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Condition: Atrial Fibrillation
Management: Food and Drug Administration (FDA)

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Total 197 results found since Jan 2013.

Antithrombotic Therapy in Nonvalvular Atrial Fibrillation: Consensus and Challenges.
This article discusses the advantages and disadvantages of currently approved oral antithrombotics in nonvalvular AF, with a special emphasis on the DOACs and their individual characteristics. PMID: 29753377 [PubMed - in process]
Source: The American Journal of the Medical Sciences - May 1, 2018 Category: General Medicine Authors: Khattak F, Alam MB, Paul TK, Rijal S, Wazir S, Lavie CJ, Saba S Tags: Am J Med Sci Source Type: research

The Case for Selective Patent Foramen Ovale Closure After Cryptogenic Stroke Advances in Interventional Cardiology
Controversy has persisted for over a decade whether transcatheter patent foramen ovale (PFO) closure reduces the rate of recurrent ischemic stroke for patients who have had a cryptogenic ischemic stroke and have a PFO. In September 2017, 3 positive randomized trials: RESPECT long-term (Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment trial), REDUCE (GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging-Confirmed TIA in Patients With Patent Foramen Ovale [PFO]), and CLOSE (Patent For...
Source: Circulation: Cardiovascular Interventions - March 16, 2018 Category: Cardiology Authors: Wiktor, D. M., Carroll, J. D. Tags: Secondary Prevention, Treatment, Ischemic Stroke Advances in Interventional Cardiology Source Type: research

EWOLUTION —The next evolution in appendage closure?
Oral anticoagulation (OAC) is a class I indication for patients with nonvalvular atrial fibrillation (AF) and ≥2 risk factors for stroke.1 However, many patients with AF are ineligible for OAC because of prohibitive bleeding. Subsequently, as a result of the pivotal role of the left atrial appendage (LAA) in the formation of thrombi, an alternative strategy to OAC is occlusion of the LAA.2 The WATCHMAN de vice (Boston Scientific Corporation, Marlborough, MA) is the only US Food and Drug Administration (FDA)–approved LAA occlusion product that has been studied in randomized control trials (RCTs) (Table).
Source: Heart Rhythm - June 22, 2017 Category: Cardiology Authors: Muhammad R. Afzal, Emile G. Daoud Tags: Editorial Commentary Source Type: research

Edoxaban: How Does the Newest Agent Fit into the DOAC Landscape?
Edoxaban is the most recently approved factor Xa inhibitor within the class of direct oral anticoagulants (DOACs). Like other DOACs, edoxaban was approved by the US Food and Drug Administration for treatment of venous thromboembolism and prevention of stroke in patients with nonvalvular atrial fibrillation. Similar to other DOACs, edoxaban has fewer drug –drug interactions than warfarin and does not require routine laboratory monitoring. Unlike other DOACs, edoxaban has yet to be approved for secondary or postoperative venous thromboembolism thromboprophylaxis.
Source: The American Journal of Medicine - April 5, 2017 Category: General Medicine Authors: Caitlin M. Gibson, Shannon W. Finks Tags: Review Source Type: research

Percutaneous left atrial appendage closure: current state of the art
Purpose of review: The authors reviewed the seminal and more recent literature surrounding the major modalities for percutaneous left atrial appendage closure used in contemporary practice, with particular emphasis on safety and efficacy, technical challenges, and future developments. Recent findings: Along with the continued practice of surgical left atrial appendage closure, which has evolved substantially with the advent of clipping techniques, a number of percutaneous methods have been developed to close the left atrial appendage with endocardial, epicardial, and hybrid approaches. The last 18 months has seen the Food...
Source: Current Opinion in Cardiology - December 1, 2016 Category: Cardiology Tags: ARRHYTHMIAS: Edited by David H. Birnie Source Type: research

