two year safety and clinical performance of the drug eluting orsiro stent in the treatment of...
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Two Year Safety And Clinical Performance Of The Drug Eluting Orsiro Stent In The Treatment Of Subjects With Single De Novo Coronary Artery
Lesions(BIOFLOW-II)
Michael Haude, Rafael Ruiz-Salmeron, Thierry Lefévre, Bernhard Witzenbichler, Karl Stangl, Ton Slagboom, Franz-Josef Neumann,
Manel Sabaté, Jean-Cristophe Macia, Gert Richardt, Béla Merkely, Javier Goicolea, Johannes Bilger, Dimitar Divchev, Paul Barragan,
Stéphane Cook, Ron Waksman, Stephan Windecker
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Prof. Michael Haude. MD I have the following potential conflicts of interest
to report:
Consultant: BIOTRONIK, ORBUSNEICH Institutional grant/research support: ABBOTT
VASCULAR, BIOTRONIK,MEDTRONIC, ORBUSNEICH,VOLCANO, CARDIAC
DIMENSIONS
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Orsiro Hybrid Drug Eluting Stent With Bioabsorbable Polymer
The hybrid structure:
A combination of passive and active components
The underlying PK Energy Stent with thin strut (60μm) design
Passive component encapsulates the stent
Active component contains bioabsorbable PLLA and sirolimus
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Overview of Current Stent Designs
Source: Stefanini G., Taniwaki M., Windecker S., Heart 2013; 0:1-11.
DurablePolymer Coated Stent
BioabsorbablePolymer Coated Stent
BIOTRONIK
OrsiroCoCr-SES
60 µm
Circumferential 4-8 µm/side
Boston
SynergyPtCr-EES
74 µm
Abluminal4 µm/side
Terumo
UltimasterCoCr-SES
80 µm
Abluminal15 µm/side
Biosensors
BioMatrix316L-BES
120 µm
Abluminal 10 µm/side
Medtronic
ResoluteCoNi-ZES
91 µm
Circumferential 6 µm/side
Abbott/Boston
Xience/PromusCoCr/PtCr-EES
81 µm
Circumferential 7-8 µm/side
Strut Thickness
PolymerCoating
Company
Device NameMaterial-Drug
DeviceDesign
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BIOFLOW II Study Design
Orsiro
452 Patients (Intention To Treat) with de novo lesions in up to two coronary arteriesAll subjects stratified for diabetes
Annual clinical follow-up to 5 years
1,6-month clinical follow-up
Prospective, multicenter, international, randomized, non-inferiority design
Co-PIs: Stephan Windecker, University Hospital Bern, Switzerland Thierry Lefevre, Hospital Jacques Cartier, Massy, France
Xience Prime2:1
9-month clinical and angiographic follow-up IVUS and OCT follow-up in pre-specified subgroups with 60 patients in each
12-month clinical follow-up
ClinicalTrials.gov Identifier: NCT01356888.
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Stent Platforms
Co-Cr, L-605
60 µm
Stent material
Strut thickness
Passive coating Silicon carbide
Polymer coating Biodegradable (PLLA)Drug Sirolimus
Orsiro
Co-Cr, L-605
81 µm
-
Durable (PBMA/PVDF-HFP)Everolimus
Xience Prime™
Source: Lefèvre T., Oral presentation, TCT 2013, San Francisco, USA.
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Inclusion/Exclusion CriteriaInclusion Criteria
Exclusion Criteria
Co-PIs: Stephan Windecker, University Hospital Bern, Switzerland Thierry Lefevre, Hospital Jacques Cartier, Massy, France
Single de novo lesions in up to 2 native coronary arteries RVD ≥2.25 mm and ≤4.0 mm, lesion lengths ≤26 mm Age ≥18 and ≤80 years old Target vessel(s) TIMI flow ≥ 2 Eligible for DAPT therapy with ASA plus either, Clopidogrel, Prasugrel, Ticlopidine, or
Ticagrelor
Evidence of MI within 72 hours prior to index procedure ≥2xURL CK level or in absence of CK, ≥3xURL CKMB <24 hours prior to PCI Unprotected left main, 3-vessel CAD, thrombotic, ostial or bifurcation (SB>2.0mm), heavily
calcified or lesions in bypass graft LVEF ≤ 30% Serum creatinine > 2.5 mg/dl
ClinicalTrials.gov Identifier: NCT01356888.
