A.Z. Sint-Blasius, Dendermonde Combination therapy : Joren ... · Physician-Initiated, prospective, multi-center (5), controled trial Investigating the Efficacy of EV Treatment of

FMRP 2016 | 1

Marc Bosiers Koen Deloose Joren Callaert

A.Z. Sint-Blasius, Dendermonde

Imelda Hospital, Bonheiden

Patrick Peeters Jürgen Verbist

OLV Hospital, Aalst

Lieven Maene Roel Beelen

R.Z. Heilig Hart, Tienen

Koen Keirse

LINC Asia Pacific 2016, Hong Kong

Combination therapy : treatment rationale and

clinical evidence

Koen Deloose, MD

FMRP 2016 |

DCB + Stent : treatment rationale

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DCB

FMRP 2016|

Proof of concepts

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DCB POBA

Sin

gle

arm

PASSEO 18 LUX

PTX 3µgr/mm²

+ BTHC

P=0.033

PACCOCATH

PTX 3µgr/mm² + Ultravist

P=0.031

IN.PACT

PTX 3µgr/mm²

+ Urea

P=0.001

CVI

PTX Excipient?

PACCOCATH

PTX 3µgr/mm² + Ultravist

P<0.001

LUTONIX

PTX 2µgr/mm²

+ polysorbate & sorbitol

P=0.016

ADVANCE

PTX 3µgr/mm²

No excipient

P=0.12

FMRP 2016|

Primary Patency at 12-months

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N.A. N.A. N.A.

FMRP 2016|

Primary Patency at 12-months

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N.A. N.A. N.A. 0

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ste

nti

ng

rate

(%

)

stenting rate

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Freedom from TLR at 12-months

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FMRP 2016|

Freedom from TLR at 12-months

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0

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ste

nti

ng

rate

(%

)

stenting rate

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Example Case of our daily practice

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baseline Stenting

Pulsar 18 6mm (Biotronik°)

Dilatation Passeo 18 Lux 6mm

(Biotronik°)

1yr result

FMRP 2016|

Stents with PACLITAXEL work…

• ZILVER PTX versus ZILVER (COOK Medical®)

• ELUVIA versus INNOVA BMS (Boston Scientific®)

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FMRP 2016|

BUT PTX footprint with DCB + BMS is bigger than DES…

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DES PTX contact DCB + BMS PTX contact

FMRP 2016|

…and DCB + BMS is more adaptable…

• Longer lengths available (balloons – stents)

• Spot stenting – full coverage

• Economical advantage?

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…DATA…

FMRP 2016|

DCB & Stent : clinical evidence

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FMRP 2016|

DCB & Stent : clinical evidence

13 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)

FMRP 2016|

DCB & Stent : clinical evidence

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120 patients – Target lesion < 19 cm

Primary endpoint : PPR @ 12 months DUS

(PSVR < 2,5)

Physician-Initiated, prospective, multi-center (5), controled trial 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)

PRELIMINARY 6 MONTH DATA

FMRP 2016|

DCB & Stent : clinical evidence

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BIOLUX4EVER

all patients enrolled

Preliminary (85/120) 6 months data

FMRP 2016|

Patient demographics

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N=85 out of 120

Male (%) 53 (62.4%)

Age (min – max; ±SD) 70.58 (43.73 – 89.12 ±10.26)

Nicotine abuse (%) 32 (37.6%)

Hypertension (%) 54 (63.5%)

Diabetes mellitus (%) 30 (35.3%)

Renal insufficiency (%) 9 (10.6%)

Hypercholesterolemia (%) 47 (55.3%)

Obesity (%) 19 (22.4%)

FMRP 2016|

Indications + Procedural characteristics

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N= 85 out of 100

Rutherford 2 (%) 29 (34.1%)

Rutherford 3 (%) 43 (40.6%)

Rutherford 4 (%) 13 (15.3%)

Duration (minutes) 49.05* (6.00 – 120.00 ; ±18.77)

Access side: - Left Common Femoral Artery (%)

- Right Common Femoral Artery (%)

41 (48.2%)

44 (51.8%)

Cross-over performed (%) 70 (82.4%)

Fluoroscopy (minutes) 9.38** (2.00 – 28.00 ; ±4.66)

Contrast dose (ml) 91.65* (17.00 – 150.00 ; ±91.65)

