SIMPÓSIO Tratamento Intervencionista da daAterosclerose XV CONGRESSO DA SMC Belo Horizonte 8 a 10 de julho de 2004

Os Estudos Randomizados: A Evidência dos Benefícios Tratamento Intervencionista da Aterosclerose Coronária Dr. Maurício de Rezende Barbosa

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 80%30% ATEROMA 0%

Lesão ampliada conduta? Fem 42 anos Lesão isolada CD

 Angioplastia convencional Restenose 6 meses 30 a 40% Pós angioplastia Lesão residual 30%

Primeiros Estudos Randomizados 33% PTCA STENT PTCA STENT

Eventos Clínicos

 Angioplastia convencional Restenose 6 meses 30 a 40% Pós angioplastia Lesão residual 30%

95% Restenose 6 meses 10 a 20% STRESS 1992 BENESTENT 1992 Conduta?  Implante de STENT Sem lesão residual

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BENESTENT II Primary Endpoint MACCE (death, MI, repeat revascularization and cerebrovascular events) at 1 year Primary Endpoint MACCE (death, MI, repeat revascularization and cerebrovascular events) at 1 year N = 827 patients de novo, native, single vessel disease N = 827 patients de novo, native, single vessel disease Palmaz-Schatz TM Stentn=414 Stentn=414 Balloon n= 413 Balloon Serruys PW et al. Lancet 1998;352: BElgium-NEtherlands STENT Investigators Aspirin + Ticlopidine Ticlopidine

Serruys PW et al. Lancet 1998;352: BENESTENT II 1-year Results BalloonStent Repeat CABG (%) Repeat PCI (%) * Any MACE (%) * * p < Day Results BalloonStent Death (%) 11.0 Q-wave MI (%) Non Q-wave MI (%) Vascular Complications (%) Subacute Thrombosis (%)

BENESTENT II Serruys PW et al. Lancet 1998;352: % 84.3% P=0.01 All Patients Balloon Stent Event-Free MACE Survival at 12 Months Event-Free MACE Survival at 12 Months

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

STENT 1 DA STENT 2 Di.

Pontes de Safena Safena Ao - CD

Pontes de Safena Safena Ao - CD STENT

Pontes de Safena Proteção Distal

Intervenção Percutânea ou Cirurgia

STENT PAMI STENT PAMI Primary Endpoint Death, re-infarction, ischemic-driven TVR or disabling stroke at 6 months Primary Endpoint Death, re-infarction, ischemic-driven TVR or disabling stroke at 6 months N = 900 patients Acute myocardial infarction  12 hours of symptoms onset N = 900 patients Acute myocardial infarction  12 hours of symptoms onset Randomized Heparin-Coated Palmaz-Schatz TM Stent n = 452 Heparin-Coated Palmaz-Schatz TM Stent n = 452 Primary PTCA n = 448 Grines CL et al. N Engl J Med 1999;341: Stent Primary Angioplasty in Myocardial Infarction

STENT PAMI STENT PAMI Grines CL et al. N Engl J Med 1999;341: Results at 6 Months Heparin- coated Stent PTCA p-Value Death (%) NS Re-infarction (%) NS Disabling stoke (%) NS Ischemic TVR (%) < Composite endpt (%) < 0.01 Final TIMI III (%) Restenosis (%) < 0.001

ARTS Primary Endpoint MACCE (death, MI, repeat revascularization and cerebrovascular events) at 1 year Primary Endpoint MACCE (death, MI, repeat revascularization and cerebrovascular events) at 1 year N = 1205 patients Multivessel disease N = 1205 patients Multivessel disease Randomized Stent Stent n = 600 Stent Stent n = 600 CABG n = 605 CABG Serruys PW et al. N Engl J Med 2001;344: Arterial Revascularization Therapy Study

ARTS Number of Conduits vs Number of Treated Lesions SURGERYSURGERYSTENTSTENT Average 2.7 anastomoses Average 2.7 lesions Conduits: 2.5  0.7

