George César Ximenes Meireles

Three vs Twelve Months of Dual Antiplatelet Therapy After Zotarolimus-Eluting Stents The OPTIMIZE Randomized Trial

IMPORTANCE The current recommendation is for at least 12 months of dual antiplatelet therapy after implantation of a drug-eluting stent. However, the optimal duration of dual antiplatelet therapy with specific types of drug-eluting stents remains unknown. OBJECTIVE To assess the clinical noninferiority of 3 months (short-term) vs 12 months (long-term) of dual antiplatelet therapy in patients undergoing percutaneous coronary intervention (PCI) with zotarolimus-eluting stents. DESIGN, SETTING, AND PATIENTS The OPTIMIZE trial was an open-label, active-controlled, 1:1 randomized noninferiority study including 3119 patients in 33 sites in Brazil between April 2010 and March 2012. Clinical follow-up was performed at 1, 3, 6, and 12 months. Eligible patients were those with stable coronary artery disease or history of low-risk acute coronary syndrome (ACS) undergoing PCI with zotarolimus-eluting stents. INTERVENTIONS After PCI with zotarolimus-eluting stents, patients were prescribed aspirin (100-200 mg daily) and clopidogrel (75 mg daily) for 3 months (n = 1563) or 12 months (n = 1556), unless contraindicated because of occurrence of an end point. MAIN OUTCOMES AND MEASURES The primary end point was net adverse clinical and cerebral events (NACCE; a composite of all-cause death, myocardial infarction [MI], stroke, or major bleeding); the expected event rate at 1 year was 9%, with a noninferiority margin of 2.7%. Secondary end points were major adverse cardiac events (MACE; a composite of all-cause death, MI, emergent coronary artery bypass graft surgery, or target lesion revascularization) and Academic Research Consortium definite or probable stent thrombosis. RESULTS NACCE occurred in 93 patients receiving short-term and 90 patients receiving long-term therapy (6.0% vs 5.8%, respectively; risk difference, 0.17 [95% CI, -1.52 to 1.86]; P = .002 for noninferiority). Kaplan-Meier estimates demonstrated MACE rates at 1 year of 8.3% (128) in the short-term group and 7.4% (114) in the long-term group (HR, 1.12 [95% CI, 0.87-1.45]). Between 91 and 360 days, no statistically significant association was observed for NACCE (39 [2.6%] vs 38 [2.6%] for the short- and long-term groups, respectively; HR, 1.03 [95% CI, 0.66-1.60]), MACE (78 [5.3%] vs 64 [4.3%]; HR, 1.22 [95% CI, 0.88-1.70]), or stent thrombosis (4 [0.3%] vs 1 [0.1%]; HR, 3.97 [95% CI, 0.44-35.49]). CONCLUSIONS AND RELEVANCE In patients with stable coronary artery disease or low-risk ACS treated with zotarolimus-eluting stents, 3 months of dual antiplatelet therapy was noninferior to 12 months for NACCE, without significantly increasing the risk of stent thrombosis. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01113372.

Estudo comparativo randomizado do implante de Stent de aço inoxidável recoberto por carbono semelhante ao diamante versus não recoberto em pacientes com doença arterial coronariana

OBJECTIVE To compare restenosis and major cardiac event rates at one and six months after DLC-coated stent implantation with those of uncoated stents. METHODS Randomized, prospective, comparative study of 180 patients with coronary insufficiency undergoing DLC coated stent (Phytis) or uncoated stent (Penta) implantation, from January, 2003 to July, 2004. Inclusion criteria were: de novo lesion with >50% diameter stenosis in a coronary artery with reference diameter > or = 2.5 mm and < or = 4 mm, and length < 20 mm. Exclusion criteria were: left main coronary artery and bifurcation lesions, chronic total occlusion, and in-stent restenosis. RESULTS Clinical and angiographic baseline characteristics of the groups were similar. Procedural success was achieved in 98.9% of the patients in both groups. One cardiac death occurred in each group during hospitalization. Reference diameter and acute gain were greater in the Penta group (3.21 +/- 0.37 mm vs. 3.34 +/- 0.8 mm, p=0.02 and 2.3 +/- 0.5 vs. 2.49 +/- 0.5, p=0.009, respectively). Angiographic follow-up at six months showed similar rates of restenosis (24.3% vs. 21.8%, p=0.84) and of major cardiac events (16.8% vs. 17.5%, p=1). CONCLUSION DLC coated stents did not provide better outcomes in relation to uncoated stents.

