Editorial: Antithrombotic Prophylaxis in Patients With Atrial Fibrillation for Stroke Prevention: Evidence From Randomized Clinical Trials, Observational Studies, Methodological Modeling, and More

In observational studies, identification of associations within particular subgroups is the usual method of investigation. As an exploratory method, it is the bread and butter of epidemiological research. Nearly everything that has been learned in epidemiology has been derived from the analysis of subgroups. In a randomized clinical trial, the entire purpose is the comparison of the test subjects and the controls, and when there is particular interest in the results of treatment in a certain section of trial participants, a subgroup analysis is performed. These subgroups are examined to see if they are liable to a greater benefit or risk from treatment. Thus, analyzing patient subsets is a natural part of the process of improving therapeutic knowledge through clinical trials. Nevertheless, the reliability of subgroup analysis can often be poor because of problems of multiplicity and limitations in the numbers of patients studied. The naive interpretation of the results of such examinations is a cause of great confusion in the therapeutic literature. We emphasize the need for readers to be aware that inferences based on comparisons between subgroups in randomized clinical trials should be approached more cautiously than those based on the main comparison. That is, subgroup analysis results derived from a sound clinical trial are not necessarily valid; one must not jump to conclusions and accept the validity of subgroup analysis results without an appropriate judgment.

Download Full-text

SAFETY AND EFFICACY OF CONCOMITANTLY USED DIRECT ORAL ANTICOAGULANT AND AMIODARONE IN PATIENTS WITH NON-VALVULAR ATRIAL FIBRILLATION: A META-ANALYSIS OF PROSPECTIVE RANDOMIZED CLINICAL TRIALS

Journal of the American College of Cardiology ◽

10.1016/s0735-1097(18)30837-4 ◽

2018 ◽

Vol 71 (11) ◽

pp. A296

Author(s):

Bradley Peltzer ◽

Florentino Lupercio ◽

Jorge Romero ◽

Carola Maraboto Gonzalez ◽

David Briceno ◽

...

Keyword(s):

Atrial Fibrillation ◽

Clinical Trials ◽

Oral Anticoagulant ◽

Randomized Clinical Trials ◽

Meta Analysis ◽

Direct Oral Anticoagulant ◽

Safety And Efficacy

Download Full-text

Abstract WMP112: Cilostazol versus Aspirin for Secondary Stroke Prevention: Systematic Review and Meta-Analysis

Stroke ◽

10.1161/str.51.suppl_1.wmp112 ◽

2020 ◽

Vol 51 (Suppl_1) ◽

Author(s):

Michelle P Lin ◽

Kevin M Barrett ◽

James F Meschia ◽

Benjamin H Eidelman ◽

Josephine F Huang ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Ischemic Stroke ◽

Random Effects ◽

Intracranial Hemorrhage ◽

Stroke Prevention ◽

Lower Risk ◽

Randomized Clinical Trials ◽

Meta Analysis ◽

Secondary Stroke Prevention

Introduction: Cilostazol has promise as an alternative to aspirin for secondary stroke prevention given its vasodilatory and anti-inflammatory properties in addition to platelet aggregation inhibition. We conducted a systematic review and meta-analysis to estimate the comparative effectiveness and safety of cilostazol compared to aspirin for stroke prevention in patients with previous stroke or TIA. Hypothesis: Cilostazol is more effective than aspirin in preventing recurrent ischemic stroke with lower risk of intracranial hemorrhage and bleeding. Methods: We searched PubMed and the Cochrane Central Register of Controlled Trials from inception to 2019. Randomized clinical trials that compared cilostazol vs aspirin and reported the endpoints of ischemic stroke, intracranial hemorrhage and bleeding were included. A random-effects estimate was computed based on Mantel-Haenszel methods. The pooled estimates with 95% confidence intervals were compared between cilostazol and aspirin and displayed as forest plots (Figure). Results: The search identified 5 randomized clinical trials comparing cilostazol vs aspirin for secondary stroke prevention that enrolled 7,240 patients from primarily Asian countries (3,615 received cilostazol and 3,625 received aspirin). The pooled results from the random-effects model showed that cilostazol was associated with significantly lower risk of recurrent ischemic stroke (Hazard ratio [HR] 0.70; 95%CI, 0.54-0.89), intracranial hemorrhage (HR 0.41; 95%CI, 0.25-0.65) and bleeding (HR 0.71; 95%CI, 0.55-0.91). See forest plots. Conclusion: This meta-analysis suggests cilostazol is more effective than aspirin in the prevention of recurrent ischemic stroke with lower risk of intracranial hemorrhage and bleeding. Confirmatory randomized trials of cilostazol for secondary stroke prevention to be performed in more generalizable populations are needed.

