Arq Bras Cardiol abc Arquivos Brasileiros de Cardiologia Arq. Bras. Cardiol. 0066-782X 1678-4170 Sociedade Brasileira de Cardiologia - SBC BBN8WctFfszfBrnFkwzkJBd S0066-782X2019000500571 10.5935/abc.20190093 Short Editorial Brazil: Two Realities for the Treatment of One Disease 0000-0002-5664-4185 Guimarães Leonardo 1 0000-0002-6287-5414 Caixeta Adriano 2 3 Laval University Quebec Heart and Lung Institute Quebec Canada Quebec Heart and Lung Institute - Laval University, Quebec - Canada Universidade Federal de São Paulo Escola Paulista de Medicina São Paulo SP Brazil Escola Paulista de Medicina - Universidade Federal de São Paulo, São Paulo, SP - Brazil Hospital Israelita Albert Einstein São Paulo SP Brazil Hospital Israelita Albert Einstein, São Paulo, SP - Brazil Mailing Address: Adriano Caixeta, Rua Salim Izar, 333. Postal Code 05617-040 Morumbi, SP - Brazil. E-mail: acaixeta@me.com 06 06 2019 05 2019 112 5 571 572 This is an Open Access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Keywords Coronary Artery Disease Cardiovascular Diseases/mortality ST Elevation Myocardial Infarction Myocardial Revascularization Diabetes Mellitus Percutaneous Coronary Intervention Drug-Eluting Stents

Current drug-eluting stents (DES) are safer and more effective (lower restenosis rates) than bare-metal stents (BMS),1,2 and are able to reduce short- and long-term cardiovascular outcomes.3,4 In patients with ST segment elevation acute myocardial infarction (STEMI), the randomized study EXAMINATION5 evaluated 1,498 patients with STEMI, who were allocated for the treatment of percutaneous coronary intervention (PCI) with new-generation DES containing everolimus or BMS. After a 5-year follow-up, there was a relative reduction of combined outcomes and mortality of 20% and 30%, respectively, in favor of DES. Finally, despite the higher initial cost in the index procedure, DESs present better cost-effectiveness compared to BMS on long-term.6 In this context, in 2018, the most current Guideline for coronary artery bypass grafting of the European Society of Cardiology considers recommendation Class I the use of DES in any and all clinical settings, including STEMI.7

Cardiovascular disease is the leading cause of death worldwide and diabetes mellitus is one of the most important risk factors for coronary atherosclerotic disease (CAD).8 Diabetic patients present 2 to 3-fold higher mortality after acute coronary syndrome compared to non-diabetics.9 Besides, as these patients present expressive endothelial dysfunction, high inflammatory response to vascular injury, diffuse CAD and coronary arteries of smaller caliber, they develop higher rates of in-stent restenosis.10,11 In view of that, using DES is even more imperative in patients with diabetes, and presents 87% less risk of in-stent restenosis and 77% less risk of revascularization of the target lesion compared to BMS.12

In this study VICTIM Oliveira et al.,13 analyzing the incorporation of DES in public and private institutions in the State of Sergipe (between 2014 and 2017; after the approval of its use in Brazil's public health system [SUS] at the amount of BRL 2,034.50), found that only 8.7% of diabetic patients with STEMI were treated with DES in the public system, while 90.6% received DES in the private healthcare system. These figures make evident the worrying reality of the Brazilian public health system regarding the treatment of STEMI, especially in a vulnerable population such as diabetics. Moreover, despite the official approval (Ordinance No. 29 issued by the Ministry of Health) of such advanced technology, in Brazil's public healthcare system, its use in non-diabetics and diabetics is important and significantly lower than that of the private healthcare system. In this study, there was no statistical difference for the number of risk factors per patient between the groups, with most of them presenting ≥ 2 cardiovascular risk factors. Noted that the main determinants to receive this globally recommended and proven superior therapy were: family income and education level and, consequently, being able to afford private healthcare. In the United States, in 2003 (one year after DES started being used), 32.7% of diabetic patients undergoing PCI received DES and, in 2011, this number was in excess of 75%.14

