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Individual treatment effect estimation of 2 doses of dabigatran on stroke and major bleeding in atrial fibrillation: Results from the RE-LY trial

Circulation May 09, 2019

Stam-Slob MC, et al. - Using a prediction model, which was proposed and validated in this study, researchers estimated the absolute benefit and harm from using dabigatran in individual patients with atrial fibrillation, as well as the optimal dose for each individual. Readily available patient features, such as sex, age, smoking, antiplatelet drugs, prior vascular disease, diabetes, blood pressure, eGFR, and hemoglobin, were included in Fine & Gray competing risk models. The model displayed good calibration and satisfactory discrimination, with a c-statistic of 0.65 and 0.69 for ischemic stroke/systemic embolism (SE) and for major bleeding, respectively. For ischemic stroke/SE with dabigatran 150 mg twice daily, the estimated 5-year absolute risk reduction (ARR) ranged from <10% in 20% of patients to >25% in 7% of patients, and the range of 5-year absolute risk increase (ARI) for major bleeding was from <5% in 53% of patients to 15-20% in 1% of patients. The estimated net benefit (ARR - ARI) was positive for 46% of patients when high-dose was compared to low-dose dabigatran.

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