Transcript Document 7168512

EuroSTAR
The European Cobalt Stent with
Antiproliferative for Restenosis Trial
As presented by
Keith D Dawkins MD FRCP FACC
Southampton University Hospital
United Kingdom
6-Month Results from Arm 1
EuroSTAR Trial
Study Administration
Principal Investigators:
Keith D. Dawkins M.D. – Southampton University
Hospital
Antonio Colombo M.D. – HSR San Raffaele Hospital
Angiographic Core Lab:
Cardialysis BV, The Netherlands
EuroSTAR Arm 1 Enrolling Investigators
Investigator
Hospital Center - Location
Patients
n = 145
Stefan Verheye, M.D.
AZ Middelheim Hospital – Antwerpen, Belgium
32
Joseph Dens, M.D.
Universitair Ziekenhuis - Leuven, Belgium
19
Professor, Dr. Harald Mudra
Krankenhaus Munchen Neuperlach – Munich, Germany
14
Professor, Dr. Helmut Schuhlen
Medizinische Klinik – Munchen, Germany
12
Dr. Keith Dawkins
Southampton University Hospital - Southampton, England
11
Dr. Martyn Thomas
King’s College Hospital – London, England
11
Professor, Dr. Wolfgang Rutsch
Universitatsklinikum Charite Mitte Humboldt Univ – Berlin,
Germany
10
Professor Patrick Serruys
Thoraxcentrum Erasmus University - Rotterdam,
Netherlands
7
Professor Pieter den Heijer
Amphia Hospital / de Klokkenberg - Breda, Netherlands
7
Professor Victor Legrand
C.H.U. Sart Tilman – Liege, Belgium
7
Dr. M. J. Suttorp
Sichting Sint Antonius Ziekenhuis – Nieuwegein,
Netherlands
7
Dr. Peter R. Stella
Universitair Medisch Centrum – Utrecht, Netherlands
5
Professor Francois Schiele
Centre Hospitalier Universitaire Jean Minjoz – Besancon,
France
3
EuroSTAR
The European Cobalt Stent with Antiproliferative for Restenosis Trial
Study Purpose:
To demonstrate the safety and performance of the Conor
CoStar™ Paclitaxel-Eluting Stent System for the
treatment of ischemic heart disease attributable to
stenotic de novo lesions in native coronary arteries.
CoStar™ Stent Design
Bridge Elements
Reservoirs
Ductile Hinges
EuroSTAR Trial
Study Design & Patient Follow-Up
Prospective, multi-center study, scheduled to sequentially enroll patients from 21
European & New Zealand centers into one of two registry arms with two different
dose formulations of paclitaxel.
An IVUS sub-study of patients from both arms is also planned.
Arm 1
Baseline Angiography
& IVUS*
10 µg PTX / 24-30 days
N = 145 patients
IVUS Sub-Study
N = 50 patients
Arm 1 vs. Arm 2
*
IVUS for Sub-Study patients only
1 Month Clinical
6 Month Clinical
6 Month Angiographic
with QCA & IVUS*
Arm 2
30 µg PTX / 24-30 days
N = 125 patients
1 Year Clinical
EuroSTAR Trial
Study Endpoints
Primary Endpoint:
Angiographic (by QCA) Late Loss at 6 Months
Secondary Endpoints:
MACE at 30 days, 6 months & 1 year
Binary Restenosis at 6 months
Late Loss at 6 months
TLR and TVR at 6 months
Procedural Success
Primary Device Success
Lesion Success
EuroSTAR Trial
Study Inclusions
Major Inclusions:
Up to two native coronary lesions in multiple vessels
that have not undergone previous PCI
RVD between 2.5mm – 3.5mm
Lesion length ≤ 25 mm in length
TIMI flow of Grade I or higher
EuroSTAR Trial
Study Exclusions
Major Exclusions:
Acute MI within 72 hours
Ejection Fraction < 30%
Patients with known drug hypersensitivities or
contraindications
Angiographic evidence of thrombus in the target vessel
Target lesions involving a bifurcation that require treatment
EuroSTAR Trial
Baseline Patient Demographics
Arm 1
N = 145 patients, 176 lesions
Age in Years (mean ± SD)
63.5 ± 10.5
Gender (% Male)
70.3% (102/145)
History of Smoking
67.6% (98/145)
Diabetes Mellitus
15.9% (23/145)
Hypertension
69.0% (100/145)
Dyslipidemia
77.9% (113/145)
Prior MI
31.7% (46/145)
Prior CABG
3.4% (5/145)
Prior Angioplasty
19.3% (28/145)
Prior Stent Implant
13.1% (19/145)
EuroSTAR Trial
Vessel Disease
15.9%
49.0%
3 Vessel
2 Vessel
35.2%
1 Vessel
EuroSTAR Trial
Lesion Location
First Lesion
(N = 144)
45.1%
36.1%
RCA
LAD
Second Lesion
LCX
(N = 32)
28.1%
34.4%
18.8%
LAD
RCA
LCX
194 CoStar™ Stents Implanted in 176 Lesions
37.5%
EuroSTAR Trial
Procedural Outcomes
Arm 1
N = 145 patients
Total Lesions Treated
176 lesions
Total Number of CoStar™ Stent Implanted
194 Stents
Average Number of Stents per Patient
