Background: Patients with atrial fibrillation (AF) have a high prevalence of coronary artery disease (CAD) ranging from 18% to 47%, due to common risk factors such as older age, hypertension and diabetes. Oral anticoagulation is required for AF patients with moderate-to-high stroke risk. The safety and effectiveness of dabigatran etexilate (dabigatran) for stroke prevention in AF has been shown in randomized trials and numerous database studies. Prospective data from routine clinical practice are less common.
Purpose: This analysis from the global registry program GLORIA-AF describes clinical outcomes of dabigatran for up to 2 years in newly diagnosed AF patients with or without history of CAD.
Methods: GLORIA-AF is a prospective, observational global registry of patients with newly diagnosed AF and a CHA2DS2-VASc score of ≥1. Patients prescribed dabigatran at baseline were followed for up to 2 years. CAD is defined here as history of coronary artery disease, myocardial infarction or angina pectoris. Baseline characteristics and event rates (incidence rates with 95% CI) in patients on dabigatran with and without a history of CAD are reported.
Results: Overall, 4873 patients were prescribed dabigatran and 4859 received it for an average of 18.3±9.2 months. Of these, 3643 patients had no history of CAD, while 1091 had CAD (for 125 patients CAD history was unknown). Compared with patients with no CAD, patients with CAD were more often male (64.7 vs 53.1%); older (mean age: 71.9 vs 69.6 years), had a higher mean CHA2DS2-VASc score (3.8 vs 3.0) and a higher mean HAS-BLED score (1.5 vs 1.2). Concurrent antiplatelet therapy was more common in patients with CAD than without, 32.2% versus 7.0%, respectively. For patients with CAD or without CAD the crude incidence rates of stroke were 0.65 and 0.68 per 100 patient-years, respectively. Major bleeding rates were 1.42 and 0.86 per 100 patient-years. Intracranial bleed rates were low with 0.06 and 0.20 per 100 patient-years in patients with or without CAD, respectively [see table for further outcomes]. Incidence rates standardized by stroke and bleeding risk will be presented.
Conclusion: This analysis provides insights on newly diagnosed patients with AF with or without co-morbid CAD. CAD adds to the disease burden of AF with increased crude rates of vascular mortality and MI compared to patients without CAD. Stroke, major bleed and intracranial bleed rates between groups were similar. Overall, over up to 2 years of treatment, the incidence rates of the assessed clinical events including stroke, major bleeding and MI were low with dabigatran, also among patients with CAD, confirming the long-term safety and effectiveness of dabigatran in clinical practice.