Diabetic Patients Treated in the IMPERIAL Randomized Trial ... · Honoraria (Boston Scientific,...
Transcript of Diabetic Patients Treated in the IMPERIAL Randomized Trial ... · Honoraria (Boston Scientific,...
Diabetic Patients Treated in the IMPERIAL Randomized Trial Comparing
Eluvia and Zilver PTX Stents Stefan Müller-Hülsbeck, MD
EBIR, FCIRSE, FICA, FSIRACADEMIC HOSPITALS Flensburg
Kiel University-Faculty of MedicineEv.-Luth. Diakonissenanstalt zu Flensburg
Tuesday, January 22, 2019
Disclosure
Speaker name: Stefan Müller-Hülsbeck
I have the following potential conflicts of interest to report:
Consulting
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
Honoraria (Boston Scientific, Terumo, Eurocor Tech)
I do not have any potential conflict of interest
X
IMPERIAL Study Devices
Eluvia™ DES
Boston Scientific
Zilver® PTX®
Cook Medical
Stent Platform Innova Zilver Flex
Material Nitinol Nitinol
PolymerBiostable Fluorinated
Polymer Matrix (PROMUS polymer)
None
Drug
Dose DensityPaclitaxel
0.167 µg/mm2
Paclitaxel3 µg/mm2
Deployment Self-expanding Self-expanding
SizesDiameter Length Diameter Length
6-7 mm 40-150 mm 6-8 mm 40-120 mm
BSC Data on file. Cook Medical (2014). Zilver PTX Drug-Eluting Peripheral Stent Instructions for Use.
IMPERIAL Clinical Study Overview
• 180 patients had medically-treated diabetes (116 Eluvia & 64 Zilver PTX)
Primary Investigators
Global: William A. Gray, MD
European: Stefan Müller-Hülsbeck, MD
Study Design
RCT
(Eluvia DES vs Zilver PTX)
Long Lesion
Sub-study
(Eluvia)
Pharmacokinetic
Sub-study (Eluvia)
• 2:1 randomized
• Single-blind
• Non-inferiority trial
• Single arm
• Lesion length 140 mm-190 mm
• Single-arm
Patients
N=465
Eluvia N=309 vs
Zilver PTX N=156
N=50 N=13
InvestigationalCenters
65 study centers: US, Canada, New Zealand, Belgium, Germany, Austria, Japan
Key Eligibility Criteria
Inclusion
• Rutherford category 2, 3, or 4
• Lesions in the native
SFA and/or PPA
• Stenosis ≥70% by visual
angiographic assessment
• Vessel diameter 4-6 mm
• Total lesion length 30-140
mm
Exclusion
• Target lesion/vessel
previously treated with DCB
(<12 months prior) or
previously stented
• Prior surgery of the SFA/PPA
in the target limb
• Use of atherectomy, laser or
other debulking devices
• Dialysis
DCB, drug-coated balloon; SFA, superficial femoral artery; PPA, proximal popliteal artery
IMPERIAL Diabetic Cohort I Baseline CharacteristicsEluvia (N=116) Zilver PTX (N=64)
Patient CharacteristicsAge (y) 67.4±9.6 66.8±9.2Male 71.6% 73.4%Smoking History 89.7% 75.0%Hypertension 82.8% 90.6%Coronary Artery Disease 59.1% 57.8%Rutherford Classification
2 34.5% 26.6%3 62.1% 67.2%4 3.4% 6.3%
Lesion CharacteristicsLesion Length (mm) 87.0±38.1 84.5±38.3Reference Vessel Diameter (mm) 5.1±0.8 5.2±0.8
Calcification
None/Mild 32.2% 28.6%
Moderate 20.9% 30.2%
Severe 46.1% 39.7%
Unknown 0.9% 1.6%
% Diameter Stenosis 79.4±16.6 80.1±15.9
<50% 2.6% 0.0%
50%-99% 72.4% 73.0%
100% (Occlusion) 25.0% 27.0%
IMPERIAL Diabetic Cohort I Primary Patency at 12 Months
Primary patency defined as duplex ultrasound PSVR ≤2.4, in the absence of clinically-driven target lesion revascularization or bypass of the target lesion, as assessed by the DUS core lab.