Real-world US post-FDA approval usage of the Watchman device presented at TCT 2016
(Cardiovascular Research Foundation) Results from the US real-world, post-FDA approval experience of the Watchman device found high procedural success and low complication rates despite implantations by a large percentage of new operators. The Watchman device was approved by the US Food and Drug Administration in March 2015 for left atrial appendage occlusion to reduce the risk of stroke in patients with non-valvular atrial fibrillation.
Source: EurekAlert! - Medicine and Health - November 7, 2016 Category: Global & Universal Source Type: news

A Review of the Clinical Subgroup Analyses From the RE-LY Trial.
Authors: Kumar R, Rahman AM, Henry BL Abstract Dabigatran was the first direct-acting oral anticoagulant approved by the US Food and Drug Administration for prevention of stroke and systemic embolism in people with atrial fibrillation, based on data from the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial. Over 18,000 patients with nonvalvular atrial fibrillation and a moderate-to-high risk of thromboembolic stroke were randomized to warfarin or dabigatran. With respect to the primary endpoints for efficacy and safety, dabigatran was superior to warfarin in the prevention of stroke and thro...
Source: Reviews in Cardiovascular Medicine - September 28, 2016 Category: Cardiology Tags: Rev Cardiovasc Med Source Type: research

Idarucizumab: Clinical Role of a Novel Reversal Agent for Dabigatran.
Authors: Teleb M, Salire K, Wardi M, Alkhateeb H, Said S, Mukherjee D Abstract Atrial fibrillation (AF), a common cardiac arrhythmia associated with increased risk of heart failure, thromboembolic phenomena and death, is a leading cause of hospitalization of adults. A major complication of atrial fibrillation is an increased risk of ischemic stroke leading to long-term disability and in severe cases, death. Historically, coumadin has been the drug of choice for chronic anticoagulation and stroke prevention in AF patients however, given the need for constant monitoring and multiple drug interactions, newer anticoagu...
Source: Cardiovascular and Hematological Disorders Drug Targets - August 3, 2016 Category: Drugs & Pharmacology Tags: Cardiovasc Hematol Disord Drug Targets Source Type: research

Novel Oral Anticoagulants in Atrial Fibrillation: Update on Apixaban.
Authors: Mezue K, Obiagwu C, John J, Sharma A, Yang F, Shani J Abstract Almost 800,000 new or recurrent strokes happen every year. Atrial fibrillation, the most common cardiac arrhythmia, is a major risk factor for stroke, accounting for 15-20% of ischemic strokes. Apixaban is a direct inhibitor of Factor Xa that was approved in December 2012 by the US Food and Drug Administration (FDA) for the prevention of stroke in patients with non-valvular atrial fibrillation. It is part of a family of novel oral anticoagulants (NOACs) which have the advantage over warfarin of less dosing variability, rapid onset of action and...
Source: Current Cardiology Reviews - July 29, 2016 Category: Cardiology Tags: Curr Cardiol Rev Source Type: research

All bleeding stops — but does idarucizumab (Praxbind) make it stop faster?
3.5 out of 5 stars Persistent life-threatening hemorrhage after administration of idarucizumab. Alhashem HM et al. Am J Emerg Med 2016 June 30 [Epub ahead of print] Reference Dabigatran (Pradaxa) is a direct thrombin inhibitor approved for stroke and embolism prophylaxis in patients with non-valve-related atrial fibrillation. When it was first released in 2008, a major disincentive to widespread use was the lack of a reliable reversal agent to treat major bleeds, or to administer before necessary invasive procedures. In October 2015, the U.S. Food and Drug Administration approved idarucizumab (Praxbind), a monoclonal ant...
Source: The Poison Review - July 27, 2016 Category: Toxicology Authors: Leon Gussow Tags: Medical anticoagulant hemorrhage idarucizumab pradaxa praxbind reversal agent Source Type: news

