Embed Size (px)
Citation preview
SIMPÓSIOSIMPÓSIOTratamento Tratamento
IntervencionistaIntervencionista da da
AteroscleroseAterosclerose
XV CONGRESSO DA SMCXV CONGRESSO DA SMC
Belo Horizonte 8 a 10 de julho de 2004
Os Estudos Os Estudos Randomizados:Randomizados:
A Evidência dos A Evidência dos BenefíciosBenefícios
Tratamento Tratamento Intervencionista daIntervencionista da
Aterosclerose CoronáriaAterosclerose Coronária
I N S T I T U T O
Dr. Maurício de Rezende BarbosaDr. Maurício de Rezende Barbosa
CoronáriCoronária a
NormalNormal
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
80% 30%
ATEROMA
0%
Lesão ampliadaLesão ampliadaconduta?conduta?
Fem42 anosLesão isolada CD
Angioplastiaconvencional
Restenose6 meses30 a 40%
Pós angioplastia
Lesão residual30%
Primeiros Estudos Primeiros Estudos RandomizadosRandomizados
33%
PTCASTENT
PTCA
STENT
Eventos ClínicosEventos Clínicos
27.1 23.718.2
Angioplastiaconvencional
Restenose6 meses30 a 40%
Pós angioplastia
Lesão residual30%
95%
Restenose 6 meses10 a 20%
STRESS 1992BENESTENT 1992
Conduta?
Implante deSTENT
Sem lesão residual
46
7
BENESTENT IIBENESTENT II
Primary EndpointMACCE (death, MI, repeat revascularization and
cerebrovascular events) at 1 year
N = 827 patientsN = 827 patientsde novo, native,de novo, native,
single vessel single vessel diseasedisease
Palmaz-SchatzPalmaz-SchatzTMTM StentStentn=414n=414
BalloonBalloonn= 413n= 413
Serruys PW et al. Lancet 1998;352:673-681
BElgium-NEtherlands STENT Investigators
Aspirin + Aspirin + TiclopidineTiclopidine
Serruys PW et al. Lancet 1998;352:673-681
BENESTENT IIBENESTENT II
1-year Results1-year Results BalloonBalloon StentStentRepeat CABG (%)Repeat CABG (%) 1.51.5 1.91.9Repeat PCI (%)Repeat PCI (%) 15.615.6 9.4*9.4*Any MACE (%)Any MACE (%) 22.422.4 15.7*15.7*
* p < 0.05* p < 0.05
30 Day Results30 Day Results BalloonBalloon StentStentDeath (%)Death (%) 11 1.01.0Q-wave MI (%)Q-wave MI (%) 1.51.5 1.91.9Non Q-wave MI (%)Non Q-wave MI (%) 2.92.9 1.51.5Vascular Complications Vascular Complications (%)(%) 1.01.0 1.21.2
Subacute Thrombosis (%) Subacute Thrombosis (%) 1.71.7 0.20.2
BENESTENT IIBENESTENT II
Serruys PW et al. Lancet 1998;352:673-681
0 50 100 150 200 250 300 350 40070
75
80
85
90
95
100
77.6%
84.3%
P=0.01
All Patients BalloonStent
Event-Free MACE Survival at 12 Months
Lesões Lesões longaslongas
FemininoFeminino82 anos82 anosAngina Angina estávelestável
Sem lesões Sem lesões graves na CEgraves na CE
Lesões Lesões longaslongas
FemininoFeminino82 anos82 anosAngina Angina estávelestável
Sem lesões Sem lesões graves na CEgraves na CE
STENT33 mm x 3,5
RestenRestenoseose
CD - CD - Stent Stent LongoLongo
12 meses12 mesesRestenose Restenose
focalfocal
CD - CD - Stent Stent LongoLongo
12 meses12 mesesRestenose Restenose
focalfocal
Pós Pós dilataçãodilatação
Lesões de BifurcaçãoLesões de Bifurcação
Lesões de BifurcaçãoLesões de Bifurcação
Lesões de BifurcaçãoLesões de Bifurcação
STENT 1DA
STENT 2Di.
