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Rct anticoagulation for AF

José Miguel Rivera-Caravaca, María Asunción Esteve-Pastor, Francisco Marín, Mariano Valdés, Vicente Vicente, Vanessa Roldán, Gregory Y H Lip
OBJECTIVE: To investigate the incidence and risk of adverse clinical outcomes in a "real- world" cohort of patients with atrial fibrillation (AF) anticoagulated with vitamin K antagonists (VKAs) from the Murcia AF Project in comparison with the warfarin arm of the randomized clinical trial (RCT) AMADEUS (Evaluating the Use of SR34006 Compared to Warfarin or Acenocoumarol in Patients With Atrial Fibrillation). PATIENTS AND METHODS: We included 1361 patients with AF from the Murcia AF Project (recruitment from May 1, 2007, to December 1, 2007) and 2293 from the AMADEUS trial (started in September 2003 and primary completed in March 2006), all taking VKA treatment...
May 2, 2018: Mayo Clinic Proceedings
Alexander C Fanaroff, Jan Steffel, John H Alexander, Gregory Y H Lip, Robert M Califf, Renato D Lopes
Real-world data (RWD) has been defined as data generated outside of traditional randomized clinical trials (RCTs). Though RWD has received increasing attention from regulatory authorities and professional societies, dividing evidence into that derived from 'real-world' vs. 'non-real-world' sources provides only one element of a much larger framework for evidence evaluation. Evidence should be evaluated on the source of the data, the method of treatment allocation (whether any intervention being evaluated was assigned or simply observed as used in practice) and the context in which the evidence was generated (overall study design)...
April 23, 2018: European Heart Journal
Kavitha Vimalesvaran, Seth J Dockrill, Diana A Gorog
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, and it leads to significant morbidity and mortality, predominantly from ischemic stroke. Vitamin K antagonists, mainly warfarin, have been used for decades to prevent ischemic stroke in AF, but their use is limited due to interactions with food and other drugs, as well as the requirement for regular monitoring of the international normalized ratio. Rivaroxaban, a direct factor Xa inhibitor and the most commonly used non-vitamin K oral anticoagulant, avoids many of these challenges and is being prescribed with increasing frequency for stroke prevention in non-valvular AF...
2018: Vascular Health and Risk Management
Elsayed Abo-Salem, Bernard Chaitman, Tarek Helmy, Eric Adjei Boakye, Hassan Alkhawam, Michael Lim
BACKGROUND: PFO is more common in cases with cryptogenic stroke compared to cases with no stroke or stroke of identified etiology. Several randomized controlled trials (RCTs) comparing PFO closure with medical therapy have been published with controversial findings. METHODS: PubMed, Embase and Cochrane library databases were searched for RCT comparing PFO closure with medical therapy including antiplatelet therapy (aspirin or clopidogrel or combination) or anticoagulation...
March 2018: Journal of Neurology
N Fluschnik, P M Becher, R Schnabel, S Blankenberg, D Westermann
Clinicians struggle daily with the optimal regimen for patients with an indication for antiplatelet therapy after stenting and in patients needing oral anticoagulation treatment for atrial fibrillation (AF). This is not only difficult in patients with acute coronary syndrome (ACS) but also in the large number of patients with AF undergoing elective percutaneous coronary intervention (PCI). The challenge is to strike a balance between the increasing risk of bleeding events and ischemic or thrombotic events. Until recently, guidelines were based on expert consensus and a few small, many of them retrospective, trials...
February 2018: Herz
Emily N Guhl, Courtney L Schlusser, Lori E Henault, Timothy W Bickmore, Everlyne Kimani, Michael K Paasche-Orlow, Jared W Magnani
BACKGROUND: Atrial Fibrillation (AF) is a common cardiac arrhythmia that is challenging for patients and adversely impacts health-related quality of life (HRQoL). Long-term management of AF requires that patients adhere to complex therapies, understand difficult terminology, navigate subspecialty care, and have continued symptom monitoring with the goal of preventing adverse outcomes. Continued interventions to ameliorate the patient experience of AF are essential. DESIGN: The Atrial Fibrillation health Literacy Information Technology Trial (AF-LITT; NCT03093558) is an investigator-initiated, 2-arm randomized clinical trial (RCT)...
