Dabigatran Use in Mechanical Heart Valve Patients
Dabigatran Use in Mechanical Heart Valve Patients
Based on the results of the most recent investigation by Eikelboom et al. in the RE-ALIGN study, the use of dabigatran in patients with mechanical heart valves should be avoided at this time. However, further research on the use of novel anticoagulants in mechanical heart valves should not be rejected prematurely.
In future studies, it is necessary to determine target plasma levels of dabigatran in mechanical heart valves in animal studies prior to conducting the study in humans. The same pharmacokinetic model from the RE-LY trial should not be assumed for patients with mechanical heart valves since the mechanism of thromboembolism is different from atrial fibrillation. Patients undergoing mechanical heart valve implantation are at high risk of early thromboembolic complications. Since the median time to reach a dabigatran plasma level of 50 ng/ml was 8 days, future studies must evaluate bridge therapy with faster-acting anticoagulants until the target plasma level is reached. It may even be better to perform a trial only after 3–6 months of valve surgery. More studies are needed to compare the dabigatran loading dose or more frequent dabigatran administration with bridge therapy. Addition of aspirin should be considered and it would also be helpful to carefully analyze the characteristics of patients who had bleeding or thrombotic complications and factors associated with these adverse events in the RE-ALIGN trial.
Future Perspective
Based on the results of the most recent investigation by Eikelboom et al. in the RE-ALIGN study, the use of dabigatran in patients with mechanical heart valves should be avoided at this time. However, further research on the use of novel anticoagulants in mechanical heart valves should not be rejected prematurely.
In future studies, it is necessary to determine target plasma levels of dabigatran in mechanical heart valves in animal studies prior to conducting the study in humans. The same pharmacokinetic model from the RE-LY trial should not be assumed for patients with mechanical heart valves since the mechanism of thromboembolism is different from atrial fibrillation. Patients undergoing mechanical heart valve implantation are at high risk of early thromboembolic complications. Since the median time to reach a dabigatran plasma level of 50 ng/ml was 8 days, future studies must evaluate bridge therapy with faster-acting anticoagulants until the target plasma level is reached. It may even be better to perform a trial only after 3–6 months of valve surgery. More studies are needed to compare the dabigatran loading dose or more frequent dabigatran administration with bridge therapy. Addition of aspirin should be considered and it would also be helpful to carefully analyze the characteristics of patients who had bleeding or thrombotic complications and factors associated with these adverse events in the RE-ALIGN trial.
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