Observed Rate: 84.6% (88/104) Eluvia vs 79.3% (46/58) Zilver PTX
Kaplan-Meier Estimate
log rank p=0.4413
Month
At risk: 6 9 12 13Eluvia 56 54 42 24.5Zilver PTX 28 24.5 17 8.5
Months Since Procedure
Pri
mar
y P
ate
ncy
Rat
e (
%)
0 1 2 3 4 5 6 7 8 9 10 11 12 13
0%
20%
40%
60%
80%
100%
80.2%
87.4%
Log-rank p= 0.2905
• 95.4% MAE-free at 12 months for patients treated with Eluvia
IMPERIAL Diabetic Cohort I Safety through 12 Months
Clinical Events Committee-adjudicated adverse events included all deaths, target limb major amputation, TLR, and stent thrombosis. Potential stent fractures were identified by radiography and verified by the angiographic core lab.
MAE, major adverse events; TLR, target lesion revascularization.
Eluvia (N=116)
Zilver PTX (N=64)
Difference[95% CI]
P-value
MAE 4.6% 13.6%-8.9%
[-18.5%, 0.7%]0.0658
All causes of death at 1 month 0.0% 0.0% 0.0% --
Target limb major amputation 0.9% 0.0%0.9%
[-0.9%, 2.7%]1.0000
Clinically-driven TLR 3.7% 13.6%-9.9%
[-19.3%, -0.4%]0.0269
Stent thrombosis 0.9% 8.1%-7.2%
[-14.2%, -0.1%]0.0235
0%
20%
40%
60%
80%
100%
Eluvia(N=115)
ZilverPTX
(N=63)
Eluvia(N=115)
ZilverPTX
(N=62)
Eluvia(N=110)
ZilverPTX
(N=58)
Eluvia(N=103)
ZilverPTX
(N=57)
Pe
rce
nta
ge o
f P
atie
nts
6
5
4
3
2
1
0
Best
Worst
IMPERIAL Diabetic Cohort I Clinical Outcomes through 12 Months
Eluvia Zilver PTX
Primary sustained clinical improvement
86.5% (90/104) 78.9% (45/57)
No or minimal symptoms (Rutherford Category 0-1)
83.7% (87/104) 82.5% (47/57)
Primary sustained clinical improvement: Improvement in Rutherford classification by one or more categories compared with baseline, without target lesion revascularization.
Baseline 1 Month 6 Months 12 Months
Rutherford Class Distribution
0%
20%
40%
60%
80%
100%
Baseline 1 Month 6 Months 12 Months
WIQ
Sco
re
Eluvia Distance Zilver PTX Distance
Eluvia Speed Zilver PTX Speed
Eluvia Stairs Zilver PTX Stairs
Eluvia Walking Impairment Zilver PTX Walking Impairment
Conclusions
• Excellent vessel patency and safety profile observed at 1 year in patients with diabetes treated with Eluvia
• Clinically-driven TLR and stent thrombosis occurred significantly more frequently among patients treated with Zilver PTX
• Data from this RCT subgroup as well as the IMPERIAL Long Lesion cohort suggest that the efficacy and safety profiles of Eluvia are not affected by challenging conditions
Status of dual layer stents for CAS:Is acute occlusion an issue?
No, neither in acute nor in elective cases...
... since you start an immeditate preparation with antiplateletmedication!
• Pre-procedural (elective treatment)
• Peri-procedural (stroke treatment) combinedwith bridging
500mg ASA i.v.
300mg Clopidogrel after control (conebeam-) CT, usually @ day 1
• Post-procedural
Diabetic Patients Treated in the IMPERIAL Randomized Trial Comparing
Eluvia and Zilver PTX Stents Stefan Müller-Hülsbeck, MD
EBIR, FCIRSE, FICA, FSIRACADEMIC HOSPITALS Flensburg
Kiel University-Faculty of MedicineEv.-Luth. Diakonissenanstalt zu Flensburg
Tuesday, January 22, 2019