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. 2021 Nov 6;21(1):241.
doi: 10.1186/s12874-021-01440-5.

Major adverse cardiovascular event definitions used in observational analysis of administrative databases: a systematic review

Elliott Bosco #  1   2 , Leon Hsueh #  3 , Kevin W McConeghy  4   5   6 , Stefan Gravenstein  4   5   3   6 , Elie Saade  7   8
Affiliations

Major adverse cardiovascular event definitions used in observational analysis of administrative databases: a systematic review

Elliott Bosco et al. BMC Med Res Methodol. .

Abstract

Background: Major adverse cardiovascular events (MACE) are increasingly used as composite outcomes in randomized controlled trials (RCTs) and observational studies. However, it is unclear how observational studies most commonly define MACE in the literature when using administrative data.

Methods: We identified peer-reviewed articles published in MEDLINE and EMBASE between January 1, 2010 to October 9, 2020. Studies utilizing administrative data to assess the MACE composite outcome using International Classification of Diseases 9th or 10th Revision diagnosis codes were included. Reviews, abstracts, and studies not providing outcome code definitions were excluded. Data extracted included data source, timeframe, MACE components, code definitions, code positions, and outcome validation.

Results: A total of 920 articles were screened, 412 were retained for full-text review, and 58 were included. Only 8.6% (n = 5/58) matched the traditional three-point MACE RCT definition of acute myocardial infarction (AMI), stroke, or cardiovascular death. None matched four-point (+unstable angina) or five-point MACE (+unstable angina and heart failure). The most common MACE components were: AMI and stroke, 15.5% (n = 9/58); AMI, stroke, and all-cause death, 13.8% (n = 8/58); and AMI, stroke and cardiovascular death 8.6% (n = 5/58). Further, 67% (n = 39/58) did not validate outcomes or cite validation studies. Additionally, 70.7% (n = 41/58) did not report code positions of endpoints, 20.7% (n = 12/58) used the primary position, and 8.6% (n = 5/58) used any position.

Conclusions: Components of MACE endpoints and diagnostic codes used varied widely across observational studies. Variability in the MACE definitions used and information reported across observational studies prohibit the comparison, replication, and aggregation of findings. Studies should transparently report the administrative codes used and code positions, as well as utilize validated outcome definitions when possible.

Keywords: Acute coronary syndrome; Acute myocardial infarction; Cardiovascular disease; Heart failure; Observational study; Reproducibility; Stroke.

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Conflict of interest statement

E.B., L.H., and E.S. declare no competing interests. K.W.M reports investigator-initiated grants from Seqirus, Pfizer and Sanofi Pasteur. S.G. reports grants from Seqirus, Sanofi; and consulting or speaker fees from Sanofi, Seqirus, Merck, and the Gerontological Society of America related to vaccines or nursing home care quality. The content and views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs or the United States government.

Figures

Fig. 1
Fig. 1
PRISMA flow diagram for included studies. Abbreviations: MACE, major adverse cardiovascular events; ICD, International Classification of Diseases
See this image and copyright information in PMC

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