abcArquivos Brasileiros de CardiologiaArq. Bras. Cardiol.0066-782X1678-4170Sociedade Brasileira de Cardiologia - SBCSão Paulo, SP, BrazilfjQqCfmqdmZNVTQsFgdcS6f00025S0066-782X2010000600025S0066-782X(10)0940062510.1590/S0066-782X2010000600025Ponto de VistaAngioplastia versus tratamento clínico em oligossintomáticos: tempo de parar?AndradePedro José Negreiros deFortalezaCearáUniversidade Federal do CearáFaculdade de Medicina Departamento de Medicina ClínicaBrazil062010946179180This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.12072010
PONTO DE VISTA
Angioplastia versus tratamento clínico em oligossintomáticos: tempo de parar?
Pedro José Negreiros de Andrade
Departamento de Medicina Clínica- Faculdade de Medicina da Universidade Federal do Ceará, Fortaleza, CE - Brasil
Acaba de ser publicado no New England Journal of Medicine, o tão esperado estudo BARI 2-D1. Na parte que interessa a cardiologistas, 2.368 pacientes com diabete tipo 2 e coronariopatia foram randomizados para dois braços: tratamento ótimo da diabete ou terapêutica de revascularização, que poderia ser por cirurgia ou angioplastia. A randomização foi realizada independente da escolha da melhor terapêutica de revascularização para cada paciente, a qual ficava a critério dos médicos, não sendo o estudo uma comparação entre angioplastia e cirurgia.
Analisando os suplementos da publicação, vemos que os pacientes eram, em sua maioria, oligossintomáticos. Do total, 17% eram assintomáticos; 21,4% não tinham angina, mas sim o que os investigadores consideraram ser o "equivalente angioso"; dos pacientes com angina, a grande maioria estava em classe funcional I ou II; só 8,6% tinham angina classe III ou IV; e só 9,5% apresentavam angina instável. Demonstrando a condição predominantemente não cirúrgica dos pacientes, apenas 17% tinham fração de ejeção menor que 50%; só 30% eram triarteriais; e só 13% tinham lesão proximal da artéria descendente anterior. Era pois um grupo, regra geral, de pouca gravidade angiográfica, em muitos dos quais a revascularização miocárdica, por qualquer método, seria questionável. A revascularização cirúrgica, por não preencherem os critérios clássicos angiográficos de indicação (tronco, três vasos com má função ventricular ou três vasos com lesão proximal de descendente anterior), e a revascularização por angioplastia, pela condição de diabéticos e, principalmente, por serem oligossintomáticos. Os resultados foram os esperados por quem quer que acompanhe trabalhos desse tipo ao longo dos últimos 27 anos2-8. A mortalidade em 5 anos foi de 11,7% no grupo terapêutica de revascularização e de 12,2% no grupo terapêutica clínica (NS). Não houve diferença nos eventos maiores, morte, infarto ou acidente vascular cerebral: 22,8% no grupo revascularização e 24,1% no grupo terapêutica clínica (NS). A angioplastia não reduziu a mortalidade (10,8% versus 10,2%), nem eventos (21,1% versus 23%). A cirurgia também não reduziu significantemente a mortalidade (13,4% versus 16,4%), embora tenha reduzido eventos (22,4% versus 30,4%), possivelmente por ser indicada para um subgrupo de doentes com lesões mais extensas.
Ao ter conhecimento dos resultados do estudo, a Sociedade Americana de Cardiologia Intervencionista divulgou nota em que lembra serem os stents eluídos em drogas a melhor opção para coronariopatas diabéticos e que eles teriam sido utilizados em uma minoria (30%) de pacientes. Realmente o pouco emprego de stents farmacológicos pode ter contribuído para o resultado pobre da angioplastia em termos de redução de eventos, mas não em termos de redução da mortalidade. Além disso, há indícios da existência de subgrupos de pacientes estáveis nos quais os benefícios da intervenção percutânea seriam maiores que os encontrados nos pacientes do estudo Bari-2D9. Mas o que vale a pena questionar é algo bem mais simples: esse estudo acrescenta alguma coisa ao que já sabíamos? Após os resultados de seis estudos randomizados (sete, com o COURAGE, totalizando mais de 5.000 pacientes) que uniformemente não mostravam benefícios da angioplastia em pacientes oligossintomáticos, porque testá-la mais uma vez em pacientes tão pouco sintomáticos, quase sempre não cirúrgicos, e com a agravante de serem diabéticos? Diante de tudo que já se sabe, não será hora de parar com estudos randomizados como esse, principalmente em face à certeza de que o julgamento clínico tende a separar melhor as opções de tratamento, conforme é consenso universal e já foi comprovado pelo estudo MASS II10?
