Abstract T P335: Eligibility and Preference of New Oral Anticoagulants in Patients With Atrial Fibrillation: Comparison Between Patients With Versus Without Stroke or TIA

Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Chang Hyo Yoon ◽  
Yoon Kyung Park ◽  
Suk Jae Kim ◽  
Miji Lee ◽  
Sookyung Ryoo ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Randomized Clinical Trials ◽  
Medical Center ◽  
Oral Anticoagulants ◽  
New Oral Anticoagulants ◽  
Therapeutic Window ◽  
Bleeding Tendency ◽  
Chads2 Score

BACKGROUNDS: Recent randomized clinical trials of new oral anticoagulants (NOACs) forms the basis for international guidelines for the management of patients with atrial fibrillation. However, strict enrollment criteria may limit the applicability of results of trials to clinical practice. We estimated the eligibility for participation in landmark trials of NOACs of an unselected group of atrial fibrillation patients with or without stroke/TIA. In addition, we compared the preference for NOACs use between patients with versus without stroke/TIA. METHODS: Four hundred patients were prospectively and consecutively enrolled in a database from a university medical center. We applied three large NOAC trials' enrollment criteria (RE-LY, ROCKET-AF, and ARISTOTLE). In addition, INR lability (time in therapeutic window for patients taking warfarin) and bleeding risk schemes (ATRIA) were measured. RESULTS: The proportions of patients fulfilling the trial enrollment criteria ranged from 20% to 75%, depending on the differences in the indications/contraindications of studies (lower in ROCKET-AF than others) and presence or absence of stroke/TIA (20-60% vs. 75%). The main reasons for ineligible for NOACs are lower CHADS2 score and planned cardioversion for patients without stroke/TIA, whereas low creatinine clearance and bleeding-related complications for those with stroke/TIA. TTR is lower in the former, especially in patients with severe disability. In addition, bleeding tendency as measured by ATRIA is much higher in patients with stroke/TIA, mainly due to concomitant use of antithrombotics. CONCLUSIONS: Our data confirm that patients enrolled in randomized clinical trials are representative of most stroke patients with atrial fibrillation, but partly of nonstroke patients, in clinical practice. When INR lability and bleeding tendency with warfarin use were considered, the use of NOACs was preferred in patients with stroke/TIA than in patients without

Primary Stroke Prevention in Nonvalvular Atrial Fibrillation: Implementing the Clinical Trial Findings

1997 ◽  
Vol 31 (10) ◽  
pp. 1187-1196 ◽  
Author(s):  
Patricia A Howard ◽  
Pamela W Duncan
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Cost Effectiveness ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Randomized Clinical Trials ◽  
Nonvalvular Atrial Fibrillation ◽  
Risk Patients

OBJECTIVE: To review the clinical trials evaluating warfarin for primary stroke prophylaxis in nonvalvular atrial fibrillation (NVAF), to discuss the relative benefits and risks of warfarin versus aspirin therapy, and to review the clinical practice guidelines and identify potential barriers to their implementation in clinical practice. DATA SOURCES: A MEDLINE literature search was performed to identify clinical trials of antithrombotic therapy for NVAF, clinical practice guidelines, studies evaluating physician practices and attitudes, cost-effectiveness studies, and pertinent review articles. Key search terms included atrial fibrillation, stroke, antithrombotic, warfarin, aspirin, and cost-effectiveness. DATA EXTRACTION: Prospective, randomized clinical trials were selected for analysis. Clinical practice guidelines from recognized panels of experts were reviewed. Comprehensive review articles were selected. DATA SYNTHESIS: NVAF is a common arrhythmia that is associated with a substantial risk for stroke. Seven prospective, randomized, clinical trials have conclusively demonstrated the efficacy of warfarin for stroke prevention. The greatest benefits are achieved in older patients and those with comorbidities that increase their risk for stroke. The potential benefits of preventing a devastating stroke, however, must be weighed against the potential for bleeding complications. Warfarin has been shown to be cost-effective in high-risk patients, provided the rate of complications is minimized. Nonetheless, many physicians remain hesitant to implement warfarin therapy in older, high-risk patients. The clinical data on aspirin are less consistent than those observed with warfarin. Aspirin appears to be most effective in younger individuals or those considered to be at low risk for stroke. CONCLUSIONS: In patients with NVAF, the personal, social, and economic consequences of stroke are often devastating. Clinical trials have provided definitive proof that the risks of stroke can be significantly reduced through the use of appropriate antithrombotic therapy. Despite this evidence and the recommendations of a number of clinical practice guidelines, variations in care exist that continue to place patients at risk. Additional outcomes research is needed to evaluate the impact of the clinical trial findings and practice guidelines on clinical practice and to develop methods for overcoming barriers to implementation.

scholarly journals Approaches to Assessing the Quality of Observational Studies of Clinical Practice Based on the Big Data Analysis

2021 ◽  
Vol 17 (4) ◽  
pp. 584-593
Author(s):  
S. R. Gilyarevsky
Keyword(s):  
Clinical Trials ◽  
Big Data ◽  
Clinical Practice ◽  
Observational Studies ◽  
Randomized Clinical Trials ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Real Life ◽  
Hierarchy Of Evidence

The article is devoted to the discussion of the problems of assessing the quality of observational studies in real clinical practice and determining their place in the hierarchy of evidence-based information. The concept of “big data” and the acceptability of using such a term to refer to large observational studies is being discussed. Data on the limitations of administrative and claims databases when performing observational studies to assess the effects of interventions are presented. The concept of confounding factors influencing the results of observational studies is discussed. Modern approaches to reducing the severity of bias in real-life clinical practice studies are presented. The criteria for assessing the quality of observational pharmacoepidemiological studies and the fundamental differences between such studies and randomized clinical trials are presented. The results of systematic reviews of real-life clinical trials to assess the effects of direct oral anticoagulants are discussed. 