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OrsiroN= 332
Xience PrimeN= 173
Preprocedure
Lesion Length (mm) 13.4 ± 6.8 13.6 ± 5.6
Reference Vessel Diameter (mm) 2.8 ± 0.5 2.7 ± 0.5
Minimum Lumen Diameter (mm) 0.9 ± 0.5 1.0 ± 0.5
Diameter stenosis (%) 66.7 ± 14.3 65.3 ± 14.5Postprocedure Minimum Lumen Diameter (mm) In-stent 2.6 ± 0.5 2.6 ± 0.4 In-segment 2.3 ± 0.5 2.3 ± 0.5 Diameter stenosis (%) In-stent 6.9 ± 7.2 7.1 ± 7.7 In-segment 17.4 ± 7.0 17.4 ± 6.6 Device Success (%) 100 100Procedure Success (%) 97.7 97.4
Baseline Procedural Characteristics
No statistical significance between study arms
Procedural Characteristics: All Lesions
Source: Ruiz-Salmeron R. Poster presentation. TCT, Washington DC, USA, September 2014.
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Baseline & Lesion CharacteristicsLesion Location
Lesion Type
Orsiro (N=332)
Xience Prime (N=173)Orsiro
(N = 298)Xience Prime
(N = 154)
Age, years mean ± SD 62.7 ± 10.4¹ 64.8 ± 9.2¹
Gender male (%) 78.2 74.7
Hypertension (%) 77.5 77.3
Hyperlipidemia (%) 67.8 73.4
History of MI (%) 30.2² 20.1²
Renal Insufficiency (%) 7.0 4.5
Congestive Heart Failure (%) 10.1 13.6
Diabetes (%) 28.2 28.6
Insulin dependent (%) 21.4 34.1
Non-insulin dependent (%) 78.6 65.9
Smoking (%) 66.4 57.8
History of stroke TIA (%) 7.0 6.5
Patient Characteristics
Source: Ruiz-Salmeron R. Poster presentation. TCT, Washington DC, USA, September 2014.
¹p=0.0344, ²p=0.0219.
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Angiographic Results at 9 Months
OrsiroN = 278
Xience PrimeN = 149
Late loss (mm) In-stent 0.10± 0.32 0.11 ± 0.29 In-segment 0.09 ± 0.35 0.09 ± 0.33
MLD (mm) In stent 2.52 ± 0.56 2.48 ± 0.50 In segment 2.25 ± 0.55 2.22 ± 0.56
Diameter stenosis (%) In stent 9.52 ± 13.49 9.43 ± 10.78 In segment 19.48 ± 12.89 19.22 ± 12.25
Binary restenosis (%) In stent 6 (2.16%) 2 (1.34%) In segment 11 (3.96%) 7 (4.70%)
Source: Windecker S. Oral presentation. EuroPCR, Paris, France. 21 May 2013.
Primary Enpoint: In-Stent LLL at 9 Months
P non-inferiority = <0.0001Difference = 0.0095% CI = -0.06 to 0.06
OrsiroXience Prime
Major Secondary Endpoints: Angiographic Results at 9 Months
0.11 ± 0.29 mm
0
-1.0In-Stent LLL (mm)
Cum
ulati
ve F
requ
ency
(%) 0.10 ± 0.32 mm
20
40
60
80
100
-0.5 0.0 0.5 1.0 1.5 2.0
No statistical significance between study arms
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Xience Prime™ (N=154)Orsiro (N=298)
0.0
10
20
0 180 365 730
TLF
univ
. def
. (%
)
8.4%10.0%
P = 0.5648
Days after PCI
Clinical Results at 24 Months All Subjects
TLF at 24 months – All Subjects
Source: Ruiz-Salmeron R. Poster presentation. TCT, Washington DC, USA, September 2014.
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Clinical Results at 24 Months Diabetic Subgroup
TLF at 24 months – Diabetic Subgroup
Source: Ruiz-Salmeron R. Poster presentation. TCT, Washington DC, USA, September 2014.
0%
10%
20%
0 180 365 730
9.7%9.1%
P = 0.8975
Days after PCI
TLF
univ
. def
. (%
)
Xience Prime™ (N=44)Orsiro (N=84)
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Clinical Results at 24 Months Small Vessel Subgroup
TLF at 24 months – Small Vessel Subgroup
Source: Ruiz-Salmeron R. Poster presentation. TCT, Washington DC, USA, September 2014.
