ID3 Medical – 2020
Koen Deloose, MD
Head Dept Vascular Surgery
AZ Sint Blasius
Dendermonde, Belgium
Full cohort 24-month Safety and Efficacy Results of the
VIM-CFA Trial
ID3 Medical – 2020
Disclosures Koen Deloose, MD
❑ I have the following potential conflicts of interest to report:
❑ Consulting: Abbott, BD, Biotronik, Boston Scientific, Cook, CTI vascular,
iVascular, Medtronic, Philips, Terumo, CyndRX, Profusa
❑ Employment in industry
❑ Stockholder of a healthcare company
❑ Owner of a healthcare company
❑ Other(s)
❑ I do not have any potential conflict of interest
ID3 Medical – 2020
1843 CFE’s reported from 2005-2010 (ACS -NSQIP database)*
Nguyen B et al. J Vasc Surg 2015;61:1489-94 - *American college of Surgery – National Surgical Quality Improvement Program
CFE is notas “benign” a procedure as previouslybelieved…
ID3 Medical – 2020
Whatabouttheendovascularalternatives?
Author, date Type study Limbs (n) Angioplasty only (n)
Stenting (n) Atherectomy (n)
Primary patency (%)
Mean FU (m) Technical success (%)
Stricker,2004 retro 33 0 33 0 86 30 100
Dick,2006 retro 55 47 0 0 71 13 85
Cotroneo,2010 retro 27 27 0 0 57,9 9,4 100
Bonvini,2011 retro 360 227 133 0 87,5 12
Baumann,2011 retro 104 74 28 0 54 16 98
Azéma, 2011 pro 40 0 40 0 90 12 100
Paris,2011 retro 26 0 26 0 88 31 100
Davies, 2013 retro 121 107 1 0 75 12 90
Soga, 2013 retro 111 98 10 0 47 60 97
Bonvini,2013 retro 97 46 37 0 80 12 92
Linni, 2014 RCT (CFE) 116 0 58 (BAS) 0 80 12 97,5
Thiney, 2015 pro 53 0 53 0 92,5 24 na
Mehta, 2016 retro 167 114 15 38 78 20 na
Gouëffic, 2017 RCT (CFE) 117 (56) 0 56 0 90 24 94,6
Deloose, 2019 pro 100 0 100 0 95,2 12 100
(1) JEVT 2004;11:281-6 (2) JEVT 2006;13:221-228 (3) Cardiovasc Intervent Radiol 2010;33:921-28 (4) JACC 2011;58(8):792-8 (5) J Vasc Surg 2011;53:1000-6
(6) Eur J Vasc Endovasc Surg 2011;41:787-793(7) Vasc Med 2011;16:109-112(8) Vasc Endovascar Surg 2013;47:423-428(9) Cardiovasc Interv Ther 2013;28:250-57(10) J Vasc Interv Radiol 2013;24:175-183
(11) JEVT 2014;21:493-502(12) Ann Vasc Surg 2015;29(5):960-7(13) J Vasc Surg 2016;64(2):369-79(14) JACC 2017;10(13):1344-54(15) J Vasc Surg 2019, under review
Davaine JM et al. J Intervent Cardiology, Vol73, Issue 9, Suppl I, March 2019;page 2065
POBA doesn’ t work in the CFA
ID3 Medical – 2020
Author, date Type study Limbs (n) Angioplasty only (n)
Stenting (n) Atherectomy (n)
Primary patency (%)
Mean FU (m) Technical success (%)
Stricker,2004 retro 33 0 33 0 86 30 100
Dick,2006 retro 55 47 0 0 71 13 85
Cotroneo,2010 retro 27 27 0 0 57,9 9,4 100
Bonvini,2011 retro 360 227 133 0 87,5 12
Baumann,2011 retro 104 74 28 0 54 16 98
Azéma, 2011 pro 40 0 40 0 90 12 100
Paris,2011 retro 26 0 26 0 88 31 100
Davies, 2013 retro 121 107 1 0 75 12 90
Soga, 2013 retro 111 98 10 0 47 60 97
Bonvini,2013 retro 97 46 37 0 80 12 92
Linni, 2014 RCT (CFE) 116 0 58 (BAS) 0 80 12 97,5
Thiney, 2015 pro 53 0 53 0 92,5 24 na
Mehta, 2016 retro 167 114 15 38 78 20 na
Gouëffic, 2017 RCT (CFE) 117 (56) 0 56 0 90 24 94,6
Deloose, 2019 pro 100 0 100 0 95,2 12 100
Scaffolds do work in the CFA
-they can deal with the calcium-they prevent early recoil-what about stent fractures in this high flexion zone?Use modern generation of self
expandable stents…
Whatabouttheendovascularalternatives?
