First Trimester Anticoagulant Exposure and Adverse Pregnancy Outcomes in Women with Preconception Venous Thromboembolism: A Nationwide Cohort Study - 04/04/22
, Flemming Skjøth, MSc, PhD b, c, Peter Brønnum Nielsen, MPH, PhD a, b, Jan Beyer-Westendorf, MD d, Torben Bjerregaard Larsen, MD, PhD a, bAbstract |
Objective |
The purpose of this study was to investigate first trimester anticoagulant exposure and risks of adverse pregnancy-related and fetal outcomes.
Methods |
Using Danish nationwide registries, we identified all pregnant women with preconception venous thromboembolism, 2000-2017, and linked data on exposure to low-molecular-weight heparin (LMWH), vitamin K antagonist (VKA), or non-VKA oral anticoagulant (NOAC) during pregnancy. We assessed pregnancy-related and fetal outcomes associated with first trimester anticoagulant exposure.
Results |
Among 4490 pregnancies in women with preconception venous thromboembolism (mean age 31 years, 40% nulliparous) during the first trimester, 63.1% were unexposed, 25.9% were exposed to LMWH, 10.4% VKA, and 0.6% NOAC. Adverse outcomes were lowest in unexposed and LMWH exposed. Compared with unexposed, VKA was associated with higher risks of preterm (adjusted odds ratio [OR] 2.26; 95% confidence interval [CI], 1.70-2.99) and very preterm birth (adjusted OR 3.78; 95% CI, 1.91-7.49), shorter mean gestational age was associated with VKA (−7.5 days; 95% CI, −9.1 to −5.9 days) or NOAC (−2.3 days; 95% CI, −8.4-3.8), and lower mean birthweight with VKA (−55 g; 95% CI, −103.1 to −8.5) or NOAC (−190 g; 95% CI, −364.1 to −16.4). Adjusted ORs for small-for-gestational-age infants were 1.07 (95% CI, 0.77-1.50) with VKA, and 3.29 (95% CI, 1.26-7.95) with NOAC. Mean 5-minute Apgar score (9.8) and congenital defect prevalence (8.4%-10%) varied little across exposure groups.
Conclusions |
Fetal risk was lowest in unexposed and LMWH-exposed pregnancies, supporting the recommendation of LMWH during pregnancy. NOAC safety during pregnancy is unclear due to the rarity of NOAC exposure.
Le texte complet de cet article est disponible en PDF.Keywords : Anticoagulant drug safety, Low-molecular-weight heparin, Non-VKA oral anticoagulant, Pregnancy, Thromboembolic complications, Vitamin K antagonist
Plan
| Funding: This research was partly funded by an unrestricted grant from the Obel Family Foundation. The sponsor had no role in the study design and conduct; the data collection, management, analysis, and interpretation; the writing of the report; or the decision to submit the paper for publication. |
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| Conflicts of Interest: MS and FS have received consulting fees from Bayer. PBN has received speaking fees from Boehringer Ingelheim, consulting fees from Bayer and Daiichi-Sankyo, and grant support from Bristol-Myers Squibb/Pfizer and Daiichi-Sankyo. JB-W has received research grants and honoraria for lectures and consultancy from Bayer, Bristol-Myers Squibb, Daiichi-Sankyo, Doasense, Pfizer, and Portola. TBL has served as an investigator for Janssen Scientific Affairs, LLC and Boehringer Ingelheim, and has received speaking fees from Bayer, Bristol-Myers Squibb/Pfizer, Boehringer Ingelheim, MSD, and AstraZeneca. |
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| Authorship: MS and FS are the guarantors; they had full access to all data in this study, and take responsibility for the data integrity and the accuracy of the data analysis. All authors contributed to the study design, analyzed and interpreted the data, drafted the article or critically revised it for important intellectual content, and approved the final version. MS: Data curation, formal analysis, funding acquisition, methodology, writing – original draft, review, and editing; FS: Data curation, formal analysis, funding acquisition, methodology, writing – original draft, review, and editing; PBN: Formal analysis, funding acquisition, methodology, writing – original draft, review, and editing; JB-W: Formal analysis, funding acquisition, methodology, writing – original draft, review, and editing; TBL: Formal analysis, funding acquisition, methodology, writing – original draft, review, and editing. |
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| Paper presentation: An abstract based on parts of these data was presented at the European Society of Cardiology Congress 2019, Paris. |
Vol 135 - N° 4
P. 493 - avril 2022 Retour au numéro
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