rad
ial F
orc
e [N
/mm
]
2,532,41
2,71
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1,00
1,50
2,00
2,50
3,00
ADVANTA V12(Ø10 x 59mm)
BeGraftPeripheral (Ø10 x
57mm)
BardLIFESTREAM
(Ø10 x 58mm)
Cri
mp
ed S
ten
t D
iam
ete
r [m
m]
BeGraft (8x57mm)
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• Prospective, non-randomized, multi-center study(70 patients)
• K. Deloose, M. Bosiers, J. Callaert - Sint-Blasius, Dendermonde• P. Peeters, J. Verbist, W. Vandeneynde - Imelda, Bonheiden• L. Maene, R. Beelen - OLV, Aalst• K. Keirse, B. Joos - Heilig Hart, Tienen
• Study objective:To evaluate the long-term safety & efficacy of the BeGraftPeripheral Stent Graft System (Bentley®)
BeGraft Peripheral PMCFStudy design
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BeGraft Peripheral PMCFIn/Exclusion Criteria
• Rutherford-Becker classification 2 to 5
• Stenotic/restenotic post POBA (≥50%) or occlusive lesions iliac arteries, categorized with a modified TASC-II classification
Exclusion of non-bifurcation aortic and/or CFA involvement
Exclusion of abdominal aneurysm presence
BeGraft Peripheral PMCFPrimary Endpoint
• Primary patency at 12 months, defined as:
Absence of restenosis (≥50% stenosis/ PSVR≥2.4) & without Target Lesion Revascularization (TLR) within 12 months
BeGraft Peripheral PMCFPatient demographics
N=70
Male (%) 45 (64.3%)
Age (min – max; ±SD) 65.04 (41– 91 ±10.01)
Nicotine abuse (%) 41(58.6%)
Hypertension (%) 46 (65.7%)
Diabetes mellitus (%) 14 (20.0%)
Renal insufficiency (%) 7 (10.0%)
Hypercholesterolemia (%) 41 (58.6%)
Obesity (%) 14 (20.0%)
Lesion side
Left (%) 26 (37.1%)
Right (%) 21 (30.0%)
Bilateral (%) 23 (32.9%) 93 lesions for 70 patients
Modified TASC II
TASC A TASC B TASC C TASC D
77,1%
14,3%
5,7% 2,9%
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BeGraft Peripheral PMCFLesion characteristics
N=93
Lesion length (min – max; ±SD) 34.3 mm (6.0 – 100.0; ±15.45)
Reference vessel diameter 7.96 mm
Mean lumen diameter 1.34 mm
Occlusion (%) 13 (14%)
Calcified lesion (%) 53 (57%)
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BeGraft Peripheral PMCF12 & 24 Month Primary Patency
Time baseline 1MFU 6MFU 12MFU 24MFU
at risk 93 92 83 71 47
% 100 98,9 96,8 94,4 92,40
92.40 %94.40 %
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BeGraft Peripheral PMCF12 & 24 Month Freedom from TLR
96.30 %
Time baseline 1MFU 6MFU 12MFU 24MFU
at risk 93 93 83 73 48
% 100 100 96,7 96,7 96,3
96.7 %
16ID3 Medical – 2018 |
BeGraft Peripheral PMCF12 & 24 Month Freedom StentGraft Occlusion
97.8 %
Time baseline 1MFU 6MFU 12MFU 24MFU
at risk 93 93 84 74 48
% 100 100 97,8 97,8 97,8
97,8 %
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BeGraft Peripheral PMCFClinical assessment & Safety
• No major amputations have been reported betweenbaseline & 24 MFU visit.
• 24 Month Limb Salvage Rate is 100%
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Conclusion
• Some evidence that stentgrafts in more complex TASC C&D lesions are performing better
• Time to study also newer generations of stentgrafts in theiliac field
• The Begraft stentgraft (Bentley) combines high crushresistance and high flexibility with low profile
• The Begraft PMCF study shows, although in relatively easy iliac lesions, outstanding results @ 24 months : PPR of 92.4%, f-TLR of 96.3% & f-SGO of 97.8%
The BeGraft study : a physician-initiatedstudy investigating the BeGraft peripheral
stentgraft in the iliac arteries :final 24-month results
Koen Deloose, MD
Head Vascular Surgery, AZ Sint Blasius,
Dendermonde, Belgium