12 Month outcomes from the Lutonix ISR randomized Trial · D e fin e d P re - D ila ta tio n ( B a...
Transcript of 12 Month outcomes from the Lutonix ISR randomized Trial · D e fin e d P re - D ila ta tio n ( B a...
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12 Month outcomes from the Lutonix ISR randomized Trial
Koen Deloose, MD
Head of Vascular Surgery, AZ Sint Blasius
Dendermonde, Belgium
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Disclosure slide
I have the following potential conflicts of interest to report:
Consulting: Medtronic, Spectranetics, Biotronik, Abbott, Bard
iVascular, Bentley, Cook, GE Healthcare
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
I do not have any potential conflict of interest
Speaker name: Koen Deloose, MD
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The results of modern generation stents?
20-30% in-stent restenosis Chemical block
Inhibiting smooth muscle cell migration and
proliferation
DEB DES
Deblocking Removing hydrated
collagen matrix/neo-intimal hyperplasia
Atherectomy
Mechanical block Creating physical
barrier/removing ISR stimulus from the equation
Covered stents
Doesn’t seem to work that
good as a stand alone therapy
Adding more lifelong metal, probably the origin of ISR,
can’t be the optimal solution
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Lutonix ISR randomized trial A Prospective, Multicenter, Single-Blind,
Randomized, Controlled Trial Comparing the Lutonix® Drug Coated Balloon vs. Standard
Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis
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Levant 2 Design: DSMB, Blinded CEC and Core Lab
Randomized Blinded Study Design
Baseline Angiogram
Test Arm
Dilatation with Drug
Coated Balloon
Control Arm
Dilatation with uncoated
balloon
Defined Pre-Dilatation
(Balloon inflated to ~1mm <RVD)/
Enrollment
Randomization
2:1
Defined bailout stenting
(if necessary) with FDA approved Stent.
Standard Post-Dilatation per physician
discretion.
Recruitment
53 patients 29 patients
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EVENT
Pre
-Pro
ced
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Pro
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Post
-Pro
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1 M
on
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6 M
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12
Mo
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24
Mo
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36
, 48
& 6
0
mo
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Rep
eat
An
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/Rev
asc
Inclusion/Exclusion Criteria √ √
Informed Consent √
Med Hx √
Pregnancy Test √
Physical Exam √ √ √ √ √ √ √
Medication Compliance √ √ √ √ √ √ √
Resting ABI √ √ √ √ √ √ √
Rutherford Classification √ √ √ √ √
WIQ & EQ5D Questionnaires √ √ √ √
Angiogram √ √
Adverse Event Monitoring √ √ √ √ √ √ √ √
Duplex Ultrasound √ √ √ √
Study Follow-up
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Summary DCB Subjects
(N=53)
PTA Subjects
(N=29)
Age (Years), Mean ± SD (n) 68.9 ± 9.35 (53) 67.0 ± 8.64 (29)
BMI ≥ 30 kg/m2(n/N) 41.5 % (22/53) 42.9% (12/28)
Diabetes, % (n/N) 37.7% (20/53) 55.2% (16/29)
Baseline Target Limb Rutherford Grade, % (n/N)
2
3
4
17.0% (9/53)
77.4% (41/53)
5.7% (3/53)
13.8% (4/29)
75.9% (22/29)
10.3% (3/29)
RVD (mm), Mean ± SD (n) 4.7 ± 0.66 (53) 4.7 ± 0.52 (29)
CTO, % (n/N) 9.4% (5/53) 6.9% (2/29)
Calcification, % (n/N) 47.2% (25/53) 71.4% (20/28)
Baseline ABI of Target Limb, Mean ± SD (n) 0.77 ± 0.15 (46) 0.78 ± 0.20 (24)
Treated Length (mm), Mean ± SD (n) 152.4 ± 62.5 (50) 142.0 ± 74.7 (27)
% Bail out / Provisional Stenting – post dilation 0.0 % 0.0%
Subject Characteristics
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Kaplan-Meier Primary Safety Survival Estimates
Primary Safety Non-Inferior to PTA
Primary Safety Endpoint: Freedom from all-cause perioperative (≤30 day) death and freedom at 1 year from index limb amputation (above and below the ankle) index limb re-intervention, and index-limb-related death.
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Freedom From DCB Subjects
% [95% CI]
PTA Subjects
% [95% CI]
All Cause Death 100.0 [NA, NA] 96.3% [76.3%, 99.5%]
Major Amputation 100.0 [NA, NA] 100.0 [NA, NA]
Minor Amputation 100.0 [NA, NA] 96.3% [76.5%, 99.5%]
Major Vascular Complications 98.1% [89.7%, 100.0%] 92.9% [76.5%, 99.1%]
Additional Safety Profile
Similar DCB and PTA Safety Profiles
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Kaplan-Meier TLR-Free Survival Estimates
Large Improvement in fTLR
28.5% Improvement with DCB
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28.6% Improvement with DCB Defined as an improvement in Rutherford Category compared to
baseline and freedom from TVR
Sustained Clinical Benefit
Sustained clinical benefit: Improvement in Rutherford Class and freedom from TVR
DCB Subjects PTA Subjects
Success %
(n/N)
95% CI Success %
(n/N)
95% Cl
12 Months 61.2% (30/49) [46.2%, 74.8%] 47.6% (10/21) [25.7%, 70.2%]
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• Only Randomized Blinded DCB ISR Study
Blinded CEC and Core Lab Adjudication
• No Bail-out / Provisional Stenting
• DCB Safety non-inferior to PTA
In lesions up to 315 mm
Low rate of vascular complications (1.9%)
• 28.5% Difference in Improvement over PTA for Freedom from Clinically Driven TLR
• 28.6% Difference in Improvement over PTA in Sustained Clinical Benefit
Conclusions
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12 Month outcomes from the Lutonix ISR randomized Trial
Koen Deloose, MD
Head of Vascular Surgery, AZ Sint Blasius
Dendermonde, Belgium