Transcript Slajd 1

A PROSPECTIVE MULTICENTRE REGISTRY
FOR THE ASSESSMENT OF SAFETY
AND EFFICACY OF BIODEGRADABLE POLYMER
TM*
COATED, PACLITAXEL ELUTING STENT
LUC
9 th month study
*(BALTON, POLAND)
P. Buszman1,2, R. Gil3, J. Rzezniczak4, T. Przewlocki5, M. Kosmider6,
J. Wojcik7, J. Janczak8, S. Trznadel2, L. Kinasz2, M. Kondys2,
M. Krol2, K. Milewski1,2
1. Silesian Medical School, Katowice
2. American Heart of Poland, Ustron
3. Central Hospital of the Ministry of Internal Affairs, Warsaw
4. Department of Cardiology, District Hospital, Poznan
5. Institute of Cardiology, CM, JU, Kraków
6. Department of Cardiology and Cardiac Surgery, Medical School, Lodz
7. Division of Cardiology, Lublin
8. Department of Cardiology, Central Military Hospital, Warsaw
LIMITATIONS OF POLYMER COATED DES’s
Although polymers can ensure predictable release of
different drugs, in some cases they cause exaggerated
inflammatory response, neointimal hyperplasia and
thrombosis.
Biodegradable polymer – drug eluting stents (BPDES) are to resolve the problem of chronic vascular
inflammation and late thrombosis.
A new concept: after the drug and polymer are eluted,
only neutral stainless steel is left in the vessel wall.
CHARACTERISTIC OF LUC STENT
The tested stents were made of the
highest quality biocompatible 316
stainless steel alloy with 0,13mm strut
thickness.
The coating was performed utilizing
biocompatible and biodegradable
polymers, whose exact composition is
proprietary to Balton Company.
A total amount of polymer mounted
on 3,5x15mm stent does not exceed
365 µg.
Paclitaxel in dose 1 μg / mm2 was
chosen as a drug which inhibits cell
proliferatin and thus can inhibit
restenosis
Molybdenu
m 3%
Nickel 15%
Manganese
2%
Chromium
17%
Others 0,4
Iron ~63%
The composition of BMS
Others: carbon, copper, phosphorus,
sulphur, silicon.
BIODEGRADATION OF TESTED POLYMER
The samples of stents covered with tested polymer and removed from
isotonic salt solution at different time points
The surface of the
stent after 1 week
The surface after 8
weeks
Residual polymer left on the stent surface after 8 weeks
ANIMAL STUDY
QCA: Late Loss
THE AIM:
To evaluate safety and intimal
hyperplasia after coronary
implantation of LUC stent
To assess the influence of
biodegradable polymer on tested
arteries
0,9
0,8
0,7
0,6
0,5
0,4
0,3
0,2
0,1
0
0,48
BMS
RESULTS:
Neointimal hyperplasia was succesfully inhibited
by LUC stents at 30 days f-up. However, after 90
days the parameters of neoitnimal hyperplasia and
stenosis severity were similar to BMS.
Qualitative histopathological examination
did not show excessively negative influence
of polymer on tested artery.
0,87
Polymer
0,15
0,52
LUC 1 month
LUC 3 months
FIRST IN MAN STUDY
Prospective, multi-center registry
•Poznan
•Warszawa
•Lodz
•Lublin
•Katowice
•Ustron
Bielsko
Biała
•Krakow
FIRST IN MAN STUDY
Silesian Medical School, Katowice
P. Buszman
Katowice
American Heart of Poland
M. Kondys
Ustron
Central Hospital of the Ministry of Internal Affairs
R. Gil
Warszawa
Department of Cardiology, District Hospital
J. Rzezniczak
Poznan
American Heart of Poland
L. Kinasz
Bielsko
Institute of Cardiology, CM, JU, Kraków
T. Przewlocki
Krakow
Department of Cardiology and Cardiac Surgery
M. Kosmider
Lodz
Division of Cardiology
J. Wojcik
Lublin
Department of Cardiology, Central Military Hospital
J. Janczak
Warszawa
FIRST IN MAN STUDY
Principle Investigator:
Pawel Buszman, MD, FESC, FSCAI
Clinical Events Committee:
Mariusz Gasior
Ciecwierz Leszek
Angiographic Core Lab:
Core Imaging Analysis Laboratory
Krakow Cardiovascular Research Institute
FIRST IN MAN STUDY
Material and method:
Enrollment of 113 patients with:
de-novo lesion in native coronary artery
vessel diameter 2.8 – 4.0 mm
lesion length 18 mm
stenosis ≥ 50% and ≤100%
Dual antiplatelet therapy required for 9months
Period of implantation: 07/2005 – 11/2005
FIRST IN MAN STUDY
Clinical endpoints:
MACE after 30 days, 6 and 9 months
Angiographic endpoints:
Late loss
Restenosis rate
F-up visits after 30 days, then subsequently after
3 and 6 months to define MACE rate.