(1) JEVT 2004;11:281-6 (2) JEVT 2006;13:221-228 (3) Cardiovasc Intervent Radiol 2010;33:921-28 (4) JACC 2011;58(8):792-8 (5) J Vasc Surg 2011;53:1000-6
(6) Eur J Vasc Endovasc Surg 2011;41:787-793(7) Vasc Med 2011;16:109-112(8) Vasc Endovascar Surg 2013;47:423-428(9) Cardiovasc Interv Ther 2013;28:250-57(10) J Vasc Interv Radiol 2013;24:175-183
(11) JEVT 2014;21:493-502(12) Ann Vasc Surg 2015;29(5):960-7(13) J Vasc Surg 2016;64(2):369-79(14) JACC 2017;10(13):1344-54(15) J Vasc Surg 2019, under review
ID3 Medical – 2020
The best single arm proof of this statement…
TIMELINE
ID3 Medical – 2020
• Primaryendpoint
✓ Efficacy endpoint :
Primary patency @12 months (DUS PSVR<2,5 -
Core lab adjudicated*) in CFA without reintervention
✓ Safety endpoint :
Periprocedural adverse events up to 30 days post
procedure, as defined per ISO 14155:2011 (TLR,
death, amputation)
*EuroImaging Srl, Rome, Italy
• Secondary endpoints✓ Technical success rate
(successfull stenting & angiographical RS<30%)
✓ Primary patency @ 6 & 24 months (same definition)
✓ Freedom from TLR @ 6, 12 & 24 months
(repeat intervention to maintain/re-establish patency within
region of treated arterial vessel + 5mm in treated lesion edge)
✓ Freedom from TVR @ 6,12 & 24 months
(repeat intervention to maintain/re-establish patency within
target vessel EIA, DFA, SFA, PA)
✓ Clinical success @6,12 & 24 months (improvement in RB classification)
✓ Safety profile @6, 12 & 24 months (death, TLR, amputation)
VMI-CFA trial : endpoints
ID3 Medical – 2020
• INCLUSION CRITERIA • EXCLUSION CRITERIA
VMI-CFA trial : in/exclusion criteria
• RB 2-4 classification
• De novo/post POBA lesions
• stenosis >50%/occlusions
• Patent DFA
• Good SFA run off
• RB 5-6 classification
• In-stent lesions CFA
• Previous surgery CFA
• occluded DFA/SFA
• Non treatable inflow lesion
• thrombus
• Debulking, DE technologies…
Azéma L. et al. EJVEVS, 41, 6 : June 2011 ; 787-793
ID3 Medical – 2020
VMI-CFA trial : patient/lesioncharacteristics
ID3 Medical – 2020
VMI-CFA trial : proceduralcharacteristics
ID3 Medical – 2020
VMI-CFA trial : 2 yearsurvival
* Freedom from > 50% restenosis as indicated by DUS PSV-ratio <2,5 in the target lesion
0
20
40
60
80
100
Survival - 24MFU- 100 patients
0 40 80 120 160 200 240 280 320 360 400 440 480 520 560 600 640 680 720 760
Time (days)
Cum
ulat
ive
surv
ical
rate
(%)
Number at risk
100 99 97 97 95 93 92 90 89 89 86 86 86 85 85 85 82 81 81 29
85,5%91,8%
time baseline 1MFU(30 days)
6MFU(180 days)
6MFU(210 days)
12MFU(365 days)
12MFU(395 days)
24MFU(730 days)
24MFU(760 days)
at risk 100 99 95 93 89 86 81 29
% 100 100 96,9 95,9 91,8 90,8 85,5 85,5
ID3 Medical – 2020
VMI-CFA trial : 2 yearprimarypatency*
0
20
40
60
80
100
Primary Patency - 24MFU - 100 patients
