Arq Bras Cardiol abc Arquivos Brasileiros de Cardiologia Arq. Bras. Cardiol. 0066-782X 1678-4170 Sociedade Brasileira de Cardiologia - SBC Vh56JTXyVn7y5M5CVymWCyv S0066-782X2019000500524 10.5935/abc.20190076 Short Editorial Evidence based decision making between PCI and CABG 0000-0003-0227-0082 Collet Carlos Cardiovascular Center OLV Aalst Belgium Cardiovascular Center OLV, Aalst - Belgium Mailing Address: Carlos Collet, Cardiovascular Center Aalst, OLV Clinic, Moorselbaan 164, Aalst - Belgium. E-mail: carloscollet@gmail.com 06 06 2019 05 2019 112 5 524 525 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 Myocardial Revascularization/mortality Percutaneous Coronary Intervention Drug-Eluting Stents Stents Coronary Vessels Randomized Controlled Trials Clinical Decision Making

For the last five decades, coronary artery bypass grafting (CABG) surgery has been recommended for patients with unprotected left main (ULM) and multivessel coronary artery disease (MVD).1 In these populations, CABG reduces mortality compared to medical management.2 In patients with MVD, several randomized clinical trials established the superiority of CABG over percutaneous coronary interventions (PCI) in terms of hard clinical endpoints.3,4 In the ULM subgroup of the SYNTAX I trial, comparable outcomes between PCI and CABG were observed at five years.5 This finding triggered the design and execution of the EXCEL and NOBLE trials that confirmed equipoise in major adverse cardiovascular and cerebral events between PCI and CABG in patients with ULM coronary artery disease (CAD).6,7

The accumulation of evidence has allowed to better understand which patients may benefit from a determined revascularization strategy.8 In the current issue of the Journal, Negreiros de Andrade et al.9 present a study-level meta-analysis comparing clinical outcomes after PCI and CABG in patients with ULMCAD and MVD. The authors should be commended for the stratified analysis aiming at providing practical information for the cardiovascular community. Based on the current state of evidence we can state that 1) in patients with ULMCAD, PCI can be considered an alternative to CABG in patients with low anatomical complexity, and 2) patients with MVD have better clinical outcomes when treated with CABG. When these two populations were combined, the present meta-analysis showed an early (<30 days) benefit of PCI in terms of mortality and stroke, and long-term advantage of CABG in death and myocardial infarction.

Heart team's interaction is the mainstay of the clinical decision-making process. Key clinical factors such as age, sex, the presence of diabetes mellitus, chronic obstructive pulmonary disease (COPD) and left ventricular ejection fraction should be accounted for in the selection between PCI and CABG. In addition, anatomical consideration based on the presence of isolated ULMCAD and/or MVD must also influence the treatment decision.8 The SYNTAX score II was developed to aid the heart team in the decision-making process considering the interaction of between clinical variables and anatomical complexity. The score incorporates the clinical variables with the anatomical SYNTAX score providing a treatment recommendation (i.e. PCI or CABG) based on predicted 4-year mortality.10 Mortality estimation based on individual patient profiles enhances heart team discussion, patient's information and shared decision making. Furthermore, the SYNTAX II score has been validated in contemporary clinical trials; in the EXCEL trial patients randomized to PCI in whom the SYNTAX score II recommended CABG had higher all-cause mortality at 3-year follow-up.11 Moreover, in the SYNTAX II study, patients with MVD selected based on a mortality risk equipoise between PCI and CABG had similar outcomes compared to a matched population undergoing CABG.12,13 A practical recommendation, supported by the findings of this meta-analysis are that: females, young patients, diabetics, low-ejection fraction and MVD with high anatomical complexity (e.g. high anatomical SYNTAX score) have better prognosis when treated with CABG, whereas in old patients, with COPD or ULMCAD with low anatomical complexity PCI is an acceptable alternative. Long term data (i.e. 10 years) from the original SYNTAX and FREEDOM have become available and showed a persistent advantage of CABG over PCI in patients with MVD.3 Long term clinical follow-up of patients with ULMCAD included in EXCEL and NOBLE are awaited to further define the best treatment strategy.

