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Evidence based decision making between PCI and CABG

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).11 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. In these populations, CABG reduces mortality compared to medical management.22 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. In patients with MVD, several randomized clinical trials established the superiority of CABG over percutaneous coronary interventions (PCI) in terms of hard clinical endpoints.33 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.,44 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. In the ULM subgroup of the SYNTAX I trial, comparable outcomes between PCI and CABG were observed at five years.55 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. 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).66 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.,77 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.

The accumulation of evidence has allowed to better understand which patients may benefit from a determined revascularization strategy.88 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. In the current issue of the Journal, Negreiros de Andrade et al.99 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 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.88 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. 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.1010 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. 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.1111 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. 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.1212 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.,1313 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]. 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.33 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. 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.1414 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.

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.
-1616 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. 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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].
  • 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.
  • 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.
  • 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.

Publication Dates

  • Publication in this collection
    06 June 2019
  • Date of issue
    May 2019
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