Derivation of an Annualized Claims-Based Major Adverse Cardiovascular Event Estimator in Type 2 Diabetes.

Background: Major adverse cardiovascular events (MACE) are a leading cause of morbidity and mortality among adults with type 2 diabetes. Currently, available MACE prediction models have important limitations, including reliance on data that may not be routinely available, narrow focus on primary prevention, limited patient populations, and longtime horizons for risk prediction.
Objectives: The purpose of this study was to derive and internally validate a claims-based prediction model for 1-year risk of MACE in type 2 diabetes.
Methods: Using medical and pharmacy claims for adults with type 2 diabetes enrolled in commercial, Medicare Advantage, and Medicare fee-for-service plans between 2014 and 2021, we derived and internally validated the annualized claims-based MACE estimator (ACME) model to predict the risk of MACE (nonfatal acute myocardial infarction, nonfatal stroke, and all-cause mortality). The Cox proportional hazards model was composed of 30 covariates, including patient age, sex, comorbidities, and medications.
Results: The study cohort comprised 6,623,526 adults with type 2 diabetes, mean age 68.1 ± 10.6 years, 49.8% women, and 73.0% Non-Hispanic White. ACME had a concordance index of 0.74 (validation index range: 0.739-0.741). The predicted 1-year risk of the study cohort ranged from 0.4% to 99.9%, with a median risk of 3.4% (IQR: 2.3%-6.5%).
Conclusions: ACME was derived in a large usual care population, relies on routinely available data, and estimates short-term MACE risk. It can support population risk stratification at the health system and payer levels, participant identification for decentralized clinical trials of cardiovascular disease, and risk-stratified observational studies using real-world data.
Competing Interests: Research reported in this work was funded through a 10.13039/100006093Patient-Centered Outcomes Research Institute (PCORI) Award (PCS-1409-24099). In the last 36 months, Dr McCoy has received support from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institute of Health (NIH), the National Institute on Aging (NIA) of the NIH, and the National Center for Advancing Translational Sciences (NCATS) for projects unrelated to this work; and serves as a consultant to Emmi (Wolters Kluwer) on developing patient education materials related to diabetes. Dr Ross currently receives research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing, from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology (NEST), from the Food and Drug Administration for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program, from the Agency for Healthcare Research and Quality, from the National Heart, Lung and Blood Institute of the NIH, and from Arnold Ventures; and he is an expert witness at the request of Relator's attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc; all unrelated to this work. Dr Galindo is supported in part by grants from NIDDK and received unrestricted research support (to Emory University) from Novo Nordisk, Eli Lilly, and Dexcom; and consulting fees from Sanofi, Novo Nordisk, Eli Lilly, Pfizer, Boehringer, Bayer, and Weight Watchers; all of which are unrelated to this work. Dr Umpierrez is partly supported by research grants from the Clinical and Translational Science Award program and NIDDK and has received research support (to Emory University) from AstraZeneca, Bayer, Abbott, and Dexcom, all of which are unrelated to this work. Dr Borah has received consulting fees from Boehringer-Ingelheim and Exact Sciences on projects unrelated to this work. Dr Herrin has received funding from the Centers for Medicare and Medicaid Services to develop measures of quality, from the NIH, NIA, National Cancer Institute (NCI), National Heart Lung and Blood Institute (NHLBI), National Institutes of Neurological Disorders and Stroke (NINDS), and PCORI for projects unrelated to this work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
(© 2024 The Authors.)