Pontes de SafenaPontes de Safena
SafenaAo - CD
Pontes de SafenaPontes de Safena
SafenaAo - CDSTENT
Pontes Pontes de de
SafenaSafena
ProteçãProteçãoo
DistalDistal
Intervenção Percutânea Intervenção Percutâneaou Cirurgia
STENT PAMISTENT PAMI
Primary EndpointDeath, re-infarction, ischemic-driven TVR or disabling
stroke at 6 months
N = 900 patientsN = 900 patientsAcute myocardial Acute myocardial
infarction infarction 12 hours 12 hours of symptoms onsetof symptoms onset
Randomized
Heparin-Coated Heparin-Coated Palmaz-SchatzPalmaz-SchatzTMTM
StentStentn = 452n = 452
Primary PTCA n Primary PTCA n = 448= 448
Grines CL et al. N Engl J Med 1999;341:1949-56
Stent Primary Angioplasty in Myocardial Infarction
STENT PAMISTENT PAMI
Grines CL et al. N Engl J Med 1999;341:1949-56
Results atResults at6 Months6 Months
Heparin-Heparin-coated coated StentStent
PTCAPTCA pp--ValueValue
Death (%)Death (%) 4.24.2 2.72.7 NSNSRe-infarction (%)Re-infarction (%) 2.42.4 2.22.2 NSNSDisabling stoke Disabling stoke (%)(%) 0.20.2 0.20.2 NSNS
Ischemic TVR (%)Ischemic TVR (%) 7.57.5 17.017.0 < 0.001< 0.001Composite endpt Composite endpt (%)(%) 12.412.4 20.120.1 < 0.01< 0.01
Final TIMI III (%)Final TIMI III (%) 89.489.4 92.792.7 0.010.01Restenosis (%)Restenosis (%) 20.320.3 33.533.5 < 0.001< 0.001
ARTSARTS
Primary EndpointMACCE (death, MI, repeat revascularization and
cerebrovascular events) at 1 year
N = 1205 patientsN = 1205 patientsMultivessel diseaseMultivessel disease
Randomized
StentStentn = 600n = 600
CABGCABGn = 605n = 605
Serruys PW et al. N Engl J Med 2001;344:1117-24
Arterial Revascularization Therapy Study
ARTS
Number of Conduits Number of Conduits vs vs Number of Number of Treated LesionsTreated Lesions
2.32.3
48.348.3
28.928.9
11.611.6
3.23.2
2.02.0
0.70.7
0.20.2
1.81.8
51.651.6
33.633.6
6.96.9
0.50.5
SURGERYSURGERY STENTSTENTAverage 2.7 anastomosesAverage 2.7 anastomoses Average 2.7 lesionsAverage 2.7 lesions12345678
Conduits: 2.5 0.7
ARTSARTS1-year Event-free Survival: Death, MI, Cerebro- vascular Accident or Repeat Revascularization
0 60 120 180 240 300 3600
90
92
94
96
98
100
P<0.001
CABG
Stenting
Even
t-fre
e Su
rviv
al (%
)
Days After Randomization
88%
74%
CABRI CABRI versusversus ARTS ARTSCABRI: 1994, ARTS: 1999
ARTS/CABRICardialysis Rotterdam ESC 1999
100100
9090
8080
7070
6060
5050Eve
n- F
ree
Sur
viva
l (%
)E
ven-
Fre
e S
urvi
val (
%)
00 6060 120120 180180 240240 300300 360360Time (days)
CABRI: CABG (90.8%)CABRI: CABG (90.8%)
ARTS: CABG (89.4%)ARTS: CABG (89.4%)
ARTS: Stent (75.2%)ARTS: Stent (75.2%)
CABRI: PTCA (58.8%)CABRI: PTCA (58.8%)
ARTSARTS -- Outcomes in DiabeticsOutcomes in Diabetics
1.8%
6.3% 6.3%
3.1%
0%
2%
4%
6%
8%
10%
39.3%
17.7%
0%
10%
20%
30%
40%
50%P=0.19P=0.19 P<0.00034P<0.00034
n = 208 (17%) patients had diabetes n = 208 (17%) patients had diabetes
P=0.09P=0.09
DeathDeath CVACVA Death, MI, CVA, TVRDeath, MI, CVA, TVR
12 Month Events:12 Month Events: StentStent CABGCABG12 Month Events:12 Month Events: StentStent CABGCABG
Abizaid A et al. Circulation 2001;104:533-538 Abizaid A et al. Circulation 2001;104:533-538
CRUISECRUISE
Primary EndpointTarget vessel revascularization at 9 months
n= 525n= 525Patients enrolled Patients enrolled
in the STARS trialin the STARS trial
Comparison
IVUS-guidedIVUS-guidedStent implantationStent implantation
Angio-guidedAngio-guidedStent implantationStent implantation
Fitzgerald PJ et al. Circulation 2000;102:523-30
Can Routine Ultrasound Influence Stent Expansion?
