full cohort 24-month safety and efficacy results of …...id3 medical –2020 koen deloose, md head...

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


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


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…


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


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


The best single arm proof of this statement…

TIMELINE


• 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


• 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


VMI-CFA trial : patient/lesioncharacteristics


VMI-CFA trial : proceduralcharacteristics


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


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


VMI-CFA trial : 2 yearfreedomfromTLR*


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)


VMI-CFA trial : 2 yearfreedomfromTVR*


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


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


0 80 160 240 320 400 480 560 640 720

Time (days)

Cu

mu

lative

fre

ed

om

fro

m T

LR

ra

te (

%)


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


0 80 160 240 320 400 480 560 640 720

Time (days)

Cu

mu

lative

fre

ed

om

fro

m T

LR

ra

te (

%)


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


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


0

20

40

60

80

100


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


0 80 160 240 320 400 480 560 640 720

Time (days)

Cum

ulat

ive fr

eedo

m fr

om T

LR ra

te (%

)


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


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

(%

)


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


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%


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


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

(%

)


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


0

20

40

60

80

100


0 80 160 240 320 400 480 560 640 720

Time (days)

Cum

ulat

ive p

rimar

y pa

tenc

y ra

te (%

)


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


0 80 160 240 320 400 480 560 640 720

Time (days)

Cum

ulat

ive fr

eedo

m fr

om T

LR ra

te (%

)


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


0 80 160 240 320 400 480 560 640 720

Time (days)

Cu

mu

lative

fre

ed

om

fro

m T

LR

ra

te (

%)


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


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%


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


0 80 160 240 320 400 480 560 640 720

Time (days)

Cu

mu

lative

fre

ed

om

fro

m T

LR

ra

te (

%)


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


0

20

40

60

80

100


0 80 160 240 320 400 480 560 640 720

Time (days)

Cum

ulat

ive p

rimar

y pa

tenc

y ra

te (%

)


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


0 80 160 240 320 400 480 560 640 720

Time (days)

Cum

ulat

ive fr

eedo

m fr

om T

LR ra

te (%

)


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


0 80 160 240 320 400 480 560 640 720

Time (days)

Cu

mu

lative

fre

ed

om

fro

m T

LR

ra

te (

%)


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


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


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


0 80 160 240 320 400 480 560 640 720

Time (days)

Cu

mu

lative

fre

ed

om

fro

m T

LR

ra

te (

%)


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


VMI-CFA trial : clinicalevolution

* Protocol deviation

*


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


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


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


• 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


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

full cohort 24-month safety and efficacy results of …...id3 medical –2020 koen deloose, md head...

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