Summary
Oral anticoagulation with vitamin k antagonists (VKAs) requires regular testing and
dose adjustment. Home-monitoring (self-testing or self-management) is more effective
than usual management. Dabigatran, does not require dose-adjustment and appears to
be more effective at reducing the risk of stroke with similar risks of bleeding in
patients with atrial fibrillation (AF). Dabigatran, however, has not been compared
to the home-monitoring. It was the objective to evaluate the efficacy of dabigatran
compared with home-monitoring of oral anticoagulation with VKAs. Randomised controlled
trials (RCTs) comparing usual management of oral anticoagulation with home-monitoring,
dabigatran with usual management, and RCTs comparing dabigatran with home-monitoring
and including patient-important outcomes (thromboembolic events, death and major bleeding)
were eligible. For our direct comparison we calculated pooled relative risks (RRs)
using the Mantzel-Haenzel random effect model. For the indirect comparison we estimated
lnRRs and back transformed to RR. We evaluated the quality of the evidence with the
GRADE system. Dabigatran, compared with warfarin, was associated with lower rates
of stroke or thromboembolism and systemic embolism but similar rates of major haemorrhage
and death. Dabigatran 150 mg also increased non-significantly the rate of myocardial
infarction. The quality of the evidence was high. Our indirect comparison of home-monitoring
of oral anticoagulation versus dabigatran showed no convincing differences in the
risk of thromboembolism, death or major bleeding. The estimates for self-management
vs. dabigatran showed stronger but still non-significant trends. The quality of the
evidence was low. In conclusion, the indirect comparison of home monitoring of oral
anticoagulation with dabigatran suggests that the treatments have similar impact on
thrombosis, bleeding and death. However, the confidence in the estimate of effect
is low to very low. Our analyses contrast with the available comparison of dabigatran
with conventional warfarin monitoring.
Keywords
Atrial fibrillation - dabigatran - oral anticoagulation - self-management