Aneurisma de artéria coronária um ano e cinco meses pós-implante de stent com eluição de sirolimus

A 52-year-old man with diagnosis of post-infarction unstable angina. Coronary angiography revealed 90% luminal obstruction in the middle third of the right coronary artery and 90% in the marginal branch of the circumflex artery. After the administration of clopidogrel 300 mg associated with acetylsalicylic acid, the patient underwent the implantation of a sirolimus-eluting stent (CYPHER; Johnson & Johnson Cordis) 2.5 x 1.8 mm in the lesion located at the left marginal branch. One year and five months after the CYPHER stent implantation, a new angiography showed intrastent coronary aneurysm at the left marginal branch. This case report suggests that the implantation of a sirolimus-coated coronary stent may cause late formation of coronary artery aneurysm.

Influence of metal alloy and the profile of coronary stents in patients with multivessel coronary disease.

BACKGROUND: In Brazil, despite the recommendations of the Brazilian Society of Hemodynamics and Interventional Cardiology, the National Health System has not yet approved the use of drug-eluting stents. In percutaneous coronary interventions performed in the public and part of the private health care system, bare metal stents are used as the only option. Therefore, new information on bare metal stents is of great importance. The primary endpoint was to evaluate the influence of the alloy and the profile of coronary stents on late loss and restenosis rates 6 months after implantation in patients with multivessel coronary disease. METHODS: Single center, randomized and prospective study comparison of cobalt–chromium versus stainless steel stent implantation in 187 patients with multivessel coronary disease. At least one cobalt–chromium and one stainless steel stent were implanted per patient. RESULTS: Mean age of patients was 59.5±10.1 years with a prevalence of males (66.3%) and patients with acute coronary syndrome (56%). Baseline clinical characteristics were similar with hypertension in 146 (78%), dyslipidemia in 85 (45.5%) and diabetes in 68 (36.4%). Two hundred and twenty-nine cobalt–chromium and 284 stainless steel stents were implanted. Angiographic variables showed no statistically significant difference. Angiographic follow-up to 6 months after implantation showed similar late loss and restenosis rates. CONCLUSION: The use of two different alloys, stainless steel and cobalt–chrome stents, in the same patient and in the same vessel produced similar 6-month restenosis and late loss rates.

Intervenção Coronária Percutânea Pelas Vias Radial e Femoral: Comparação Entre Desconfortos Relacionados ao Procedimento e Custos

BACKGROUND: There are few studies on quality of life and costs after percutaneous coronary intervention (PCI) using different vascular accesses. We have compared procedure-related discomforts and costs of PCI using the radial or femoral approaches during hospital stay. METHODS: Prospective, single center registry, including patients undergoing elective PCI. Procedure related complaints were assessed at the end of bed rest using a specific questionnaire. Costs per unit of all the materials used in PCI were taken into account. RESULTS: Patients treated by the radial approach were younger, male, and stable angina was the most common clinical presentation in both groups. Procedural duration, number of vessels treated and stents per patient were similar in both groups. There were no major vascular complications after PCI. We observed greater overall discomfort associated with the procedure (60.3% vs. 81.0%; P = 0.01), back pain (1.7% vs. 17.2%; P < 0.01), difficult urination (1.7% vs. 12.1%; P = 0.03) and patients dependence to carry on basic activities (70.7% vs. 98.3%; P < 0.01) during the post-procedural observation period in the femoral group. No significant differences were observed between groups when costs were compared, with or without taking into account stent-related costs. CONCLUSIONS: PCI using the radial approach demonstrated to provide greater comfort for patients when compared to the femoral approach during hospitalization. Costs of the procedure using the two accesses were similar.

Stent dislodgement in the treatment of left main coronary artery dissection

Correspondencia: George Cesar Ximenes Meireles • Rua Sena Madureira, 1265/102, Vila Clementino, CEP 04021-051, Sao Paulo, SP – Brasil E-mail: gcxm@cardiol.br, george.ximenes@terra.com.br Artigo recebido em 17/09/12, revisado em 21/12/12, aceito em 08/01/13. Palavras-chave Arterias Coronarias, Disseccao, Angioplastia Coronaria com Balao, Stents. Introducao A disseccao acidental do tronco da arteria coronaria esquerda (TCE) e uma das complicacoes mais temidas pelo cardiologista intervencionista, cuja ocorrencia pode ter consequencia grave se nao diagnosticada e tratada prontamente com a revascularizacao miocardica. A incidencia da disseccao ocasionada pelo cateter e menor que 0,1%, elevando-se para 1,05% em pacientes com lesao obstrutiva do TCE1-4. A realizacao de intervencao percutânea imediata com implante de stent parece ser a medida apropriada para tratamento de disseccao acidental do TCE de moderada/ grande extensao, como demonstrado no presente caso.