Download Full-text

Should all patients with atrial fibrillation receive warfarin? Evidence from randomized clinical trials

European Heart Journal ◽

10.1093/oxfordjournals.eurheartj.a014933 ◽

1996 ◽

Vol 17 (5) ◽

pp. 674-681 ◽

Cited By ~ 22

Author(s):

J. G. F. Cleland ◽

P. J. Cowburn ◽

R. H. Falk

Keyword(s):

Atrial Fibrillation ◽

Clinical Trials ◽

Randomized Clinical Trials

Download Full-text

Stroke Prevention in Atrial Fibrillation

Circulation ◽

10.1161/circulationaha.120.049768 ◽

2020 ◽

Vol 142 (24) ◽

pp. 2371-2388

Author(s):

Aristeidis H Katsanos ◽

Hooman Kamel ◽

Jeff S. Healey ◽

Robert G. Hart

Keyword(s):

Atrial Fibrillation ◽

Clinical Trials ◽

High Risk ◽

Vitamin K ◽

Stroke Prevention ◽

Oral Anticoagulant ◽

Oral Anticoagulants ◽

Vitamin K Antagonist ◽

Bleeding Complications ◽

Secondary Stroke Prevention

Ischemic strokes related to atrial fibrillation are highly prevalent, presenting with severe neurologic syndromes and associated with high risk of recurrence. Although advances have been made in both primary and secondary stroke prevention for patients with atrial fibrillation, the long-term risks for stroke recurrence and bleeding complications from antithrombotic treatment remain substantial. We summarize the major advances in stroke prevention for patients with atrial fibrillation during the past 30 years and focus on novel diagnostic and treatment approaches currently under investigation in ongoing clinical trials. Non–vitamin K antagonist oral anticoagulants have been proven to be safer and equally effective compared with warfarin in stroke prevention for patients with nonvalvular atrial fibrillation. Non–vitamin K antagonist oral anticoagulants are being investigated for the treatment of patients with atrial fibrillation and rheumatic heart disease, for the treatment of patients with recent embolic stroke of undetermined source and indirect evidence of cardiac embolism, and in the prevention of vascular-mediated cognitive decline in patients with atrial fibrillation. Multiple clinical trials are assessing the optimal timing of non–vitamin K antagonist oral anticoagulant initiation after a recent ischemic stroke and the benefit:harm ratio of non–vitamin K antagonist oral anticoagulant treatment in patients with atrial fibrillation and history of previous intracranial bleeding. Ongoing trials are addressing the usefulness of left atrial appendage occlusion in both primary and secondary stroke prevention for patients with atrial fibrillation, including those with high risk of bleeding. The additive value of prolonged cardiac monitoring for subclinical atrial fibrillation detection through smartphone applications or implantable cardiac devices, together with the optimal medical management of individuals with covert paroxysmal atrial fibrillation, is a topic of intensive research interest. Colchicine treatment and factor XIa inhibition constitute 2 novel pharmacologic approaches that might provide future treatment options in the secondary prevention of cardioembolic stroke attributable to atrial fibrillation.

Download Full-text

Associations of Plant-Based Foods and Diets with Gestational Diabetes: A Systematic Review of Observational Studies and Clinical Trials

Current Developments in Nutrition ◽

10.1093/cdn/nzaa054_020 ◽

2020 ◽

Vol 4 (Supplement_2) ◽

pp. 948-948

Author(s):

Tristesse Burton ◽

James Alexander ◽

Petar Planinic ◽

Arpita Basu

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Gestational Diabetes ◽

Observational Studies ◽

Randomized Clinical Trials ◽

Chinese Herb ◽

Nutrition Therapy ◽

Cross Sectional ◽

Evening Primrose ◽

Funding Sources

Abstract Objectives Gestational diabetes mellitus (GDM) is one of the most common health complications during pregnancy. Medical nutrition therapy is the mainstay of treatment for GDM, however, there is no current consensus on the optimal dietary approaches for prevention and management of hyperglycemia during pregnancy. Our objective is to assess the relationship of plant-based diets, foods, and dietary supplements with GDM and maternal glycemic biomarkers in observational and clinical studies. Methods A systematic review was performed using PubMed to identify original articles from 1999–2019 following the PRISMA checklist statement. Articles were excluded if they were review articles, conference abstracts, not in English or did not meet the pre-defined PICOS (Population, Intervention/exposure, Comparison, Outcome, Study design) criteria. Articles were screened for relevance, extracted and summarized, and assessed for risk of bias and quality. Results A total of 431 articles were screened, 33 observational studies (prospective cohort: n = 26, case-control: n = 3, cross-sectional: n = 4) involving 147,576 women and 11 randomized clinical trials involving 3940 women were included. Among the observational studies, Mediterranean diet (MedDiet), fiber, and vegetable rich diets were associated with a significant decrease in GDM risk. Among the clinical trials, Dietary Approaches to Stop Hypertension (DASH) diet, MedDiet, soy, phytosterol spread, evening primrose, chili powder and a traditional Chinese herb, Artemisia scoparia Waldst. & Kit. (Asteraceae) (n = 1) exhibited improved maternal hyperglycemia, insulin resistance or sensitivity, and hypoadiponectinemia. Conclusions These findings suggest that plant-based diets may be effective in preventing and managing hyperglycemia during pregnancy. Particularly, adherence to a MedDiet may improve maternal glycemic biomarker and decrease risk of GDM. Funding Sources UNLV Faculty research start up award.

Download Full-text