(226) Use of Rivaroxaban During Pregnancy and Description of Pregnancy Outcomes

Publication Number: 557

Background: The direct oral antiocoagulant rivaroxaban (RVX) is i.a. used for the treatment and prevention of venous thromboembolism, a condition also occurring in women of childbearing age.

Objectives: To assess patterns of RVX use before and during pregnancy and to describe pregnancy outcomes.

Methods: Using the German Pharmacoepidemiological Research Database (GePaRD, claims data from ~20% of the German population) we selected a cohort of girls/women aged 12-50 years initiating RVX treatment between December 2011 and December 2016 and followed the cohort until end of 2018. Based on established algorithms, we identified pregnancies occurring during follow-up and linked the mothers’ and the babies’ data. We classified a pregnancy as exposed during the critical time window for malformations if there was (i) a RVX dispensing during day 1-56 or (ii) a supply overlapping it with a follow-up dispensing within 30 days. Comprehensive patient profiles of pregnant women and their linked live-born children were reviewed to describe pregnancy outcomes.

Results: The cohort included 14,953 women in whom 778 pregnancies were identified during follow-up. In 133 pregnancies, there was a dispensing of RVX in the 90 days before onset (group 1), in 48 during 1st trimester (group 2), in 2 during 2nd trimester, and in 1 during 3rd trimester. In 630 pregnancies, there was no RVX dispensing in these time windows (group 3). In group 1, 2, and 3, respectively, the proportion ending in a live birth was 83%, 75%, and 91%. The respective proportions for terminations were 12%, 21% and 5%. One stillbirth was observed in a pregnancy with a dispensing during 1st trimester.
43 pregnancies were classified as exposed to RVX during the critical time window (10 terminations, one ectopic pregnancy, 32 live births). All terminations were within the first 14 weeks and review of the profiles gave no indication of malformation. 27 of the live births (84%) could be linked to the mother. Of these, 3 (11%) were preterm births and another was coded as too small for gestational age. One of the preterm births had Q-codes for microcephaly (Q02) and “congenital malformation syndromes predominantly associated with short stature” (Q87.1). All others had no or only minor anomalies according to EUROCAT.

Conclusions: Although RVX is contraindicated during pregnancy, we observed more than 100 pregnancies with a dispensing probably overlapping or starting in the first trimester. Larger studies are needed to assess a potential association of RVX use with risk of stillbirths, congenital malformations, preterm birth and low birth weight.