Trombose coronariana tardia secundária a implante de stent com paclitaxel sem reestenose dos stents convencionais

A male 39 year-old patient with post-infarction angina. The coronary angiography showed total proximal obstruction of right coronary artery (RCA), obstructive lesions of 95% of the anterior descending artery (ADA), 80% of the second left marginal branch (LM2), and 95% of the circumflex artery (CXA). The patient was successfully implanted with a Taxus 3.0 x 24 mm stent and an Express 2.75 x 24 mm stent in the proximal and distal thirds of the RCA, respectively, and with an Infinnium 3.0 x 24 mm stent in the ADA. After seven months, the patient had an anterior acute myocardial infarct (AMI) due to thrombosis of the Infinnium stent and restenosis of the Taxus stent, with no loss of results in the conventional stents.

Perfil clínico-angiográfico na doença arterial coronariana: desfecho hospitalar com ênfase nos muito idosos

FUNDAMENTO: Conhecer fatores de risco e manifestacoes clinicas da doenca arterial coronariana (DAC) permite-nos intervir de maneira mais eficaz junto a uma determinada populacao. OBJETIVO: Identificar perfis clinicos e angiograficos dos pacientes submetidos a cateterismo cardiaco, atendidos em um hospital terciario e tratados por meio de intervencoes coronarianas percutâneas (ICP). METODOS: Casuistica de 1.282 pacientes submetidos a 1.410 cateterismos cardiacos, selecionados de mar/2007-mai/2008 em um banco de dados de um hospital geral para diagnostico de doenca arterial coronariana (DAC). Fatores de risco, indicacao do exame, detalhes tecnicos da ICP e desfechos intra-hospitalares foram prospectivamente coletados. RESULTADOS: Foram 688 (54,0%) pacientes do sexo masculino, com media de idade de 65,4 ± 10,9 anos, sendo 20,0% acima dos 75 anos. O quadro clinico confirmado com mais frequencia foi o de sindrome coronariana aguda (SCA) sem supradesnivelamento do segmento ST (SST) (38,7%). A DAC multiarterial ocorreu em 46,4%, foi indicada ICP em 464 pacientes, sendo tratadas 547 lesoes-alvo (tipo B2 ou C, em 86,0%), sendo destas, 14,0% tratadas com stent farmacologico. Dentre os IAM com SST, ICP primaria foi realizada em 19,0% dos pacientes, sendo que, destes, 77,0% foram transferidos dos hospitais de origem tardiamente (ICP tardia) e nao receberam trombolitico previo, e 4,0% realizaram ICP de resgate. Foi obtido sucesso angiografico em 94,2% das ICPs. Aconteceu obito em 5,6% dos pacientes, tendo estes uma media de idade de 75,2 ± 10,2 anos. CONCLUSAO: Observamos predominio de idosos (estando 20,1% > 75 anos) e do sexo masculino. Dos fatores de risco para DAC, os mais frequentes foram hipertensao arterial sistemica e dislipidemia. Ocorreu predominio da SCA. A idade > 75 anos, DAC multiarterial e a insuficiencia renal cronica foram os preditores de obito intra-hospitalar.BACKGROUND knowing the risk factors and clinical manifestations of coronary artery disease (CAD) allows us to intervene more effectively with a particular population. OBJECTIVE to identify clinical and angiographic profiles of patients undergoing cardiac catheterization, treated at a tertiary hospital and treated by percutaneous coronary interventions (PCI). METHODS the study of 1,282 patients who underwent 1,410 cardiac catheterizations, selected from March/2007 to May/2008 from a database in a general hospital for diagnosis of coronary artery disease (CAD). Risk factors, indication for examination, technical details of PCI and in-hospital outcomes were prospectively collected. RESULTS there were 688 (54.0%) males, mean age 65.4 ± 10.9 years and 20.0% above 75 years age. The most frequent clinical condition was acute coronary syndrome (ACS) without ST-segment elevation (STS) (38.7%). The multi artery CAD occurred in 46.4%, PCI was indicated in 464 patients, 547 target lesions were treated (type B2 or C, 86.0%), and of these, 14.0% treated with drug eluting stents. Among those with AMI with STS, primary PCI was performed in 19.0% of the patients, from these, 77.0% were transferred from the origin hospitals late (late PCI) and had not received prior thrombolytic, and 4.0% had PCI rescue. Angiographic success was achieved in 94.2% of PCIs. Death occurred in 5.6% of patients, with average age of 75.2 ± 10.2 years. CONCLUSION the prevalence of elderly (20.1% being > 75 years) and male was observed. From the risk factors for CAD, the most common were systemic hypertension and dyslipidemia. There was a predominance of ACS. Age > 75 years old, multiarterial CAD and chronic renal failure were predictors of in-hospital deaths.

