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Efficacy and Safety of Rivaroxaban in Patients with Diabetes and Nonvalvular Atrial Fibrillation: The ROCKET AF Trial
Conclusions and Relevance The relative efficacy and safety of rivaroxaban vs. warfarin was similar in patients with and without DM, supporting use of rivaroxaban as an alternative to warfarin in diabetic patients with AF.
Source: American Heart Journal - July 30, 2015 Category: Cardiology Source Type: research

Systemic, non-cerebral, arterial embolism in 21,105 patients with atrial fibrillation randomized to edoxaban or warfarin: Results from the ENGAGE AF-TIMI 48 trial
Conclusion Although considerably less frequent than stroke, systemic embolism is associated with significant morbidity and mortality in patients with AF. While the overall number of events was too small to show a significant difference in the risk of SEE between edoxaban and warfarin, a meta-analysis of all the NOAC trials demonstrates that NOACs significantly reduce the risk of SEE compared with warfarin.
Source: American Heart Journal - July 30, 2015 Category: Cardiology Source Type: research

Genetic Mutations in African Patients with Atrial Fibrillation: Rationale and Design of the Study of Genetics of Atrial Fibrillation in an African Population (SIGNAL)
Conclusion This is the first study determining genetic associations in valvular and non-valvular atrial fibrillation in sub-Saharan Africa with a control population. The results advance knowledge about atrial fibrillation and will enhance international efforts to decrease atrial fibrillation-related morbidity.
Source: American Heart Journal - June 16, 2015 Category: Cardiology Source Type: research

Urinary 11-dehydro-thromboxane B2 is associated with cardiovascular events and mortality in atrial fibrillation patients
Conclusions Urinary 11-dehydro-TxB2 levels are associated with a residual risk of CVEs and CV mortality in AF patients despite anticoagulant treatment.
Source: American Heart Journal - May 23, 2015 Category: Cardiology Source Type: research

Patients’ time in therapeutic range on warfarin among US patients with atrial fibrillation: Results from ORBIT-AF registry
Conclusions Among patients with AF in US clinical practices, TTR on warfarin is suboptimal, and those at highest predicted risks for stroke and bleeding were least likely to be in therapeutic range.
Source: American Heart Journal - April 23, 2015 Category: Cardiology Source Type: research

Novel oral anticoagulants and reversal agents: Considerations for clinical development
This article reflects the views of the authors and should not be construed to represent FDA's views or policies.
Source: American Heart Journal - April 8, 2015 Category: Cardiology Source Type: research

Patients’ Time in Therapeutic Range on Warfarin Among U.S. Atrial Fibrillation Patients: Results from ORBIT-AF Registry
Conclusions Among AF patients in US clinical practices, TTR on warfarin is suboptimal and those at highest predicted risks for stroke and bleeding were least likely to be in therapeutic range.
Source: American Heart Journal - April 3, 2015 Category: Cardiology Source Type: research

Novel Oral Anticoagulants (NOAC) and Reversal Agents: Considerations for Clinical Development
This article reflects the views of the authors and should not be construed to represent FDA’s views or policies.
Source: American Heart Journal - April 3, 2015 Category: Cardiology Source Type: research

Predictors of long-term outcomes in patients with hypertrophic cardiomyopathy undergoing cardiopulmonary stress testing and echocardiography
Conclusions In HCM patients undergoing CPT, a higher % of achieved age-gender predicted VO2 and surgical relief of LVOT obstruction were associated with better outcomes, whereas abnormal HRR, atrial fibrillation, and lower LVEF were associated with worse outcomes.
Source: American Heart Journal - March 10, 2015 Category: Cardiology Source Type: research

A prospective evaluation of edoxaban compared to warfarin in subjects undergoing cardioversion of atrial fibrillation: The EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation (ENSURE-AF STUDY)
Publication date: Available online 21 February 2015 Source:American Heart Journal Author(s): Gregory Y.H. Lip , Jose Merino , Michael Ezekowitz , Kenneth Ellenbogen , Dmitry Zamoryakhin , Hans Lanz , James Jin , Naab Al-Saadi , Michele Mercuri , Andreas Goette We designed a prospective, randomized, open-label, blinded endpoint evaluation(PROBE) parallel group Phase 3b clinical trial comparing edoxaban (a new oral factor Xa inhibitor) with enoxaparin/warfarin followed by warfarin alone in subjects undergoing planned electrical cardioversion of non-valvular AF. The primary efficacy endpoint is the composite endpoints of st...
Source: American Heart Journal - February 25, 2015 Category: Cardiology Source Type: research

Predictors of long-term outcomes in hypertrophic cardiomyopathy patients undergoing cardiopulmonary stress testing and echocardiography
Conclusions In HCM patients undergoing CPT, a higher % of achieved age-gender predicted V02 and surgical relief of LVOT obstruction were associated with better outcomes, while abnormal HRR, atrial fibrillation and lower LVEF were associated with worse outcomes.
Source: American Heart Journal - February 25, 2015 Category: Cardiology Source Type: research

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)
Conclusion Compared with those without, AF patients with obstructive sleep apnea have worse symptoms and higher risks of hospitalization, but similar mortality, major adverse cardiovascular outcome and AF progression rates. Clinical Trial Registration: NCT01165710 (http://www.clinicaltrials.gov)
Source: American Heart Journal - February 7, 2015 Category: Cardiology Source Type: research

Rationale and design of a study exploring the efficacy of once-daily oral rivaroxaban (X-TRA) on the outcome of left atrial/left atrial appendage thrombus in non-valvular atrial fibrillation or atrial flutter and a retrospective observational registry providing baseline data (CLOT-AF)
In conclusion, X-TRA and CLOT-AF will provide some answers to the many unresolved issues concerning patient outcomes and prognostic factors in patients with AF and LAA thrombi. Results from this study program would provide the first prospective interventional study (X-TRA) and a large international retrospective observational registry (CLOT-AF) on the prevalence and natural history of LA/LAA thrombi. Unique data on clot resolution with rivaroxaban in a prospective cohort would be obtained in X-TRA.
Source: American Heart Journal - January 6, 2015 Category: Cardiology Source Type: research

Clinical events after transitioning from apixaban versus warfarin to warfarin at the end of the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial
Conclusions The excess in thrombotic and bleeding events in the apixaban group after study drug discontinuation appears to be related to an increased risk associated with the initiation of a VKA rather than a direct effect of apixaban. Whether ≥2 days of apixaban bridging improves outcomes during VKA transition is unknown and deserves further evaluation.
Source: American Heart Journal - December 9, 2014 Category: Cardiology Source Type: research

Accuracy and Validation of an Automated Electronic Algorithm to Identify Patients with Atrial Fibrillation at Risk for Stroke
Conclusions Automated methods can be used to identify patients with prevalent AF indicated for anticoagulation, but may suffer from misclassification up to 12%, which limits the utility of relying on administrative data alone for quality assessment. Misclassification is minimized by requiring comorbidity diagnoses within the prior year and using a CHA2DS2-Vasc based algorithm. Despite differences in accuracy between algorithms, system-wide anticoagulation rates assessed were similar regardless of algorithm used.
Source: American Heart Journal - October 31, 2014 Category: Cardiology Source Type: research

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