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Invited Commentary
June 1, 2020

Should Percutaneous Coronary Intervention Be Considered for Left Main Coronary Artery Disease?Insights From a Bayesian Reanalysis of the EXCEL Trial

Author Affiliations
  • 1Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles, California
JAMA Intern Med. 2020;180(7):1002-1003. doi:10.1001/jamainternmed.2020.1644

In this issue of JAMA Internal Medicine, Brophy1 presents a bayesian analysis of randomized clinical trials comparing revascularization strategies for treatment of left main coronary artery disease (LMCAD). This article is important because of the recent publication of the 5-year results of the EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial comparing percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) in patients with LMCAD of low or intermediate anatomical complexity.2 The EXCEL trial has ignited a firestorm of controversy. The investigators concluded that there was no significant difference between PCI and CABG in the primary outcome of death or myocardial infarction (MI) or stroke (major adverse cardiac events, MACEs) (difference, 2.8%; 95% CI, −0.9% to 6.5%), even though the odds ratio for mortality was 38% higher in the PCI arm (difference, 3.1%; 95% CI, 0.2%-6.1%).2 This conclusion highlights the perils of misinterpreting differences that do not reach statistical significance. The 95% CI estimate of the difference in MACE rates between PCI and CABG ranges from 0.9% absolute reduction to 6.5% increase with PCI.2 Thus, to state that EXCEL showed these interventions were comparable is misleading because it discounts altogether the clinically relevant effect size and a 95% CI that lies mostly above 0%. Absence of evidence is not evidence of absence.

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    1 Comment for this article
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    A Bayesian comment
    Lovel gGunio, MD, PhD | University Hospital Split
    If one extends the use of Bayes from purely statistical to a more clinical role, as a common-sense guide in approach to the controversy of left main revascularization, few observations come to mind.
    First, it is interesting that a JAMA Internal Medicine invited commentary, more or less equal to an editorial, that calls for nothing less than a change in guidelines, a prohibition of PCI in LM, and implying, albeit as the worst possibility, risk of unnecessary and avoidable deaths, evokes so little response from the U.S. interventional cardiology community. Has the horse already left the barn? Do most
    of the U.S. interventional cardiologists consider the opinion of the commentator as not relevant to their practice, today?
    If so, what could be the cause?
    Kaul's critique of the interventional approach looks, if approached without prior bias, i.e., "from a Martian point of view“, a little bit scholastic, medieval in its refusal to confront reality.
    Interventional cardiologists started treating LM obstruction as a part of acute STEMI treatment decades ago. Around 5% of all STEMI patients have LM obstruction. It is deadly, there is no time for surgery, so it's PCI. Sometimes we even use hemodynamic support, although not (yet) supported by RTC. Most of the patients do well.
    Some patients are refused by surgeons. So, it's PCI. And again, most do well.
    If it can be done in extremis, is it possible to do it on purpose? Trial after the trial showed that in the appropriate patients the difference is statistically nonexistent, or very small, and as Excel trial showed, getting smaller. Honestly, the difference is statistically borderline and is perceived by the most important in this story, the patients, as clinically not relevant. And the PCI technique gets better, from being able to see what you are doing (IVUS; OCT), to knowing better what to do (IVUS, OCT, DK crush), to the improvement in material (stents, guide extensions), to hemodynamic support (Impella, ECMO).
    Decisions on revascularization are made by the heart team, i.e. surgeon, cardiologist, and finally patient. Currently, in practice, in the less complicated LM disease, PCI and surgery are perceived by the majority in the heart team, as equivalent. And most patients prefer PCI.
    CONFLICT OF INTEREST: None Reported
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