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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. Coronária Normal.
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XV CONGRESSO DA SMC SIMPÓSIO Tratamento Intervencionista da Aterosclerose Belo Horizonte 8 a 10 de julho de 2004
Tratamento Intervencionista daAterosclerose Coronária Os Estudos Randomizados: A Evidência dos Benefícios Dr. Maurício de Rezende Barbosa
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% 30% 0%
Lesão ampliadaconduta? Fem 42 anos Lesão isolada CD
Lesão residual 30% Pós angioplastia • Angioplastia • convencional Restenose 6 meses 30 a 40%
Primeiros Estudos Randomizados PTCA STENT PTCA STENT 33%
Eventos Clínicos 27.1 23.7 18.2
Lesão residual 30% Pós angioplastia • Angioplastia • convencional Restenose 6 meses 30 a 40%
Sem lesão residual Conduta? 95% • Implante de STENT Restenose 6 meses 10 a 20% STRESS 1992 BENESTENT 1992
46 7
BENESTENT II BElgium-NEtherlands STENT Investigators Palmaz-SchatzTM Stent n=414 N = 827 patients de novo, native, single vessel disease 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 Serruys PW et al. Lancet 1998;352:673-681
BENESTENT II Stent All Patients 100 Balloon Event-Free MACE Survival at 12 Months 95 90 84.3% 85 P=0.01 80 77.6% 75 70 0 50 100 150 200 250 300 350 400 Serruys PW et al. Lancet 1998;352:673-681
Lesões longasFeminino82 anosAngina estávelSem lesões graves na CE
Lesões longasFeminino82 anosAngina estávelSem lesões graves na CE STENT 33 mm x 3,5
STENT 2 Di. STENT 1 DA Lesões de Bifurcação
Pontes de Safena Safena Ao - CD
Pontes de Safena Safena Ao - CD STENT
Intervenção Percutânea ou Cirurgia Intervenção Percutânea
STENT PAMI StentPrimary Angioplasty in Myocardial Infarction Heparin-Coated Palmaz-SchatzTM Stent n = 452 N = 900 patients Acute myocardial infarction 12 hours of symptoms onset Randomized Primary PTCA n = 448 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 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
ARTS Number of Conduits vs Number of Treated Lesions SURGERY STENT Average 2.7 anastomoses Average 2.7 lesions 1 1.8 2.3 2 48.3 51.6 3 28.9 33.6 4 6.9 11.6 5 0.5 3.2 6 2.0 7 0.7 Conduits: 2.5 0.7 8 0.2
1-year Event-free Survival: Death, MI, Cerebro- vascular Accident or Repeat Revascularization 100 CABG 98 88% 96 P<0.001 94 Event-free Survival (%) 74% 92 Stenting 90 0 0 60 120 180 240 300 360 Days After Randomization ARTS
CABRI: 1994, ARTS: 1999 100 CABRI: CABG (90.8%) 90 ARTS: CABG (89.4%) 80 Even- Free Survival (%) ARTS: Stent (75.2%) 70 60 CABRI: PTCA (58.8%) 50 0 60 120 180 240 300 360 Time (days) ARTS/CABRI Cardialysis Rotterdam ESC 1999 CABRI versus ARTS
CRUISE Can Routine Ultrasound Influence Stent Expansion? IVUS-guided Stent implantation n= 525 Patients enrolled in the STARS trial Comparison Angio-guided Stent implantation Primary Endpoint Target vessel revascularization at 9 months Fitzgerald PJ et al. Circulation 2000;102:523-30
FIM StudyFirst-In-Man Study with Sirolimus Eluting Bx VelocityTMStent 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 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
RAVEL Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable 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
SIRIUS A U.S. Multicenter, Randomized, Double-Blind Study of the SIRolImUS-Eluting Stent in De Novo Native Coronary Lesions CYPHER TM Stent n= 533 P.I. Drs. Leon/ Moses N = 1058 patients de novo, native coronary artery Randomized Uncoated Bx VelocityTM Stent n= 525 Primary Endpoint Target Vessel Failure (cardiac death, MI, or repeat revascularization) at 9 months
TAXUS Express Paclitaxel Eluting Stents BOSTON SCIENTIFIC