Abstract
Introduction
Collectively, coronary artery disease (CAD) and peripheral artery disease (PAD) are highly prevalent and are associated with increased risk of major adverse cardiovascular events (MACE) and major adverse limb events (MALE). Improved ability to identify those at highest risk of these events may help optimize secondary prevention efforts in this population.
Methods
Using the Optum Integrated Database, a healthcare claims database linked to electronic medical records (EMR), we identified patients with CAD and/or PAD between January 1, 2009, and September 30, 2016. Index date was the earliest date on which chronic and stable disease was established. Follow-up ran from index date until earliest of patient death, plan disenrollment, or end of study. We developed multivariate Cox proportional hazards models to identify predictors of MACE and/or MALE, limited to measures presumed available to clinicians during patient encounters (e.g., age, presence of selected comorbidities).
Results
A total of 20,932 patients met all selection criteria; 86.9% had CAD and 26.1% had PAD; 13% (n = 2753) experienced MACE and/or MALE during a mean follow-up of 2.3 years, for a rate of 7.1 events per 100 person-years (PYs). We identified 11 predictors of MACE and/or MALE. Most (95.1%) patients had ≥ 1 predictors; 34.0% and 6.9% had ≥ 4 and ≥ 6, respectively. Incidence of MACE and/or MALE was strongly correlated with number of predictors (r2 = 0.98), ranging from 2.3 per 100 PYs among those without predictors (4.9% of patients) to 18.7 per 100 PYs among those with ≥ 6 (6.9%). Patients with ≥ 1 predictor experienced 7.4 MACE and/or MALE per 100 PYs.
Conclusion
Readily identifiable predictors can be used to identify subgroups with chronic CAD and/or PAD at elevated risk of MACE and/or MALE. Further research is required to understand the degree to which these subgroups may benefit from early identification and treatment with secondary prevention therapies.
Funding
Janssen Pharmaceuticals.
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Change history
13 January 2020
In the original article. The third author name is incorrect. The correct name is Nicholas J. Leeper.
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Acknowledgements
Funding
This work was sponsored by Janssen Pharmaceuticals who were responsible for financing the study and the decision to publish the findings. The journal’s Rapid Service Fee was funded by Janssen Pharmaceuticals.
Editorial Assistance
We thank Sean Smith of Evidera for his editorial assistance in the development of this manuscript. This assistance was funded by Janssen Pharmaceuticals.
Authorship
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
Disclosures
Ariel Berger is employed by Evidera, a research and consulting company to the biopharma industry. In this salaried position, he works with a variety of companies and organizations and is precluded from receiving payment or honoraria directly from these organizations for services rendered. Brian Murphy is employed by Evidera, a research and consulting company to the biopharma industry. In this salaried position, he works with a variety of companies and organizations and is precluded from receiving payment or honoraria directly from these organizations for services rendered. Beth Nordstrom is employed by Evidera, a research and consulting company to the biopharma industry. In this salaried position, she works with a variety of companies and organizations and is precluded from receiving payment or honoraria directly from these organizations for services rendered. Nicholas J. Leeper reports other modest research support from Bayer and Janssen. Windsor Ting reports a modest research grant from Janssen. Jeffrey Berger reports other modest research support from Janssen and AstraZeneca. Qi Zhao is currently employed at Eisai, Woodcliff Lake, NJ, USA. Alex Simpson was an employee of Evidera at the time research was conducted.
Compliance with Ethics Guidelines
This was a retrospective database study that used only completely de-identified data. Accordingly, institutional review board approval and informed consent were neither required nor sought.
Data Availability
The datasets generated during and/or analyzed during the current study are not publicly available because of being “work for hire,” but are available from the corresponding author on reasonable request.
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The original version of this article was revised due to incorrect name of the third author in the author group.
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Berger, A., Simpson, A., Leeper, N.J. et al. Real-World Predictors of Major Adverse Cardiovascular Events and Major Adverse Limb Events Among Patients with Chronic Coronary Artery Disease and/or Peripheral Arterial Disease. Adv Ther 37, 240–252 (2020). https://doi.org/10.1007/s12325-019-01132-z
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DOI: https://doi.org/10.1007/s12325-019-01132-z