The Study

a physician-initiated study investigating the combination therapyfor treatment with DCB and BMS in femoropopliteal lesions.

Dr. Michel Bosiers

Conflict of interest

have the following potential conflicts of interest to report:ConsultingEmployment in industryStockholder of a healthcare companyOwner of a healthcare companyOther(s)

I do not have any potential conflict of interest

2

✓

FMRP - 2017

DCB + Stent : treatment rationale

DCB

3FMRP - 2017

Proof of concepts DCB

Sin

gle

arm

PASSEO 18 LUX

PTX 3µgr/mm²

+ BTHC

P=0.033

PACCOCATH

PTX 3µgr/mm² + Ultravist

P=0.031

IN.PACT

PTX 3,5µgr/m

m² + Urea

P=0.001

CVI

PTXExcipient?

PACCOCATH

PTX 3µgr/mm² + Ultravist

P<0.001

LUTONIX

PTX 2µgr/mm²

+ polysorbate& sorbitol

P=0.016

ADVANCE

PTX 3µgr/mm²

No excipient

P=0.124FMRP - 2017

Primary Patency at 12-months

5FMRP - 2017

N.A.0

20

40

60

80

100

ste

nti

ng

rate

(%)

stenting ratePrimary Patency at 12-months

N.A. N.A.

6FMRP - 2017

Example Case of our daily practice

baseline

DilatationPasseo 18 Lux 6mm

(Biotronik)

StentingPulsar 18 6mm

(Biotronik) 1 year result

7FMRP - 2017

…a lot of remaining questions….

?? First DCB… then BMS ??

?? Bail-out stenting ??

?? Primary stenting ??

?? Spot stenting ??

?? Full lesion coverage??

?? First BMS… then DCB ??

8FMRP - 2017

DCB & Stent : clinical evidence

9FMRP - 2017

DCB & Stent : clinical evidence

Liistro et al. JACC 2013;6(12):1295-1302

✓ Single center, randomized trial✓ 110 lesions :

55 DCB (IN.Pact Admiral) + BMS (Maris SX) vs 55 POBA + BMS

✓ Primary endpoint : 12 m binary restenosis✓ A.L.L. : 94 + 60 (DCB + BMS) vs 96 + 69 (POBA + BMS)

DEBATE SFA

10FMRP - 2017

DCB & Stent : clinical evidence

Liistro et al. JACC 2013;6(12):1295-1302

DEBATE SFA

11FMRP - 2017

DCB & Stent : clinical evidence

Liistro et al. JACC 2013;6(12):1295-1302

Restenosis @1 yr

Freedom TLR @1 yr Restenosis ~ lesion length

DEBATE SFA

12FMRP - 2017

DCB & Stent : clinical evidence

✓ Single center, prospective, single arm trial✓ 65 lesions : Pulsar 18 BMS + Passeo 18 LUX post-dil✓ Primary endpoint : 12/24 m ppr (PSVR<2,5)✓ A.L.L. : 187.7 mm

Mwipatayi P. Presented @ Veith 2015, NYC, US

6m PP = 98.0 %

time 1MFU 6MFU 12MFU 18MFU 24MFU

at risk 50 50 48 47 45

% 98 98 94.1 92.2 88.2

13FMRP - 2017

DEBAS

DOES IT WORK ON THE LONG(ER) RUN???✓ Single center, prospective, single arm trial✓ 65 lesions : Pulsar 18 BMS + Passeo 18 LUX post-dil✓ Primary endpoint : 12/24 m ppr (PSVR<2,5)✓ A.L.L. : 187.7 mm

Mwipatayi P. Presented @ Veith 2015, NYC, US

12m PP = 94.1 %

time 1MFU 6MFU 12MFU 18MFU 24MFU

at risk 50 50 48 47 45

% 98 98 94.1 92.2 88.2

DEBAS

14FMRP - 2017

DOES IT WORK ON THE LONG(ER) RUN???✓ Single center, prospective, single arm trial✓ 65 lesions : Pulsar 18 BMS + Passeo 18 LUX post-dil✓ Primary endpoint : 12/24 m ppr (PSVR<2,5)✓ A.L.L. : 187.7 mm

