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Leipzig Interventional CourseJanuary 22 – 25, 2019
Bi-directional, self-expanding stent forsuperficial femoral artery lesions –
2-year interim-results from the Q3 registry
Hans Krankenberg on behalf of the Q3-Investigators
Department of Angiology, Asklepios Klinikum Harburg
Hamburg, Germany
Disclosure
Speaker name: Hans Krankenberg
I have the following potential conflicts of interest to report.
• Speakers fee: QualiMed Medizinprodukte, Wedel, Germany
• Hans Krankenberg, Hamburg
• Jarwed Arjumand, Christian Jacke, Gabriela Marin, Wuppertal
• Gunnar Tepe, Rosenheim
• Erwin Blessing, Karlsbad
• Markus Spanagel, Achmet Mechmet, Eric Ipcsics, Waldbröl
• Viktor Reichert, Sindelfingen
• Stefan Betge, Bad Bevensen
• Ralph Wickenhöfer, Thorsten Kanis, Dernbach
• Jörg Teßarek, Lingen
Q3 registry
Q3-Investigators
ClinicalTrials.gov NCT02307292
Bi-directional SFA stent*
8 Tantalum markers
Self-expanding Nitinolstent, laser-cut
5-zone flexibility delivery catheter
Delivery catheter is operable by onehand
Wave-like segments with flexible conectors
* QualiMed Medizinproduckte, Wedel, Hamburg; Germany
Designed to resist „bi-directional torsion“.
Patient CharacteristicsN = 199 (Dec 2014 – Aug 2018)
Age, yrs 60.3 ± 9.1
Male 70.4%
Diabetes mellitus 37.2%
Hypertension 83.8%
Hyperlipidemia 69.8%
Renal insufficiency 11.8%
Smoker (current and former) 52.6%
Adipositas 23.6%
Critical ischemia 11.6%
ABI 0.60 ± 0.24
Q3 Registry
Lesion Characteristics
Lesion length 97.6 ± 83.4 mm
Lesions ≥ 150 mm 23.5%
Stents/lesion 1.4 ± 0.7
Stented length 114.3 ± 82.7 mm
% Diameter stenosis 91.2 ± 13.1%
Total occlusion 43.5%
PTA Restenosis 3.0%
Multifocal or diffuse pattern 47.6%
Heavy calcification 27.3%
Q3 Registry
Hemodynamic Improvement
1.0
1.4
1.2
0.8
0.6
0.4
0.2
Baseline 1 month 6 months 1 year 2 years
p < 0.0001 for each FU vs. Baseline
Hemodynamic improvement 92.1% 76.2% 71.0% 73.6%
by ≥ 0.15 or to ≥ 0.9 n=165 n=143 n=107 n=47
Ankle
-bra
chia
l in
dex
(AB
I)
Clinical Improvement
p < 0.0001 for each FU vs. baseline
Baseline 6 months 1 year 2 years
Pati
ents
(%)
Rutherfordcategory
5
4
3
2
1
0
100%
Clinical improvement 92.1% 92.2% 92.3%
by ≥ 1 Rutherford category n=151 n=115 n=78
Freedom from TLR
0 6 12 18 24 months
Patients at risk 199 152 114 63
100
80
60
40
20
0
Fre
edom
fro
mT
LR
(%
)
6 months 98.7% (SE 0.9%)
12 months 95.5% (SE 1.8%)
24 months 85.7% (SE 3.7%)
30 days 99.4% (SE 0.6%)
Freedom from TLR
0 6 12 24 months
Patients at risk 150 112 85 52
46 38 26 10
100
80
60
40
20
0
Fre
edom
fro
mT
LR
(%
)
Lesions ≥ 150 mmØ 228 mm
Lesions < 150 mmØ 58 mm
Mean survival time: 20.8 months (20.5 to 21.1)
Mean survival time: 16.6 months (15.2 to 18.1)
Log-rank p < 0.0001
82.4%
94.9%
100% 100% 94.5%
0
20
40
60
80
100
12 months 24 months
Freedom from TLR
Zeller 2016, Matsumura 2013, Laird 2014, Laird 2012, Werner 2014, Dake 2013
Freedom from MACLE*
0 6 12 18 24 months
Patients at risk 199 150 106 57
100
80
60
40
20
0
Fre
edom
fro
mM
AV
E (
%)
6 months 96.1% (SE 1.6%)
12 months 90.3% (SE 2.6%)
24 months 78.9% (SE 4.3%)4 Myocardial infarctions3 TIA
0 Death0 Major amputation1 Minor amputation14 TLR
30 days 100%
* CV death, MI, stroke, TIA, target limb minor or major amputation, bypass surgery, TLR
0 6 12 24 months
Patients at risk 150 110 82 47
46 38 24 8
100
80
60
40
20
0
Fre
edom
fro
mT
LR
(%
)
Lesions ≥ 150 mmØ 228 mm
Lesions < 150 mmØ 58 mm
Mean survival time: 21.1 months (20.4 to 21.8)
Mean survival time: 16.0 months (16.0 to 17.6)
Log-rank p < 0.0001
75.8%
94.9%
97.3% 96.1% 88.6%
Freedom from MACLE
Conclusion
It did not raise any safety concerns.
Interim analysis suggests a comparatively high
effectiveness of the bi-directional SFA stent.
Hans Krankenberg
Bi-directional, self-expanding stent forsuperficial femoral artery lesions –
2-year interim-results from the Q3 registry