Thromboprophylaxis in Patients With Fontan Circulation
Key result
NOACs cut thromboembolic events ~89% vs. no prophylaxis in Fontan patients, alongside warfarin and aspirin.
- IRR 0.11
- 95% CI 0.03-0.40
Why the study?
The optimal strategy for thromboprophylaxis in patients with a Fontan circulation is unknown.
Do aspirin, warfarin, or NOACs reduce thromboembolic events in patients with a Fontan circulation compared to no thromboprophylaxis?
Key Points
- To compare the efficacy and safety of aspirin, warfarin, and nonvitamin K oral anticoagulants in patients with Fontan circulation.
- Included studies published by February 2022
- Conducted frequentist network meta-analyses to estimate incidence rate ratios
- Assessed primary efficacy outcome of thromboembolic events and secondary safety outcome of major bleeding.
- NOACs associated with reduced thromboembolic events (IRR: 0.11; 95% CI: 0.03-0.40) compared to no thromboprophylaxis.
- Warfarin and aspirin also showed significant reduction in thromboembolic events (IRR: 0.23 [95% CI: 0.14-0.37] and IRR: 0.24 [95% CI: 0.15-0.39], respectively).
- No significant differences in major bleeding rates among the three treatment groups.
Study Design
Type
Meta-Analysis
Structured PICO
Do aspirin, warfarin, or NOACs reduce thromboembolic events in patients with a Fontan circulation compared to no thromboprophylaxis?
P
Population
Patients with a Fontan circulation (21 studies, 26,546 patient-years)
I
Intervention
Aspirin, warfarin, and nonvitamin K oral anticoagulants (NOACs)
C
Comparator
No thromboprophylaxis
O
Outcome
Thromboembolic eventshard clinical
Main Result
Effect estimate: IRR 0.11 (95% CI 0.03-0.40)
Aspirin, warfarin, and NOACs are all effective at reducing thromboembolic events compared to no thromboprophylaxis in patients with a Fontan circulation, without significantly increasing major bleeding.
Limitations
- Limited number of patients using NOACs
- Heterogeneity of studies using NOACs
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“While the Fontan procedure is primarily a cardiac solution, the long-term effects extend far beyond the heart. We can see multiorgan involvement in these patients, and that's what we're working to address with PittFON. The goal is to catch morbidities early and prevent them from leading to significant deterioration.”
Implication
May support thromboprophylaxis in Fontan patients without bleeding penalty; leaves open optimal agent pending RCTs.
Abstract
BACKGROUND The optimal strategy for thromboprophylaxis in patients with a Fontan circulation is unknown. OBJECTIVES The aim of this study was to compare the efficacy and safety of aspirin, warfarin, and nonvitamin K oral anticoagulants (NOACs) in a network meta-analysis. METHODS Relevant studies published by February 2022 were included. The primary efficacy outcome was thromboembolic events; major bleeding was a secondary safety outcome. Frequentist network meta-analyses were conducted to estimate the incidence rate ratios (IRRs) of both outcomes. Ranking of treatments was performed based on probability (P) score. RESULTS A total of 21 studies were included (26,546 patient-years). When compared with no thromboprophylaxis, NOAC (IRR: 0.11; 95% CI: 0.03-0.40), warfarin (IRR: 0.23; 95% CI: 0.14-0.37), and aspirin (IRR: 0.24; 95% CI: 0.15-0.39) were all associated with significantly lower rates of thromboembolic events. However, the network meta-analysis revealed no significant differences in the rates of major bleeding (NOAC: IRR: 1.45 [95% CI: 0.28-7.43]; warfarin: IRR: 1.38 [95% CI: 0.41-4.69]; and aspirin: IRR: 0.72 [95% CI: 0.20-2.58]). Rankings, which simultaneously analyze competing interventions, suggested that NOACs have the highest P score to prevent thromboembolic events (P score 0.921), followed by warfarin (P score 0.582), aspirin (P score 0.498), and no thromboprophylaxis (P score 0.001). Aspirin tended to have the most favorable overall profile. CONCLUSIONS Aspirin, warfarin, and NOAC are associated with lower risk of thromboembolic events. Recognizing the limited number of patients and heterogeneity of studies using NOACs, the results support the safety and efficacy of NOACs in patients with a Fontan circulation.
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Cite This Study
Eynde et al. (2023) conducted a meta-analysis in Fontan circulation. NOACs, warfarin, and aspirin vs. No thromboprophylaxis was evaluated on Thromboembolic events (IRR 0.11, 95% CI 0.03-0.40). NOACs, warfarin, and aspirin reduced thromboembolic events compared to no thromboprophylaxis in Fontan circulation patients.