According to the Brazilian National Health Agency (ANS), in 2019, only 24.3% of Brazilians have private health insurance and, because of that, less than one quarter of the population has access to the treatment recommended by international and Brazilian guidelines.15 On the other hand, the vast majority of the population of diabetics only have BMS available. In the international scientific community, unlike the Brazilian reality, the debate about the use of BMS versus DES is now outdated. Also, progress of a new generation of DES such as those of ultrathin struts with bioabsorbable and non-polymeric polymers is discussed.

Thus, as demonstrated in the VICTIM registry, Brazil - a developing country - could be divided into two major nations regarding the treatment of STEMI by PCI: one, the public healthcare system, with most of the population exposed to non-contemporary treatment and unequivocally inferior clinical outcomes; another, the private health system with a population with better socioeconomic conditions and access to the best technologies, similar to those of developed countries. By addressing the deficiencies found in Brazil's public healthcare system in the treatment of a significant portion of the population, this study is expected to stimulate reflections and changes in health promotion and the provision of new treatments to the impoverished population.

Short Editorial to the article: Disparities In The Use Of Drug-eluting Stents For Diabetic Patients With ST-elevation Acute Myocardial Infarction Assisted In the Public versus Private Network - VICTIM Register

 References 1 Spaulding C, Henry P, Teiger E, Beatt K, Bramucci E, Caré D, et al. et al. Sirolimus-eluting versus uncoated stents in acute myocardial infarction. Ne Engl J Med. 2006;2006;355(11):1093-104. Spaulding C Henry P Teiger E Beatt K Bramucci E Caré D Sirolimus-eluting versus uncoated stents in acute myocardial infarction Ne Engl J Med 2006 355 11 1093 1104 2 Kastrati A, Dibra A, Spaulding C, Laarman GJ, Menichelli M, Valgimigli M, et al.et al. Meta-analysis of randomized trials on drug-eluting stents vs. bare-metal stents in patients with acute myocardial infarction. Eur Heart J. 2007;28(22):2706-13. Kastrati A Dibra A Spaulding C Laarman GJ Menichelli M Valgimigli M Meta-analysis of randomized trials on drug-eluting stents vs: bare-metal stents in patients with acute myocardial infarction Eur Heart J 2007 28 22 2706 2713 3 Baber U, Mehran R, Sharma SK, Brar S, Yu Jm Suh JW, et al. Impact of the everolimus-eluting stent on stent thrombosis: a meta-analysis of 13 randomized trials. J Am Coll Cardiol. 2011;58J. J Am Coll Cardiol. 