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Comparative Effectiveness and Safety of Direct Oral Anticoagulants and Warfarin in Patients With Atrial Fibrillation and Chronic Liver Disease: A Nationwide Cohort Study
CONCLUSION: Among patients with AF and chronic liver disease, DOACs as a class were associated with lower risks of hospitalization for ischemic stroke/systemic embolism and major bleeding versus warfarin. However, the incidence of clinical outcomes among patients with AF and chronic liver disease varied between individual DOACs and warfarin, and in head-to-head DOAC comparisons.PMID:36762560 | DOI:10.1161/CIRCULATIONAHA.122.060687
Source: Circulation - February 10, 2023 Category: Cardiology Authors: Oluwadolapo D Lawal Herbert D Aronow Fisayomi Shobayo Anne L Hume Tracey H Taveira Kelly L Matson Yichi Zhang Xuerong Wen Source Type: research

Predictors of Development of Atrial Fibrillation in Patients With Embolic Stroke Of Undetermined Source: An Analysis of the RE-SPECT ESUS Trial
Conclusions: Besides age as the most important variable, several other factors, including hypertension, higher body mass index, and lack of diabetes, are independent predictors of AF after ESUS. When baseline NT-proBNP was available, only older age and elevation of this biomarker were predictive of subsequent AF. Understanding who is at higher risk of developing AF will assist in identifying patients who may benefit from more intense, long-term cardiac monitoring.PMID:34649459 | DOI:10.1161/CIRCULATIONAHA.121.055176
Source: Circulation - October 15, 2021 Category: Cardiology Authors: Maria Cecilia Bahit Ralph L Sacco J Donald Easton Juliane Meyerhoff Lisa Cronin Eva Kleine Claudia Grauer Martina Brueckmann Hans-Christoph Diener Renato D Lopes Michael Brainin Philippe Lyrer Rolf Wachter Tomas Segura Christopher B Granger Source Type: research

Benefit-Risk Tradeoffs in Assessment of New Drugs and Devices.
Abstract Balancing benefits and risks is a complex task that poses a major challenge, both to the approval of new medicines and devices by regulatory authorities and in therapeutic decision-making in practice. Several analysis methods and visualization tools have been developed to help evaluate and communicate whether the benefit-risk profile is favorable or unfavorable. In this White Paper, we describe approaches to benefit-risk assessment using qualitative approaches such as the Benefit Risk Action Team framework developed by the Pharmaceutical Research and Manufacturers of America, and the Benefit-Risk Framewor...
Source: Circulation - November 17, 2020 Category: Cardiology Authors: Kaul S, Stockbridge N, Butler J Tags: Circulation Source Type: research

Individual Treatment Effect Estimation of 2 Doses of Dabigatran on Stroke and Major Bleeding in Atrial Fibrillation: Results from the RE-LY Trial.
CONCLUSIONS: The absolute treatment benefits and harms of dabigatran in atrial fibrillation can be estimated based on readily available patient characteristics. Such treatment effect estimations can be used for shared decision-making before starting dabigatran treatment, and to determine the optimal dose. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov Unique identifier: NCT00262600. PMID: 31046423 [PubMed - as supplied by publisher]
Source: Circulation - May 2, 2019 Category: Cardiology Authors: Stam-Slob MC, Connolly SJ, van der Graaf Y, van der Leeuw J, Dorresteijn JAN, Eikelboom JW, Peters RJG, Alings M, Visseren FLJ Tags: Circulation Source Type: research

Outcomes Associated with Apixaban Use in End-Stage Kidney Disease Patients with Atrial Fibrillation in the United States.
Conclusions -Among ESKD patients with AF on dialysis, apixaban use may be associated with lower risk of major bleeding compared with warfarin, with a standard 5 mg twice a day dose also associated with reductions in thromboembolic and mortality risk. PMID: 29954737 [PubMed - as supplied by publisher]
Source: Circulation - June 28, 2018 Category: Cardiology Authors: Siontis KC, Zhang X, Eckard A, Bhave N, Schaubel DE, He K, Tilea A, Stack AG, Balkrishnan R, Yao X, Noseworthy PA, Shah ND, Saran R, Nallamothu BK Tags: Circulation Source Type: research