TLF
univ
. def
. (%
)
Xience Prime™ (N=91)Orsiro (N=168)
9.4%13.3%
P = 0.3153
0%
10%
20%
0 180 365 730Days after PCI
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Sten
t thr
ombo
sis
(%)
0.0
10
0 180 365 7300.0%
Days after PCI
0.7%P = 0.3407
Stent Thrombosis at 24 Months All Subjects
Stent Thrombosis at 24 months – All Subjects
Source: Ruiz-Salmeron R. Poster presentation. TCT, Washington DC, USA, September 2014.
Xience Prime™ (N=154)Orsiro (N=298)
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0.0%0.0%
Days after PCI
0.0
10
0 180 365 730
P = >0.9999
0.0
10
0 180 365 730
P = 0.3437
Days after PCI
ST (%
)
0.0%2.3%
Stent Thrombosis at 24 Months Subgroups
Stent Thrombosis at 24 months – Diabetic Subgroup
Source: Ruiz-Salmeron R. Poster presentation. TCT, Washington DC, USA, September 2014.
Xience Prime™ (N=91)Orsiro (N=168)
Stent Thrombosis at 24 months – Small Vessel Subgroup
ST (%
)
Xience Prime™ (N=44)Orsiro (N=84)
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Stent Thrombosis at 24 Months
Orsiro
N = 298
Xience Prime
N = 154
Acute (0-48h) 0 % 0 %
Subacute (48h-30d) 0 % 0 %
Late (>30d-12m) 0 % 0 %
Very late (>12m) 0% 0%
Overall 0 % 0 %
Orsiro
N = 298
Xience Prime
N = 154
Acute (0-48h) 0 % 0 %
Subacute (48h-30d) 0 % 0 %
Late (>30d-12m) 0 % 0 %
Very late (>12m) 0% 0.7%
Overall 0 % 0.7 %
Definite Stent Thrombosis Definite, Probable and Possible Stent Thrombosis
Source: Ruiz-Salmeron R. Poster presentation. TCT, Washington DC, USA, September 2014.
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OCT and IVUS results at 9 Months
Source: Byrne R., EuroPCR, Paris, France, May 2014. Oral Presentation.Source: Windecker S. TCT, San Francisco, USA, October 2013. Oral presentation.
Maturity: 58.8% [13.5 – 92.9]
Maturity: 64.2% [8.9 – 97.0]
Adjusted p value = 0.62
Orsiro Xience Prime P
Well-apposed struts 98.6% 98.8% 0.62
Incomplete Strut Apposition 1.0% 0.6% 0.32
Non-apposed side branch 0.4% 0.6% 0.37
Covered Struts 98.3% 97.5% 0.042
Neointimal Area
1.00 ± 0.44 mm2
0.74 ± 0.38 mm2
P=0.024
Apposition and coverage
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IVUS results at 9 Months
Source: Byrne R., EuroPCR, Paris, France, May 2014. Oral Presentation.Source: Windecker S. TCT, San Francisco, USA, October 2013. Oral presentation.
Mature
Immature
-0.4
-0.3
-0.2
-0.1
0
0.1
0.2
0.3
0.4
0.5
-0.10
0.16
-0.34
0.43
9-month IVUS Results
Orsiro (N=31)
Xience Prime (N=25)
Δ Mean lumen area @ 9 M FUP
Δ Neointimal hyperplasia @ 9 M FUP
P = 0.34 P = 0.043
Stent apposition by IVUS @ 9-month FUP was 100% in both study arms
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OCT appearance at 9 MonthsOrsiro
Neointima coverage
Xience Prime
Neointima coverage
*With the courtesy of Prof. Haude/Neuss
Source: Lefèvre T., Oral presentation, TCT 2013, San Francisco, USA.
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Conclusion Orsiro is a thin-strut cobalt-chromium sirolimus-eluting stent with a biodegradable
polymer coating. In this randomized controlled trial the clinical event rates of the Orsiro SES with a
biodegradable polymer were low and comparable to the Xience Prime up to 24 months in all three analyzed populations.
One possible late stent thrombosis occurred in the Xience Prime™ diabetic cohort. No stent thrombosis was observed in the Orsiro cohorts through 24 months.
The BIOFLOW-II OCT/IVUS sub group analysis showed similar results between the Orsiro and Xience Prime.
Safe inhibition of neointimal hyperplasia was seen in both arms with struts well covered with a thin, uniform neointima.
Orsiro was associated with a significantly lower area of neointimal hyperplasia than Xience Prime.
Orsiro achieved an excellent strut apposition.