0 40 80 120 160 200 240 280 320 360 400 440 480 520 560 600 640 680 720 760
Time (days)
Cum
ulat
ive
prim
ary
pate
ncy
rate
(%)
Number at risk
100 99 97 97 94 88 86 85 84 81 68 67 67 66 66 66 66 66 66 18time baseline 1MFU
(30 days)
6MFU(180 days)
6MFU(210 days)
12MFU(365 days)
12MFU(395 days)
24MFU(730 days)
24MFU(760 days)
at risk 100 99 91 84 78 76 66 18
% 100 100 100 98,9 95,2 92,8 92,8 92,8
* Freedom from > 50% restenosis as indicated by DUS PSV-ratio <2,5 in the target lesion, CORE LAB ADJUDICATED**
92,8%95,2%
**EuroImaging Srl, Rome, Italy
ID3 Medical – 2020
VMI-CFA trial : 2 yearfreedomfromTLR*
* Freedom from > 50% restenosis as indicated by DUS PSV-ratio <2,5 in the target lesion
0
20
40
60
80
100
Freedom from TLR - 24MFU - 100 patients
0 40 80 120 160 200 240 280 320 360 400 440 480 520 560 600 640 680 720 760
Time (days)
Cum
ulat
ive
freed
om fr
om T
LR ra
te (%
)
Number at risk
100 99 97 97 95 93 91 90 89 88 85 85 85 84 84 84 81 80 80 29time baseline 1MFU(30 days)
6MFU(180 days)
6MFU(210 days)
12MFU(365 days)
12MFU(395 days)
24MFU(730 days)
24MFU(760 days)
at risk 100 99 95 92 88 88 80 29
% 100 100 100 98,9 97,8 97,8 97,8 97,8
97,8% 97,8%
* repeat intervention to maintain/re-establish patency within region of treated arterial vessel + 5mm in treated lesion edge)
ID3 Medical – 2020
VMI-CFA trial : 2 yearfreedomfromTVR*
* Freedom from > 50% restenosis as indicated by DUS PSV-ratio <2,5 in the target lesion
0
20
40
60
80
100
Freedom from TLR - 24MFU - 100 patients
0 40 80 120 160 200 240 280 320 360 400 440 480 520 560 600 640 680 720 760
Time (days)
Cum
ulat
ive
freed
om fr
om T
LR ra
te (%
)
Number at risk
100 99 97 97 95 93 91 90 89 88 85 85 85 84 84 84 81 80 80 29
* repeat intervention to maintain/re-establish patency within region of treated arterial vessel + 5mm in treated lesion edge)
0
20
40
60
80
100
Freedom from TVR - 24MFU - 100 patients
0 40 80 120 160 200 240 280 320 360 400 440 480 520 560 600 640 680 720 760
Time (days)
Cum
ulat
ive
freed
om fr
om T
VR ra
te (%
)
Number at risk
100 99 95 95 91 89 87 86 85 84 80 80 80 79 77 77 72 71 70 22time baseline 1MFU(30 days)
6MFU(180 days)
6MFU(210 days)
12MFU(365 days)
12MFU(395 days)
24MFU(730 days)
24MFU(760 days)
at risk 100 99 91 88 84 83 69 22
% 100 100 95,9 94,8 92,6 91,5 84,3 84,3
92,6%
84,3%
* repeat intervention to maintain/re-establish patency within EIA, DFA, SFA, PA
ID3 Medical – 2020
0
20
40
60
80
100
Primary Patency - 100 patients - 24MFU
0 80 160 240 320 400 480 560 640 720
Time (days)
Cum
ulat
ive
prim
ary
patre
ncy
rate
(%)
Number at risk
Group: B
52 51 51 51 48 46 45 45 44 42 34 33 33 33 33 33 33 33 33 12
Group: C
47 47 46 46 46 42 41 40 40 39 34 34 34 33 33 33 33 33 33 6
Azema_type
B
C
0
20
40
60
80
100
Freedom from TLR - 100 patients - 24MFU
0 80 160 240 320 400 480 560 640 720