Antes que venha a ocorrer um novo, grande e caro estudo, comparando stents revestidos com tratamento clínico em pacientes similares, essas perguntas precisam ser respondidas.
Correspondência:
Pedro José Negreiros de Andrade
Francisco Holanda, 992/1101 - Dionisio Torres
60130-040 - Fortaleza, CE - Brasil
E-mail:
pedroneg@cardiol.br,
pedroneg@gmail.com
Artigo recebido em 30/06/09; revisado recebido em 30/10/09; aceito em 15/12/09.
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POINT OF VIEW
Pedro José Negreiros de Andrade
Departamento de Medicina Clínica- Faculdade de Medicina da Universidade Federal do Ceará, Fortaleza, CE - Brazil
The long-awaited BARI 2-D1 study has just been published in the New England Journal of Medicine. In the part that would be of interest to cardiologists, 2,368 patients with type 2 diabetes and coronary artery disease were randomized into two groups: optimal treatment for diabetes, and revascularization therapy, either by surgery or angioplasty. The randomization was performed independently of the selecting of optimal therapy for each patient, which was left at the discretion of the physicians; the study was not a comparison between angioplasty and surgery.
Analyzing the publication of supplements, we observed that most patients were mildly symptomatic. Of the total, 17% were asymptomatic; and 21.4% did not have angina, but what the researchers considered to be an "angina equivalent". Of the patients with angina, most were in functional class I or II; only 8.6 % were in angina class III or IV; and only 9.5% had unstable angina. Demonstrating the predominantly non-surgical conditions of the patients, only 17% had an ejection fraction of less than 50%; only 30% had three-vessel disease; and only 13% had a proximal left anterior descending artery obstruction. It was thus a sample of patients with generally minor angiographic changes, in many of whom myocardial revascularization, by any method, would be questionable: surgical revascularization would be questionable because they did not meet the traditional angiographic indication criteria (left main, three vessels with poor ventricular function, or three vessels with proximal left anterior descending obsctruction); and coronary angioplasty would be questionable because they were diabetic, and especially because they were mildly symptomatic. The results were as the expected by anyone accompanying such studies over the past 27 years2-8. The 5-year mortality was 11.7% in the revascularization therapy group, and 12.2% in the clinical treatment group (NS). There was no difference in major events, deaths, heart attacks, or strokes: 22.8% in the revascularization group, and 24.1% in the clinical treatment group (NS). Angioplasty did not reduce mortality (10.8% versus 10.2%) or events (21.1% versus 23%). Surgery has not significantly reduced mortality (13.4% versus 16.4%), although it has reduced events (22.4% versus 30.4%), possibly because it was indicated for a subgroup of patients with more extensive lesions.
On learning the results of the study, the American Society of Interventional Cardiology issued a statement reminding that drug-eluting stents are the best option for diabetics with coronary artery disease, and that they have been used in a minority (30%) of patients. Actually the limited use of drug-eluting stents may have contributed to the poor outcome of angioplasty in terms of reducing events, but not in terms of reducing mortality. Moreover, there is evidence of the existence of subgroups of stable patients in whom the benefits of PCI were higher than those found in the patients of the Bari-2D study9 . But it is worth questioning something much simpler: Does this study add anything to what we already know? After the results of six randomized studies (seven with the COURAGE study, totaling more than 5,000 patients) which uniformly showed no benefit of angioplasty in patients with mild symptoms, why test it once more in patients with so few symptoms, often non-surgical patients, and with the aggravating circumstance of diabetes? Given all that is already known, hasn't the time come to stop randomized studies like this, especially when confronted with the certainty that the clinical judgement tend to better separate the treatment options as universally agreed and already proven by the MASS II study?10.
Before a new, large and expensive study comparing coated stents with medical treatment in similar patients is conducted, these questions must be answered.