Viva lutonix real world global registry 10 31- 2014

1. A First Look at and Interim Analysis
of 12 month Outcomes from the
Lutonix Global SFA Registry
A Prospective, Global Multicenter, Single Arm Real-World
Registry Investigating the Clinical Use and Safety of the
Lutonix® Drug Coated PTA Dilatation Catheter
Dr. Michael Lichtenberg
Karolinen Hospital, Germany

2. Conflicts of Interest

3. Registry Objectives
Demonstrate safety and assess the
clinical use and outcomes of the Lutonix
DCB in a heterogeneous patient
population in real-world clinical practice.

4. Registry Design
Enrollment
• Up to 1000 patients with
femoropopliteal lesions
• Registry to include up to 75
sites
• Follow up 1m, 6m, 12m and
24m by phone or at clinic
• Patient consent for 5 year F/U
Inclusion
• Male or non-pregnant female ≥ 18
years
• Rutherford Class ≤ 4
• Stenotic or obstructive vascular
lesions of the Fem-Pop artery
treated per IFU
• At least one patent native outflow
artery to the ankle free from
significant lesion (≥ 50% stenosis)
as confirmed by angiography

5. GReal World Global Registry Status
Enrollment ended with 691 patients
• Global, real world, all comer
data
• Multi center participation: 38
sites from 11 countries
participated in the Registry
• Enrollment: Dec 2012 – Jul
2014
6 13
18
28
28
49
53
59
68
371
Enrollment by country
France Spain Switzerland Poland UK
Belgium Greece Italy Austria Germany
5

6. Primary End Points
• Freedom from TLR at 12
months
Effectiveness
• Freedom at 30 days from
• TVR
• Major limb amputation
• Device or procedure related
death
Safety

7. Baseline Clinical Characteristics
N 691
Age, mean ± SD (n) 68.2 ± 9.8 (687)
Male gender, % (n/N) 67.5% (464/687)
Hypertension, % (n/N)* 85.2% (585/687)
Diabetes Mellitus, % (n/N) 39.6% (272/687)
Dyslipidemia, % (n/N) 70.5% (484/687)
Current Smoker, % (n/N) 36.6% (251/686)
History of chronic renal insufficiency,
% (n/N) 10.5 % (72/687)

8. Rutherford Class Breakup
6.7%
4.4%
17.4%
62.9%
7.3%
1.2%
0.1%
NA
Class 1
Class 2
Class 3
Class 4
Class 5
Class 6

9. Lesion Characteristics
Target Lesion length (mm), mean
± SD (n)
101.8 ± 84.3
(675)
Total treated length, min - max (mm)
197.3 ± 133.5
(201)
Calcification % (n/N) 34.4% (233/678)
Total Occlusion, % (n/N) 30.8% (208/675)
Lesion location
Proximal SFA 7.7% (52/673)
Mid SFA 25.3% (170/673)
Distal SFA 37.1% (249/67)
Proximal Popliteal 16.9% (114/673)
Mid Popliteal 10.3% (69/673)
Distal Popliteal 2.7% (18/673)

10. Case:
Lutonix DCB Final ResultPre-Procedure

11. Real World 12 Month Outcomes
Primary End Points
• Freedom from TLR at 12
months 89.3%
• N = 201 @ 12 months
Effectiveness
• Site-Reported Safety
Endpoint 99.3%
N = 608 @ 30 days
Safety

12. Real World Primary Patency
12 month Secondary End Point

13. 12 Month Outcomes
Secondary End Points*
All Cause Death 1.8% (4/215)
Device or procedure related death 0.0% (0/211)
Major index limb amputation 0.0% (0/211)
Minor index limb amputation 0.9% (2/213)
Reintervention for treatment of embolization to its
distal vasculature
0.9% (2/213)
Reintervention for treatment of thrombosis of the
target vessel
0.0% (0/211)
* CEC Adjudicated

14. Summary at 12 months
↑ Real-World Freedom from TLR 89.3% comparable
to blinded Levant2 trial (89.7%)
↑ Real World Site-Reported primary patency 81%
↑ Reinforced Confidence in Lutonix Safety
↓ Major index limb amputation 0.0%
↓ Re-intervention for treatment of embolization to distal
vasculature 0.9%
↓ Reintervention for treatment of thrombosis of the target
vessel 0.0%