Mwipatayi P. Presented @ Veith 2015, NYC, US

24m PP = 88.2 %

time 1MFU 6MFU 12MFU 18MFU 24MFU

at risk 50 50 48 47 45

% 98 98 94.1 92.2 88.2

DEBAS

15FMRP - 2017

120 patients – Target lesion < 19 cmPrimary endpoint : PPR @ 12 months DUS

(PSVR < 2,5)

Physician-Initiated, prospective, multi-center (5), controledtrial Investigating the Efficacy of EV Treatment of Fempop

Arterial Stenotic Disease with BIOtronik Passeo-18 LUX Drug Releasing Balloon & Biotronik Pulsar-18 Stent

(comparing with 4EVER trial results)

DCB & Stent : clinical evidence

16FMRP - 2017

Participating centers• Imelda Hospital, Bonheiden

Dr. P. Peeters, Dr. J. Verbist, Dr. W. Van den Eynde

• AZ Sint-Blasius Hospital, DendermondeDr. K. Deloose, Dr. M. Bosiers, Dr. J. Callaert

• OLV Hospital, AalstDr. L. Maene, Dr. R. Beelen

• RZ Heilig Hart, TienenDr. K. Keirse, Dr. B. Joos

• University Hospital AntwerpProf. J. Hendriks, Prof. P. Lauwers

17FMRP - 2017

Patient demographics

N = 120 out of 120

Male (%) 79 (65.83%)

Age (min – max; ±SD) 70.87 years (43.73 – 92.41; ±10.52)

Nicotine abuse (%) 73 (60.83%)

Hypertension (%) 76 (63.33%)

Diabetes mellitus (%) 23 (19.17%)

Renal insufficiency (%) 15 (12.50%)

Hypercholesterolemia (%) 66 (55.00%)

Obesity (%) 28 (23.33%)

*missing data for 1 patient

32%

51%

17%

Rutherford Classification

Rutherford 2 Rutherford 3 Rutherford 4

18FMRP - 2017

Indications & Procedural characteristics

Reference Vessel Diameter 5.26 mm (4.0 – 6.0 ; ±0.59)

DCBSTENT

N = 151N = 131

Mean DCB diameter (min – max; ±SD) 5.15 mm (4.0 – 6.0 ; ±0.57)

Mean STENT diameter (min – max; ±SD) 5.78 mm (5.0 – 7.0 ; ±0.53)

Occlusion (%) 40 (33.33%)

Calcified lesion (%) 60 (50.00%)

Lesion length (min – max; ±SD) 83.33 mm (6.0 – 190.0; ±49.49)

19FMRP - 2017

12 Month Primary Patency

time baseline 1MFU 6MFU12MFU(D365)

12MFU(D395)

% 100 100 94.7 89.9 86.9

89.9 %

20FMRP - 2017

12 Month freedom from TLR

time baseline 1MFU 6MFU12MFU(D365)

12MFU(D395)

% 100 100 97.4 93.6 91.6

93.6 %

21FMRP - 2017

24 Month Primary Patency – 100 pts

time baseline 1MFU 6MFU 12MFU 24MFU

% 100 100 94.90 89.30 83.30

83.30 %

22FMRP - 2017

24 Month freedom from TLR – 100 pts

time baseline 1MFU 6MFU 12MFU 24MFU

% 100 100 97.90 93.60 86.40

86.40 %

23FMRP - 2017

Combining Passeo Lux® with Pulsar18® stent creates a win-win situation as shown in preliminary 12 monthsdata of BIOLUX 4EVER and confirmed in DEBAS results

Conclusion

24FMRP - 2017

DCB for popliteal artery stenosis

Dr. Michel Bosiers

Conflict of interest

have the following potential conflicts of interest to report:ConsultingEmployment in industryStockholder of a healthcare companyOwner of a healthcare companyOther(s)

I do not have any potential conflict of interest

FMRP - 2017 26

Admiral Drug Coated Balloon

27FMRP - 2017

IN.Pact Flexion study

A Prospective, non-randomized, multi center studyinvestigating the Efficacy of the Admiral Drug

Coated Balloon for treatment of popliteal lesions

FMRP - 2017 28

Study design

• Study Objective:To evaluate the performance of the

for the treatment of .

