Stroke RSS Page 6

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

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Total 197 results found since Jan 2013.

Icosapent Ethyl: drug profile and evidence of reduced residual cardiovascular risk in patients with statin-managed LDL-C cholesterol.
Authors: Bazarbashi N, Miller M Abstract INTRODUCTION: Icosapent Ethyl (IPE) is a highly purified (>96%) form of eicosapentanoic acid, a marine-derived omega-3 fatty acid known to reduce serum triglyceride levels. Experimental and human studies also support anti-atherosclerotic properties of IPE including antioxidant, anti-inflammatory, endothelial and plaque stabilizing effects. In the Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial (REDUCE-IT)l),the addition of 4 grams IPE daily resulted in a 25% reduction in cardiovascular events beyond statins and other standard of care therapies. ...
Source: Expert Review of Cardiovascular Therapy - April 2, 2020 Category: Cardiology Tags: Expert Rev Cardiovasc Ther 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

Off-label reduced-dose apixaban does not reduce hemorrhagic risk in Taiwanese patients with nonvalvular atrial fibrillation: A retrospective, observational study
East Asians are reportedly at high risk of anticoagulant-related bleeding; therefore, some physicians prefer to prescribe low-dose direct oral anticoagulants (DOACs). Little is known about the therapeutic effectiveness and safety of off-label reduced-dose apixaban in East Asians with nonvalvular atrial fibrillation (AF). We aimed to investigate the effectiveness and safety of off-label reduced-dose apixaban in Taiwanese patients with nonvalvular AF. This retrospective cohort study enrolled 1073 patients with nonvalvular AF who took apixaban between July 2014 and October 2018 from 4 medical centers in southern Taiwan. Th...
Source: Medicine - June 11, 2021 Category: Internal Medicine Tags: Research Article: Observational Study Source Type: research

Procedural and Short-Term Follow-Up Outcomes of Amplatzer Amulet Occluder versus Watchman FLX Device: A Meta-Analysis
Left atrial appendage (LAA) occlusion provides effective protection against thromboembolic (TE) events in high-risk atrial fibrillation patients. Two percutaneous devices are currently available in the United States for stroke prophylaxis: the WatchmanTM device (Boston Scientific, USA) and the AmplatzerTM AmuletTM Left Atrial Appendage Occluder (Abbott, USA). The latter has recently received Food and Drug Administration approval as a result of the findings of the Amulet IDE randomized trial (1), which showed superiority for LAA occlusion (lower rates of leaks>5mm) based on a comparison between the second generation Amplatz...
Source: Heart Rhythm - February 11, 2022 Category: Cardiology Authors: Domenico G. Della Rocca, Michele Magnocavallo, Carola Gianni, Sanghamitra Mohanty, Veronica N. Natale, Amin Al-Ahmad, Carlo Lavalle, Rodney P. Horton, Luigi Di Biase, Andrea Natale Source Type: research

Adverse events associated with the AtriClip device for left atrial appendage occlusion: A Food and Drug Administration MAUDE database study
Based on autopsy studies, the left atrial appendage has been implicated as the cause of stroke in>90% of cases with nonvalvular atrial fibrillation. The AtriClip device (Atricure, West Chester, OH) is used for left atrial appendage exclusion at the time of median sternotomy or thoracoscopically (as a stand-alone procedure or at the time of hybrid epicardial-endocardial ablation for atrial fibrillation).1–3 The real-world safety profile of AtriClip has not been evaluated, and we analyzed adverse events related to its use reported to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database.
Source: Heart Rhythm - April 28, 2022 Category: Cardiology Authors: Tahmeed Contractor, Rahul Bhardwaj, Ravi Mandapati, Kamal Kotak, Jalaj Garg Tags: Research Letter Source Type: research

Andexanet Alfa and its Clinical Application
Heart Int. 2020 Jun 19;14(1):20-23. doi: 10.17925/HI.2020.14.1.20. eCollection 2020.ABSTRACTFactor Xa (FXa) inhibitors are widely used for stroke prevention in patients with nonvalvular atrial fibrillation, and for the treatment and prevention of deep venous thrombosis and pulmonary embolism. Compared with warfarin, individual FXa inhibitors are associated with a lower risk of major bleeding. Nevertheless, bleeding remains a feared complication of any anticoagulant therapy. Despite their demonstrated safety, implementation of FXa inhibitors in clinical practice may have been limited by the lack of a specific antidote. Rece...
Source: Heart International - October 24, 2022 Category: Cardiology Authors: Fauve A Noordergraaf Marco Alings Source Type: research

New Era: Mavacamten for Obstructive Hypertrophic Cardiomyopathy
Cardiovasc Hematol Agents Med Chem. 2022 Oct 19. doi: 10.2174/1871525721666221019095218. Online ahead of print.ABSTRACTObstructive hypertrophic cardiomyopathy results from asymmetric septal hypertrophy which eventually obstructs the outflow of the left ventricle. Obstructive hypertrophic cardiomyopathy is linked to mutations in genes that encode for sarcomere proteins including actin, &#946:myosin heavy chain, titin, and troponin. The mutations lead to structural abnormalities in myocytes and myofibrils causing conduction irregularities and abnormal force generation. Obstructive hypertrophic cardiomyopathy is a chronic...
Source: Cardiovascular and Hematological Agents in Medicinal Chemistry - October 24, 2022 Category: Cardiology Authors: Ma'Lik Woodland Rami A Al-Horani Source Type: research

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