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

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Total 197 results found since Jan 2013.

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

The Left Atrial Appendage: Target for Stroke Reduction in Atrial Fibrillation.
Abstract A patient with atrial fibrillation (AF) has a greater than 5% annual risk of major stroke, a 5-fold increase compared to the general population. While anticoagulation remains the standard stroke prevention strategy, the nature of lifelong anticoagulation inevitably carries an increased risk of bleeding, increased stroke during periods of interruption, increased cost, and significant lifestyle modification. Many patients with atrial fibrillation have had their left atrial appendage (LAA) ligated or excised by surgeons during cardiac surgery, a decision based largely on intuition and with no clear evidence ...
Source: Methodist DeBakey Cardiovascular Journal - April 1, 2015 Category: Cardiology Authors: Ramlawi B, Abu Saleh WK, Edgerton J Tags: Methodist Debakey Cardiovasc J Source Type: research

Milvexian Granted U.S. FDA Fast Track Designation for All Three Indications Under Evaluation in Phase 3 Librexia Program: Ischemic Stroke, Acute Coronary Syndrome and Atrial Fibrillation
RARITAN, NJ, May 25, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that all three prospective indications for milvexian, an investigational oral factor XIa (FXIa) inhibitor (being developed in collaboration with Bristol Myers Squibb), have now been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). The designations cover all three indication-seeking studies within the Phase 3 Librexia development program (Librexia STROKE, Librexia ACS and Librexia AF), which are all dosing patients. The Librexia program is unrivaled as the most comprehensive FXIa clinical...
Source: Johnson and Johnson - May 25, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news

Practical use of dabigatran etexilate for stroke prevention in atrial fibrillation
Summary Atrial fibrillation (AF) is associated with an increased risk of thromboembolism, and is the most prevalent factor for cardioembolic stroke. Vitamin K antagonists (VKAs) have been the standard of care for stroke prevention in patients with AF since the early 1990s. They are very effective for the prevention of cardioembolic stroke, but are limited by factors such as drug–drug interactions, food interactions, slow onset and offset of action, haemorrhage and need for routine anticoagulation monitoring to maintain a therapeutic international normalised ratio (INR). Multiple new oral anticoagulants have been develope...
Source: International Journal of Clinical Practice - April 5, 2013 Category: Internal Medicine Authors: K. Huber, S. J. Connolly, A. Kher, F. Christory, G.‐A. Dan, R. Hatala, R. G. Kiss, B. Meier, B. Merkely, B. Pieske, T. Potpara, J. Stępińska, N. Vene Klun, D. Vinereanu, P. Widimský Tags: Consensus 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

An evidence-based review of edoxaban and its role in stroke prevention in patients with nonvalvular atrial fibrillation
Tushar Acharya, Prakash Deedwania Division of Cardiology, Department of Internal Medicine, University of California, San Francisco, Fresno, CA, USA Abstract: Atrial fibrillation is the most common arrhythmia in the elderly. It is responsible for significant morbidity and mortality from cardioembolic complications like stroke. As a result, atrial fibrillation patients are risk-stratified using the CHADS2 or CHA2DS2-VASc scoring systems. Those at intermediate-to-high risk have traditionally been treated with therapeutic anticoagulation with warfarin for stroke prevention. Although effective, warfarin use is fraught with mult...
Source: Core Evidence - April 27, 2015 Category: Drugs & Pharmacology Tags: Core Evidence Source Type: research

Stroke Prevention in Atrial Fibrillation: Impact of Novel Oral Anticoagulants
New orally administered anticoagulants will simplify stroke-prevention strategies in patients with atrial fibrillation (AF). Novel anticoagulants, such as dabigatran etexilate, a direct thrombin inhibitor, and rivaroxaban, a direct factor Xa inhibitor, have been approved by the US Food and Drug Administration for the prevention of stroke and systemic embolism in patients with nonvalvular AF. In addition, the factor Xa inhibitor apixaban has been reported to be as effective as warfarin in a large, randomized clinical trial, and the efficacy of edoxaban is being assessed in a phase III warfarin comparison trial. This review ...
Source: Clinical and Applied Thrombosis/Hemostasis - June 3, 2013 Category: Hematology Authors: Haft, J. I. Tags: Review Source Type: research

