Dabigatran Use in Mechanical Heart Valve Patients
A total of 252 patients were enrolled starting in November 2011. The trial was terminated early at the recommendation of the data and safety monitoring board in October 2012 in population A and November 2012 in population B due to excess thromboembolic and bleeding events in the dabigatran group. Baseline characteristics were similar in both groups. Most of the enrolled patients were categorized in population A (79%), had aortic valve replacement (68%), and intermediate or high thromboembolic risk (71%).
Target trough plasma levels of dabigatran were achieved for an average of 86% of the time. During the first 4 weeks of therapy, dabigatran plasma levels obtained 10–16 h after the last dose administered were lower in population A than population B. The composite of stroke, transient ischemic attack, systemic embolism, myocardial infarction or death occurred in 9% of the patients in the dabigatran group and 5% of the patients in the warfarin group (hazard ratio: 1.94; 95% CI: 0.64–5.86; p = 0.11). Dabigatran was discontinued in 32% of the patients.
A major bleeding event was observed in 4% of patients in the dabigatran group and 2% of patients in the warfarin group (population A only), appearing almost exclusively in the pericardium in the early period. Any other type of bleeding occurred in 27% of patients in the dabigatran group and 12% of patients in the warfarin group (hazard ratio: 2.45; 95% CI: 1.23–4.86; p = 0.01). Clinical outcomes observed from the 12-week RE-ALIGN trial were consistent with the 84-month RE-ALIGN-EX trial.
Results
A total of 252 patients were enrolled starting in November 2011. The trial was terminated early at the recommendation of the data and safety monitoring board in October 2012 in population A and November 2012 in population B due to excess thromboembolic and bleeding events in the dabigatran group. Baseline characteristics were similar in both groups. Most of the enrolled patients were categorized in population A (79%), had aortic valve replacement (68%), and intermediate or high thromboembolic risk (71%).
Target trough plasma levels of dabigatran were achieved for an average of 86% of the time. During the first 4 weeks of therapy, dabigatran plasma levels obtained 10–16 h after the last dose administered were lower in population A than population B. The composite of stroke, transient ischemic attack, systemic embolism, myocardial infarction or death occurred in 9% of the patients in the dabigatran group and 5% of the patients in the warfarin group (hazard ratio: 1.94; 95% CI: 0.64–5.86; p = 0.11). Dabigatran was discontinued in 32% of the patients.
A major bleeding event was observed in 4% of patients in the dabigatran group and 2% of patients in the warfarin group (population A only), appearing almost exclusively in the pericardium in the early period. Any other type of bleeding occurred in 27% of patients in the dabigatran group and 12% of patients in the warfarin group (hazard ratio: 2.45; 95% CI: 1.23–4.86; p = 0.01). Clinical outcomes observed from the 12-week RE-ALIGN trial were consistent with the 84-month RE-ALIGN-EX trial.