Faculty Opinions recommendation of The effect of dabigatran plasma concentrations and patient characteristics on the frequency of ischemic stroke and major bleeding in atrial fibrillation patients: the RE-LY Trial (Randomized Evaluation of Long-Term Anticoagulation Therapy).

2017 ◽  
Author(s):  
J David Spence
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Major Bleeding ◽  
Plasma Concentrations ◽  
Anticoagulation Therapy ◽  
Patient Characteristics ◽  
Randomized Evaluation

scholarly journals Personalizing the decision of dabigatran versus warfarin in atrial fibrillation: A secondary analysis of the Randomized Evaluation of Long-term anticoagulation therapY (RE-LY) trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (8) ◽  
pp. e0256338
Author(s):  
Samuel W. Reinhardt ◽  
Nihar R. Desai ◽  
Yuanyuan Tang ◽  
Philip G. Jones ◽  
Jeremy Ader ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Anticoagulation Therapy ◽  
Bleeding Risk ◽  
Systemic Embolism ◽  
Randomized Evaluation ◽  
Risk Patients ◽  
The Mean ◽  
Prior Stroke

Background The RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial demonstrated that higher-risk patients with atrial fibrillation had lower rates of stroke or systemic embolism and a similar rate of major bleeding, on average, when treated with dabigatran 150mg compared to warfarin. Since population-level averages may not apply to individual patients, estimating the heterogeneity of treatment effect can improve application of RE-LY in clinical practice. Methods and results For 18040 patients randomized in RE-LY, we used patient-level data to develop multivariable models to predict the risk for stroke or systemic embolism and for major bleeding including all three treatment groups (dabigatran 110mg, dabigatran 150mg, and warfarin) over a median follow up of 2.0 years. The mean predicted absolute risk reduction (ARR) for stroke/systemic embolism with dabigatran 150mg compared to warfarin was 1.32% (range 11.6% lower to 3.30% higher risk). The mean predicted ARR for bleeding was 0.41% (range 8.93% lower to 63.4% higher risk). Patients with increased stroke/systemic embolism risk included those with prior stroke/TIA (OR 2.01), diabetics on warfarin (OR 2.00), and older patients on dabigatran 150mg (OR 1.68 for every 10-year increase). Major bleeding risk was higher in patients on aspirin (OR 1.25), with a history of diabetes (OR 1.34) or prior stroke/TIA (OR 1.22), those with heart failure on dabigatran 110mg (OR 1.52), older patients on either dabigatran 110mg or 150mg (OR 1.57 and 1.93, respectively, for each 10-year increase), and heavier patients on dabigatran 110mg or 150mg; patients in a region outside the United States and Canada and with better renal function had lower bleeding risk. Conclusions There is substantial heterogeneity in the benefits and risks of dabigatran relative to warfarin among patients with atrial fibrillation. Using individualized estimates may enable shared decision making and facilitate more appropriate use of dabigatran; as such, it should be prospectively tested. Clinical trial registration www.clinicaltrials.gov number, NCT00262600.

Reasons for hospitalization and risk of mortality in patients with atrial fibrillation treated with dabigatran or warfarin in the Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) trial

EP Europace ◽  
2019 ◽  
Vol 21 (7) ◽  
pp. 1023-1030 ◽  
Author(s):  
Aiman Alak ◽  
Stefan H Hohnloser ◽  
Mandy Fräßdorf ◽  
Paul Reilly ◽  
Michael Ezekowitz ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Sudden Cardiac Death ◽  
Cardiac Death ◽  
Dabigatran Etexilate ◽  
Anticoagulation Therapy ◽  
Post Discharge ◽  
Vascular Death ◽  
Randomized Evaluation ◽  
Increased Risk

Aims Hospitalizations are common among patients with atrial fibrillation. This article aimed to analyse the causes and consequences of hospitalizations occurring during the Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) trial. Methods and results The RE-LY database was used to evaluate predictors of hospitalization using multivariate regression modelling. The relationship between hospitalization and subsequent major adverse cardiac events was evaluated in a time dependent Cox proportional-hazard modelling. Of the 18 113 patients in RE-LY, 7200 (39.8%) were hospitalized at least once during a mean follow-up of 2 years. First hospitalization rates were 2312 (39.5%) for dabigatran etexilate (DE) 110, 2430 (41.6%) for DE 150, and 42.6% (N = 2458) for warfarin. Hospitalization was associated with post-discharge death [absolute event rate 9.1% vs. 2.2%; adjusted hazard ratio (HR) 3.6, 95% confidence interval (CI) 3.2–4.0, P < 0.0001], vascular death (adjusted HR 2.9, 95% CI 2.5–3.3, P < 0.0001), and sudden cardiac death (adjusted HR 2.3; 95% CI 1.8–2.9, P < 0.0001). Cardiovascular hospitalization was also associated with an increased risk of post-discharge death (adjusted HR 2.8, 95% CI 2.5–3.2, P < 0.0001), vascular death (adjusted HR 2.8, 95% CI 2.4–3.2, P < 0.0001), and sudden cardiac death (adjusted HR 2.1, 95% CI 1.6–2.7, P < 0.0001) compared with patients not hospitalized for any cardiovascular reason. Conclusion Hospitalizations are associated an increased risk of with death and cardiovascular death in patients with atrial fibrillation.

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