(A-289) Application of Administrative Claims-Based Algorithms to Characterize Pregnancy in Atherosclerotic Cardiovascular Disease or Likely Familial Hypercholesterolemia

Background: Current National Lipid Association and American Heart Association guidelines caution against pregnancy and use of most lipid lowering therapies (LLTs) in pregnancy in females with familial hypercholesterolemia (FH) or atherosclerotic cardiovascular disease (ASCVD). Current guideline adherence is unclear due limited data on pregnancy rates, demographics, and LLT use in females of childbearing potential (FoCBP) (12-51 years) with ASCVD or FH in the US.

Objectives: To estimate annual pregnancy rates among FoCBP with evidence of existing ASCVD or likely FH (LFH). To describe (1) demographics and LLT use among FoCBP who did and did not experience pregnancy and (2) pregnancy outcomes and LLT use relative to pregnancy in FoCBP who experienced pregnancy.

Methods: We conducted a retrospective cohort study, using Optum Clinformatics (2017-2023), a large, geographically representative US claims database. We used published algorithms to identify last menstrual period and pregnancy outcomes. Evidence of pregnancy was defined as >1 inpatient (IP) or outpatient (OP) Z3A (Z3A codes refer to gestational weeks) or non-Z3A pregnancy codes. We identified FoCBP with an initial ASCVD or LFH diagnosis (ASCVD: >1 IP or >2 OP ASCVD ICD-10 or procedure codes >30 days apart; LFH: >1 IP or OP FH ICD-10 code) (index date). We estimated annual pregnancy rates standardized to the 2020 US Census. We described demographics and LLT use (overall and relative to pregnancy) in pregnant and non-pregnant FoCBP.

Results: Among FoCBP with ASCVD or LFH, we identified 2,425 with and 125,822 without evidence of pregnancy, respectively. The mean age (years) at index date was significantly lower in the pregnancy (32.4; standard deviation (SD): 6.6) vs. non-pregnancy cohort (42.6; SD: 8.3). There was lower use of ezetimibe (0.9% vs. 2.1%; p< 0.001) and statins (20.0% vs. 40.3%; p< 0.001) in the pregnancy vs. non-pregnancy cohort. The annual pregnancy rate ranged from 26.4-37.3 per 1,000 FoCBP. Pregnancy outcomes among those with a known outcome were livebirth (62.0%), all types abortion (36.8%), preterm birth (0.6%), and stillbirth (0.6%). Statins were the leading LLT used pre pregnancy (10.9%), during (1st trimester (TM): 8.0%, 2nd TM: 2.7%, 3rd TM: 2.1%), and post outcome (6 months: 8.7%, 1 year: 12.3%).

Conclusions: This is the first study to date to assess pregnancy rates, outcomes, and LLT use relative to pregnancy in FoCBP with ASCVD or LFH. Compared to the US general population, the annual pregnancy rates in our study are ~2-3X lower and pregnancy outcomes appear to be similar except for preterm births. Preterm births may be under captured as they are usually recorded on infant records which were unavailable. The low annual pregnancy rates and low use of LLTs during pregnancy suggest current guideline adherence.