The Problem With Composite End Points in Cardiovascular Studies
Open accessAbstract
Objectives Our purpose was to evaluate the heterogeneity and validity of composite end points, major adverse cardiac events (MACE) in particular, in cardiology research.Background The term MACE is a commonly used end point for cardiovascular research. By definition, MACE is a composite of clinical events and usually includes end points reflecting safety and effectiveness. There is no standard definition for MACE, as individual outcomes used to make this composite end point vary by study. This inconsistency calls into question whether use of MACE in cardiology research is of value.Methods We conducted a 2-phase literature review on the use of MACE as a composite end point: 1) studies that have compared use of bare-metal versus drug-eluting stents; and 2) studies published in the Journal in calendar year 2006. We subsequently tested 3 different definitions of MACE during 1-year of follow-up among 6,922 patients in the DEScover registry who received at least 1 drug-eluting stent.Results The review identified substantial heterogeneity in the study-specific individual outcomes used to define MACE. Markedly different results were observed for selected patient subsets of acute myocardial infarction (MI) (vs. no MI) and multilesion stenting (vs. single-lesion stenting) according to the various definitions of MACE.Conclusions Varying definitions of composite end points, such as MACE, can lead to substantially different results and conclusions. Therefore, the term MACE, in particular, should not be used, and when composite study end points are desired, researchers should focus separately on safety and effectiveness outcomes, and construct separate composite end points to match these different clinical goals.
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The definition of MACE varies by study.
“There is no standard definition for MACE, and the definition varies by study, whereas most studies include MI and death to define MACE.30”
From Gut Microbiota Metabolites and Risk of Major Adverse Cardiovascular Disease Events and Death: A Systematic Review and Meta‐Analysis of Prospective Studies (2017) · cites this paper as [30]
There is no standard definition for MACE.
“There is no standard definition for MACE, and the definition varies by study, whereas most studies include MI and death to define MACE.30”
From Gut Microbiota Metabolites and Risk of Major Adverse Cardiovascular Disease Events and Death: A Systematic Review and Meta‐Analysis of Prospective Studies (2017) · cites this paper as [30]
Most studies include MI and death to define MACE.
“There is no standard definition for MACE, and the definition varies by study, whereas most studies include MI and death to define MACE.30”
From Gut Microbiota Metabolites and Risk of Major Adverse Cardiovascular Disease Events and Death: A Systematic Review and Meta‐Analysis of Prospective Studies (2017) · cites this paper as [30]
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- Authors
- Kip, K. E., Hollabaugh, K., Marroquin, O. C., & Williams, D. O.
- Affiliations
- University of South Florida (US)
- University of Pittsburgh (US)
- Rhode Island Hospital (US)
- Venue
- Journal of the American College of Cardiology
- Publisher
- Elsevier BV
- Published
- 2008-02
- Volume
- 51
- Issue
- 7
- Pages
- 701-707
- ISSN
- 0735-1097 (ISSN-L)
- OpenAlex
- W1673665560
- Cited by
- 348
- References
- 64
- Citations by year
- 2026: 18 · 2025: 24 · 2024: 17 · 2023: 22 · 2022: 23 · 2021: 36 · 2020: 32 · 2019: 33 · 2018: 23 · 2017: 23 · 2016: 16 · 2015: 21 · 2014: 13 · 2013: 8 · 2012: 11
- FWCI
- 1.34
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of the American College of Cardiology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Surgery › Coronary Interventions and Diagnostics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
- Keywords
- major adverse cardiac events, composite endpoints, drug-eluting stents, bare-metal stents, acute myocardial infarction
- MeSH terms
- Coronary Disease, Humans, Myocardial Infarction, Terminology as Topic, Prognosis, Stents, Angioplasty, Balloon, Coronary, Proportional Hazards Models, Randomized Controlled Trials as Topic, Outcome Assessment, Health Care, Endpoint Determination, Drug-Eluting Stents
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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