Resolution of left ventricular thrombus with apixaban in a patient with hypertrophic cardiomyopathy.
Abstract Anticoagulation with warfarin is the main treatment of intracardiac thrombus. While novel oral anticoagulants (NOACs) have been approved by the US Food and Drug Administration (FDA) for stroke prevention in patients with nonvalvular atrial fibrillation (AF), they are not indicated for resolution of intracardiac thrombus. The case of a 60-year-old woman with left ventricular (LV) thrombus secondary to hypertrophic cardiomyopathy and AF is described in the present report. Indications for oral anticoagulation were AF and LV thrombus. Thrombus was dissolved after 1 month of apixaban treatment. To the best of ...
Source: Turk Kardiyoloji Dernegi arsivi - May 31, 2016 Category: Cardiology Authors: Kaya A, Hayıroğlu Mİ, Keskin M, Tekkeşin Aİ, Alper AT Tags: Turk Kardiyol Dern Ars Source Type: research

New reversal agent for factor Xa inhibitors shows promise
Commentary on: Siegal DM, Curnette JT, Connolly SJ, et al.. Andexanet alfa for the reversal of Factor Xa inhibitor activity. N Engl J Med 2015;373:2413–24. Context Direct oral anticoagulants (DOACs) have emerged as alternatives to vitamin K-antagonists (eg, warfarin) for the long-term management of stroke prevention for non-valvular atrial fibrillation or venous thromboembolic disease. Favourable side-effect profiles and absence of therapeutic monitoring are important benefits of these newer agents. Warfarin is readily reversed with fresh frozen plasma (FFP) or prothrombin complex concentrates.1 The first reversal ag...
Source: Evidence-Based Medicine - May 22, 2016 Category: Internal Medicine Authors: Ghadimi, K., Welsby, I. J. Tags: Clinical trials (epidemiology), Immunology (including allergy), Drugs: cardiovascular system, Stroke, Venous thromboembolism, Unwanted effects / adverse reactions Therapeutics/Prevention Source Type: research

Edoxaban for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
Authors: Dzeshka MS, Lip GY Abstract INTRODUCTION: Oral anticoagulation is central to the management of patients with atrial fibrillation (AF) and at least one additional stroke risk factor. For decades, the vitamin K antagonists (e.g. warfarin) remained the only oral anticoagulant available for stroke prevention in AF. The non-vitamin K oral anticoagulants (NOACs) are now available, and these drugs include the direct thrombin inhibitors and factor Xa inhibitors. The latter class includes edoxaban, which has recently been approved for stroke prevention in AF by the United States Food and Drug Administration and the...
Source: Expert Opinion on Pharmacotherapy - February 14, 2016 Category: Drugs & Pharmacology Tags: Expert Opin Pharmacother Source Type: research

Severe jaundice due to intrahepatic cholestasis after initiating anticoagulation with rivaroxaban
Rivaroxaban, a highly selective direct factor Xa inhibitor, is a new oral anticoagulant approved by the US Food and Drug Administration in November 2011 for stroke prophylaxis in patients with nonvalvular atrial fibrillation. Because of its efficacy and once-a-day dosing, it is commonly preferred in patients with nonvalvular atrial fibrillation and intolerance to warfarin in clinical practice. However, it can result in some adverse effects such as bleeding, rashes and liver injury. Here, we described a very rare adverse reaction of rivaroxaban, jaundice due to intrahepatic cholestasis, appeared in a 71-year-old male patien...
Source: Blood Coagulation and Fibrinolysis - February 2, 2016 Category: Hematology Tags: Case Reports Source Type: research

Reversing the effects of the new anti-clotting drugs
The oral anticoagulant warfarin (Coumadin) became available for prescription in 1954. This anti-clotting drug commanded national attention when President Dwight Eisenhower received the drug as part of his treatment following a heart attack. No other oral anticoagulant was successfully developed and marketed in the United States until 2010. Warfarin is a dangerous drug. Along with insulin, it is responsible for the most emergency hospitalizations due to adverse drug reactions. Whereas insulin causes low blood sugar, warfarin is notorious for the complication of major bleeding. Warfarin is plagued by hundreds of drug-drug an...
Source: New Harvard Health Information - December 9, 2015 Category: Consumer Health News Authors: Samuel Z. Goldhaber, MD Tags: Drugs and Supplements Health Heart Health Hypertension and Stroke anti-clotting coumadin deep-vein-thrombosis DVT Source Type: news