viva lutonix real world global registry 10 31- 2014
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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
Conflicts of Interest
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.
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
G\Real 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
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
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)
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
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)
Case: Lutonix DCB Final Result Pre-Procedure
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
Real World Primary Patency 12 month Secondary End Point
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
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%
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