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Risk Framing in Cardiovascular Medicine II

      To the Editor:
      We read with interest the commentary by Alkhouli and Rihal.
      • Alkhouli M.
      • Rihal C.S.
      The odyssey of risk framing in cardiovascular medicine: a patient-centered perspective.
      The authors accurately remark about the need of easily understood tools, available to clinicians and patients at point of care, that could simplify the assessment of individual patient risk benefit and harm of an intervention. In particular, they observed the paucity of intervention-specific, individualized risk/benefit scores that facilitate the identification of higher risk individuals that benefit the most from an intervention, with acceptable probability of harm. Such an example is provided by the TIMI Risk Score for Secondary Prevention,
      • Bohula E.A.
      • Morrow D.A.
      • Giugliano R.P.
      • et al.
      Atherothrombotic risk stratification and ezetimibe for secondary prevention.
      a risk score that identifies those patients who benefit from the addition of ezetimibe to statin therapy after acute coronary syndrome. Although those patients who have 2 or more risk indicators derive some benefit, those who have 0 or 1 do not. In contrast, it could be interpreted from their statement on the Table that the likelihood of no benefit from an intervention, which they calculated as 1 minus the absolute risk reduction, means that most (>97 %) patients are not likely to benefit on the trials exemplified. It has been observed that the absolute risk reduction (or any other measure of risk reduction) represents the average risk reduction in the study group, and given the logarithmic distribution of risk in a disease with overall outcome rate < 50%, it translates that approximately one-third of patients in a randomized clinical trial benefit from an intervention, the so-called Lake Wobegon effect.
      • Vickers A.J.
      • Kent D.M.
      The Lake Wobegon effect: why most patients are at below-average risk.
      It is important then to distinguish between the magnitude of risk reduction and the percentage of individuals in a population likely to benefit. We completely agree with the authors that we need the tools to identify with ease and clarity those patients who lie in that area of risk to communicate effectively with patients and share the decision whether to apply a given intervention.

      References

        • Alkhouli M.
        • Rihal C.S.
        The odyssey of risk framing in cardiovascular medicine: a patient-centered perspective.
        Mayo Clin Proc. 2020; 95: 1315-1317
        • Bohula E.A.
        • Morrow D.A.
        • Giugliano R.P.
        • et al.
        Atherothrombotic risk stratification and ezetimibe for secondary prevention.
        J Am Coll Cardiol. 2017; 69: 911-921
        • Vickers A.J.
        • Kent D.M.
        The Lake Wobegon effect: why most patients are at below-average risk.
        Ann Intern Med. 2015; 162: 866-867

      Linked Article

      • Risk Framing in Cardiovascular Medicine I
        Mayo Clinic ProceedingsVol. 95Issue 11
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          We applaud the work of Drs Alkhouli and Rihal1 in examining the important topic of risk/benefit framing in patient-centered decision making. However, we disagree with the choice of a sodium-glucose cotransporter 2 inhibitor (SGLT2i), canagliflozin, as an example in their arguments and that “the other 98% [of treated patients] would see no incremental benefit from the treatment.”(p.1316) First, to clarify, the primary outcome in Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation was not a composite major adverse cardiovascular event outcome as stated, but rather a composite of end-stage kidney disease, doubling of the serum creatinine level from baseline sustained for at least 30 days, or death from renal or cardiovascular disease.
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      • In reply—Risk Framing in Cardiovascular Medicine I and II
        Mayo Clinic ProceedingsVol. 95Issue 11
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          We thank the authors for their insightful comments on our perspective published in the journal.1 We agree with Dr Modarressi1 that sodium-glucose cotransporter-2 inhibitors indeed represent an important new treatment for patients with heart failure. Although we used the trial definition of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, or stroke) in the text and in the table’s footnote, we acknowledge that this was a secondary and not a primary end point.
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      • The Odyssey of Risk Framing in Cardiovascular Medicine: A Patient-Centered Perspective
        Mayo Clinic ProceedingsVol. 95Issue 7
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          “The best interest of the patient is the only interest to be considered.”1— William J. Mayo, MD
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