Further refinement in the evaluation of patients with ULM and MVD can be achieved using coronary physiology indexes. Systematic use of fractional flow reserve has been shown to reduce the number of lesions that appear to be angiographically significant, reclassify a significant proportion of patients to lower SYNTAX score tertiles and improve clinical outcomes compared to angiographic-guided PCI and optimal medical therapy.14-16 A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease (FAME 3) will further provide answers on the best revascularization strategy tailoring treatment decision based on coronary physiology. In the near future, virtual tool predicting functional improvement after PCI or CABG will further refine patients' selection potentially improving clinical outcomes in stable CAD.

Short Editorial related to the article: Stent versus Coronary Artery Bypass Surgery in Multi-Vessel and Left Main Coronary Artery Disease: A Meta- Analysis of Randomized Trials with Subgroups Evaluation

 References 1 Collet C, Capodanno D, Onuma Y, Banning A, Stone GW, Taggart DP, Sabik J and Serruys PW. Left main coronary artery disease: pathophysiology, diagnosis, and treatment. Nat Rev Cardiol. 2018;15(6):321-31. Collet C Capodanno D Onuma Y Banning A Stone GW Taggart DP Sabik J Serruys PW Left main coronary artery disease: pathophysiology, diagnosis, and treatment Nat Rev Cardiol 2018 15 6 321 331 2 Yusuf S, Zucker D, Peduzzi P, Fisher LD, Takaro T, Kennedy JW, et al. Effect of coronary artery bypass graft surgery on survival: overview of 10-year results from randomised trials by the Coronary Artery Bypass Graft Surgery Trialists Collaboration. Lancet.1994;344(8922):563-70. Yusuf S Zucker D Peduzzi P Fisher LD Takaro T Kennedy JW Effect of coronary artery bypass graft surgery on survival: overview of 10-year results from randomised trials by the Coronary Artery Bypass Graft Surgery Trialists Collaboration Lancet 1994 344 8922 563 570 3 Farkouh ME, Domanski M, Dangas GD, Godoy LC, Mack MJ, Siami FS,et al. Long-Term Survival Following Multivessel Revascularization in Patients With Diabetes: The FREEDOM Follow-On Study. J Am Coll Cardiol. 2019;73(6):629-38. Farkouh ME Domanski M Dangas GD Godoy LC Mack MJ Siami FS Long-Term Survival Following Multivessel Revascularization in Patients With Diabetes: The FREEDOM Follow-On Study J Am Coll Cardiol 2019 73 6 629 638 4 Mohr FW, Morice MC, Kappetein AP, Feldman TE, Stahle E, Colombo A, et al. Coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with three-vessel disease and left main coronary disease: 5-year follow-up of the randomised, clinical SYNTAX trial. Lancet. 2013;381(9867):629-38. Mohr FW Morice MC Kappetein AP Feldman TE Stahle E Colombo A Coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with three-vessel disease and left main coronary disease: 5-year follow-up of the randomised, clinical SYNTAX trial Lancet 2013 381 9867 629 638 5 Morice MC, Serruys PW, Kappetein AP, Feldman TE, Stahle E, Colombo A, et al. Five-year outcomes in patients with left main disease treated with either percutaneous coronary intervention or coronary artery bypass grafting in the synergy between percutaneous coronary intervention with taxus and cardiac surgery trial. Circulation. 2014;129(23):2388-94. Morice MC Serruys PW Kappetein AP Feldman TE Stahle E Colombo A Five-year outcomes in patients with left main disease treated with either percutaneous coronary intervention or coronary artery bypass grafting in the synergy between percutaneous coronary intervention with taxus and cardiac surgery trial Circulation 2014 129 23 2388 2394 6 Stone GW, Sabik JF, Serruys PW, Simonton CA, Genereux P, Puskas J, et al. Everolimus-Eluting Stents or Bypass Surgery for Left main coronary artery disease. N Engl J Med. 2016;375(23):2223-35. Stone GW Sabik JF Serruys PW Simonton CA Genereux P Puskas J Everolimus-Eluting Stents or Bypass Surgery for Left main coronary artery disease N Engl J Med 2016 375 23 2223 2235 7 Makikallio T, Holm NR, Lindsay M, Spence MS, Erglis A, Menown IB, et al. Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial. Lancet. 2016;388(10061):2743-52. Makikallio T Holm NR Lindsay M Spence MS Erglis A Menown IB Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial Lancet 2016 388 10061 2743 2752 8 Head SJ, Milojevic M, Daemen J, Ahn JM, Boersma E, Christiansen EH,et al., Mortality after coronary artery bypass grafting versus percutaneous coronary intervention with stenting for coronary artery disease: a pooled analysis of individual patient data. Lancet . 