Transcript A 12-Months clinical outcome after implantation of

Clinical Experience with the
Bio Active Stent (BAS)
in FINLAND
Pasi Karjalainen, MD, PhD
9e CFCI
Hotel Meridien Etoile
Paris, France
10 Octobre 2007
Presenter Disclosure Information
P Karjalainen, MD, PhD
No relationships exist related to this
presentation
Subject Groups of the Presentation
PORI stent registries,
3-years follow-up
A prospective, randomized, multicenter
TITAX AMI trial
Background
PCI is the most frequently used method
for revascularization
As a consequence, the prevention
and treatment of ISR have
become priorities in
Better outcome with the PCI, but in-stent
interventional
cardiology
restenosis
(ISR) compromises
the! longterm results
Background
The use of DES is the most effective way to reduce ISR
according to randomized trials in
selected patient groups
As a result, some cardiologists
have tended to revert to more
predictable devices e.g., BMS or
However, there is no evidence that BMS or DES could
influence
mortality
or prevent
MI active
stents that
are
coated
with
compounds, such as
Recently, growing concern has been expressed about
the safety
of DES most notably with respect to
titanium-nitride-oxide
late Stent Thrombosis
Bio Active Stent (BAS)
TITAN®- stent by Hexacath (France)
Stent geometry
Material
Strut thickness
TITANOX
Coating
316L+TITANOX (TitaniumNitride-Oxide)
COATING
HELICOIDAL
DESIGN
70-90 MICRONS
Crimped profile < 1mm
Nitrogen, Oxygen and Titanium atoms are
bounded with electronic and atomic links.
(L.Pauling classification)
Bio Active Stent in Finland
Helistent®
Hexacath, Fra
 2002
First Treated
Patient in PORI
May 2003
TITAX AMI trial
TITAX AMI
Nov 2005Nov 2006
EuroPCR2007
Late Breaking Trials
TCT2007
Karjalainen P, et al.
J Invasive Cardiol 2006;18:462-468
Titan® Stent
in Finland
August 2002
PORI stent
registry
May 2003 – Nov 2004
Pori Stent Registry
Eurointerv. 2006
J Invasive Cardiol. 2006
TCT2005, TCT2006
3 Years Follow up of the PORI
Stent Registries
PURPOSE OF THE STUDY
Compare clinical outcome of a stainless steel
Stent coated with titanium nitride oxide
(TITANOX), paclitaxel eluting stent (PES) and
bare metal stent (BMS) in routine clinical practice
Between May 2003 and November 2004, all
consecutive patients scheduled for stent
implantation were considered for these registries
Baseline Clinical Characteristics
TITANOX
(201)
PES
(204)
BMS
(184 )
Age (years)
67 ± 10
64 ± 10*
68 ± 10
Men, n (%)
143 (71)
147 (72)
120 (65)
Diabetes, n (%)
34 (17)
37 (18)
45 (24)
Current smoking, n (%)
58 (29)
53 (26)
44 (24)
Hypercholesterolemia, n (%)
181 (90)*
167 (82)
147 (80)
Hypertension, n (%)
133 (66)*
110 (54)
107 (58)
Acetylsalicylic acid
189 (94)
190 (93)
175 (95)
ß-Blockers
152 (76)
160 (78)
147 (80)
ACE inhibitor
33 (16)
36 (18)
37 (20)
Lipid-lowering agents
177 (88)
164 (80)
155 (84)
Medical Treatment, n (%)
* p < 0.05
Baseline Clinical Characteristics
TITANOX
(201)
PES
(204)
BMS
(184 )
89 (44)*
65 (32)
58 (32)
Previous PCI, n (%)
29 (14)
49 (24)*
13 (7)
Previous CABG, n (%)
25 (12)
20 (10)
20 (11)
Multivessel disease, n (%)
133 (66)
137 (67)
120 (65)
Acute STEMI, n (%)
62 (31)*
41 (20)
39 (21)
Primary angioplasty, n (%)
22 (11)*
10 (5)
9 (5)
Rescue angioplasty, n (%)
40 (20)
31 (15)
29 (16)
Acute NSTEMI, n (%)
52 (26)
49 (24)
71 (39)*
Unstable angina, n (%)
20 (10)
20 (10)
15 (8)
Previous myocardial infarction, n (%)
* p < 0.05
Procedural and Lesion Characteristics
TITANOX
PES
BMS
(218 lesions/ 221
stents)
(244 lesions/ 247
stents)
(202 lesions/ 218
stents)
LAD
100 (46)
124 (51)
68 (34)
LCX
48 (22)
37 (15)
57 (28)
RCA
54 (25)
68 (28)
57 (28)
Left Main
7 (3)
7 (3)
8 (4)
Bypass graft (venous)
9 (4)
8 (3)
12 (6)
A
26 (12)
54 (22)
49 (24)
B1 / B2
137 (63)
171 (70)
145 (72)
C
55 (25)*
19 (8)
8 (4)
35 (16)
34 (14)
24 (12)
Target Vessel, n (%)
Lesion Type, n (%)
Thrombus present, n (%)
