Evaluation of Treatment Safety in Patients with Atrial Fibrillation on Edoxaban Therapy in Real-Life in Turkey Study: Design and Rationale.

OBJECTIVE: Safety and effectiveness of edoxaban was demonstrated in phase III, Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48 (ENGAGE-AF-TIMI 48) trial and is being confirmed in the post-authorization Edoxaban Treatment in routiNe clinical prActice for patients with Atrial Fibrillation in Europe (ETNA-AF-Europe) study in patients with atrial fibrillation. However, any post-authoriza tion safety study focusing on the safety of edoxaban treatment in Turkey with a prospective design has not been performed yet. The Evaluation of Treatment Safety in Patients with Atrial Fibrillation on Edoxaban Therapy in Real-Life in Turkey (ETAF-TR) study is designed to evaluate the safety and effectiveness of edoxaban treatment in atrial fibrillation in routine practice. The present article describes the design and rationale for the ETAF-TR Study. METHODS: The ETAF-TR (NCT04594915) is a national, multicenter, prospective, observational study that enrolled 858 patients from 32 centers. The primary outcome of the ETAF-TR study is any overt bleeding (consisting of major bleeding or clinically relevant nonmajor bleeding or any bleeding that does not meet this definition but is considered as overt bleeding by the par ticipating physician). Effectiveness, treatment persistence, and posology will also be evaluated in an explorative manner. The overall duration of follow-up will be 1 year; the first patient was enrolled in August 2020. CONCLUSIONS: Results of ETAF-TR will add data from clinical practice to those from ENGAGE-AF trial and also ETNA-AF study. Comparing their results will enable to test the external validity of ENGAGE-AF trial in the country conditions.

Demographic, Clinical, and Angiographic Characteristics of Atrial Fibrillation Patients Suffering From de novo Acute Myocardial Infarction: A Subgroup Analysis of the MINOCA-TR Study Population.

BACKGROUND: Atrial fibrillation (AF) prevalence in patients with acute myocardial infarction (MI) ranges from 3% to 25%. However demographic, clinical, and angiographic characteristics of AF patients who admitted with de novo MI are unclear. The aim of this study was to investigate the prevalence of patients presenting with de novo MI with AF. METHODS: The study was performed as a sub-study of the MINOCA-TR (Myocardial Infarction with Non-obstructive Coronary Arteries in Turkish Population) Registry, a multicenter, cross-sectional, observational, all-comer registry. MI patients without a known history of stable coronary artery disease and/or prior coronary revascularization were enrolled in the study. Patients were divided into AF and Non-AF groups according to presenting cardiac rhythm. RESULTS: A total of 1793 patients were screened and 1626 were included in the study. The mean age was 61.5 (12.5) years. 70.7% of patients were men. The prevalence of AF was 3.1% (51 patients). AF patients were older [73.4 (9.4) vs. 61.0 (12.4) years, p<0.001] than non-AF patients. The proportion of women to men in the AF group was also higher than in the non-AF group (43.1% vs. 28.7%, p=0.027). Only 1 out of every 5 AF patients (10 patients, 19.6%) was using oral anticoagulants (OAC). CONCLUSIONS: AF prevalence in patients presenting with de novo MI was lower than previous studies that issued on AF prevalence in MI cohorts. The majority of AF patients did not have any knowledge of their arrhythmia and were not undergoing OAC therapy at admission, emphasizing the vital role of successful diagnostic strategies, patient education, and implementations for guideline adaptation.

Giant saccular aneurysm of the left main coronary artery.

Coronary aneurysms represent anomalies identified in 0.15%-4.9% of patients undergoing coronary angiography. At present, there is no uniform definition of this pathology. Aneurysms of the left main coronary artery (LMCA) are extremely uncommon, with an incidence of 0.1%. It has been demonstrated that atherosclerosis is the main cause of these anomalies in adults, and Kawasaki disease in children and adolescents. Other causes include connective tissue disorders, trauma, vasculitis, congenital, mycotic, and idiopathic. These dilated sections of the coronary artery are not benign pathology because they are subject to spasm, thrombosis, and subsequent distal embolism, spontaneous dissection and rupture. Treatment options include anticoagulation, custom-made covered stents, reconstruction, resection, and exclusion with bypass. Our report on an old case illustrates the giant saccular LMCA aneurysm leading to myocardial ischemia due to coronary steal phenomenon.

Digoxin intoxication: An old enemy in modern era.

OBJECTIVES: Although development of new treatment modalities limited digoxin usage, digoxin intoxication is still an important issue which could be easily overlooked. In this report, we analyzed a case series definitively diagnosed as digoxin intoxication in the modern era. METHODS: We analyzed 71 patients hospitalized with digoxin intoxication confirmed by history, complaints, clinical and electrocardiograph (ECG) findings, and serum digoxin levels > 2.0 ng/mL, during a five year period. The demographic and clinical data, indications for digoxin use, digoxin dosage, concurrent medications, laboratory data, hospital monitoring, and ECG findings were obtained from all patients. RESULTS: Thirty-eight of 71 patients (53.5%) had symptoms of heart failure during admission or later. Sixty-four percent of patients were older than 75 years. The percentage of females was 67%. Atrial fibrillation, hypertension and gastrointestinal complaints were more frequent in the females (64% in females, 30% in males, P = 0.007; 81% in female, 52% in males, P = 0.01; 50% in female, 17.3% in males, P = 0.008, respectively). The mortality rate during the hospital course was 7%. CONCLUSIONS: This report demonstrated the reduced mortality rates in patients with digoxin intoxication over the study period. Gastrointestinal complaints are the most common symptoms in this population.

G protein beta3 subunit gene polymorphism in Turkish hypertensives.

OBJECTIVE: G protein is one of the most important regulators of intracellular signaling pathways. C825T polymorphism of G protein b3 subunit is associated with increased intracellular signal transduction. The 825T allele has been found associated with a variety of cardiovascular risk factors, including hypertension. The aim of the present study was to investigate the association between the C825T polymorphism of the G protein b3 subunit and essential hypertension in Turkish population. METHODS: This cross-sectional, case-controlled study included 209 patients with essential hypertension (Patient group) and 82 subjects with normal blood pressure (Control group). The G protein b3 subunit C825T gene polymorphism was determined by polymerase chain reaction. Hypertension was defined according to JNC VII criteria. Statistical analysis was performed using Chi square and unpaired t tests. Logistic regression analysis was used to study association between hypertension and genotypes. RESULTS: We found that the frequencies of the G protein b3 subunit C825T polymorphism in hypertensive and control groups were 17.7%, 59.3%, 23.0% and 32.9%, 48.8%, 18.3%, (CC, CT, TT) respectively (chi2=7.963, p=0.019). In the multivariate logistic regression analysis CT genotype had 2.2 (OR=2.262, 95% CI 1.228-4.167, p=0.009), and TT genotype had 2.3 times (OR=2.335, 95% CI 1.089-5.008, p=0.029) greater risk of hypertension compared to CC genotype. CONCLUSION: It seems that the G protein b3 subunit C825T gene polymorphism is associated with systolic and diastolic blood pressure. Furthermore, the study indicates that the G protein b3 subunit may be a susceptible gene to essential hypertension.