Combination anticoagulation strategy in pregnancy with mechanical valves: The KYBELE study
Authors' conclusion
The combined anticoagulation strategy of LMWH plus low-dose warfarin during the first trimester of pregnancy may result in less maternal complications with comparable fetal outcomes in patients with MHVs.
Study context
- Population
- Pregnant women with mechanical heart valvespregnancies in 65 women
- Participants
- 78 pregnancies
- Exposure
- Low-molecular-weight heparin (LMWH) + warfarin vs lone LMWH during first trimester
- Outcome
- Primary maternal outcome: death, thromboembolism, severe bleeding or need for treatment of mechanical valve thrombosis; primary fetal outcome: any fetal loss
Methodological detailsmulticentre
- Multicentre
Main finding
As reported in the abstract
Primary maternal outcome
Lone LMWH vs LMWH + 4 mg warfarin: P < 0.001 · LMWH + 2.5 mg warfarin vs Lone LMWH: P = 0.015
Observational data: associations, not effects.
Further findings
Primary fetal outcome: fetal loss
- Obstructive mechanical valve thrombosis (MVT), MVT requiring treatment, cerebral embolism · Lone LMWH vs LMWH + 4 mg warfarin · obstructive MVT 16 vs 0%
- P = 0.04
- Obstructive MVT, MVT requiring treatment, cerebral embolism · Lone LMWH vs LMWH + 4 mg warfarin · MVT requiring treatment 28 vs 0%
- P = 0.003
- Obstructive MVT, MVT requiring treatment, cerebral embolism · Lone LMWH vs LMWH + 4 mg warfarin · cerebral embolism 24 vs 3.4%
- P = 0.041
- Obstructive MVT, MVT requiring treatment, cerebral embolism · LMWH + 2.5 mg warfarin vs Lone LMWH · treatment for MHV thrombus 4.2 vs 28%
- P = 0.049
- Primary fetal outcome: fetal loss: P = .890 for 3-group
Safety
Warfarin-related embryopathy
- Not observed in any case
- 0
Original publication
Combination anticoagulation strategy in pregnancy with mechanical valves: The KYBELE study. Am Heart J. Published 1 April 2024. doi:10.
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