XV CONGRESSO DA SMC
SIMPÓSIO
Tratamento Intervencionista
da
Aterosclerose
Belo Horizonte 8 a 10 de julho de 2004
Tratamento Intervencionista da
Aterosclerose Coronária
Os Estudos Randomizados:
A Evidência dos Benefícios
Dr. Maurício de Rezende Barbosa
I N S T I T U T O
Coronária
Normal
Mecanismo da Angioplastia
•Ruptura das camadas
•Redistribuição do
material ateromatoso
•Dilatação das paredes da
artéria
•Retração elástica
•Perda do resultado
•Dissecção das camadas
•Trombose e oclusão aguda
ATEROMA
80%
0%
30%
Lesão ampliada
conduta?
Fem
42 anos
Lesão isolada CD
Pós
angioplastia
Angioplastia
convencional
Lesão residual
30%
Restenose
6 meses
30 a 40%
Primeiros Estudos Randomizados
PTCA
STENT
PTCA
STENT
33%
Eventos Clínicos
27.1
23.7
18.2
Pós
angioplastia
Angioplastia
convencional
Lesão residual
30%
Restenose
6 meses
30 a 40%
Conduta?
Implante de
STENT
Sem lesão
residual
95%
Restenose 6 meses
10 a 20%
STRESS 1992
BENESTENT 1992
46
7
BENESTENT II
BElgium-NEtherlands STENT Investigators
N = 827 patients
de novo, native,
single vessel
disease
Palmaz-SchatzTM
Stent
n=414
Aspirin +
Ticlopidine
Balloon
n= 413
Primary Endpoint
MACCE (death, MI, repeat revascularization and
cerebrovascular events) at 1 year
Serruys PW et al. Lancet 1998;352:673-681
BENESTENT II
30 Day Results
Death (%)
Q-wave MI (%)
Non Q-wave MI (%)
Vascular Complications (%)
Subacute Thrombosis (%)
Balloon
1
1.5
2.9
1.0
1.7
Stent
1.0
1.9
1.5
1.2
0.2
1-year Results
Repeat CABG (%)
Repeat PCI (%)
Any MACE (%)
Balloon
1.5
15.6
22.4
Stent
1.9
9.4*
15.7*
* p < 0.05
Serruys PW et al. Lancet 1998;352:673-681
BENESTENT II
Stent
Balloon
All Patients
100
95
90
84.3%
85
P=0.01
80
Event-Free
MACE
Survival at
12 Months
77.6%
75
70
0
50
100 150
200
250 300
350
400
Serruys PW et al. Lancet 1998;352:673-681
Lesões
longas
Feminino
82 anos
Angina estável
Sem lesões graves
na CE
Lesões
longas
Feminino
82 anos
Angina estável
Sem lesões graves
na CE
STENT
33 mm x 3,5
Restenose
CD Stent
Longo
12 meses
Restenose focal
CD Stent
Longo
12 meses
Restenose focal
Pós dilatação
Lesões de Bifurcação
Lesões de Bifurcação
Lesões de Bifurcação
STENT 2
Di.
STENT 1
DA
Pontes de Safena
Safena
Ao - CD
Pontes de Safena
Safena
STENT
Ao - CD
Pontes de
Safena
Proteção
Distal
Intervenção Percutânea
Intervenção Percutânea
ou Cirurgia
STENT PAMI
Stent Primary Angioplasty in Myocardial Infarction
N = 900 patients
Acute myocardial
infarction  12 hours
of symptoms onset
Randomized
Heparin-Coated
Palmaz-SchatzTM
Stent
n = 452
Primary PTCA
= 448
n
Primary Endpoint
Death, re-infarction, ischemic-driven TVR or disabling
stroke at 6 months
Grines CL et al. N Engl J Med 1999;341:1949-56
STENT PAMI
Results at
6 Months
Death (%)
Re-infarction (%)
Disabling stoke (%)
Ischemic TVR (%)
Composite endpt (%)
Final TIMI III (%)
Restenosis (%)
Heparincoated Stent
PTCA
p-Value
4.2
2.4
0.2
7.5
12.4
89.4
20.3
2.7
2.2
0.2
17.0
20.1
92.7
33.5
NS
NS
NS
< 0.001
< 0.01
0.01
< 0.001
Grines CL et al. N Engl J Med 1999;341:1949-56
ARTS
Arterial Revascularization Therapy Study
Stent
n = 600
N = 1205 patients
Multivessel disease
Randomized
CABG
n = 605
Primary Endpoint
MACCE (death, MI, repeat revascularization and
cerebrovascular events) at 1 year
Serruys PW et al. N Engl J Med 2001;344:1117-24
Number of Conduits vs Number of Treated Lesions
SURGERY
Average 2.7 anastomoses
1
2
3
4
5
6
7
8
1.8
STENT
Average 2.7 lesions
2.3
48.3
51.6
33.6
28.9
6.9
11.6
0.5
Conduits: 2.5  0.7
3.2
2.0
0.7
0.2
ARTS
ARTS
1-year Event-free Survival: Death, MI, CerebroEvent-free Survival (%)
vascular Accident or Repeat Revascularization
100
CABG
98
88%
96
P<0.001
94
74%
92
Stenting
90
0
0
60
120
180
240
300
Days After Randomization
360
CABRI versus ARTS
Even- Free Survival (%)
CABRI: 1994, ARTS: 1999
100
CABRI: CABG (90.8%)
90
ARTS: CABG (89.4%)
80
ARTS: Stent (75.2%)
70
60
CABRI: PTCA (58.8%)
50
0
60
ARTS/CABRI
Cardialysis Rotterdam ESC 1999
120 180 240
Time (days)
300
360
ARTS - Outcomes in Diabetics
n = 208 (17%) patients had diabetes
12 Month
Month Events:
Events:
12
10%
P=0.19
P=0.19
Stent
P=0.09
P=0.09
8%
40%
6.3%
P<0.00034
P<0.00034
39.3%
6.3%
6%
4%
50%
CABG
30%
20%
3.1%
1.8%
2%
0%
Death
CVA
17.7%
10%
0%
Death, MI, CVA, TVR
Abizaid A
A et
et al.