2011;58(15):1569-77. Baber U Mehran R Sharma SK Brar S Jm Yu Suh JW Impact of the everolimus-eluting stent on stent thrombosis: a meta-analysis of 13 randomized trials J Am Coll Cardiol 2011 58 15 1569 1577 4 Valgimigli M, Sabaté M, Kaiser C, Brugalet al. Effects of cobalt-chromium everolimus eluting stents or bare metal stent on fatal and non-fatal cardiovascular events: patient level meta-analysis. BMJ. 2014;349:g6427. Valgimigli M Sabaté M Kaiser C Brugal Effects of cobalt-chromium everolimus eluting stents or bare metal stent on fatal and non-fatal cardiovascular events: patient level meta-analysis BMJ 2014 349 g6427 g6427 5 Sabaté M, Brugaletta S, Cequier A, Mainar V, et al. Clinical outcomes in patients with ST-segment elevation myocardial infarction treated with everolimus-eluting stents versus bare-metal stents (EXAMINATION): 5-year results of a randomised trial. Lancet 2016;387(10016):357-66. Sabaté M Brugaletta S Cequier A Mainar V Clinical outcomes in patients with ST-segment elevation myocardial infarction treated with everolimus-eluting stents versus bare-metal stents (EXAMINATION): 5-year results of a randomised trial Lancet 2016 387 10016 357 366 6 Schur N, Brugaletta S, Cequier A, Inigues AF Cost-effectiveness of everolimus-eluting versus bare-metal stents in ST-segment elevation myocardial infarction: An analysis from the EXAMINATION randomized controlled trial. PLoS ONE 2018;13(8):e0201985. Schur N Brugaletta S Cequier A Inigues AF Cost-effectiveness of everolimus-eluting versus bare-metal stents in ST-segment elevation myocardial infarction: An analysis from the EXAMINATION randomized controlled trial PLoS ONE 2018 13 8 e0201985 7 Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, et al. 2018 ESC/EACTS guidelines on myocardial revascularization. Scientific Document Group. Eur Heart J. 2019;40(2):87-165. Neumann FJ Sousa-Uva M Ahlsson A Alfonso F Banning AP Benedetto U 2018 ESC/EACTS guidelines on myocardial revascularization Scientific Document Group Eur Heart J 2019 40 2 87 165 8 Tillin T, Hughes AD, Mayet J, Whincup P, Sattar N, Foroughi NG, et al. The Relationship Between Metabolic Risk Factors and Incident Cardiovascular Disease in Europeans, South Asians, and African Caribbeans: SABRE (Southall and Brent Revisited)-A Prospective Population-Based Study. J Am Coll Cardiol. 2013;61(17):1777-86. Tillin T Hughes AD Mayet J Whincup P Sattar N Foroughi NG The Relationship Between Metabolic Risk Factors and Incident Cardiovascular Disease in Europeans, South Asians, and African Caribbeans: SABRE (Southall and Brent Revisited)-A Prospective Population-Based Study J Am Coll Cardiol 2013 61 17 1777 1786 9 O'Donoghue ML, Vaidya A, Afsal R, Alfredsson J, Boden WE, Braunwald E, et al. An Invasive or Conservative Strategy in Patients With Diabetes Mellitus and Non-ST-Segment Elevation Acute Coronary Syndromes: A Collaborative Meta-Analysis of Randomized Trials. J Am Coll Cardiol.2012;60(2):106-11. O'Donoghue ML Vaidya A Afsal R Alfredsson J Boden WE Braunwald E An Invasive or Conservative Strategy in Patients With Diabetes Mellitus and Non-ST-Segment Elevation Acute Coronary Syndromes: A Collaborative Meta-Analysis of Randomized Trials J Am Coll Cardiol 2012 60 2 106 111 10 Patti G, Pasceri V, Melfi R, Goffredo G, Chello M, D'Ambrosio A, et al.et al. Impaired flow-mediated dilation and risk of restenosis in patients undergoing coronary stent implantation. Circulation. 