1.3
Average Number of Stents per Lesion
1.1
Direct Stenting per Lesion
51.7%
Procedural Success
97.2%
Lesion Success
99.0%
Device Success
99.0%
EuroSTAR Trial
Clinical Outcomes – In Hospital
Arm 1
Events
N = 145 patients, 176 lesions
Death
0% (0/145)
Myocardial Infarction:
0% (0/145)
Q-Wave
0% (0/145)
Non Q-Wave
1.4% (2/145)
Emergent CABG
0% (0/145)
TLR*
0% (0/176)
In-Hospital MACE
1.4% (2/145)
Cumulative MACE
1.4% (2/145)
*
Clinically Driven TLR based on number of lesions
EuroSTAR Trial
Clinical Outcomes – 30 Days
Arm 1
Events
N = 145 patients, 176 lesions
Death
0% (0/145)
Myocardial Infarction:
0% (0/145)
Q-Wave
0% (0/145)
Non Q-Wave
1.4% (2/145)
Emergent CABG
0% (0/145)
TLR*
0% (0/176)
Revascularization per Patient
0% (0/145)
Cumulative MACE
1.4% (2/145)
*
Clinically Driven TLR based on number of lesions
EuroSTAR Trial
Clinical Outcomes – 6 Months
Events
Death
Arm 1
N = 144# patients, 176 lesions
1.4%
Myocardial Infarction:
0%
Q-Wave
0%
Non Q-Wave
1.4%
Emergent CABG
0%
TLR*
1.7%
Revascularization per Patient
2.1%
Cumulative MACE
4.8%
Late Thrombosis
0.7%
*
Clinically Driven TLR based on number of lesions
One patient was a failure to cross and followed only to 30 days
#
EuroSTAR Trial
QCA analysis
Arm I
(N = 145 patients)
Reference Vessel Diameter (mean ± SD)
Lesion Length
Stent Length
(mean ± SD)
(mm)
In-Stent Diameter Stenosis
In-Stent MLD
(mean ± SD)
(%)
Index
2.62 ± 0.54 mm
Follow-up
8 Months
2.64 ± 0.46 mm
10.97 ± 5.28 mm
-
17.08 ± 7.46 mm
17.62 ± 7.56 mm
61.89 ± 10.32%
23.42 ± 13.39%
1.00 ± 0.35 mm
2.12 ± 0.54 mm
Angiographic Follow-Up
Binary Restenosis Rate (6 Months)*
*
Binary Restenosis Rates per protocol/matched (n = 149 lesions)
Restenosis Rate %
10
8
6
4.7
4
3.4
2.0
2
0.7
0
In-Stent
Prox Edge
Distal Edge
In-Segment
Subgroup Analysis by Vessel Diameter
Binary Restenosis Rate (6 Months)*
*
Binary Restenosis Rates per protocol/matched (n = 149 lesions)
Restenosis Rate %
10.0
8.0
6.6
6.0
4.0
3.3
3.4
3.4
3.3
2.0
1.1
1.1
0.0
0.0
In-Stent
Prox Edge
≤ 2.5mm (N=61)
Distal Edge
> 2.5mm (N=88)
In-Segment
Subgroup Analysis by Stent Length
Binary Restenosis Rate (6 Months)*
*
Binary Restenosis Rates per protocol/matched (n = 149 lesions)
Restenosis Rate %
10.0
8.0
6.0
4.0
5.3
3.2
3.7
3.2
2.0
1.1
0.0
0.0
0.0
0.0
In-Stent
Prox Edge
≤ 20mm (N=95)
Distal Edge
> 20mm (N=54)
In-Segment
Subgroup Analysis for Diabetes
Binary Restenosis Rate (6 Months)*
*
Binary Restenosis Rates per protocol/matched (n = 149 lesions)
Restenosis Rate %
10.0
8.0
5.5
6.0
4.0
3.9
2.4
2.0
0.8
0.0
0.0
0.0
0.0
0.0
In-Stent
Prox Edge
Non-Diabetics (N=127)
Distal Edge
Diabetics (N=22)
In-Segment
Subgroup Analysis
Binary Restenosis Rate (6 Months)*
10.0
*
In-Stent Restenosis (%)
Binary Restenosis Rates per protocol/matched (n = 149 lesions)
8.0
6.0
4.0
3.4
3.3
3.4
3.9
3.7
3.2
2.0
0.0
0.0
All Patients
≤2.5mm
>2.5mm
≤20mm
>20mm
Stent Length
Diabetics Non-Diabetics
Angiographic Follow-Up
Late Loss (6 Months)*
*
0.60
Late Loss per protocol/matched, n = 149 lesions
0.50
Late Loss (mm)
0.40
0.30
0.26mm
0.20
0.07mm
0.06mm
0.10
0.00
-0.10
In-Stent
Prox Edge
-0.04mm
Distal Edge
In-Segment
Subgroup Analysis
Late Loss (6 Months)*
*
In-Stent Late Loss (mm)
0.70
Late Loss per protocol/matched, n = 149 lesions
0.60
0.50
0.45mm
0.40
0.30
0.26mm
0.30mm
0.29mm
0.23mm
0.23mm
>2.5mm
≤20mm
0.22mm
0.20
0.10
0.00
All Patients
≤2.5mm
>20mm
Stent Length
Diabetics Non-Diabetics
EuroSTAR Trial
Conclusions
 The CoStar™ Cobalt Chromium stent system is highly deliverable,
radiopaque and permits high rates of acute success and direct
stenting.
 The Costar stent is safe with acceptably low rates of complications
in both single and multi-vessel patient populations.
 The CoStar Stent is effective with low rates of clinical recurrence
(1.7% TLR), MACE (4.8%), in-stent late loss (0.26mm) and in-stent
restenosis (3.4%) at 8 months.
 Low in-stent restenosis rates for <2.5mm vessels demonstrates
effectiveness of CoStar in small vessels.
 Extremely low rates of in-segment late loss (0.07mm) and no
demonstrable edge effects are probably reflective of unique stent
design and absence of a surface coating.