Win, win, win? A critical perspective on student volunteering
a physician-initiated study investigating the combination ... · win-win situation as shown in...
Transcript of a physician-initiated study investigating the combination ... · win-win situation as shown in...
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The Study
a physician-initiated study investigating the combination therapyfor treatment with DCB and BMS in femoropopliteal lesions.
Dr. Michel Bosiers
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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
✓
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DCB + Stent : treatment rationale
DCB
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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
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Primary Patency at 12-months
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N.A.0
20
40
60
80
100
ste
nti
ng
rate
(%)
stenting ratePrimary Patency at 12-months
N.A. N.A.
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Example Case of our daily practice
baseline
DilatationPasseo 18 Lux 6mm
(Biotronik)
StentingPulsar 18 6mm
(Biotronik) 1 year result
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…a lot of remaining questions….
?? First DCB… then BMS ??
?? Bail-out stenting ??
?? Primary stenting ??
?? Spot stenting ??
?? Full lesion coverage??
?? First BMS… then DCB ??
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DCB & Stent : clinical evidence
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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
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DCB & Stent : clinical evidence
Liistro et al. JACC 2013;6(12):1295-1302
DEBATE SFA
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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
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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
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DEBAS
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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
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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
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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
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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
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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
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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)
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12 Month Primary Patency
time baseline 1MFU 6MFU12MFU(D365)
12MFU(D395)
% 100 100 94.7 89.9 86.9
89.9 %
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12 Month freedom from TLR
time baseline 1MFU 6MFU12MFU(D365)
12MFU(D395)
% 100 100 97.4 93.6 91.6
93.6 %
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24 Month Primary Patency – 100 pts
time baseline 1MFU 6MFU 12MFU 24MFU
% 100 100 94.90 89.30 83.30
83.30 %
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24 Month freedom from TLR – 100 pts
time baseline 1MFU 6MFU 12MFU 24MFU
% 100 100 97.90 93.60 86.40
86.40 %
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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
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DCB for popliteal artery stenosis
Dr. Michel Bosiers
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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
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Admiral Drug Coated Balloon
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IN.Pact Flexion study
A Prospective, non-randomized, multi center studyinvestigating the Efficacy of the Admiral Drug
Coated Balloon for treatment of popliteal lesions
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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.
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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
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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%)
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1 M 6 M 12 MBaseline
Medication
Physical examination
Rutherford
ABI
Duplex Ultrasound
VascuQol
dischTimeline
Study overview
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Patient Demographics
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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
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Procedural characteristics
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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%)
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Lesion Characteristics
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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%)
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12-month Primary Patency – 60 pts
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87.30%
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12-month Freedom from TLR – 60 pts
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90.90%
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12-month Rutherford evolution – 60 pts
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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
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Conclusion
•Preliminary results suggest that the Admiral DCB isa valid and effective alternative to treat popliteallesions
•Awaiting for the final 12-month results
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