Comparative effectiveness of acenocoumarol and low-dose dabigatran in patients with atrial fibrillation and recent ischemic stroke in everyday clinical practice

Konstantinos Tziomalos, Vasilios Giampatzis, Stella D. Bouziana, Marianna Spanou, Stavroula Kostaki, Maria Papadopoulou, Stella-Maria Angelopoulou, Filitsa Konstantara, Christos Savopoulos, Apostolos I. Hatzitolios



Aim: To compare the efficacy of dabigatran 110 mg bid and acenocoumarol in patients with atrial fibrillation (AF) discharged after ischemic stroke. Methods: We prospectively studied 436 consecutive patients who were discharged after hospitalization for acute ischemic stroke (39.2% males, age 78.6±6.7 years). Approximately 1 year after discharge, the patients and/or their proxy were contacted by phone and the functional status was assessed with the modified Rankin scale (mRS). Adverse outcome was defined as mRS between 2 and 6. The occurrence of ischemic stroke, myocardial infarction (MI) and death was recorded. Results: At discharge, 142 patients had AF (32.6% of the total study population). Acenocoumarol and dabigatran 110 mg bid were prescribed to 52.1 and 6.3% of these patients, respectively. At 1 year after discharge, there was a trend for patients treated with acenocoumarol to have lower mRS than patients prescribed dabigatran (2 (0-6) and 5 (1-6), respectively, p = 0.054). Adverse outcome rates did not differ between the 2 groups (50.0 and 77.8%, respectively, p=0.288). The incidence of stroke during follow-up was also similar in the 2 groups (20.3 and 33.3%, respectively, p=0.602). In contrast, the incidence of MI was almost 3 times higher in patients prescribed dabigatran than in those prescribed acenocoumarol, but this difference did not reach significance (11.1 and 4.0%, respectively, p=0.254). The incidence of cardiovascular death was also almost 3 times higher in the former, but again this difference was not significant (33.3 and 12.2%, respectively, p=0.237). However, the incidence of all-cause mortality did not differ between patients prescribed dabigatran and those prescribed acenocoumarol (33.3 and 21.6%, respectively, p=0.698). Conclusion: In real-world patients with acute ischemic stroke, dabigatran 110 mg bid is as effective as acenocoumarol in preventing stroke but appears to be associated with worse long-term functional outcome and higher incidence of MI.

Keywords: atrial fibrillation stroke, dabigatran, acenocoumarol, warfarin, vitamin K antagonists, functional outcome, myocardial infarction, mortality, cardiovascular death