al. Circulation
Circulation 2001;104:533-538
2001;104:533-538
Abizaid
CRUISE
Can Routine Ultrasound Influence Stent Expansion?
n= 525
Patients enrolled
in the STARS trial
IVUS-guided
Stent implantation
Comparison
Angio-guided
Stent implantation
Primary Endpoint
Target vessel revascularization at 9 months
Fitzgerald PJ et al. Circulation 2000;102:523-30
CRUISE
(%)
9-Month TLR (n
(n == 525)
525)
16
12
14.5
P=0.04
8.4
8
4
0
IVUS
ANGIO
ERA DOS STENTS RECOBEDRTOS
TM”
The “CypherTM
Sirolimus- Eluting Stent Program
FIM Study
First-In-Man Study with Sirolimus Eluting Bx VelocityTM
Stent
P.I. Dr. Souza/ Dr. Serruys
De Novo Coronary
Lesions
Diameter: 2.5-3.5 mm
Length: <18mm
CYPHERTM
Stent
n = 45
Primary Endpoint: Angiography and IVUS follow-up at 46 months, 12-18 months, 24 months (Sousa) and 4 years
Clinical FU: 1, 4-6, 12-18 and 24 months out to 5 years
2-Year Angiographic
Follow-up
FIM: 2-Year
Angiographic Follow-up
FIM:
Changes in % DS and MLD In-Stent
80
64.5
2.85
2.80
2.75
2.75
mm
mm
3
70
2.5
60
50
2
40
1.5
30
20
1
1.05
10
Pre
4.6
4.8
Post
4 Mo
5.8
1 Year
8
2 Year
Sousa JE
JE et
et al.
al. Circulation
Circulation 2001;103:192-195
2001;103:192-195
Sousa
Sousa JE
JE et
et al.
al. Circulation
Circulation 2001;104:2007-11
2001;104:2007-11
Sousa
Sousa JE
JE et
et al.
al. Circulation
Circulation 2003;107:381-83
2003;107:381-83
Sousa
0.5
RAVEL
Randomized Study with the Sirolimus-Coated Bx Velocity BalloonExpandable Stent in the Treatment of Patients with de Novo Native
Coronary Artery Lesions
Sirolimus-coated
Bx VelocityTM Stent
n = 120
P.I. Dr. M C Morice
N = 238 patients
de novo, native
coronary artery
Randomized
Uncoated
Bx VelocityTM Stent
n = 118
Primary Endpoint
Minimum lumen diameter measured by quantitative
angiographic analysis at 6 months
RAVEL - Event-Free Survival @ 210 Days
Morice MC et al. N Engl J Med 2002;346:1773-80
RAVEL
Resultados de 3 anos
Cypher – sirolimus
Moderador – Stephen Ellis
ACC – New Orleans – Março 2004
RAVEL 3 ANOS
SIRIUS
A U.S. Multicenter, Randomized, Double-Blind Study of the SIRolImUSEluting Stent in De Novo Native Coronary Lesions
P.I. Drs. Leon/ Moses
CYPHER TM Stent
n= 533
N = 1058 patients
Randomized
de novo, native
coronary artery
Uncoated
Bx VelocityTM Stent
n= 525
Primary Endpoint
Target Vessel Failure (cardiac death, MI, or repeat
revascularization) at 9 months
SIRIUS - Restenosis
Sirolimus (n=349)
Control (n=353)
36.3
35.4
%
P<0.001
91%
P<0.001
75%
8.9
3.2
In-stent
In-segment
Moses JW
JW and
and Leon
Leon MB
MB et
et al.
al. N
N Engl
Engl JJ Med
Med (in
(in press)
press)
Moses
TAXUS Express Paclitaxel
Eluting Stents
BOSTON SCIENTIFIC
Evolução PTCA x STENT
HOSPITAL BIOCOR
Hospital Biocor
Uso de Stents Recobertos
60
50
40
2003
2004- 6m.
2004-12m.
30
20
10
0
2003
2004- 6m. 2004-12m.