TY - JOUR
T1 - Aspirin Discontinuation at 24 to 28 Weeks' Gestation in Pregnancies at High Risk of Preterm Preeclampsia:
T2 - A Randomized Clinical Trial
AU - Mendoza, M
AU - Bonacina, E
AU - Garcia-Manau, P
AU - López, M
AU - Caamiña, S
AU - Vives, À
AU - Lopez-Quesada, E
AU - Ricart, M
AU - Maroto, A
AU - de, Mingo L
AU - Pintado, E
AU - Ferrer-Costa, R
AU - Martin, Lourdes
AU - Rodríguez-Zurita, Alicia
AU - García, Esperanza
AU - Pallarols, Mar
AU - Vidal-Sagnier, Laia
AU - Teixidor, Miereia
AU - Orizales-Lago, Carmen
AU - Pérez-Gómez, Adela
AU - Ocaña, Vanesa
AU - Puerto, Linda
AU - Millán, Pilar
AU - Alsius, Mercè
AU - Díaz, Sonia
AU - Maíz, Nerea
AU - Carreras, Elena
AU - Suy, A
N1 - Publisher Copyright:
© 2023 American Medical Association. All rights reserved.
PY - 2023/2/21
Y1 - 2023/2/21
N2 - IMPORTANCE Aspirin reduces the incidence of preterm preeclampsia by 62% in pregnant individuals at high risk of preeclampsia. However, aspirin might be associated with an increased risk of peripartum bleeding, which could be mitigated by discontinuing aspirin before term (37 weeks of gestation) and by an accurate selection of individuals at higher risk of preeclampsia in the first trimester of pregnancy.OBJECTIVE To determine whether aspirin discontinuation in pregnant individuals with normal soluble fms-like tyrosine kinase-1 to placental growth factor (sFlt-1:PlGF) ratio between 24 and 28 weeks of gestation was noninferior to aspirin continuation to prevent preterm preeclampsia.DESIGN, SETTING, AND PARTICIPANTS Multicenter, open-label, randomized, phase 3, noninferiority trial conducted in 9 maternity hospitals across Spain. Pregnant individuals (n = 968) at high risk of preeclampsia during the first-trimester screening and an sFlt-1:PlGF ratio of 38 or less at 24 to 28 weeks of gestation were recruited between August 20, 2019, and September 15, 2021; of those, 936 were analyzed (intervention: n = 473; control: n = 463). Follow-up was until delivery for all participants.INTERVENTIONS Enrolled patients were randomly assigned in a 1:1 ratio to aspirin discontinuation (intervention group) or aspirin continuation until 36 weeks of gestation (control group).MAIN OUTCOMES AND MEASURES Noninferiority was met if the higher 95% CI for the difference in preterm preeclampsia incidences between groups was less than 1.9%.RESULTS Among the 936 participants, the mean (SD) age was 32.4 (5.8) years; 3.4% were Black and 93% were White. The incidence of preterm preeclampsia was 1.48%(7/473) in the intervention group and 1.73%(8/463) in the control group (absolute difference, -0.25% [95% CI, -1.86% to 1.36%]), indicating noninferiority.CONCLUSIONS AND RELEVANCE Aspirin discontinuation at 24 to 28 weeks of gestation was noninferior to aspirin continuation for preventing preterm preeclampsia in pregnant individuals at high risk of preeclampsia and a normal sFlt-1:PlGF ratio.
AB - IMPORTANCE Aspirin reduces the incidence of preterm preeclampsia by 62% in pregnant individuals at high risk of preeclampsia. However, aspirin might be associated with an increased risk of peripartum bleeding, which could be mitigated by discontinuing aspirin before term (37 weeks of gestation) and by an accurate selection of individuals at higher risk of preeclampsia in the first trimester of pregnancy.OBJECTIVE To determine whether aspirin discontinuation in pregnant individuals with normal soluble fms-like tyrosine kinase-1 to placental growth factor (sFlt-1:PlGF) ratio between 24 and 28 weeks of gestation was noninferior to aspirin continuation to prevent preterm preeclampsia.DESIGN, SETTING, AND PARTICIPANTS Multicenter, open-label, randomized, phase 3, noninferiority trial conducted in 9 maternity hospitals across Spain. Pregnant individuals (n = 968) at high risk of preeclampsia during the first-trimester screening and an sFlt-1:PlGF ratio of 38 or less at 24 to 28 weeks of gestation were recruited between August 20, 2019, and September 15, 2021; of those, 936 were analyzed (intervention: n = 473; control: n = 463). Follow-up was until delivery for all participants.INTERVENTIONS Enrolled patients were randomly assigned in a 1:1 ratio to aspirin discontinuation (intervention group) or aspirin continuation until 36 weeks of gestation (control group).MAIN OUTCOMES AND MEASURES Noninferiority was met if the higher 95% CI for the difference in preterm preeclampsia incidences between groups was less than 1.9%.RESULTS Among the 936 participants, the mean (SD) age was 32.4 (5.8) years; 3.4% were Black and 93% were White. The incidence of preterm preeclampsia was 1.48%(7/473) in the intervention group and 1.73%(8/463) in the control group (absolute difference, -0.25% [95% CI, -1.86% to 1.36%]), indicating noninferiority.CONCLUSIONS AND RELEVANCE Aspirin discontinuation at 24 to 28 weeks of gestation was noninferior to aspirin continuation for preventing preterm preeclampsia in pregnant individuals at high risk of preeclampsia and a normal sFlt-1:PlGF ratio.
KW - Adult
KW - Aspirin/adverse effects
KW - Biomarkers/blood
KW - Female
KW - Hemorrhage/blood
KW - Humans
KW - Infant, Newborn
KW - Peripartum Period
KW - Placenta Growth Factor/blood
KW - Pre-Eclampsia/blood
KW - Pregnancy
KW - Pregnancy Complications/blood
KW - Pregnancy Trimester, First
KW - Premature Birth/blood
KW - Vascular Endothelial Growth Factor Receptor-1/blood
KW - Withholding Treatment
UR - http://www.scopus.com/inward/record.url?scp=85148678064&partnerID=8YFLogxK
U2 - 10.1001/jama.2023.0691
DO - 10.1001/jama.2023.0691
M3 - Article
C2 - 36809321
SN - 0002-9955
VL - 329
SP - 542
EP - 550
JO - JAMA
JF - JAMA
IS - 7
ER -