*missing data for 2 patients, ** missing data for 7 patients

FMRP 2016|

Lesion characteristics

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N = 85 out of 100

Left/Right limb (%) 41 (48.2%) / 44 (51.8%)

Lesion length (min – max; ±SD) 79.72 mm (6.0 – 190.0; ±49.12)

Reference vessel diameter 5.27 mm

Mean lumen diameter 0.58 mm

Occlusion (%) 24 (28.2%)

Calcified lesion (%) 35 (41.18%)

FMRP 2016| 19

6 Month Primary Patency (interim)

time baseline 1MFU 6MFU

at risk 85 85 71

% 100 100. 96.1

96.1 %

FMRP 2016| 20

6 Month Freedom from TLR (interim)

98.8 %

time baseline 1MFU 6MFU

at risk 85 85 73

% 100 100 98.8

FMRP 2016|

DCB & Stent : clinical evidence

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Single center, prospective, single arm trial

65 lesions : Pulsar 18 BMS + Passeo

18 LUX post-dil

Strut width :

the bigger, the

lower direct

PTX contact

Strut thickness

: the bigger,

the lower direct

PTX contact

Pulsar

Stent

85micro

140m

icro

FMRP 2016|

DCB & Stent : clinical evidence

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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

1 Month 6 Months 12 Months 18 Months 24 Months

Patients at risk (n) 50 50 48 47 45

Patency (%) 98 98 94.1 92.2 88.2

6m PP = 98.0%

FMRP 2016|

DOES IT WORK ON THE LONG(ER) RUN???

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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

1 Month 6 Months 12 Months 18 Months 24 Months

Patients at risk (n) 50 50 48 47 45

Patency (%) 98 98 94.1 92.2 88.2

12m PP = 94.1%

FMRP 2016|

DOES IT WORK ON THE LONG(ER) RUN???

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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

1 Month 6 Months 12 Months 18 Months 24 Months

Patients at risk (n) 50 50 48 47 45

Patency (%) 98 98 94.1 92.2 88.2

24m PP = 88.2%

FMRP 2016|

IS IT WORTHWILE TO ADD DCB???

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BIOLUX4EVER

DEBAS 4EVER

Primary patency 6 months

PPR 6m

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98.0 96,1 89,4

7%

LL (cm) 7,9 18,8 11,2 7,2

PSVR (<) 2,5 2,5 2,5 2,5

91,3

PEACE

FMRP 2016|

IS IT WORTHWILE TO ADD DCB???

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BIOLUX 4EVER DEBAS 4EVER

Primary Patency 12 months

PEACE

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94.1 81,4

13%

LL (cm) 7,9 18,8 11,2 7,2

PSVR (<) 2,5 2,5 2,5 2,5

81,2

FMRP 2016|

IS IT WORTHWILE TO ADD DCB???

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BIOLUX 4EVER DEBAS 4EVER

Primary Patency 24 months

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72,3 88,2

16%

LL (cm) 7,9 18,8 7,2

PSVR (<) 2,5 2,5 2,5

FMRP 2016|

IS IT COMPARABLE TO DES DATA?

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Zilver PTX RCT Zilver PTX JapanesePMS

MAJESTIC DEBAS

Benchmarking in the DES world

PPR 1yr f TLR

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84,4 96,1 84,8 94.1 91,6 91,4 96,2 94,1

LL (cm) 5,5 14,7 7,0 18,7

PSVR (<) 2,0 2,4 2,5 2,5

FMRP 2016|

Conclusion

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DCB are effective (PPR & fTLR) & safe in treatment of SFA/pop lesions

The longer the lesion, the more stents are used

Combining DCB with low profile (!) modern BMS creates a win-win

situation as shown in preliminary 6 months data of BIOLUX 4EVER

and confirmed in DEBAS results, even up to 2 year

Benchmarking with DES studies (although very difficult) shows

comparable results with DCB + modern BMS LP

Longer (and potentially cheaper) lesion length treatment with less

metallic implants seems a reasonable advantage for DCB + BMS LP

FMRP 2016 | 30

Marc Bosiers Koen Deloose Joren Callaert

A.Z. Sint-Blasius, Dendermonde

Imelda Hospital, Bonheiden

Patrick Peeters Jürgen Verbist

OLV Hospital, Aalst

Lieven Maene Roel Beelen

R.Z. Heilig Hart, Tienen

Koen Keirse

LINC Asia Pacific 2016, Hong Kong

Combination therapy : treatment rationale and

clinical evidence

Koen Deloose, MD