Clinical and angiographic profile in coronary artery disease: hospital outcome with emphasis on the very elderly

FUNDAMENTO: Conhecer fatores de risco e manifestacoes clinicas da doenca arterial coronariana (DAC) permite-nos intervir de maneira mais eficaz junto a uma determinada populacao. OBJETIVO: Identificar perfis clinicos e angiograficos dos pacientes submetidos a cateterismo cardiaco, atendidos em um hospital terciario e tratados por meio de intervencoes coronarianas percutâneas (ICP). METODOS: Casuistica de 1.282 pacientes submetidos a 1.410 cateterismos cardiacos, selecionados de mar/2007-mai/2008 em um banco de dados de um hospital geral para diagnostico de doenca arterial coronariana (DAC). Fatores de risco, indicacao do exame, detalhes tecnicos da ICP e desfechos intra-hospitalares foram prospectivamente coletados. RESULTADOS: Foram 688 (54,0%) pacientes do sexo masculino, com media de idade de 65,4 ± 10,9 anos, sendo 20,0% acima dos 75 anos. O quadro clinico confirmado com mais frequencia foi o de sindrome coronariana aguda (SCA) sem supradesnivelamento do segmento ST (SST) (38,7%). A DAC multiarterial ocorreu em 46,4%, foi indicada ICP em 464 pacientes, sendo tratadas 547 lesoes-alvo (tipo B2 ou C, em 86,0%), sendo destas, 14,0% tratadas com stent farmacologico. Dentre os IAM com SST, ICP primaria foi realizada em 19,0% dos pacientes, sendo que, destes, 77,0% foram transferidos dos hospitais de origem tardiamente (ICP tardia) e nao receberam trombolitico previo, e 4,0% realizaram ICP de resgate. Foi obtido sucesso angiografico em 94,2% das ICPs. Aconteceu obito em 5,6% dos pacientes, tendo estes uma media de idade de 75,2 ± 10,2 anos. CONCLUSAO: Observamos predominio de idosos (estando 20,1% > 75 anos) e do sexo masculino. Dos fatores de risco para DAC, os mais frequentes foram hipertensao arterial sistemica e dislipidemia. Ocorreu predominio da SCA. A idade > 75 anos, DAC multiarterial e a insuficiencia renal cronica foram os preditores de obito intra-hospitalar.BACKGROUND knowing the risk factors and clinical manifestations of coronary artery disease (CAD) allows us to intervene more effectively with a particular population. OBJECTIVE to identify clinical and angiographic profiles of patients undergoing cardiac catheterization, treated at a tertiary hospital and treated by percutaneous coronary interventions (PCI). METHODS the study of 1,282 patients who underwent 1,410 cardiac catheterizations, selected from March/2007 to May/2008 from a database in a general hospital for diagnosis of coronary artery disease (CAD). Risk factors, indication for examination, technical details of PCI and in-hospital outcomes were prospectively collected. RESULTS there were 688 (54.0%) males, mean age 65.4 ± 10.9 years and 20.0% above 75 years age. The most frequent clinical condition was acute coronary syndrome (ACS) without ST-segment elevation (STS) (38.7%). The multi artery CAD occurred in 46.4%, PCI was indicated in 464 patients, 547 target lesions were treated (type B2 or C, 86.0%), and of these, 14.0% treated with drug eluting stents. Among those with AMI with STS, primary PCI was performed in 19.0% of the patients, from these, 77.0% were transferred from the origin hospitals late (late PCI) and had not received prior thrombolytic, and 4.0% had PCI rescue. Angiographic success was achieved in 94.2% of PCIs. Death occurred in 5.6% of patients, with average age of 75.2 ± 10.2 years. CONCLUSION the prevalence of elderly (20.1% being > 75 years) and male was observed. From the risk factors for CAD, the most common were systemic hypertension and dyslipidemia. There was a predominance of ACS. Age > 75 years old, multiarterial CAD and chronic renal failure were predictors of in-hospital deaths.

Avaliação do custo do implante programado de múltiplos stents em mais de uma intervenção percutânea em pacientes com doença coronária multiarterial

FUNDAMENTOS: O Sistema Unico de Saude estabelece que a angioplastia coronaria com implante de dupla protese intraluminal nao devera exceder o total de 20% das angioplastias realizadas, resultando na necessidade de escalonar a maioria dos procedimentos nos pacientes com doenca coronaria multiarterial. O objetivo deste estudo foi comparar os custos do escalonamento estabelecido pelo SUS para implante de stent ao planejamento de implante de stent considerado ideal pela equipe de cardiologia intervencionista, em pacientes com doenca coronaria multiarterial, com indicacao de implante de mais um stent por procedimento. METODO: Os custos foram comparados em uma serie consecutiva de 100 pacientes com doenca multiarterial com indicacao de revascularizacao completa por intervencao coronaria percutânea com o implante de dois ou mais stents por paciente. As coronariografias foram previamente avaliadas pela equipe de cardiologia intervencionista, que indicou o escalonamento considerado ideal para o tratamento das estenoses coronarias em cada paciente. Em seguida, foram realizados os procedimentos de acordo com os criterios do SUS e os custos das duas estrategias comparados. O valor do procedimento de implante de um stent pela tabela SUS e de R