Oral anticoagulation therapy in atrial fibrillation patients at high risk of bleeding: Clinical characteristics and treatment strategies based on data from the Polish multicenter register of atrial fibrillation (POL-AF).

BACKGROUND: Despite its benefits, oral anticoagulant (OAC) therapy in patients with atrial fibrillation (AF) is associated with hemorrhagic complications. AIMS: We aimed to evaluate clinical characteristics of AF patients at high risk of bleeding and the frequency of OAC use as well as identify factors that predict nonuse of OACs in these patients. METHODS: Consecutive AF patients hospitalized for urgent or planned reasons in cardiac centers were prospectively included in the registry in 2019. Patients with HAS-BLED ≥3 (high HAS-BLED group) were assumed to have a high risk of bleeding. RESULTS: Among 3598 patients enrolled in the study, 29.2% were at high risk of bleeding (44.7% female; median [Q1-Q3] age 72 [65-81], CHA2DS2-VASc score 5 [4-6], HAS-BLED 3 [3-4]). In this group, 14.5% of patients did not receive OACs, 68% received NOACs, and 17.5% VKAs. In multivariable analysis, the independent predictors of nonuse of oral OACs were as follows: creatinine level (odds ratio [OR], 1.441; 95% confidence interval [CI], 1.174-1.768; P <0.001), a history of gastrointestinal bleeding (OR, 2.918; 95% CI, 1.395-6.103; P = 0.004), malignant neoplasm (OR, 3.127; 95% CI, 1.332-7.343; P = 0.009), and a history of strokes or transient ischemic attacks (OR, 0.327; 95% CI, 0.166-0.642; P = 0.001). CONCLUSIONS: OACs were used much less frequently in the group with a high HAS-BLED score than in the group with a low score. Independent predictors of nonuse of OACs were creatinine levels, a history of gastrointestinal bleeding, and malignant neoplasms. A history of stroke or transient ischemic attack increased the chances of receiving therapy.

Elective cardioversion of atrial fibrillation is safe without transesophageal echocardiography in patients treated with non-vitamin K antagonist oral anticoagulants: Multicenter experience.

BACKGROUND: Current guidelines recommend electrical cardioversion (ECV) in patients with atrial fibrillation (AF) after at least 3 weeks of adequate non-vitamin K antagonist oral anticoagulant (NOAC) treatment without prior transesophageal echocardiography (TEE). However, in clinical practice in some centres, TEE is performed before ECV in patients with AF. The aim of the study was to evaluate prevalence of thromboembolic and hemorrhagic complications in patients with AF treated with NOACs and undergoing ECV without prior TEE. METHODS: This observational, multicentre study included consecutive patients with AF treated with NOACs who were admitted for ECV without prior TEE. Thromboembolic events and major bleeding complications were investigated during a 30-day follow-up. RESULTS: In the study group there were 611 patients, mean age was 66.3 ± 9.2 years, 40% were women. 52 (8.5%) patients had a low thromboembolic risk, 148 (24.2%) patients had an intermediate thromboembolic risk and 411 (67.2%) patients had a high thromboembolic risk. In the study group 253 (41.4%) patients were treated with rivaroxaban, 252 (41.2%) patients were treated with dabigatran and 106 (17.3%) patients were treated with apixaban. Reduced doses of NOACs were administered to 113 (18.9%) patients. In the entire study group, there were no thromboembolic events or major bleeding complications during the in-hospital stay and the 30-day follow-up. CONCLUSIONS: In this "real-world" study of AF patients treated with NOACs, it was proved that ECV is safe without a preceding TEE, regardless of the risk of thromboembolic complications and of the type of NOAC used.

Do Patients with Atrial Fibrillation and a History of Ischemic Stroke Overuse Reduced Doses of NOACs?-Results of the Polish Atrial Fibrillation (POL-AF) Registry.