scholarly journals The risk of bleeding minimization with direct oral anticoagulants

2021 ◽  
pp. 106-126
Author(s):  
Т. N. Novikova
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trials ◽  
Anticoagulant Therapy ◽  
Randomized Clinical Trials ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Blood Analysis ◽  
Systemic Embolism ◽  
Risk Of Bleeding ◽  
Wide Range

This review is devoted to the safety issues of anticoagulant therapy prescribed for the prevention of stroke and systemic embolism in patients with atrial fibrillation. Direct oral anticoagulants are considered worldwide in accordance with the guidelines for the diagnosis and treatment of atrial fibrillation as the preferred anticoagulant choice for the prevention of stroke and systemic embolism. Direct oral anticoagulants in comparison with vitamin K antagonists generally have similar efficacy, but different safety profiles, primarily, this concerns the risk of large extracranial and, primarily, gastrointestinal hemorrhages. To minimize the risk of bleeding during therapy with direct oral anticoagulants, an individual approach to the choice of the drug for each individual patient is required after assessing the risk of bleeding, searching for a potential bleeding substrate, correcting existing risk factors and eliminating, if possible, the substrate. When choosing an anticoagulant therapy, special attention should be paid to the most vulnerable categories of patients, such as patients of older age groups and patients with concomitant chronic kidney disease. Among the direct oral anticoagulants registered in the Russian Federation, according to meta-analyzes of key randomized clinical trials and real clinical trials, apixaban has the most optimal benefit: risk ratio in a wide range of patients, including vulnerable populations. Dynamic observation, including regular assessment of renal function, control of clinical blood analysis, erythrocyte and platelet levels, after prescribing an individually selected anticoagulant to the patient, ensures the maximum safety of therapy. Small, so-called, annoying bleeding is not a reason for canceling the anticoagulant, but requires a careful search for the causes of bleeding and their correction.

New anticoagulants in clinical practice. Effectiveness and problems

2016 ◽  
Vol 94 (5) ◽  
pp. 383-387
Author(s):  
Igor N. Bokarev ◽  
T. B. Kondrat’eva
Keyword(s):  
Atrial Fibrillation ◽  
Acute Coronary Syndrome ◽  
Clinical Practice ◽  
Oral Anticoagulants ◽  
New Oral Anticoagulants ◽  
Coronary Syndrome ◽  
New Anticoagulants ◽  
Antivitamins K

We analyze the effectiveness of new oral anticoagulants and antivitamins K for the treatment of patients with venous problems, atrial fibrillation, and acute coronary syndrome with reference to advantages of this therapy and methods of prevention of complications of these conditions.

Experience in Daily Clinical Practice of Ambulatory Cardioversion of Atrial Fibrillation Treated With New Oral Anticoagulants

2014 ◽  
Vol 67 (11) ◽  
pp. 960-961
Author(s):  
Enrique Santas ◽  
José Méndez ◽  
Ángel Martínez-Brotons ◽  
Julio Núñez ◽  
Francisco Javier Chorro ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Practice ◽  
Oral Anticoagulants ◽  
Daily Clinical Practice ◽  
New Oral Anticoagulants

scholarly journals Direct Oral Anticoagulants after Ischemic Stroke: Which Patient? Which Drug? And How Early?

2021 ◽  
Vol 41 (01) ◽  
pp. 031-034
Author(s):  
Gian Marco De Marchis
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trials ◽  
Ischemic Stroke ◽  
Vitamin K ◽  
Randomized Clinical Trials ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Reversal Agents

AbstractDirect oral anticoagulants (DOACs) are recommended over vitamin K antagonists (VKAs) in patients with atrial fibrillation (AF) and ischemic stroke. The main advantage of DOAC over VKA is the lower rate of bleeding and mortality. This review covers challenges clinicians can encounter when treating patients with AF and ischemic stroke, including timing of DOAC start and ongoing randomized clinical trials, appropriate dosing, and available comparative evidence across DOACs. For patients without AF but with an ischemic stroke, the review outlines the role of DOACs. Finally, the risk of thrombotic events associated with specific DOAC reversal agents and DOAC pausing is reviewed.

scholarly journals Patient with myocardial infarction, atrial fibrillation and high risk for hemorrhage: reasonable choice of anticoagulant for effective prevention of ischemic events

2019 ◽  
Vol 7 (4S) ◽  
pp. 135-145 ◽  
Author(s):  
T. B. Pecherina ◽  
V. O. Zlydneva ◽  
V. V. Kashtalap ◽  
O. L. Barbarash
Keyword(s):  
Myocardial Infarction ◽  
Atrial Fibrillation ◽  
Clinical Practice ◽  
High Risk ◽  
Randomized Clinical Trials ◽  
Case Reports ◽  
Oral Anticoagulants ◽  
Effective Prevention ◽  
Continuous Increase ◽  
Coronary Syndrome

Current clinical practice faces the challenges in selecting optimal drugs and the duration of antithrombotic treatment in patients with acute coronary syndrome with atrial fibrillation. A continuous increase of using non-vitamin K oral anticoagulants (NOAC), dabigatran, rivaroxaban, apixaban, edoxaban, and novel antiplatelet agents, prasugrel and ticagrelor, has complicated the decision-making process in this group of patients. The presented clinical case reports the use of dabigatran as a part of double antithrombotic therapy in an elderly patient with type 2 myocardial infarction, paroxysmal AF and a high risk for hemorrhage. The drug choice and its dosage were chosen using the personalized risk assessment. The presented approach has been early proved by the results of the recent randomized clinical trials and, therefore, may be translated into routine clinical practice.

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