2018;391(10124):939-48. Head SJ Milojevic M Daemen J Ahn JM Boersma E Christiansen EH Mortality after coronary artery bypass grafting versus percutaneous coronary intervention with stenting for coronary artery disease: a pooled analysis of individual patient data Lancet 2018 391 10124 939 948 9 Negreiros de Andrade PJ, Falcão JLA, Falcão BA, Rocha HAL.10 Uso de stent vc cirurgia de revascularização miocárdica em multiarteriais e doença de tronco de coronária esquerda: uma metanálise de estudos randomizados com avaliação de subgrupos. Arq Bras Cardiol. 2019; 112(5):511-523 Negreiros de Andrade PJ Falcão JLA Falcão BA Rocha HAL 10 Uso de stent vc cirurgia de revascularização miocárdica em multiarteriais e doença de tronco de coronária esquerda: uma metanálise de estudos randomizados com avaliação de subgrupos Arq Bras Cardiol 2019 112 5 511 523 10 Sotomi Y, Collet C, Cavalcante R, Morel MA, Suwannasom P, Farooq V, et al. Tools and Techniques - Clinical: SYNTAX score II calculator. EuroIntervention. 2016;12(1):120-3. Sotomi Y Collet C Cavalcante R Morel MA Suwannasom P Farooq V Tools and Techniques - Clinical: SYNTAX score II calculator EuroIntervention 2016 12 1 120 123 11 Serruys P, Collet C, Onuma Y, Morel M-A, Dressler O, Zhang Y, et al. TCT-221 Treatment Recommendations Based on SYNTAX Score II and Observed 3-year Mortality in the EXCEL Trial. J Am Coll Cardiol. 2017;70(18 Suppl 8):893. Serruys P Collet C Onuma Y Morel M-A Dressler O Zhang Y TCT-221 Treatment Recommendations Based on SYNTAX Score II and Observed 3-year Mortality in the EXCEL Trial J Am Coll Cardiol 2017 70 18 Suppl 8 893 893 12 Escaned J, Collet C, Ryan N, De Maria GL, Walsh S, Sabate M, et al.. Clinical outcomes of state-of-the-art percutaneous coronary revascularization in patients with de novo three vessel disease: 1-year results of the SYNTAX II study. Eur Heart J. 2017;38(42):3124-34. Escaned J Collet C Ryan N De Maria GL Walsh S Sabate M Clinical outcomes of state-of-the-art percutaneous coronary revascularization in patients with de novo three vessel disease: 1-year results of the SYNTAX II study Eur Heart J 2017 38 42 3124 3134 13 Serruys PW, Kogame N, Katagiri Y, Modolo R, Buszman PE, Iniguez-Romo A, et al. Clinical outcomes of state-of-the-art percutaneous coronary revascularization in patients with three-vessel disease: 2-year follow-up of the SYNTAX II study. EuroIntervention. 2019 Jan 15,pii.EIJ-D-18-00980 [Epub ahead of print]. Serruys PW Kogame N Katagiri Y Modolo R Buszman PE Iniguez-Romo A Clinical outcomes of state-of-the-art percutaneous coronary revascularization in patients with three-vessel disease: 2-year follow-up of the SYNTAX II study EuroIntervention 15 01 2019 EIJ-D-18-00980 [Epub ahead of print] 14 Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' Veer M,et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009;360(3):213-24. Tonino PA De Bruyne B Pijls NH Siebert U Ikeno F van' Veer M Fractional flow reserve versus angiography for guiding percutaneous coronary intervention N Engl J Med 2009 360 3 213 224 15 Xaplanteris P, Fournier S, Pijls NHJ, Fearon WF, Barbato E, Tonino PAL, et al. Five-Year Outcomes with PCI Guided by Fractional Flow Reserve. N Engl J Med. 2018;379(3):250-9. Xaplanteris P Fournier S Pijls NHJ Fearon WF Barbato E Tonino PAL Five-Year Outcomes with PCI Guided by Fractional Flow Reserve N Engl J Med 2018 379 3 250 259 16 Collet C, Miyazaki Y, Ryan N, Asano T, Tenekecioglu E, Sonck J, et al. Fractional flow reserve derived from computed tomographic angiography in patients with multivessel CAD. J Am Coll Cardiol. 2018;71(24):2756-69. Collet C Miyazaki Y Ryan N Asano T Tenekecioglu E Sonck J Fractional flow reserve derived from computed tomographic angiography in patients with multivessel CAD J Am Coll Cardiol 2018 71 24 2756 2769 Minieditorial Decisão Baseada em Evidências entre ICP e CRM 0000-0003-0227-0082 Collet Carlos Cardiovascular Center OLV, Aalst - Bélgica Correspondência: Carlos Collet, Cardiovascular Center Aalst, OLV Clinic, Moorselbaan 164, Aalst - Bélgica. E-mail: carloscollet@gmail.com Palavras-chave Revascularização Miocárdica/mortalidade Intervenção Coronária Percutânea Stents Farmacológicos Stents Vasos Coronários Ensaios Clínicos Controlados Aleatórios Tomada de Decisão Clínica

