a.z. sint-blasius, dendermonde combination therapy : joren ... · physician-initiated, prospective,...
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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
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Primary Patency at 12-months
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N.A. N.A. N.A.
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Primary Patency at 12-months
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N.A. N.A. N.A. 0
20
40
60
80
100
ste
nti
ng
rate
(%
)
stenting rate
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Freedom from TLR at 12-months
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Freedom from TLR at 12-months
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0
20
40
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80
100
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
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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
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…and DCB + BMS is more adaptable…
• Longer lengths available (balloons – stents)
• Spot stenting – full coverage
• Economical advantage?
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…DATA…
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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%)
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6 Month Primary Patency (interim)
time baseline 1MFU 6MFU
at risk 85 85 71
% 100 100. 96.1
96.1 %
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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