Evolution of Stroke Prevention in Nonvalvular Atrial Fibrillation Patients ∗
The PREVAIL (Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) trial is the latest in the series of studies evaluating left atrial appendage (LAA) occlusion with the Watchman device (Boston Scientific, Natick, Massachusetts) as an alternative to warfarin therapy for the prevention of stroke in patients with nonvalvular atrial fibrillation (NVAF). The PREVAIL trial was initially designed as a follow-up study to PROTECT AF (Watchman Left Atrial Appendage Closure Technology for Embolic Protection in Patients With Atrial Fibrillation), which demonstrated noninferiority to warfa...
Source: Journal of the American College of Cardiology: Cardiovascular Imaging - July 3, 2014 Category: Radiology 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

Watching, but not waiting: vascular neurology perspective on the disparate regulatory pathways for stroke
Vascular neurologists have keenly watched the Watchman device (Atritech, Plymouth, Minnesota, USA) regulatory approval process. We are, as always, searching for additional options in the prevention and treatment of stroke to better care for our patients, and new approaches to the management of atrial fibrillation play a large part in this effort. Recently, a Food and Drug Administration (FDA) panel voted 13:1 in favor of the Watchman device for the prevention of ischemic stroke in non-valvular atrial fibrillation.1 The panelists came to this decision after reviewing data from large randomized trials that compared anticoagu...
Source: Journal of NeuroInterventional Surgery - May 14, 2015 Category: Neurosurgery Authors: Sheth, S. A., Nogueira, R. G., Noorian, A. R., Liebeskind, D. S. Tags: Editorials Source Type: research

Percutaneous management of late leak after lariat transcatheter ligation of the left atrial appendage in patients with atrial fibrillation at high risk for stroke
ABSTRACT Left atrial appendage (LAA) occlusion or ligation is a novel approach to stroke prevention in atrial fibrillation that may obviate the need for long‐term anticoagulation. The Lariat device has received Food and Drug Administration 510K clearance for the approximation of soft tissue and has been applied to transcatheter LAA ligation using a combined trans‐pericardial and transseptal approach. The occurrence of late leak after transcatheter LAA ligation and its percutaneous management has not been previously reported. Herein, we report three cases of late leak with reconstitution of the LAA after initially succe...
Source: Catheterization and Cardiovascular Interventions - October 15, 2013 Category: Cardiovascular & Thoracic Surgery Authors: William J. Mosley, Michael R. Smith, Matthew J. Price Tags: Case Report Source Type: research

Problems in addition to stroke and bleeding after left atrial appendage closure
We read the article by Waksman et al. about the discussions between the US Food and Drug Administration (FDA) and the sponsor regarding approval of the WATCHMAN-device for interventional left atrial appendage closure (LAAC).[1] We would like to stimulate the discussion by the following contribution: LAAC is primarily intended as an alternative for stroke prevention in patients with atrial fibrillation (AF) in whom oral anticoagulation (OAC) is not possible because of contraindications about a high bleeding risk.
Source: The American Journal of Cardiology - April 24, 2015 Category: Cardiology Authors: Claudia Stöllberger, Josef Finsterer, Birke Schneider 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

FDA Approves Expanded Peripheral Artery Disease (PAD) Indication for XARELTO ® (rivaroxaban) Plus Aspirin to Include Patients After Lower-Extremity Revascularization (LER) Due to Symptomatic PAD
RARITAN, N.J., August 24, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded peripheral artery disease (PAD) indication for the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) to include patients following recent lower-extremity revascularization (LER) due to symptomatic PAD. The approval is based on data from the Phase 3 VOYAGER PAD study. With this approval, XARELTO® is the first and only therapy indicated to help reduce the risks of major cardiovascular (CV) events in p...
Source: Johnson and Johnson - August 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

New Phase 3 Data Suggest Positive Effect and Show Similar Safety with XARELTO ® (rivaroxaban) Compared to Aspirin in Pediatric Fontan Procedure Patients at Risk for Blood Clots and Blood Clot-Related Events
RARITAN, NJ, September 27, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new data from the Phase 3 UNIVERSE study showing treatment with XARELTO® (rivaroxaban) in an oral suspension formulation, compared to treatment with aspirin, was associated with numerically fewer blood clots and clinical events strongly associated with blood clots in pediatric patients (aged 2-8 years) who have undergone the Fontan procedure. [1] These findings, which were published this month in the Journal of the American Heart Association and included in a recent New Drug Application submitted to the U.S. F...
Source: Johnson and Johnson - September 27, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news