Time (days)
Cum
ulat
ive fr
eedo
m fr
om T
LR ra
te (%
)
Number at riskGroup: B
52 51 51 51 49 48 47 47 46 45 43 43 43 43 43 43 40 40 40 18Group: C
47 47 46 46 46 45 44 43 43 43 42 42 42 41 41 41 41 40 40 11
Azema_typeBC
time baseline 1MFU 6MFU(180 days)
6MFU(210 days)
12MFU(365 days)
12MFU(395 days)
24MFU(730 days)
24MFU(760 days)
AzemaB
at risk 52 51 47 45 42 39 33 12
% 100% 100% 100% 100% 95,3% 90,7% 90,7% 90,7%
AzemaC
at risk 47 47 44 39 37 37 33 6
% 100% 100% 100% 97,7% 95,1% 95,1% 95,1% 95,1%
0
20
40
60
80
100
Freedom from TLR - 100 patients - 24MFU
0 80 160 240 320 400 480 560 640 720
Time (days)
Cu
mu
lative
fre
ed
om
fro
m T
LR
ra
te (
%)
Number at riskGroup: B
52 51 51 51 49 48 47 47 46 45 43 43 43 43 43 43 40 40 40 18Group: C
47 47 46 46 46 45 44 43 43 43 42 42 42 41 41 41 41 40 40 11
Azema_typeBC
0
20
40
60
80
100
Freedom from TLR - 100 patients - 24MFU
0 80 160 240 320 400 480 560 640 720
Time (days)
Cu
mu
lative
fre
ed
om
fro
m T
LR
ra
te (
%)
Number at riskGroup: B
52 51 51 51 49 48 47 47 46 45 43 43 43 43 43 43 40 40 40 18Group: C
47 47 46 46 46 45 44 43 43 43 42 42 42 41 41 41 41 40 40 11
Azema_typeBC
time baseline 1MFU 6MFU(180 days)
6MFU(210 days)
12MFU(365 days)
12MFU(395 days)
24MFU(730 days)
24MFU(760 days)
AzemaB
at risk 52 51 49 48 45 43 40 18
% 100% 100% 100% 100% 97,8% 97,8% 97,8% 97,8%
AzemaC
at risk 47 47 46 44 43 42 40 11
% 100% 100% 100% 97,8% 97,8% 97,8% 97,8% 97,8%
P=0,96p=0,37
90,7%
95,1%
97,8%
97,8%
Subanalysis – Azéma B vs C
ID3 Medical – 2020
0
20
40
60
80
100
Primary Patency - 100 patients - 24MFU
0 80 160 240 320 400 480 560 640 720
Time (days)
Cum
ulat
ive p
rimar
y pa
tenc
y ra
te (%
)
Number at riskGroup: 0
79 78 76 76 74 71 69 68 67 64 55 54 54 54 54 54 54 54 54 15Group: 1
21 21 21 21 20 17 17 17 17 17 13 13 13 12 12 12 12 12 12 3
Claudicant01
0
20
40
60
80
100
Freedom from TLR - 100 patients - 24MFU
0 80 160 240 320 400 480 560 640 720
Time (days)
Cum
ulat
ive fr
eedo
m fr
om T
LR ra
te (%
)
Number at riskGroup: 0
79 78 76 76 75 74 73 72 71 70 67 67 67 66 66 66 63 63 63 22Group: 1
21 21 21 21 20 19 18 18 18 18 18 18 18 18 18 18 18 17 17 7
Claudicant01
0
20
40
60
80
100
Freedom from TLR - 100 patients - 24MFU
0 80 160 240 320 400 480 560 640 720
Time (days)
Cu
mu
lativ
e f
ree
do
m f
rom
TL
R r
ate
(%
)
Number at riskGroup: 0
79 78 76 76 75 74 73 72 71 70 67 67 67 66 66 66 63 63 63 22Group: 1
21 21 21 21 20 19 18 18 18 18 18 18 18 18 18 18 18 17 17 7
Claudicant01
time baseline 1MFU 6MFU(180 days)
6MFU(210 days)
12MFU(365 days)
12MFU(395 days)
24MFU(730 days)
24MFU(760 days)
Claudicant
at risk 79 78 73 70 62 56 54 15
% 100% 100% 100% 100% 95,5% 94,0% 94,0% 94,0%
CLIat risk 21 21 20 18 18 14 12 3
% 100% 100% 100% 94,7% 94,7% 89,2% 89,2% 89,2%
time baseline 1MFU 6MFU(180 days)