ARTS 1-year Event-free Survival: Death, MI, Cerebro- vascular Accident or Repeat Revascularization P<0.001 CABG Stenting Event-free Survival (%) Days After Randomization 88% 74%

CABRI versus ARTS CABRI: 1994, ARTS: 1999 ARTS/CABRI Cardialysis Rotterdam ESC Even- Free Survival (%) Time (days) CABRI: CABG (90.8%) ARTS: CABG (89.4%) ARTS: Stent (75.2%) CABRI: PTCA (58.8%)

CRUISE Primary Endpoint Target vessel revascularization at 9 months Primary Endpoint Target vessel revascularization at 9 months n= 525 Patients enrolled in the STARS trial in the STARS trial n= 525 Patients enrolled in the STARS trial in the STARS trial Comparison IVUS-guided Stent implantation IVUS-guided Angio-guided Angio-guided Fitzgerald PJ et al. Circulation 2000;102: Can Routine Ultrasound Influence Stent Expansion?

ERA DOS STENTS RECOBEDRTOS

FIM Study TM FIM Study First-In-Man Study with Sirolimus Eluting Bx Velocity TM Stent De Novo Coronary Lesions Diameter: mm Length: <18mm De Novo Coronary Lesions Diameter: mm Length: <18mm CYPHER TM Stent n = 45 CYPHER TM Stent n = 45 Primary Endpoint: Angiography and IVUS follow-up at 4- 6 months, months, 24 months (Sousa) and 4 years Clinical FU: 1, 4-6, and 24 months out to 5 years Primary Endpoint: Angiography and IVUS follow-up at 4- 6 months, months, 24 months (Sousa) and 4 years Clinical FU: 1, 4-6, and 24 months out to 5 years P.I. Dr. Souza/ Dr. Serruys

N = 238 patients de novo, native de novo, native coronary artery coronary artery N = 238 patients de novo, native de novo, native coronary artery coronary artery Randomized Sirolimus-coated Sirolimus-coated Bx Velocity TM Stent Bx Velocity TM Stent n = 120 Sirolimus-coated Sirolimus-coated Bx Velocity TM Stent Bx Velocity TM Stent n = 120 Uncoated Bx Velocity TM Stent Bx Velocity TM Stent n = 118 Uncoated Bx Velocity TM Stent Bx Velocity TM Stent n = 118 Primary Endpoint Minimum lumen diameter measured by quantitative angiographic analysis at 6 months Primary Endpoint Minimum lumen diameter measured by quantitative angiographic analysis at 6 months 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 210 Days Morice MC et al. N Engl J Med 2002;346:

RAVEL Resultados de 3 anos Cypher – sirolimus Moderador – Stephen Ellis ACC – New Orleans – Março 2004

RAVEL 3 ANOS

SIRIUS Randomized CYPHER TM Stent CYPHER TM Stent n= 533 CYPHER TM Stent CYPHER TM Stent n= 533 Uncoated Bx Velocity TM Stent n= 525 Uncoated Bx Velocity TM Stent n= 525 N = 1058 patients de novo, native de novo, native coronary artery coronary artery N = 1058 patients de novo, native de novo, native coronary artery coronary artery Primary Endpoint Target Vessel Failure Target Vessel Failure (cardiac death, MI, or repeat revascularization) at 9 months Primary Endpoint Target Vessel Failure Target Vessel Failure (cardiac death, MI, or repeat revascularization) at 9 months A U.S. Multicenter, Randomized, Double-Blind Study of the SIRolImUS- Eluting Stent in De Novo Native Coronary Lesions P.I. Drs. Leon/ Moses

TAXUS Express Paclitaxel Eluting Stents BOSTON SCIENTIFIC

Evolução PTCA x STENT HOSPITAL BIOCOR

Hospital Biocor Uso de Stents Recobertos