In the Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER) trial, a total of 27 564 patients with clinically evident atherosclerotic cardiovascular disease already receiving statin therapy were randomized to receive either additional lipid-lowering therapy with evolocumab or to placebo.1 The broad primary composite end point of cardiovascular events, that included cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, was reduced from 11.3% in patients treated with placebo to 9.8% in patients treated with evolocumab. Aside from cardiovascular death, which is obviously the most important and hardest clinical end point in the trial, many clinicians, academicians, health care organization and insurance company administrators, guideline formulators, and policy makers focused attention on reduction in myocardial infarction (MI). In the primary FOURIER results publication, however, no criteria for the diagnosis of MI are given (presumably due to word count considerations), and in the supplementary appendix one learns that diagnostic biomarker elevation is defined as any elevation above the 99th percentile of the upper reference limit. One is left to wonder about the type, size, and clinical significance of such MIs that were prevented with evolocumab in this trial.
Levine GN. Toward a More Detailed Reporting of MI Reduction in Clinical Trials—A Welcome and Needed Step in the Right Direction. JAMA Cardiol. Published online April 29, 2020. doi:10.1001/jamacardio.2020.0749
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