6MFU(210 days)
12MFU(365 days)
12MFU(395 days)
24MFU(730 days)
24MFU(760 days)
Claudicant
at risk 79 78 75 74 70 68 63 22
% 100% 100% 100% 100% 98,6% 98,6% 98,6% 94,0%
CLIat risk 21 21 20 18 18 18 17 7
% 100% 100% 100% 94,7% 94,7% 94,7% 94,7% 89,2%
0
20
40
60
80
100
Freedom from TLR - 100 patients - 24MFU
0 80 160 240 320 400 480 560 640 720
Time (days)
Cu
mu
lativ
e f
ree
do
m f
rom
TL
R r
ate
(%
)
Number at riskGroup: 0
79 78 76 76 75 74 73 72 71 70 67 67 67 66 66 66 63 63 63 22Group: 1
21 21 21 21 20 19 18 18 18 18 18 18 18 18 18 18 18 17 17 7
Claudicant01
p=0,14 p=0,30
CLI CLI
94,0%
89,2%
98,6%
94,7%
Subanalysis – Claudicant vs CLI
ID3 Medical – 2020
0
20
40
60
80
100
Primary Patency - 100 patients - 24MFU
0 80 160 240 320 400 480 560 640 720
Time (days)
Cum
ulat
ive p
rimar
y pa
tenc
y ra
te (%
)
Number at riskGroup: 0
65 65 64 64 61 55 53 52 51 50 40 40 40 39 39 39 39 39 39 12Group: 1
35 34 33 33 33 33 33 33 33 31 28 27 27 27 27 27 27 27 27 6
Diabetes01
0
20
40
60
80
100
Freedom from TLR - 100 patients - 24MFU
0 80 160 240 320 400 480 560 640 720
Time (days)
Cum
ulat
ive fr
eedo
m fr
om T
LR ra
te (%
)
Number at riskGroup: 0
65 65 64 64 62 60 58 57 56 56 55 55 55 54 54 54 51 50 50 22Group: 1
35 34 33 33 33 33 33 33 33 32 30 30 30 30 30 30 30 30 30 7
Diabetes01
0
20
40
60
80
100
Freedom from TLR - 100 patients - 24MFU
0 80 160 240 320 400 480 560 640 720
Time (days)
Cu
mu
lative
fre
ed
om
fro
m T
LR
ra
te (
%)
Number at riskGroup: 0
65 65 64 64 62 60 58 57 56 56 55 55 55 54 54 54 51 50 50 22Group: 1
35 34 33 33 33 33 33 33 33 32 30 30 30 30 30 30 30 30 30 7
Diabetes01
time baseline 1MFU 6MFU(180 days)
6MFU(210 days)
12MFU(365 days)
12MFU(395 days)
24MFU(730 days)
24MFU(760 days)
Non-diabetic
at risk 65 65 60 54 48 41 39 12
% 100% 100% 100% 98,2% 96,3% 94,3% 94,3% 94,3%
Diabeticat risk 35 34 33 33 31 28 27 6
% 100% 100% 100% 100% 93,9% 90,9% 90,9% 90,9%
time baseline 1MFU 6MFU(180 days)
6MFU(210 days)
12MFU(365 days)
12MFU(395 days)
24MFU(730 days)
24MFU(760 days)
Non-diabetic
at risk 65 65 62 59 56 55 50 22
% 100% 100% 100% 98,3% 98,3% 98,3% 98,3% 98,3%
Diabeticat risk 35 34 33 33 32 30 30 7
% 100% 100% 100% 100% 97,0% 97,0% 97,0% 97,0%
p=0,79 p=0,69
0
20
40
60
80
100
Freedom from TLR - 100 patients - 24MFU
0 80 160 240 320 400 480 560 640 720
Time (days)
Cu
mu
lative
fre
ed
om
fro
m T
LR
ra
te (
%)
Number at riskGroup: 0
65 65 64 64 62 60 58 57 56 56 55 55 55 54 54 54 51 50 50 22Group: 1
35 34 33 33 33 33 33 33 33 32 30 30 30 30 30 30 30 30 30 7
Diabetes0194,3%
90,9%
98,3%
97,0%
Subanalysis – Diabetic vs non Diabetics
ID3 Medical – 2020
0
20
40
60
80
100
Primary Patency - 100 patients - 24MFU
0 80 160 240 320 400 480 560 640 720
Time (days)
Cum
ulat
ive p
rimar
y pa
tenc
y ra
te (%
)
Number at riskGroup: 2