Nas últimas cinco décadas, a cirurgia de revascularização do miocárdio (CRM) tem sido recomendada para pacientes com lesões de tronco de coronária esquerda não-protegido (TCE-NP) e doença arterial coronariana multivascular (DAC MV).1 Nessas populações, a CRM reduz a mortalidade quando comparada ao tratamento clínico.2 Em pacientes com DAC MV, vários ensaios clínicos randomizados estabeleceram a superioridade da CRM sobre as intervenções coronárias percutâneas (ICP) em termos de desfechos clínicos bem definidos.3,4 No subgrupo TCE-NP do estudo SYNTAX I, foram observados resultados comparáveis entre ICP e CRM após cinco anos.5 Esse achado desencadeou o desenho e a execução dos estudos EXCEL e NOBLE, que confirmaram um equilíbrio nos grandes eventos adversos cardiovasculares e cerebrais entre a ICP e a CRM em pacientes com doença arterial coronariana (DAC) no TCE-NP.6,7

O acúmulo de evidências permitiu compreender melhor quais pacientes podem se beneficiar de uma estratégia de revascularização específica.8 Na edição atual da Revista, Negreiros de Andrade et al.,9 apresentam uma metanálise a nível de estudo comparando desfechos clínicos após a ICP e a CRM em pacientes com DAC no TCE-NP e DAC MV. Os autores devem ser elogiados pela análise estratificada com o objetivo de fornecer informações práticas para a comunidade cardiovascular. Com base no atual estado das evidências, podemos afirmar que 1) em pacientes com DAC no TCE-NP, a ICP pode ser considerada uma alternativa à revascularização miocárdica em pacientes com baixa complexidade anatômica, e 2) pacientes com DAC MV apresentam melhores desfechos clínicos quando tratados com CRM. Quando essas duas populações foram combinadas, a presente metanálise mostrou um benefício precoce (<30 dias) da ICP em termos de mortalidade e acidente vascular cerebral, e vantagem em longo prazo da CRM em relação à morte e infarto do miocárdio.

