Dabigatran for stroke prevention in nonvalvular atrial fibrillation: focus in the geriatric population

Abstract

Objective: To evaluate the safety and efficacy of dabigatran for stroke prevention in the elderly population.

Data sources: MEDLINE (1948-June 2013), Web of Science (1980-June 2013), and Google Scholar were used to identify relevant literature. Search terms included dabigatran, dabigatran etexilate, geriatric, elderly.

Study selection: All articles evaluating the use of dabigatran in the elderly were considered for inclusion. Data derived from controlled clinical studies were given priority for inclusion.

Data extraction: Only the Randomized Evaluation of Long-Term Anticoagulant Therapy trial has evaluated dabigatran etexilate for the prevention of stroke in nonvalvular atrial fibrillation. A post hoc analysis of this study was completed to identify the risks and benefits of therapy in patients 75 years of age and older. Numerous case reports and case series have been published that suggest an increased risk of bleeding in the elderly. Large observational studies, however, have not supported the hypotheses generated by these case reports.

Data synthesis: Since the approval of dabigatran etexilate, numerous case reports have suggested the potential dangers of bleeding complications, especially given that there is no known antidote. Observational studies have challenged these case reports and suggest that the increased risk of bleeding is similar or lower compared with warfarin therapy. The increased reporting of bleeding complications may be a result of reporting bias.

Conclusions: Advanced age alone should not exclude the use of dabigatran. Clinicians should base their decision on patient characteristics and careful assessment of risk versus benefit.

Keywords: ACCF = American College of Cardiology Foundation; ACCP = American College of Chest Physicians; AF = Atrial fibrillation; AHA = American Heart Association; ATRIA = Anticoagulation and Risk Factors in Atrial Fibrillation; Abnormal renal/liver function, Stroke, Bleeding, Labile INR, Elderly and concomitant drug/alcohol use; Anticoagulation; Atrial fibrillation; Bleeding; CHADS2 = Congestive heart failure, hypertension, age ≯ 75 years, diabetes mellitus, stroke; CI = Confidence interval; Clcr = Creatinine clearance; Dabigatran; ECT = Ecarin clotting time; FDA = Food and Drug Administration; FEIBA = Factor eight inhibitor bypass activity; FFP = Fresh frozen plasma; GI = Gastrointestinal; HAS-BLED = Hypertension; HEMORR2HAGES = Hepatic or Renal disease, Ethanol Abuse, Malignancy, Older Age, Reduced Platelet Count or Function, Rebleeding, Hypertension, Anemia, Genetic factors, Excessive fall risk and Stroke; HR = Hazard ratio; INR = International normalized ratio; ISMP = Institute for Safe Medication Practices; NVAF = Nonvalvular atrial fibrillation; Nonvalvular atrial fibrillation; OBRI = Outpatient Bleeding Risk Index; P-gp = P-glycoprotein; PCC = Prothrombin complex concentrate; RE-LY = Randomized Evaluation of Long Term Anticoagulant Therapy; Stroke; TT = Thrombin time; apt = Activated partial thromboplastin time; rVIIa = Recombinant factor VIIa; sCr = Serum creatinine.