2005;111(1):70-5. Patti G Pasceri V Melfi R Goffredo G Chello M D'Ambrosio A Impaired flow-mediated dilation and risk of restenosis in patients undergoing coronary stent implantation Circulation 2005 111 1 70 75 11 Di Sciascio G, Patti G, Nasso G, Manzoli A, D'Ambrosio A, Abbate A. Early and long-term results of stenting of diffuse coronary artery disease. Am J Cardiol. 2000;86(11):1166-70. Di Sciascio G Patti G Nasso G Manzoli A D'Ambrosio A Abbate A Early and long-term results of stenting of diffuse coronary artery disease Am J Cardiol 2000 86 11 1166 1170 12 Patti G, Nusca A, Di Sciascio G. Meta-analysis comparison (nine trials) of outcomes with drug-eluting stents versus bare metal stents in patients with diabetes mellitus. Am J Cardiol. 2008;102(10):1328-34. Patti G Nusca A Di Sciascio G Meta-analysis comparison (nine trials) of outcomes with drug-eluting stents versus bare metal stents in patients with diabetes mellitus Am J Cardiol 2008 102 10 1328 1334 13 Oliveira JC, Oliveira LCS, Oliveira JC, Barretto IDC, Almeida-Santos MA, Lima TCR, et al. Disparities In The Use Of Drug-eluting Stents For Diabetic Patients With ST-elevation Acute Myocardial Infarction Assisted In the Public versus Private Network - VICTIM Register. Arq Bras Cardiol. 2019; 112(5):564-570 Oliveira JC Oliveira LCS Oliveira JC Barretto IDC Almeida Santos MA Lima TCR Disparities In The Use Of Drug-eluting Stents For Diabetic Patients With ST-elevation Acute Myocardial Infarction Assisted In the Public versus Private Network - VICTIM Register Arq Bras Cardiol 2019 112 5 564 570 14 Bangalore S, Gupta N, Guo Y, Feit F. Trend in the use of drug eluting stents in the United States: insight from over 8.1 million coronary interventions. Int J Cardiol. 2014;175(1):108-19. Bangalore S Gupta N Guo Y Feit F Trend in the use of drug eluting stents in the United States: insight from over 8.1 million coronary interventions Int J Cardiol 2014 175 1 108 119 15 Feres F, Costa RA, Siqueira D, Costa JR Jr, Chamié D, Staico R, et al. Diretriz da Sociedade Brasileira de Cardiologia e da Socidade Brasileira de Hemodinâmica e Cardiologia Intervencionista sobre Intervenção Coronária Percutânea. Arq Bras Cardiol. 2017;109(1 Suppl 1):1-81. Feres F Costa RA Siqueira D Costa JR Jr Chamié D Staico R Diretriz da Sociedade Brasileira de Cardiologia e da Socidade Brasileira de Hemodinâmica e Cardiologia Intervencionista sobre Intervenção Coronária Percutânea Arq Bras Cardiol 2017 109 1 Suppl 1 1 81 Minieditorial Brasil: Duas Realidades para o Tratamento da Mesma Doença 0000-0002-5664-4185 Guimarães Leonardo 1 0000-0002-6287-5414 Caixeta Adriano 2 3 Quebec Heart and Lung Institute - Laval University, Quebec - Canadá Escola Paulista de Medicina - Universidade Federal de São Paulo, São Paulo, SP - Brasil Hospital Israelita Albert Einstein, São Paulo, SP - Brasil Correspondência: Adriano Caixeta, Rua Salim Izar, 333. CEP 05617-040 Morumbi, SP - Brasil. E-mail: acaixeta@me.com Palavras-chave Doença da Artéria Coronariana Doenças Cardiovasculares/mortalidade Infarto do Miocárdio com Supradesnivelamento do Segmento ST Diabetes Mellitus Revascularização Miocárdica Intervenção Coronária Percutânea Stents Farmacológicos

