The ENBALV study – D’après la présentation “Efficacy and safety of edoxaban in anticoagulant therapy early after surgical bioprosthetic valve replacement: ENBALV trial”
After surgical valve replacement (RV) with a bioprosthesis, AVKs are recommended for 3 to 6 months depending on the recommendations. To date, there have been no convincing attempts to replace VKAs with direct oral anticoagulants in this context. This is the task that the Japanese investigators of the ENBALV trial took on.
Methodology and results
This is an open trial, having randomized 410 patients after VR by bioprosthesis into 2 arms: warfarin with target INR of 2.5 or edoxaban 30 or 60 mg depending on renal function. The average age was 72 years, and 87% had had an aortic RV, almost 10% a mitral RV and 3% both. AF was present in 20% of cases. In the AVK arm, the time spent in the therapeutic zone (TTR) was only 19% (!).
The primary endpoint was the occurrence of a stroke or systemic embolism, which only occurred in 4 patients, one in the edoxaban arm and 3 in the warfarin arm (p=ns). On the other hand, hemorrhagic complications were numerically more frequent under edoxaban (8 cases) than under AVK (2 cases), including only one fatal case under AVK. Among the secondary endpoints, 2 patients on VKA presented an intracardiac thrombus (none on edoxaban), but there was no systematic CT scan in this trial.
Figure 2
Conclusion
From these elements, the authors supported the principle of being able to use edoxaban, a very questionable conclusion (and discussed during the session). These results are all the more difficult to interpret as the particularly low TTR under AVK is well below that found in our practices. This trial will probably not influence future recommendations.
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