Use of Intravenous Recombinant Tissue Plasminogen Activator in Acute Ischemic Stroke Patients Taking Non-Vitamin K Antagonist Oral Anticoagulants (NOACs) Before Stroke.
CONCLUSIONS: -While experience of using rt-PA in ischemic stroke patients on a NOAC is limited, these preliminary observations suggest that rt-PA appears to be reasonably well tolerated without prohibitive risks for adverse events among selected NOAC treated patients. Future study should evaluate the safety and efficacy of intravenous rt-PA in ischemic stroke patients taking NOACs. PMID: 28119380 [PubMed - as supplied by publisher]
Source: Circulation - January 23, 2017 Category: Cardiology Authors: Xian Y, Federspiel JJ, Hernandez AF, Laskowitz D, Schwamm LH, Bhatt DL, Smith EE, Fonarow GC, Peterson ED Tags: Circulation Source Type: research

Comparison of Dabigatran versus Warfarin in Patients with Atrial Fibrillation and Valvular Heart Disease: The RE-LY Trial.
CONCLUSIONS: -The presence of any VHD did not influence the comparison of dabigatran with warfarin. Clinical Trial Registration-URL: http://clinicaltrials.gov. Unique Identifier: NCT00262600. PMID: 27496855 [PubMed - as supplied by publisher]
Source: Circulation - August 4, 2016 Category: Cardiology Authors: Ezekowitz MD, Nagarakanti R, Noack H, Brueckmann M, Litherland C, Jacobs M, Clemens A, Reilly PA, Connolly SJ, Yusuf S, Wallentin L Tags: Circulation Source Type: research

Efficacy and Harms of Direct Oral Anticoagulants in the Elderly for Stroke Prevention in Atrial Fibrillation and Secondary Prevention of Venous Thromboembolism: Systematic Review and Meta-Analysis.
CONCLUSIONS: -DOACs demonstrated at least equal efficacy to VKA in managing thrombotic risks in the elderly however bleeding patterns were distinct. In particular, dabigatran was associated with a higher risk of gastrointestinal bleeding than VKA. Insufficient published data for apixaban, edoxaban and rivaroxaban indicates further work is needed to clarify their bleeding risks in the elderly. PMID: 25995317 [PubMed - as supplied by publisher]
Source: Circulation - May 20, 2015 Category: Cardiology Authors: Sharma M, Cornelius VR, Patel JP, Davies JG, Molokhia M Tags: Circulation Source Type: research

Dabigatran and Rivaroxaban Use in Atrial Fibrillation Patients on Hemodialysis.
CONCLUSIONS: -More dialysis patients are being started on dabigatran and rivaroxaban, even when their use is contraindicated and there are no studies to support the benefits outweigh the risks of these drugs in ESRD. PMID: 25595139 [PubMed - as supplied by publisher]
Source: Circulation - January 16, 2015 Category: Cardiology Authors: Chan KE, Edelman ER, Wenger JB, Thadhani RI, Maddux FW Tags: Circulation Source Type: research

Cardiovascular, Bleeding, and Mortality Risks in Elderly Medicare Patients Treated with Dabigatran or Warfarin for Non-Valvular Atrial Fibrillation.
CONCLUSIONS: -In general practice settings, dabigatran was associated with reduced risk of ischemic stroke, intracranial hemorrhage, and death, and increased risk of major gastrointestinal hemorrhage compared with warfarin in elderly patients with non-valvular AF. These associations were most pronounced in patients treated with dabigatran 150 mg twice daily, whereas the association of 75 mg twice daily with study outcomes was indistinguishable from warfarin except for a lower risk of intracranial hemorrhage with dabigatran. PMID: 25359164 [PubMed - as supplied by publisher]
Source: Circulation - October 30, 2014 Category: Cardiology Authors: Graham DJ, Reichman ME, Wernecke M, Zhang R, Southworth MR, Levenson M, Sheu TC, Mott K, Goulding MR, Houstoun M, MaCurdy TE, Worrall C, Kelman JA Tags: Circulation Source Type: research

Efficacy and Safety of Dabigatran Compared with Warfarin in Relation to Baseline Renal Function in Patients with Atrial Fibrillation: A RE-LY Trial Analysis.
CONCLUSIONS: The efficacy of both dosages of dabigatran was consistent with the overall trial irrespective of renal function. However, with the CKD-EPI and MDRD equations both dabigatran doses displayed significantly lower rates of major bleeding in patients with GFR ≥80 ml/min. CLINICAL TRIAL REGISTRATION INFORMATION: www.clinicaltrials.gov. Identifier: NCT00262600. PMID: 24323795 [PubMed - as supplied by publisher]
Source: Circulation - December 9, 2013 Category: Cardiology Authors: Hijazi Z, Hohnloser SH, Oldgren J, Andersson U, Connolly SJ, Eikelboom JW, Ezekowitz MD, Reilly PA, Siegbahn A, Yusuf S, Wallentin L Tags: Circulation Source Type: research

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