Os stents farmacológicos (SF) atuais são mais seguros e eficazes (menores taxas de reestenose) que os stents convencionais (SC),1,2 sendo capazes de reduzir desfechos cardiovasculares em curto e longo prazos.3,4 Em pacientes com infarto agudo do miocárdio com supradesnivelamento do segmento ST (IAMCSST), o estudo randomizado EXAMINATION5 avaliou 1.498 pacientes com IAMCSST que foram alocados para o tratamento de intervenção coronária percutânea (ICP) com SF de nova geração eluídos com everolimus ou SC. Após o seguimento de 5 anos, houve redução relativa de desfechos combinados e de mortalidade de 20% e 30%, respectivamente, em favor dos SF. Por fim, apesar do maior custo inicial no procedimento índice, os SF apresentam melhor custo-efetividade em relação ao SC a longo prazo.6 Neste contexto, em 2018, a Diretriz mais atual de revascularização do miocárdio da Sociedade Europeia de Cardiologia considera recomendação Classe I o uso de SF em todo e qualquer cenário clínico, incluindo IAMCSST.7

A doença cardiovascular é a principal causa de morte em todo o mundo, e o diabetes melito é um dos mais importantes fatores de risco para a doença aterosclerótica coronariana (DAC).8 Pacientes diabéticos apresentam mortalidade de 2 a 3 vezes maior após síndrome coronariana aguda quando comparado aos não-diabéticos.9 Adicionalmente, estes pacientes, por apresentarem expressiva disfunção endotelial, alta resposta inflamatória à injúria vascular, DAC difusa e artérias coronárias de mais fino calibre, desenvolvem maiores taxas de reestenose intra-stent.10,11 Desta forma, em pacientes diabéticos, o uso de SF torna-se ainda mais imperioso e apresenta 87% menos risco de reestenose intra-stent e 77% menos risco de necessidade de revascularização da lesão alvo em comparação aos SC.12

No presente estudo VICTIM de Oliveira et al.,13 analisando a penetração do uso dos SF na rede pública e privada no Estado de Sergipe (entre 2014 e 2017; após a aprovação do seu uso no sistema único de saúde [SUS] ao valor de ressarcimento de R$ 2.034,50), mostraram que apenas 8,7% dos pacientes diabéticos com IAMCSST foram tratados com SF no sistema público, enquanto 90,6% receberam SF no sistema privado de saúde. Esses números deixam evidente a preocupante realidade do sistema público de saúde brasileiro no tratamento de IAMCSST, principalmente em uma população vulnerável como a dos diabéticos. Além disso, observa-se que, a despeito da aprovação oficial (portaria número 29 do Ministério da Saúde) de uma avançada tecnologia, no SUS o seu uso em não diabéticos e diabéticos é importante e significativamente inferior ao da saúde suplementar. Neste estudo, não houve diferença estatística para o número de fatores de risco por paciente entre os grupos, com a maioria apresentando ≥ 2 fatores de risco cardiovascular. Nota-se que os principais determinantes para receber esta terapia mundialmente recomendada e comprovadamente superior foram: a renda familiar e escolaridade e, por consequência, a possibilidade de acesso a saúde privada. Nos Estados Unidos, no ano de 2003 (1 ano após o início do uso de SF no país), 32,7% dos pacientes diabéticos submetidos à ICP receberam SF e, em 2011, este número ultrapassou 75%.14

Segundo a Agência Nacional de Saúde (ANS), em 2019, apenas 24,3% dos brasileiros possuem assistência médica por saúde suplementar e com isso, menos de um quarto da população possuem acesso ao tratamento recomendado pelas diretrizes internacionais e brasileira.15 Por outro lado, a imensa maioria da população de diabéticos tendo disponível, majoritariamente, apenas o SC. Na comunidade científica internacional, diferentemente da realidade brasileira, tornou-se extemporâneo o debate sobre o uso de SC versus SF. Outrossim, discute-se avanços sobre uma nova geração de SF como os de malhas ultrafinas, com polímeros bioabsorvíveis e não poliméricos.

Deste modo, como demonstrado no registro VICTIM, o Brasil, um país em desenvolvimento, poderia ser divido em duas grandes nações no que diz respeito ao tratamento do IAMCSST por ICP: uma, o SUS, com grande parte da população exposta a tratamento não contemporâneo e com resultados clínicos inequivocadamente inferiores; outra, o sistema de saúde suplementar, com uma população com melhores condições socioeconômicas e acesso as melhores tecnologias, análogas aos de países desenvolvidos. Espera-se que o presente estudo, expondo as deficiências do SUS no tratamento de uma parcela importante da população, estimule reflexões e mudanças na promoção de saúde e disponibilização de novos tratamentos à população mais carente.

Minieditorial referente ao artigo: Disparidades no Uso de Stents Farmacológicos para Pacientes Diabéticos com Infarto Agudo do Miocárdio com Supradesnivelamento do Segmento ST Assistidos na Rede Pública versus Privada - Registro VICTIM