21 20 19 19 18 17 17 16 16 16 12 12 12 12 12 12 12 12 12 3Group: 3
58 58 57 57 56 54 52 52 51 48 43 42 42 42 42 42 42 42 42 12Group: 4
20 20 20 20 19 17 17 17 17 17 13 13 13 12 12 12 12 12 12 3Group: 5
1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 0 0 0
R_screening2345
0
20
40
60
80
100
Freedom from TLR - 100 patients - 24MFU
0 80 160 240 320 400 480 560 640 720
Time (days)
Cum
ulat
ive fr
eedo
m fr
om T
LR ra
te (%
)
Number at riskGroup: 2
21 20 19 19 19 18 18 17 17 17 16 16 16 16 16 16 15 15 15 6Group: 3
58 58 57 57 56 56 55 55 54 53 51 51 51 50 50 50 48 48 48 16Group: 4
20 20 20 20 19 18 17 17 17 17 17 17 17 17 17 17 17 17 17 7Group: 5
1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 0 0 0
R_screening2345
0
20
40
60
80
100
Freedom from TLR - 100 patients - 24MFU
0 80 160 240 320 400 480 560 640 720
Time (days)
Cu
mu
lative
fre
ed
om
fro
m T
LR
ra
te (
%)
Number at riskGroup: 2
21 20 19 19 19 18 18 17 17 17 16 16 16 16 16 16 15 15 15 6Group: 3
58 58 57 57 56 56 55 55 54 53 51 51 51 50 50 50 48 48 48 16Group: 4
20 20 20 20 19 18 17 17 17 17 17 17 17 17 17 17 17 17 17 7Group: 5
1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 0 0 0
R_screening2345
time baseline 1MFU 6MFU(180 days)
6MFU(210 days)
12MFU(365 days)
12MFU(395 days)
24MFU(730 days)
24MFU(760 days)
R2at risk 21 20 18 17 15 12 12 3
% 100% 100% 100% 100% 100% 100% 100% 100%
R3at risk 58 58 55 53 47 44 42 12
% 100% 100% 100% 100% 94,1% 92,1% 92,1% 92,1%
R4at risk 20 20 19 17 17 13 12 3
% 100% 100% 100% 94,7% 94,7% 89,2% 89,2% 89,2%
R5at risk 1 1 1 1 1 1 0 0
% 100% 100% 100% 100% 100% 100% NA NA
time baseline 1MFU 6MFU(180 days)
6MFU(210 days)
12MFU(365 days)
12MFU(395 days)
24MFU(730 days)
24MFU(760 days)
R2at risk 21 20 19 18 17 16 15 4
% 100% 100% 100% 100% 100% 100% 100% 100%
R3at risk 58 58 56 56 53 51 48 15
% 100% 100% 100% 100% 98,1% 98,1% 98,1% 98,1%
R4at risk 20 20 19 17 17 17 17 4
% 100% 100% 100% 94,4% 94,4% 94,4% 94,4% 94,4%
R5at risk 1 1 1 1 1 1 0 0
% 100% 100% 100% 100% 100% 100% NA NA
0
20
40
60
80
100
Freedom from TLR - 100 patients - 24MFU
0 80 160 240 320 400 480 560 640 720
Time (days)
Cu
mu
lative
fre
ed
om
fro
m T
LR
ra
te (
%)
Number at riskGroup: 2
21 20 19 19 19 18 18 17 17 17 16 16 16 16 16 16 15 15 15 6Group: 3
58 58 57 57 56 56 55 55 54 53 51 51 51 50 50 50 48 48 48 16Group: 4
20 20 20 20 19 18 17 17 17 17 17 17 17 17 17 17 17 17 17 7Group: 5
1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 0 0 0
R_screening2345
p=0,37 p=0,70
100%
92,1%
89,2%
NA
100%
98,1%
94,4%
NA
Subanalysis – Rutherford 2 – 3 – 4
ID3 Medical – 2020
VMI-CFA trial : clinicalevolution
* Protocol deviation
*
ID3 Medical – 2020
VMI-CFA trial : Safety evaluation
Primary safety endpoint 30 days 6 months 12 months 24 months
Device or procedure related death (N) 0 0 0 0