* TITANOX vs. PES / BMS, p < 0.05
Procedural and Lesion Characteristics
TITANOX
PES
BMS
(218 lesions/ 221
stents)
(244 lesions/ 247
stents)
(202 lesions/ 218
stents)
2.95 ± 0.34
2.97 ± 0.35
3.00 ± 0.48
13.1 ± 3.4
13.5 ± 4.2
13.4 ± 4.5
2.98 ± 0.34
2.97 ± 0.34
3.04 ± 0.5
15.6 ± 3.5
21.2 ± 6.7 *
16.4 ± 5.2
Direct stenting, n (%)
48 (22)
46 (19)
46 (23)
Gp IIb/IIIa inhib. n (%)
54 (27)
49 (24)
37 (20)
Clopidogrel, (months)
7.7 ± 3.3
8.2 ± 3.0
8.3 ± 3.6
RVD, (mm)
Lesion length, (mm)
Stent diameter
Stent length used
* PES vs. TITANOX / BMS, p < 0.05
30 Days MACE Composition
%
8
p = 0.004
6
5,4
p = 0.02
4,9
p = 0.02
3,9 3,8
4
3,4
PES
2,5
2,2
2
TITANOX
p = 0.04
BMS
1,5
1,1
0,5
0
0
0
0
0
0
Cardiac
Death
AMI
TLR
ST
MACE
12 Months MACE Composition
%
20
17,9
Control Angiography
16
TITANOX
20%
PES
19%
BMS
22%
12
13,7
10,9
10,3
TITANOX
9,2
PES
7,1
8
BMS
p = 0.03
4
2,5
3,3
3,9 4,3
4,5
5 4,9
3,4
2,5
1,6
0,5
0
0
Cardiac
Overall
Death
Death
AMI
TLR
ST
MACE
Late Follow up: End points > 12 months
TITANOX
(201)
PES
(204)
BMS
(184)
P
value
40 ± 5 (39)
43 ± 5 (43)
42 ± 5 (41)
0.001
Death, n (%)
6 (3.0)
5 (2.5)
8 (4.3)
0.6
Death from cardiac causes, n (%)
1 (0.5)
2 (1.0)
5 (2.7)
0.2
Myocardial infarction, n (%)
6 (3.0)
19 (9.3)
10 (5.4)
0.03
TVR, n (%)
1 (0.5)
9 (3.9)
11 (6.0)
0.01
1 (0.5)
9 (4.4)
9 (4.9)
0.03
0 (0)
0 (0)
2 (1.1)
0.1
7 (3.5)
21 (10.3)
25 (13.6)
0.002
0 (0)
8 (3.9)
2 (1.1)
0.007
FU, months ± SD, (median)
TLR, n (%)
TVR (non-TLR), n (%)
MACE, n (%)
Stent thrombosis, n (%)
36 Months MACE Composition
%
40
p < 0.001
31,5
30
p = 0.003
23,5
TITANOX
19,1
20
PES
14,7
8,7
10
6
5,5
6,4
3,4
1
BMS
13,9
7,5
[0.002]
[
<0.001
]
0
Cardiac Death Overall Death
AMI
MACE
36 Months MACE Composition
%
40
p < 0.001
31,5
30
23,5
TITANOX
20
14,2
13,9
10
BMS
12
11,3
9,3
8,5
7,4
5,5
3
2
2,7
2,2
[<0.001 ]
0
0
TVR
TLR
PES
non-TLR
TVR
ST
MACE
Cumulative Rate of Events
October 2007: FU 36 – 52 months
TITANOX
(201)
PES
(204)
BMS
(184)
P
value
40 ± 5 (39)
43 ± 5 (43)
42 ± 5 (41)
0.001
Death, n (%)
11 (5,5)
13 (6.4)
16 (8.7)
0.4
Death from cardiac causes, n (%)
2 (1.0)
7 (3.4)
11 (6.0)
0.06
Myocardial infarction, n (%)
15 (7.5)
40 (19.6)
27 (14.7)
0.002
TVR, n (%)
17 (8.5)
23 (11.3)
27 (14.7)
0.2
TLR, n (%)
11 (5.5)
19 (9.3)
22 (12.0)
0.08
TVR (non-TLR), n (%)
6 (3.0)
4 (2.0)
5 (2.7)
NS
29 (14.4)
49 (24.0)
58 (31.5)
<0.001
0 (0)
15 (7.4)
5 (2.7)
<0.001
FU, months ± SD, (median)
MACE, n (%)
Stent thrombosis, n (%)
Late Follow up in the Year Following
Clopidogrel Discontinuation
• The 519 patients (TITANOX 184, PES 183, BMS 152)
who were MACE free at the time of the discontinuation
of clopidogrel treatment were followed for an
additional 12 months after discontinuation.
• The goal was to evaluate late thrombotic events
related to clopidogrel discontinuation.
Late Follow up in the Year Following
Clopidogrel Discontinuation
%
5
All Death / Cardiac death
4
2,7 2,6
3
TITANOX (184)
2
2
1,6
1,6
1
0
0
All Death
All Death, p = 0.75
Cardiac Death, p = 0.18
Cardiac Death
PES (183)
BMS (152)
Late Follow up in the Year Following
Clopidogrel Discontinuation
%
15
All Death / Cardiac death
12
p = 0.004
8,2
9
TITANOX (184)
PES (183)
6
4,9
BMS (152)
3,9
3
2,2
2
1,1
0
MI
Myocardial Infarction (MI), p = 0.004
Target Lesion Revascularization (TLR), p = 0.10
TLR
Late Follow up in the Year Following
Clopidogrel Discontinuation
%
15
All Death / Cardiac death
12
9,3
9
7,9
p = 0.007
PES (183)
6
3,8
3,8
3
0
0,7
0
Stent
Thrombosis
Stent Thrombosis, p = 0.007
MACE, p = 0.10
TITANOX (184)
MACE
BMS (152)
PORI Stent Registries
Conclusions
•
Lower rates of recurrent MI and MACE with the use
of TITANOX coated stent compared with PES or
BMS
•
Secondly, very low TLR rate with the use of
TITANOX coated stent (5.5 %)
•
PES  higher rates of MI and Stent Thrombosis
after the discontinuation of clopidogrel compared
with TITANOX coated stent or BMS