November 2017: Contemporary Clinical Trials
Abdulaali R Almutairi, Lili Zhou, Walid F Gellad, Jeannie K Lee, Marion K Slack, Jennifer R Martin, Wei-Hsuan Lo-Ciganic
PURPOSE: The findings from the observational studies comparing the effectiveness and safety of non-vitamin K antagonist oral anticoagulants (NOACs) versus vitamin K antagonists (VKAs) for atrial fibrillation (AF) and venous thromboembolism (VTE) are inconsistent. We conducted separate meta-analyses examining the efficacy/effectiveness and safety of NOACs versus VKAs by disease (AF vs VTE), study design (randomized controlled trials [RCTs] vs observational studies), and NOAC (dabigatran, rivaroxaban, apixaban, and edoxaban)...
July 2017: Clinical Therapeutics
N A Koziolova, E A Polyanskaya, I I Kolegova
The review shows the prevalence of atrial fibrillation (AF) in patients with chronic kidney disease (CKD), depending on the severity of the disease. Patients with non-valvular AF and CKD have a significantly increased risk of both bleeding and thromboembolic complications, and death from all causes. Evaluation of the results of randomized clinical trials (RCTs), meta-analyzes of RCTs demonstrated the advantages of the new oral anticoagulants (NOAC), such as dabigatran, rivaroxaban, apixaban, compared with warfarin in reducing the risk of bleeding in patients with AF and CKD in predialysis stage...
January 2017: Kardiologiia
Shilpa D Kailas, Sirisha Reddy Thambuluru
Direct oral anticoagulants (DOACs), previously also known as novel oral anticoagulants (NOACs), have increased the therapeutic options for stroke prevention in atrial fibrillation (AF). Previous studies comparing their relative efficacy and safety do not address age-related differences, such as comorbidities and physical and social boundaries. This review aimed to summarize and compare the clinical and safety outcomes of DOACs and warfarin for stroke prevention in AF in the elderly population (≥ 65 years)...
October 18, 2016: Curēus
Peter Moffitt, Deirdre A Lane, Helen Park, Janice O'Connell, Terence J Quinn
OBJECTIVE: atrial fibrillation (AF) is associated with dementia. If AF-related cognitive decline is driven by cerebral embolic events, thromboprophylaxis may impact on this. This systematic review assessed the association between cognitive impairment and AF thromboprophylaxis. METHODS: two independent reviewers searched CINAHL, EMBASE, MEDLINE, PsycINFO, Web of Science Core Collection and Cochrane Library from inception until 12 November 2014. Eligible studies compared AF thromboprophylaxis to control with an outcome measure of cognition or dementia...
November 2016: Age and Ageing
Guowei Li, Anne Holbrook, Yanling Jin, Yonghong Zhang, Mitchell A H Levine, Lawrence Mbuagbaw, Daniel M Witt, Mark Crowther, Stuart Connolly, Chatree Chai-Adisaksopha, Zhongxiao Wan, Ji Cheng, Lehana Thabane
Emerging observational studies using propensity score (PS) methods assessed real-world comparative effectiveness of non-vitamin K antagonist oral anticoagulants (NOACs) versus warfarin in patients with non-valvular atrial fibrillation (AF). We aimed to compare treatment effect estimates of NOACs between PS studies and randomized controlled trials (RCTs). Electronic databases and conference proceedings were searched systematically. Primary outcomes included stroke or systemic embolism (SE) and major bleeding...
June 2016: European Journal of Epidemiology
Marco Marietta
Direct oral anticoagulants (DOAC) represent an innovative and relevant treatment for the prevention of cardiac embolism in patients with atrial fibrillation (AF). Their introduction has been followed by an ample debate on their appropriate use, considering that they can offer an effective treatment for the many patients with AF, which are not taking any effective anticoagulant treatment, even though they have a substantial thromboembolic risk (1). On the other hand, DOAC are much less tested in everyday clinical practice and much more expensive than anti-vitamin k anticoagulants (AVKs)...
September 2015: Internal and Emergency Medicine
Daniel Caldeira, Filipe B Rodrigues, Márcio Barra, Ana Teresa Santos, Daisy de Abreu, Nilza Gonçalves, Fausto J Pinto, Joaquim J Ferreira, João Costa
OBJECTIVE: Non-vitamin K antagonist oral anticoagulants (NOACs) are efficacious and safe antithrombotic drugs but the non-availability of an antidote for potential fatal haemorrhagic events is clinically perceived as a strong limitation. We aimed at evaluating the risk of haemorrhage-related fatalities associated with NOACs in patients requiring long-term anticoagulation. METHODS: MEDLINE, Cochrane Library and Web of Science databases were searched in November 2014 for atrial fibrillation (AF) or venous thromboembolism (VTE) phase III randomised controlled trials (RCT) comparing NOACs with vitamin K antagonists (VKAs) or low molecular weight heparin (LMWH) followed by VKAs...