BACKGROUND: The aim of our study was to assess if patients with AF (atrial fibrillation) and a history of ischemic stroke (IS) excessively receive reduced doses of NOACs (non-vitamin K antagonist oral anticoagulants). METHODS: The Polish AF (POL-AF) registry is a prospective, observational, multicenter study, including patients with AF from 10 cardiology hospital centers. In this study we focused on patients with IS in their past. RESULTS: Among 3999 patients enrolled in the POL-AF registry, 479 (12%) had a previous history of IS. Compared to patients without IS history, post-stroke subjects had a higher CHA2DS2-VASc score (median score 7 vs. 4, p < 0.05). Of these subjects, 439 (92%) had anticoagulation therapy, 83 (18.9%) were treated with a vitamin K antagonist (VKA), 135 (30.8%) with rivaroxaban, 112 (25.5%) with dabigatran, and 109 (24.8%) with apixaban. There were a significant number of patients after IS with reduced doses of NOACs (48.9% for rivaroxaban, 45.5% for dabigatran, and 36.7% for apixaban). In many cases, patients were prescribed reduced doses of NOACs without any indication for reduction (28.8% of rivaroxaban use, 56.9% of dabigatran use, and 60.0% of apixaban use-out of reduced dosage groups, p = 0.06). CONCLUSIONS: A significant proportion of AF patients received reduced doses of NOAC after ischemic stroke in a sizeable number of cases, without indication for dose reduction.

Association of Hyperuricemia with Impaired Left Ventricular Systolic Function in Patients with Atrial Fibrillation and Preserved Kidney Function: Analysis of the POL-AF Registry Cohort.

Hyperuricemia is associated with the risk of developing atrial fibrillation (AF) and heart failure. However, coexisting chronic kidney disease and certain cardiovascular drugs make it difficult to determine whether hyperuricemia is a risk factor or merely a marker of pathology. We retrieved data from the Polish Atrial Fibrillation (POL-AF) registry, which included consecutive patients hospitalized with AF from January to December, 2019. We included 829 patients (mean age: 72.7 ± 11.1 years) with data on serum uric acid (UA, mean: 6.56 ± 1.78 mg/dL) and estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2. We found that UA and ejection fraction (EF) were significantly correlated (r = −0.15, p < 0.05), but not EF and eGFR or eGFR and UA. A multiple regression analysis adjusted for age, body mass index, eGFR, and UA, showed that UA was significantly associated with a reduced EF (R2: 0.021; p < 0.001). The UA cut-off indicative of an EF < 40% was 6.69 mg/dL (AUC, area under the curve: 0.607; 95% CI: 0.554−0.660; p = 0.001). Among drugs known to effect UA concentrations, we found that only diuretics were used more frequently in patients with high UA (above the median) than in patients with low UA (77.5% vs. 67%, p < 0.001). Among patients that used diuretics, UA remained significantly correlated with EF. Thus, we showed that reduced EF was associated with UA in patients with AF and normal renal function, independent of eGFR and diuretic use.

Why Did All Patients with Atrial Fibrillation and High Risk of Stroke Not Receive Oral Anticoagulants? Results of the Polish Atrial Fibrillation (POL-AF) Registry.

BACKGROUND: Most atrial fibrillation (AF) patients are at high risk of thromboembolic, and the use of oral anticoagulants (OACs) is advised in such cases. The aim of the study was to evaluate the frequency at which OACs were used in patients with AF and high risk thromboembolic complications, and identify factors that result in OACs not being used in the researched group of patients. METHODS: The prospective, multicenter and non-interventional POL-AF registry is a study that includes AF patients from ten Polish cardiology centers. They were consecutively hospitalized between January and December of 2019. All the patients in the study were of high stroke risk. RESULTS: A total of 3614 patients with AF and high stroke risk were included. Among the total study population, 91.5% received OAC therapy; antiplatelet therapy was prescribed for 3.7% of patients, heparin for 2.7%, and 2.1% of patients did not receive any stroke prevention therapy. Independent predictors of no OAC prescription were intracranial bleeding (OR 0.15, 95%CI 0.07-0.35, p < 0.001), gastrointestinal bleeding (OR 0.25, 95%CI 0.17-0.37, p < 0.001), cancer (OR 0.37, 95%CI 0.25-0.55, p < 0.001), hospitalization due to acute coronary syndrome (OR 0.48, 95%CI 0.33-0.69, p < 0.001), and anemia (OR 0.62, 95%CI 0.48-0.81, p < 0.001). CONCLUSIONS: Most AF patients with a high thromboembolic risk received OACs. The factors predisposing a lack of OAC use in these patients were conditions that significantly increased the risk of bleeding complications.

