NOBLE trial—is it time to revise the guidelines?

Abstract

The Nordic–Baltic–British left main revascularization trial (NOBLE) is a prospective, randomized, multicentre, non-inferiority trial comparing percutaneous coronary angioplasty (PCI) with coronary artery bypass grafting (CABG) for revascularization of patients with unprotected left main coronary artery (LMCA) stenosis. The primary outcome was a combined endpoint of all-cause mortality, stroke, non-procedural myocardial infarction and repeat revascularization. CABG was found to be superior to PCI with respect to the 5-year MACCE rates (28% vs. 19%) with a hazard ratio (HR) of 1.58 (95% CI 1.24–2.01). All-cause mortality rates were similar, but PCI was associated with increased occurrence of non-procedural myocardial infarction (p = 0.0002) and repeat revascularization (p = 0.0009). There was no difference in the stroke rates (p = 0.11) at 5 years. Currently, European Society of Cardiology and the European Association for Cardio-Thoracic Surgery (ESC/EACTS) guidelines on myocardial revascularization assign a class 1A recommendation to PCI in patients with unprotected LMCA stenosis with a SYNTAX score < 23. The findings of the NOBLE trial challenge this premise.

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References

  1. 1.

    Holm NR, Mäkikallio T, Lindsay MM, et al. Percutaneous coronary angioplasty versus coronary artery bypass grafting in the treatment of unprotected left main stenosis: updated 5-year outcomes from the randomised, non-inferiority NOBLE trial. The Lancet. 2020;395:191–9.

    Article  Google Scholar 

  2. 2.

    Stone GW, Kappetein AP, Sabik JF, et al. Five-year outcomes after PCI or CABG for left main coronary disease. N Engl J Med. 2019;381:1820–30.

    Article  Google Scholar 

  3. 3.

    Buszman PE, Buszman PP, Banasiewicz-Szkróbka I, et al. Left main stenting in comparison with surgical revascularization: 10-year outcomes of the (left main coronary artery stenting) LE MANS trial. JACC Cardiovasc Interv. 2016;9:318–27.

    Article  Google Scholar 

  4. 4.

    Morice MC, Serruys PW, Kappetein AP, 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;129:2388–94.

    Article  Google Scholar 

  5. 5.

    Boudriot E, Thiele H, Walther T, et al. Randomized comparison of percutaneous coronary intervention with sirolimus-eluting stents versus coronary artery bypass grafting in unprotected left main stem stenosis. J Am Coll Cardiol. 2011;57:538–45.

    Article  Google Scholar 

  6. 6.

    Ahn JM, Roh JH, Kim YH, et al. Randomized trial of stents versus bypass surgery for left main coronary artery disease: 5-year outcomes of the PRECOMBAT study. J Am Coll Cardiol. 2015;65:2198–206.

    Article  Google Scholar 

  7. 7.

    Neumann FJ, Sousa-Uva M, Ahlsson A, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019;40:87–165.

    Article  Google Scholar 

  8. 8.

    Giustino G, Serruys PW, Sabik JF, et al. Mortality after repeat revascularization following PCI or CABG for left main disease: The EXCEL trial. JACC Cardiovasc Interv. 2020;13:375–87.

    Article  Google Scholar 

  9. 9.

    Lee PH, Kang SH, Han S, et al. Generalizability of EXCEL and NOBLE results to a large registry population with unprotected left main coronary artery disease. Coron Artery Dis. 2017;28:675–82.

    Article  Google Scholar 

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Correspondence to Pradeep Narayan.

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Narayan, P. NOBLE trial—is it time to revise the guidelines?. Indian J Thorac Cardiovasc Surg (2020). https://doi.org/10.1007/s12055-020-00965-6

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Keywords

  • NOBLE
  • EXCEL
  • CABG