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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
12 Month outcomes from the Lutonix ISR randomized Trial
Koen Deloose, MD
Head of Vascular Surgery, AZ Sint Blasius
Dendermonde, Belgium
2 ID3 Medical – 2017 |
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
3 ID3 Medical – 2017 |
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
4 ID3 Medical – 2017 |
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
5 ID3 Medical – 2017 |
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
6 ID3 Medical – 2017 |
EVENT
Pre
-Pro
ced
ure
Pro
ced
ure
Post
-Pro
ced
ure
1 M
on
th
6 M
on
th
12
Mo
nth
24
Mo
nth
36
, 48
& 6
0
mo
nth
s
Rep
eat
An
gio
/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
7 ID3 Medical – 2017 |
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
8 ID3 Medical – 2017 |
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.
9 ID3 Medical – 2017 |
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
10 ID3 Medical – 2017 |
Kaplan-Meier TLR-Free Survival Estimates
Large Improvement in fTLR
28.5% Improvement with DCB
11 ID3 Medical – 2017 |
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%]
12 ID3 Medical – 2017 |
• 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
12 Month outcomes from the Lutonix ISR randomized Trial
Koen Deloose, MD
Head of Vascular Surgery, AZ Sint Blasius
Dendermonde, Belgium
