Purpose: An audit was conducted to determine if the benefits of dabigatran treatment, as demonstrated in the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial, are applicable to patients with nonvalvular atrial fibrillation managed by a pharmacist-run anticoagulation clinic (PAC).
Methods: The records of warfarin-treated patients managed by a PAC program over a three-year period were screened to identify patients with diagnosed nonvalvular atrial fibrillation and a goal International Normalized Ratio (INR) of 2-3; the case selection criteria were similar to those used in the RE-LY trial. Abstracted data included dates and results of INR monitoring and information needed to calculate CHADS2 (Congestive Heart Failure, Hypertension, Age, Diabetes, and Stroke [doubled]) scores. Warfarin time in the therapeutic range (TTR) was the primary endpoint. A pairwise comparison of TTR distributions in subsets of patients grouped by CHADS2 score was performed to test the hypothesis that any two groups had identical distributions.
Results: Data on 314 PAC patients, including 9772 INR values, were analyzed. The mean±S.D. TTR was 62.4%±24.5% (median, 66.7%), which was similar to the mean TTR reported in the RE-LY trial (p=0.092). The distribution of TTR values in the PAC population differed significantly in patients with a CHADS2 score of 2 versus a score of 3 (p=0.0333 for Kuiper test), but no other significant differences were noted.
Conclusion: TTR values among PAC-managed patients with nonvalvular atrial fibrillation were comparable to those reported in the RE-LY trial.
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http://dx.doi.org/10.2146/ajhp130800 | DOI Listing |
J Am Coll Cardiol
October 2024
TIMI Study Group, Division of Cardiovascular Medicine, Brigham & Women's Hospital, and Harvard Medical School, Boston, Massachusetts, USA. Electronic address:
Sci Rep
February 2024
Population Health Research Institute, Hamilton, ON, Canada.
While novel oral anticoagulants are increasingly used to reduce risk of stroke in patients with atrial fibrillation, vitamin K antagonists such as warfarin continue to be used extensively for stroke prevention across the world. While effective in reducing the risk of strokes, the complex pharmacodynamics of warfarin make it difficult to use clinically, with many patients experiencing under- and/or over- anticoagulation. In this study we employed a novel implementation of deep reinforcement learning to provide clinical decision support to optimize time in therapeutic International Normalized Ratio (INR) range.
View Article and Find Full Text PDFCirculation
September 2023
Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiology, Beth Israel Deaconess Medical Center (R.A., E.S., U.A.T., R.W.Y.), Harvard Medical School, Boston.
Background: Current clinical decision tools for assessing bleeding risk in individuals with atrial fibrillation (AF) have limited performance and were developed for individuals treated with warfarin. This study develops and validates a clinical risk score to personalize estimates of bleeding risk for individuals with atrial fibrillation taking direct-acting oral anticoagulants (DOACs).
Methods: Among individuals taking dabigatran 150 mg twice per day from 44 countries and 951 centers in this secondary analysis of the RE-LY trial (Randomized Evaluation of Long-Term Anticoagulation Therapy), a risk score was developed to determine the comparative risk for bleeding on the basis of covariates derived in a Cox proportional hazards model.
Clin Pharmacol Ther
October 2023
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Trial results may not be generalizable to target populations treated in clinical practice with different distributions of baseline characteristics that modify the treatment effect. We used outcome models developed with trial data to predict treatment effects in Medicare populations. We used data from the Randomized Evaluation of Long-Term Anticoagulation Therapy trial (RE-LY), which investigated the effect of dabigatran vs.
View Article and Find Full Text PDFJ Biomed Inform
July 2023
Stanford Center for Biomedical Informatics Research, Stanford University, CA, United States of America; Department of Medicine, School of Medicine, Stanford University, Stanford, CA, United States of America; Clinical Excellence Research Center, Stanford University, Stanford, CA, United States of America; Technology and Digital Solutions, Stanford Healthcare, Stanford, CA, United States of America.
Objective: To apply the latest guidance for estimating and evaluating heterogeneous treatment effects (HTEs) in an end-to-end case study of the Long-term Anticoagulation Therapy (RE-LY) trial, and summarize the main takeaways from applying state-of-the-art metalearners and novel evaluation metrics in-depth to inform their applications to personalized care in biomedical research.
Methods: Based on the characteristics of the RE-LY data, we selected four metalearners (S-learner with Lasso, X-learner with Lasso, R-learner with random survival forest and Lasso, and causal survival forest) to estimate the HTEs of dabigatran. For the outcomes of (1) stroke or systemic embolism and (2) major bleeding, we compared dabigatran 150 mg, dabigatran 110 mg, and warfarin.
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