August 2015: Heart: Official Journal of the British Cardiac Society
D A Lane, S Raichand, D Moore, M Connock, A Fry-Smith, D A Fitzmaurice
BACKGROUND: Previous research suggests uncertainty whether or not there is any additional benefit in adding antiplatelet therapy (APT) to anticoagulation therapy (ACT) in patients with high-risk atrial fibrillation (AF) in terms of reduction in vascular events, including stroke. The existing guidelines acknowledge an increased risk of bleeding associated with such a strategy; however, there is no consensus on the treatment pathway. OBJECTIVES: To determine, by undertaking a systematic review, if the addition of APT to ACT is beneficial compared with ACT alone in patients with AF who are considered to be at high risk of thromboembolic events (TEs)...
July 2013: Health Technology Assessment: HTA
Neil S Roskell, Miny Samuel, Herbert Noack, Brigitta U Monz
AIMS: Clinical trials have shown that anticoagulation with vitamin K antagonists (VKAs), e.g. warfarin, decreases the risk of stroke in patients with atrial fibrillation (AF); however, increased bleeding risk is one of the safety concerns. The primary objective was to conduct a systematic review of the published literature, assessing the risk of major bleeding and mortality in patients with AF treated with VKAs. METHODS AND RESULTS: Online searches of MEDLINE, EMBASE, BIOSIS, and the Cochrane Library were performed to a pre-specified protocol from 1960 to March 2012 for randomized controlled trials (RCTs) and from January 1990 to March 2012 for observational studies...
June 2013: Europace: European Pacing, Arrhythmias, and Cardiac Electrophysiology
(no author information available yet)
OBJECTIVE: To assess the effectiveness, cost-effectiveness, and demand in Ontario for catheter ablation of complex arrhythmias guided by advanced nonfluoroscopy mapping systems. Particular attention was paid to ablation for atrial fibrillation (AF). CLINICAL NEED: Tachycardia Tachycardia refers to a diverse group of arrhythmias characterized by heart rates that are greater than 100 beats per minute. It results from abnormal firing of electrical impulses from heart tissues or abnormal electrical pathways in the heart because of scars...
2006: Ontario Health Technology Assessment Series
C I Coleman, D M Sobieraj, S Winkler, P Cutting, M Mediouni, S Alikhanov, J Kluger
Various antiplatelet and anticoagulation options are available for stroke prevention in patients with atrial fibrillation (AF). Currently, it is unclear whether these agents differ in their propensity to cause major gastrointestinal bleeding (MGIB). To our knowledge, no systematic evaluation of MGIB rates from randomised controlled trials (RCTs) of pharmacological stroke prevention in patients with AF has been conducted. Two independent investigators conducted systematic literature searches in MEDLINE and CENTRAL from the earliest possible date through November 2010...
January 2012: International Journal of Clinical Practice
Sheharyar Ali, Mauricio Hong, Eduardo S Antezano, Iqwal Mangat
Atrial fibrillation (AF) is the most common clinically encountered arrhythmia affecting 0.4% of the general population. Its prevalence increases with age, affecting more than 6% of people over 80 years of age. The annual risk of ischemic stroke in patients with lone AF is approximately 1.3%. This annual risk increases up to 10% -12% in patients with a prior stroke or transient ischemic attack. Randomized clinical trials (RCT) comparing adjusted-dose oral anticoagulation and placebo showed a risk reduction of 61% (95% CI 47% to 71%)...
December 2006: Cardiovascular & Hematological Disorders Drug Targets
John Kellett
BACKGROUND: Although several randomized, control trials (RTC) suggest that oral anticoagulation (OAC) benefits patients with atrial fibrillation (AF), this might not be true for hospitalized patients with co-morbid conditions. If the results of the RTCs are valid, then how many patients in AF admitted to an acute medical unit will benefit from OAC? METHODS: An RCT-based decision analysis model calculated the quality-adjusted life expectancy (QALE) gain from OAC for 141 unselected consecutive patients over 65 years of age with AF admitted to an acute medical unit...
April 2005: European Journal of Internal Medicine
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