The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation...

Area of Science:

• Cardiology
• Pharmacology
• Clinical Trials

Background:

• The Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) trial previously established dabigatran etexilate's efficacy and safety for stroke prevention in atrial fibrillation patients.
• A need existed for extended follow-up data on dabigatran and direct comparisons between its two dosage regimens.

Purpose of the Study:

• To evaluate the long-term safety and effectiveness of two dabigatran etexilate doses (150 mg and 110 mg twice daily) in atrial fibrillation patients.
• To extend the follow-up period beyond the initial RE-LY trial for patients continuing dabigatran treatment.

Main Methods:

• The Long-term Multicenter Extension of Dabigatran Treatment in Patients with Atrial Fibrillation (RELY-ABLE) trial enrolled patients from the RE-LY trial who continued their assigned dabigatran dose.
• Follow-up extended up to 28 months post-RE-LY, with a median follow-up of 2.3 years for 5851 enrolled patients.
• Event rates for stroke, systemic embolism, major hemorrhage, and death were analyzed for both dabigatran doses.

Main Results:

• Stroke or systemic embolism rates were comparable between the two doses: 1.46%/year for 150 mg and 1.60%/year for 110 mg (HR 0.91; 95% CI, 0.69-1.20).
• Major hemorrhage rates were higher with dabigatran 150 mg (3.74%/year) compared to 110 mg (2.99%/year) (HR 1.26; 95% CI, 1.04-1.53).
• Mortality rates were similar between the two groups: 3.02%/year for 150 mg and 3.10%/year for 110 mg (HR 0.97; 95% CI, 0.80-1.19).

Conclusions:

• Extended dabigatran treatment for 2.3 years showed similar rates of stroke and death for both 150 mg and 110 mg twice daily doses.
• A significantly higher incidence of major bleeding was observed with the 150 mg dose compared to the 110 mg dose.