• Primary Endpoint:, defined as absence of a

hemodynamically significant stenosis on duplex ultrasound (systolicvelocity ratio ≤2.4) at the target lesion and without reintervention.

29FMRP - 2017

Participating centers

• BELGIUM• M. Bosiers, K. Deloose, J. Callaert - AZ Sint-Blasius, Dendermonde

• P. Peeters, J. Verbist, W. Van den Eynde - Imelda Hospital, Bonheiden

• L. Maene, R. Beelen - OLV, Aalst

• K. Keirse - RZ Heilig Hart, Tienen

• J. Hendriks, P. Lauwers – University Hospital Antwerp, Edegem

FMRP - 2017 30

Inclusion criteria

Main inclusion criteria

in the femoropopliteal arteries, suitable for endovascular therapy

• Total target lesion length

IN.Pact flexion91 out of 100 patients enrolled (91%)

FMRP - 2017 31

1 M 6 M 12 MBaseline

Medication

Physical examination

Rutherford

ABI

Duplex Ultrasound

VascuQol

dischTimeline

Study overview

FMRP - 2017 32

Patient Demographics

FMRP - 2017 33

N = 60 out of 100

Male (%) 36 (60.00%)

Age (min – max; ±SD) 74.70 (48.70 – 96.21; ±10.33) years

Nicotine abuse (%) 29 (48.33%)

Hypertension (%) 37 (61.67%)

Diabetes mellitus (%) 20 (33.33%)

Renal insufficiency (%) 9 (15.00%)

Hypercholesterolemia (%) 31 (51.67%)

Obesity (%) 12 (20.00%)

11

31

6

12

Rutherford Classification

RF 2 RF 3 RF 4 RF 5

Procedural characteristics

FMRP - 2017 34

N = 60 out of 100

Procedure time (min-max ; ±SD) 37.85 (12-74 ; ±14.05) minutes

Scopy time (min – max; ±SD) 11.21 (2 – 60; ±9.33) minutes

Contrast (min – max; ±SD) 103 (60 – 200; ±25.69) mL

Cross-over performed (%) 38 (63.33%)

Inflow Lesion (%) 11 (18.33%)

Outflow lesion (%) 3 (5.00%)

Lesion Characteristics

FMRP - 2017 35

N = 60 out of 100

Lesion length (min – max; ±SD) 54.75 (20 – 140; ±34.97) mm

Ref Vessel Diameter (min – max; ±SD) 5.02 (4.0 – 7.0; ±0.601) mm

Pre-dilatation (%) 37 (61.67%)

1 DCB (%)

2 DCB’s (%)

54 (90.00%)

6 (10.00%)

Post-dilatation (%) 12 (20.00%)

Bail-out stenting (%) 8 (13.33%)

Occlusion (%) 15 (25.00%)

Calcified lesion (%) 31 (51.67%)

12-month Primary Patency – 60 pts

FMRP - 2017 36

87.30%

12-month Freedom from TLR – 60 pts

FMRP - 2017 37

90.90%

12-month Rutherford evolution – 60 pts

FMRP - 2017 38

BL 1MFU 6MFU 12MFU

RF5 12 0 1 1

RF4 6 2 0 0

RF3 31 2 0 0

RF2 11 1 1 2

RF1 0 6 5 2

RF0 0 43 41 35

0

10

20

30

40

50

60

70

Rutherford Evolution

RF0 RF1 RF2 RF3 RF4 RF5

Conclusion

•Preliminary results suggest that the Admiral DCB isa valid and effective alternative to treat popliteallesions

•Awaiting for the final 12-month results

FMRP - 2017 39