Outcomes of Young and Elderly Patients with Non-Valvular Atrial Fibrillation and Low Bleeding Risk Treated with High Dose (150mg bid) Dabigatran - The 67th Annual Conference of the Israel Heart Society

Aharon Erez ¹ Gregory Golovchiner ¹ Gustavo Goldenberg ¹ Ehud Kadmon ¹ Robert Klempfner ³ Ilan Goldenberg ² Alon Barsheshet ¹

¹Department of Cardiology, Rabin Medical Center (Beilinson Campus), Petah Tikva, Israel
²Division of Cardiology, University of Rochester Medical Center Rochester NY, USA
³Cardiology, Leviev Heart Center and the Israeli Association for Cardiovascular Trials Sheba Medical Center Tel Hashomer Israel., Israel

Introduction: In patients with non-valvular atrial fibrillation (AF), high dose dabigatran is considered to be superior to warfarin with respect to stroke and systemic embolism whereas low dose dabigatran is superior to warfarin with respect to major bleeding. For elderly patients (> 75 years) treated with dabigatran, it was suggested that the lower dose (110mg bid) should be used.

Material and Methods: Patient data from a prospective cohort study of patients with non-valvular AF with low bleeding risk (HAS-BLED score < 3) that were treated with either dabigatran or warfarin was analyzed. Patients were followed up for 1 year. The primary end point was the composite of all-cause mortality, major bleeding event, systemic emboli and stroke.

Results and Discussion: This prospective cohort included 1351 patients. In the young (<=75 years), 239(30%) were treated with warfarin, 275(67%) were treated with dabigatran 110mg bid (DE110) and 285(36%) were treated with dabigatran 150mg bid (DE150). In the elderly (>75 years), 151(28%) were treated with warfarin, 312(58%) were treated with DE110 and 79(15%) were treated with DE150. Among the young, the proportion of patients who experienced the composite end point was similar among the groups (8%, 10% , and 10% for the Warfarin, DE110 and DE150 groups, respectively p=0.84). Among the elderly, the proportion of patients who experienced the composite end point was significantly lower (9%) in the DE150 as compared with the warfarin (16%) and DE110 (24%) groups (p-val=0.004). After adjustment for clinical characteristics, DE150 was associated with a reduced risk for the primary outcome in the elderly (OR=0.32, C.I 0.13-0.75, p=0.009), but not in the young (OR=0.95, C.I 0.51-1.74, p=0.86).

Conclusion: Elderly patients treated with DE150 were highly selected and had a favorable one year outcome suggesting that high dose dabigatran may be safe and effective in low risk elderly patients.