Key result
Including unstable angina in composite endpoints boosts feasibility but risks high bias from subjective assessment.
Why the study?
Unstable angina is only occasionally included in primary composite endpoints in clinical cardiovascular trials, prompting an evaluation of the potential benefits and disadvantages of its inclusion.
Unstable angina should be carefully considered before inclusion in primary composite endpoints, requiring strict criteria and blinded adjudication to minimize bias.
Requires strict criteria and blinded adjudication if UA is included in composites; leaves open optimal endpoint selection for contemporary ACS trials.
BACKGROUND: Unstable angina (UA) is a component of acute coronary syndrome that is only occasionally included in primary composite endpoints in clinical cardiovascular trials. The aim of this paper is to elucidate the potential benefits and disadvantages of including UA in such contexts. SUMMARY: UA comprises <10% of patients with acute coronary syndromes in contemporary settings. Based on the pathophysiological similarities, it is ideal as a part of a composite endpoint along with myocardial infarction (MI). By adding UA as a component of a primary composite endpoint, the number of events and feasibility of the trial should increase, thus decreasing its size and cost. Furthermore, UA has both economic and quality of life implications on a societal and an individual level. However, there are important challenges associated with the use of UA as an endpoint. With the introduction of high-sensitivity troponins, the number of individuals diagnosed with UA has decreased to rather low levels, with a reciprocal increase in the number of MI. In addition, UA is particularly challenging to define given the subjective assessment of the index symptoms, rendering a high risk of bias. To minimize bias, strict criteria are warranted, and events should be adjudicated by a blinded endpoint adjudication committee. KEY MESSAGES: UA should only be chosen as a component of a primary composite endpoint in cardiovascular trials after thoroughly evaluating the pros and cons. If it is chosen to include UA, appropriate precautions should be taken to minimize possible bias.
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Kristensen et al. (2022) conducted a review in Unstable angina. Inclusion of unstable angina in primary composite endpoints was evaluated. Including unstable angina in primary composite endpoints increases trial feasibility by adding events, but poses a high risk of bias due to subjective symptom assessment.
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