9-months control coronarography
PATIENT CHARACTERISTICS
Male
83 [73,4 %]
Hypercholesterolaemia
68 [60,2 %]
Family history
27 [23,8 %]
Smoking
64 [56,6%]
Diabetes
24 [21,2 %]
Hypertension
80 [70,8 %]
Pior MI
43 [38,1 %]
Stable angina
98 [86,7 %]
Unstable angina
10 [8,8 %]
STEMI, NSTEMI
2 [1,8 %]
Vessel disease
Triple
7,1%
Double
47,8%
Single
45,1%
ANGIOGRAPHIC DATA
Lesion type
Lesion location
LAD
41%
B1 42%
37%
RCA
B2 39%
A 10%
others 5%
LCx 17%
Direct stenting: n = 74
Predilatation:
n = 31
Success rate:
100%
C 9%
Calcification (moderate to severe)
10%
Thrombus
1%
Eccentric
70%
Angulation
<450
93%
45-900
7%
CLINICAL OUTCOME
0-1 month
1-6 month
6-9 month
Total 0-9 month
Any MACE
1
1
1
3 (2.7%)
Death
0
0
0
0
MI
0
1
0
1 (0,9%)
Acute stent thrombosis
1
0
0
1 (0,9%)
Clinically driven TLR
1
1
1
3 (2,7%)
3,0
2,7
2,7
2,0
1,0
0,9
0,9
MI
Stent
thrombosis
0
0,0
Any MACE
death
TLR
ANGIOGRAPHIC DATA
Before
procedure
After
procedure
Follow up
9months
(n=90)
Reference
diameter (mm)
2.90 ± 0.44
3.07 ± 0.41
2.98 ± 0.4
MLD (mm)
1.09 ± 0.45
2.65 ± 0.36
2.21 ± 0.6
Lesion length (mm)
13.94 ± 4.7
15.9 ± 4.2
16.0± 4.2
% DS.
62.8 ± 14
13.8 ± 10
27.1±18.4
Acute Gain (mm)
-
1.55 ± 0.55
-
Late loss (mm)
-
-
0.45 ±0.5
DISTRIBUTION OF STENOSIS SEVERITY
26
24
22
20
18
16
n
14
12
10
8
6
4
2
0
-20
-10
0
10
20
30
40
50
60
70
80
90
100
%DS
Percent diameter stenosis after 9 months
110
BINARY RESTENOSIS RATE AT 9 MONTHS
Patterns of in-stent restenosis
(Mehran classification)
15
10
10%
10%
5
Focal
4
In-stent
4
Diffuse
1
Occlusive
0
16
14
12
10
8
0
15,8%
6
in-stent
in-segment
Restenosis rate
4
11,1%
2
5,7%
0%
B2
C
0
A
B1
Risk of restenosis in relation to type of lesion
LUC vs OTHER DES’s
1,0
13,3
14
12
0,62
10
10
8,9
7,9
0,45
8
0,39
6
0,17
4
2
0,0
0
LUC
Endeavor-II
Taxus-IV
Sirius
Comparison Among DES Trials
Late Loss
LUC
Endeavor-II
Taxus-IV
Sirius
Comparison Among DES TRIALS
Binary Restenosis (In Stent)
LUC vs OTHER DES’s
10
8,5
9
7,4
8
7,1
7
6
5
4
3
2,7
2
1
0
LUC
Endeavor-II
Taxus-IV
Sirius
Comparison Among DES Trials
MACE
SUMMARY
 Excellent procedural outcome with device
success 100%
 Low MACE rate over 9 months after
implantation (2.7%)
 Favorable late (9 months) angiographic
results:
- Binary restenosis 10,0%
- Late loss 0.45 mm