James V. Freeman

Cost-Effectiveness of Dabigatran Compared With Warfarin for Stroke Prevention in Atrial Fibrillation

BACKGROUND Warfarin reduces the risk for ischemic stroke in patients with atrial fibrillation (AF) but increases the risk for hemorrhage. Dabigatran is a fixed-dose, oral direct thrombin inhibitor with similar or reduced rates of ischemic stroke and intracranial hemorrhage in patients with AF compared with those of warfarin. OBJECTIVE To estimate the quality-adjusted survival, costs, and cost-effectiveness of dabigatran compared with adjusted-dose warfarin for preventing ischemic stroke in patients 65 years or older with nonvalvular AF. DESIGN Markov decision model. DATA SOURCES The RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial and other published studies of anticoagulation. The cost of dabigatran was estimated on the basis of pricing in the United Kingdom. TARGET POPULATION Patients aged 65 years or older with nonvalvular AF and risk factors for stroke (CHADS₂ score ≥1 or equivalent) and no contraindications to anticoagulation. TIME HORIZON Lifetime. PERSPECTIVE Societal. INTERVENTION Warfarin anticoagulation (target international normalized ratio, 2.0 to 3.0); dabigatran, 110 mg twice daily (low dose); and dabigatran, 150 mg twice daily (high dose). OUTCOME MEASURES Quality-adjusted life-years (QALYs), costs (in 2008 U.S. dollars), and incremental cost-effectiveness ratios. RESULTS OF BASE-CASE ANALYSIS The quality-adjusted life expectancy was 10.28 QALYs with warfarin, 10.70 QALYs with low-dose dabigatran, and 10.84 QALYs with high-dose dabigatran. Total costs were

Procedural complications, rehospitalizations, and repeat procedures after catheter ablation for atrial fibrillation.

143 193 for warfarin,

Interpretation of the Electrocardiogram of Young Athletes

164 576 for low-dose dabigatran, and

The relation between hospital procedure volume and complications of cardioverter-defibrillator implantation from the implantable cardioverter-defibrillator registry.

168 398 for high-dose dabigatran. The incremental cost-effectiveness ratios compared with warfarin were

Physician Procedure Volume and Complications of Cardioverter-Defibrillator Implantation

51 229 per QALY for low-dose dabigatran and

Impact of obstructive sleep apnea and continuous positive airway pressure therapy on outcomes in patients with atrial fibrillation—Results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF)

45 372 per QALY for high-dose dabigatran. RESULTS OF SENSITIVITY ANALYSIS The model was sensitive to the cost of dabigatran but was relatively insensitive to other model inputs. The incremental cost-effectiveness ratio increased to

Effectiveness and Safety of Digoxin Among Contemporary Adults With Incident Systolic Heart Failure

50 000 per QALY at a cost of

Digoxin and Risk of Death in Adults With Atrial Fibrillation The ATRIA-CVRN Study

13.70 per day for high-dose dabigatran but remained less than

Association Between Atrial Fibrillation Symptoms, Quality of Life, and Patient Outcomes Results From the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF)

85 000 per QALY over the full range of model inputs evaluated. The cost-effectiveness of high-dose dabigatran improved with increasing risk for stroke and intracranial hemorrhage. LIMITATION Event rates were largely derived from a single randomized clinical trial and extrapolated to a 35-year time frame from clinical trials with approximately 2-year follow-up. CONCLUSION In patients aged 65 years or older with nonvalvular AF at increased risk for stroke (CHADS₂ score ≥1 or equivalent), dabigatran may be a cost-effective alternative to warfarin depending on pricing in the United States. PRIMARY FUNDING SOURCE American Heart Association and Veterans Affairs Health Services Research & Development Service.

Feasibility of Extended Ambulatory Electrocardiogram Monitoring to Identify Silent Atrial Fibrillation in High‐risk Patients: The Screening Study for Undiagnosed Atrial Fibrillation (STUDY‐AF)

OBJECTIVES The purpose of this study was to estimate rates and identify predictors of inpatient complications and 30-day readmissions, as well as repeat hospitalization rates for arrhythmia recurrence following atrial fibrillation (AF) ablation. BACKGROUND AF is the most common clinically significant arrhythmia and is associated with increased morbidity and mortality. Radiofrequency or cryotherapy ablation of AF is a relatively new treatment option, and data on post-procedural outcomes in large general populations are limited. METHODS Using data from the California State Inpatient Database, we identified all adult patients who underwent their first AF ablation from 2005 to 2008. We used multivariable logistic regression to identify predictors of complications and/or 30-day readmissions and Kaplan-Meier analyses to estimate rates of all-cause and arrhythmia readmissions. RESULTS Among 4,156 patients who underwent an initial AF ablation, 5% had periprocedural complications, most commonly vascular, and 9% were readmitted within 30 days. Older age, female, prior AF hospitalizations, and less hospital experience with AF ablation were associated with higher adjusted risk of complications and/or 30-day readmissions. The rate of all-cause hospitalization was 38.5% by 1 year. The rate of readmission for recurrent AF, atrial flutter, and/or repeat ablation was 21.7% by 1 year and 29.6% by 2 years. CONCLUSIONS Periprocedural complications occurred in 1 of 20 patients undergoing AF ablation, and all-cause and arrhythmia-related rehospitalizations were common. Older age, female sex, prior AF hospitalizations, and recent hospital procedure experience were associated with a higher risk of complications and/or 30-day readmission after AF ablation.