O processo de tomada de decisões clínicas no contexto da interação da Equipe Cardíaca é a base da seleção dos pacientes. Fatores clínicos importantes como idade, sexo, presença de diabetes mellitus, doença pulmonar obstrutiva crônica (DPOC) e fração de ejeção do ventrículo esquerdo devem ser contabilizados no processo de seleção entre a ICP e a CRM. Além disso, considerações anatômicas baseadas na presença de DAC isolada no TCE-NP e/ou DAC MV também deve influenciar a decisão sobre o tratamento.8 O escore SYNTAX II foi desenvolvido para auxiliar a equipe cardíaca no processo de tomada de decisão, considerando a interação entre as variáveis clínicas e a complexidade anatômica. O escore incorpora as variáveis clínicas com o escore SYNTAX anatômico, fornecendo uma recomendação de tratamento (isto é, ICP ou CRM) com base na mortalidade prevista aos 4 anos.10 A estimativa de mortalidade baseada em perfis individuais dos pacientes melhora as discussões na equipe cardíaca, as informações sobre o paciente e a tomada de decisão compartilhada. Além disso, o escore SYNTAX II foi validado em ensaios clínicos atuais; no estudo EXCEL, os pacientes randomizados para ICP nos quais o SYNTAX II havia recomendado CRM, apresentaram mortalidade por todas as causas mais alta em 3 anos de seguimento.11 Além disso, no estudo SYNTAX II, pacientes com DAC MV selecionados com base em um risco de mortalidade equilibrado entre ICP e CRM apresentaram desfechos semelhantes quando comparados à uma população pareada submetida à CRM.12,13 Uma recomendação prática, apoiada pelos achados desta metanálise, é: mulheres, pacientes jovens, diabéticos, com fração de ejeção baixa e DAC MV com alta complexidade anatômica (por exemplo, escore SYNTAX anatômico alto) têm melhor prognóstico quando tratados com CRM, enquanto a ICP é uma alternativa aceitável para pacientes idosos, com DPOC ou DAC no TCE-NP com baixa complexidade anatômica. Dados de longo prazo (isto é, 10 anos) do estudo SYNTAX original e do estudo FREEDOM se tornaram disponíveis e mostraram uma vantagem persistente da CRM sobre a ICP em pacientes com DAC MV.3 São esperados seguimentos clínicos de longo prazo de pacientes incluídos nos estudos EXCEL e NOBLE, com DAC no TCE-NP, para uma definição adicional da melhor estratégia de tratamento.

O uso sistemático de fluxo fracionado de reserva demonstrou reduzir o número de lesões que parecem ser angiograficamente significativas, reclassificar uma proporção significativa de pacientes para diminuir os tercis do escore SYNTAX e melhorar os resultados clínicos em comparação com a ICP guiada por angiografia e o tratamento clínico ideal.14-16 O estudo Comparação da Intervenção Coronária Percutânea Guiada por Reserva de Fluxo Fracionário e a Cirurgia de Revascularização do Miocárdio em Pacientes com Doença Coronariana Multiarterial (FAME 3) fornecerá respostas sobre a melhor estratégia de revascularização, fazendo com que a tomada de decisão em relação ao tratamento seja realizada com base na fisiologia coronariana. Em um futuro próximo, uma ferramenta virtual que prevê a melhora funcional após a ICP ou CRM refinará ainda mais a seleção dos pacientes, potencialmente melhorando os resultados clínicos na DAC estável.

Minieditorial referente ao artigo: Uso de Stent vs. Cirurgia de Revascularização Miocárdica em Multiarteriais e Doença de Tronco de Coronária Esquerda: Uma Metanálise de Estudos Randomizados com Avaliação de Subgrupos