CD-TLR (N) 0 1 2 2
Target limb major amputation (N) 0 0 0 0
ID3 Medical – 2020
Let us randomize to golden standard……
SUPERSURG RCT
Evaluation of the safety and efficacy of the endovascular treatment of stenotic, restenotic or occlusive lesions of the CFA with Supera stent compared to surgical CFA Endarterectomy
A.Z. Sint-Blasius @ DendermondeOnze-Lieve Vrouwziekenhuis @ Aalst
Ziekenhuis Oost-Limburg @ GenkAz Groeninge @ Kortrijk
A.Z. Jan Portaels @ VilvoordeImelda @ Bonheiden
Noordwest Ziekenhuisgroep – AlkmaarSt. Antonius Ziekenhuis – Utrecht
Heart+Vascular center – MaastrichtMaasstad Ziekenhuis - Rotterdam
Dijklander Ziekenhuis - Hoorn
Guy’s & St Thomas’ Hospital – LondonNorth West University Healthcare – London
Leeds Teaching Hospital - Leeds
Hospital of Lord’s Transfiguration - Poznań
286 patients
1:1 RandomisationStratification: BMI – Azéma - Calcium
ID3 Medical – 2020
SUPERSURG RCT: endpoints
Primary endpoint Secondary endpoints
• Efficacy endpoint @ 12MFUPrimary patency as composite of freedom fromCD-TLR and binary restenosis (PSVR ≥2.4)
To demonstrate non-inferior efficacy of endovascular treatment VS endarterectomy
• Safety endpoint @ 30daysSafety as composite of all-cause death, cardiac, pulmonary, renal complications, sepsis, TLR and wound-related complications
To demonstrate superior safety of endovascular treatment VS endarterectomy
• Technical success
• PP in DFA @ 6, 12, 24 and 36 months
• PP @ 6, 24 and 36 months
• TLR @ 6, 12, 24 and 36 months
• TVR @ 6, 12, 24 and 36 months
• Binary restenosis @ 6, 12, 24 and 36 months
• Duration of initial hospital stay
• Clinical success @ 6, 12, 24 and 36 months
• All cause death @ 6, 12, 24 and 36 months
• Thrombosis at TL @ 6, 12, 24 and 36 months
ID3 Medical – 2020
• In 2019, although CFE still remains the golden standard, the historical “no endovascular for this baby”-statement is wrong.
• There are some indicative papers that show there is definitely a place for safer & as-efficient endovascular therapy in CFA treatment.
• Newer generation of devices, like the high crush resistant, repuncturable Superastent, are facilitating this endo-approach
• With this particular device, the VMI-CFA trial shows excellent 2 year results : primary patency of 92.8%, freedom TLR of 97.8% , clear clinical benefit & a very high safety profile
• More fragile (to invasive surgery) population like CLI patients and diabetic cohorts show outstanding endovascular results in the CFA
• The head to head SUPERSURG-RCT (Supera vs CFE) will definitively clarify the safety and efficacy CFA-treatment discussion
Take home messages
ID3 Medical – 2020
Koen Deloose, MD
Head Dept Vascular Surgery
AZ Sint Blasius
Dendermonde, Belgium
Full cohort 24-month Safety and Efficacy Results of the
VIM-CFA Trial