CRUISECRUISE
9-Month TLR (n = 525)9-Month TLR (n = 525)
8.4
14.5
0
4
8
12
16
P=0.04P=0.04
(%)(%)
IVUS ANGIO
9-Month TLR (n = 525)9-Month TLR (n = 525)
8.4
14.5
0
4
8
12
16
P=0.04P=0.04
(%)(%)
IVUS ANGIO
The “CypherTM” Sirolimus- Eluting Stent Program
The “CypherTMTM” Sirolimus- Eluting Stent Program
ERA DOS STENTS RECOBEDRTOS
FIM StudyFIM Study First-In-Man Study with Sirolimus Eluting
Bx VelocityTMTM Stent De NovoDe Novo Coronary Coronary
Lesions Lesions
Diameter: 2.5-3.5 mmDiameter: 2.5-3.5 mmLength: Length: <<18mm18mm
CYPHERCYPHERTMTM
StentStentn = 45n = 45
Primary Endpoint: Angiography and IVUS follow-up at 4-6 months, 12-18 months, 24 months (Sousa) and 4 years
Clinical FU: 1, 4-6, 12-18 and 24 months out to 5 years
P.I. Dr. Souza/ Dr. Serruys
Changes in % DS and MLD InChanges in % DS and MLD In--Stent Stent
PrePre PostPost 4 Mo4 Mo 1 1 YearYear 2 2 YearYear
FIM: 2-Year Angiographic Follow-upFIM: 2FIM: 2--Year Angiographic FollowYear Angiographic Follow--upup
4.8 5.8 84.6
64.5mmmm
10
20
30
40
50
60
70
80
0.5
1
1.5
2
2.5
3mmmm
10
20
30
40
50
60
70
80
0.5
1
1.5
2
2.5
3
1.051.05
2.852.85 2.802.80 2.752.75 2.752.75
Sousa JE et al. Circulation 2003;107:381-83Sousa JE et al. Circulation 2003;107:381-83
Sousa JE et al. Circulation 2001;103:192-195Sousa JE et al. Circulation 2001;103:192-195Sousa JE et al. Circulation 2001;104:2007-11Sousa JE et al. Circulation 2001;104:2007-11Sousa JE et al. Circulation 2001;103:192-195Sousa JE et al. Circulation 2001;103:192-195Sousa JE et al. Circulation 2001;104:2007-11Sousa JE et al. Circulation 2001;104:2007-11
N = 238 patientsN = 238 patients de novode novo, native, native coronary arterycoronary artery
Randomized
Sirolimus-coatedSirolimus-coated Bx VelocityBx VelocityTMTM Stent Stent
n = 120n = 120
Uncoated Uncoated Bx VelocityBx VelocityTMTM Stent Stent
n = 118n = 118
Primary EndpointMinimum lumen diameter measured by quantitative
angiographic analysis at 6 months
RAVEL RAVEL Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native
Coronary Artery Lesions
P.I. Dr. M C Morice
RAVEL - Event-Free Survival @ RAVEL - Event-Free Survival @ 210 Days 210 Days
Morice MC et al. N Engl J Med 2002;346:1773-80
RAVELRAVELResultados de 3 anosResultados de 3 anos
Cypher – sirolimusCypher – sirolimus
Moderador – Stephen EllisModerador – Stephen EllisACC – New Orleans – Março ACC – New Orleans – Março
20042004
RAVEL 3 ANOS
SIRIUSSIRIUS
Randomized
CYPHER CYPHER TMTM Stent Stentn= 533n= 533
Uncoated Uncoated Bx VelocityBx VelocityTMTM Stent Stent
n= 525n= 525
N = 1058 patientsN = 1058 patients de novo, nativede novo, native coronary arterycoronary artery
Primary EndpointTarget Vessel FailureTarget Vessel Failure (cardiac death, MI, or repeat
revascularization) at 9 months
A U.S. Multicenter, Randomized, Double-Blind Study of the A U.S. Multicenter, Randomized, Double-Blind Study of the SIRSIRololIImmUSUS--Eluting Stent in De Novo Native Coronary Lesions Eluting Stent in De Novo Native Coronary Lesions
P.I. Drs. Leon/ Moses
SIRIUSSIRIUS -- RestenosisRestenosis
8.93.2
35.4 36.3
In-stent In-segment
%Sirolimus (n=349) Control (n=353)
8.93.2
35.4 36.3
In-stent In-segment
%Sirolimus (n=349) Control (n=353)
P<0.001P<0.001P<0.001P<0.001
91%91% 75%75%
Moses JW and Leon MB et al. N Engl J Med (in press)Moses JW and Leon MB et al. N Engl J Med (in press)
TAXUS Express PaclitaxelEluting Stents
BOSTON SCIENTIFIC
Evolução Evolução PTCAPTCA x x STENTSTENT
HOSPITAL BIOCOR
Hospital BiocorUso de Stents Recobertos
0
10
20
30
40
50
60
2003 2004- 6m. 2004-12m.
20032004- 6m.2004-12m.
