Emulating a target trial of surgical removal of uterine fibroids on atherosclerotic cardiovascular disease.
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OBJECTIVE: To emulate a target trial comparing surgical removal (hysterectomy, myomectomy, or no surgery) of uterine fibroids on atherosclerotic cardiovascular disease (CVD) risk. DESIGN: Retrospective cohort study leveraging Optum's deidentified Clinformatics Data Mart Database in the United States (2000-2024). SUBJECTS: Eligible individuals were females aged 18-50 with codes for uterine fibroids. Individuals were followed until an atherosclerotic CVD event, disenrollment in the healthcare plan, or 11/1/2024. EXPOSURE: Sequential monthly ‟trials" classified individuals as undergoing myomectomy, hysterectomy (without oophorectomy, which has distinct indications), or no surgery during 2000-2019. MAIN OUTCOME MEASURES: The 5-year risk of atherosclerotic CVD was estimated as a composite of coronary artery disease, cerebrovascular disease, and peripheral artery disease. Individual components and events (e.g., myocardial infarction) were evaluated. Baseline confounding by age, cardiovascular risk factors, reproductive and mental health was adjusted for using inverse probability weighting (IPW). Exploratory and subgroup analyses by surgical route, considering oophorectomy, race and ethnicity, and age were conducted. Additional models accounted for subsequent surgeries using time-varying IPW. RESULTS: Analysis included 11,106 individuals with uterine fibroids who underwent myomectomy, 23,089 hysterectomy, and 27,657 no surgery. Compared with no surgery, myomectomy was not associated with 5-year atherosclerotic CVD risk (adjusted risk difference [aRD] -0.93 percentage points, 95% confidence interval [CI]: -2.04-1.30) whereas hysterectomy was associated with a 1.24 percentage-point higher risk (95% CI: -0.01-2.03). Analyses accounting for subsequent surgeries were consistent. Hysterectomy was associated with increased risk of coronary artery disease (0.88 percentage points, 95% CI: 0.03-1.66) and myocardial infarction (0.52 percentage points, 95% CI: 0.02-1.05). In exploratory analyses, open/abdominal hysterectomy was associated with a 2.75 percentage point higher atherosclerotic CVD risk (95% CI: 0.94-4.06). Among individuals aged <40 years, hysterectomy was associated with a 1.86 percentage point increased 5-year risk, although imprecise (95% CI: -0.35-3.08). CONCLUSIONS: Myomectomy was not strongly associated with atherosclerotic CVD risk in individuals with uterine fibroids, whereas hysterectomy (without oophorectomy) was modestly associated with a higher 5-year atherosclerotic CVD risk, particularly among younger individuals. These associations warrant further investigation.