Hyperuricemia as a Marker of Reduced Left Ventricular Ejection Fraction in Patients with Atrial Fibrillation: Results of the POL-AF Registry Study.

Background: Hyperuricemia is an established risk factor for cardiovascular disease, including atrial fibrillation (AF). The prevalence of hyperuricemia and its clinical significance in patients with already diagnosed AF remain unexplored. Methods: The Polish Atrial Fibrillation (POL-AF) registry includes consecutive patients with AF hospitalized in 10 Polish cardiology centers from January to December 2019. This analysis included patients in whom serum uric acid (SUA) was measured. Results: From 3999 POL-AF patients, 1613 were included in the analysis. The mean age of the subjects was 72 ± 11.6 years, and the mean SUA was 6.88 ± 1.93 mg/dL. Hyperuricemia was found in 43% of respondents. Eighty-four percent of the respondents were assigned to the high cardiovascular risk group, and 45% of these had SUA >7 mg/dL. Comparison of the extreme SUA groups (<5 mg/dL vs. >7 mg/dL) showed significant differences in renal parameters, total cholesterol concentration, and left ventricular ejection fraction (EF). Multivariate regression analysis showed that SUA >7 mg/dL (OR 1.74, 95% CI 1.32-2.30) and GFR <60 mL/min/1.73 m2 (OR 1.94, 95% CI 1.46-2.48) are significant markers of EF <40% in the study population. Female sex was a protective factor (OR 0.74, 95% CI 0.56-0.97). The cut-off point for SUA with 60% sensitivity and specificity indicative of an EF <40% was 6.9 mg/dL. Conclusions: Although rarely assessed, hyperuricemia appears to be common in patients with AF. High SUA levels may be a significant biomarker of reduced left ventricular EF in AF patients.

Symptomatic and Asymptomatic Patients in the Polish Atrial Fibrillation (POL-AF) Registry.

BACKGROUND: Atrial fibrillation (AF) can cause severe symptoms, but it is frequently asymptomatic. We aimed to compare the clinical features of patients with asymptomatic and symptomatic AF. METHODS: A prospective, observational, multicenter study was performed (the Polish Atrial Fibrillation (POL-AF) registry). Consecutive hospitalized AF patients over 18 years of age were enrolled at ten centers. The data were collected for two weeks during each month of 2019. RESULTS: A total of 2785 patients were analyzed, of whom 1360 were asymptomatic (48.8%). Asymptomatic patients were more frequently observed to have coronary artery disease (57.5% vs. 49.1%, p < 0.0001), heart failure with preserved ejection fraction (39.8% vs. 26.5%, p < 0.0001), a previous thromboembolic event (18.2% vs. 13.1%, p = 0.0002), and paroxysmal AF (52.3% vs. 45.2%, p = 0.0002). In multivariate analysis, history of electrical cardioversion, paroxysmal AF, heart failure, coronary artery disease, previous thromboembolic event, and higher left ventricular ejection fraction were predictors of a lack of AF symptoms. First-diagnosed AF was a predictor of AF symptoms. CONCLUSIONS: In comparison to symptomatic patients, more of those hospitalized with asymptomatic AF had been previously diagnosed with this arrhythmia and other cardiovascular diseases. However, they presented with better left ventricular function and were more frequently treated with cardiovascular medicines.

Characteristics and Treatment of Atrial Fibrillation with Respect to the Presence or Absence of Heart Failure. Insights from the Multicenter Polish Atrial Fibrillation (POL-AF) Registry.

BACKGROUND: We aimed to assess characteristics and treatment of AF patients with and without heart failure (HF). METHODS: The prospective, observational Polish Atrial Fibrillation (POL-AF) Registry included consecutive patients with AF hospitalized in 10 Polish cardiology centers in 2019-2020. RESULTS: Among 3999 AF patients, 2822 (71%) had HF (AF/HF group). Half of AF/HF patients had preserved ejection fraction (HFpEF). Compared to patients without HF (AF/non-HF), AF/HF patients were older, more often male, more often had permanent AF, and had more comorbidities. Of AF/HF patients, 98% had class I indications to oral anticoagulation (OAC). Still, 16% of patients were not treated with OAC at hospital admission, and 9%-at discharge (regardless of the presence of HF and its subtypes). Of patients not receiving OAC upon admission, 61% were prescribed OAC (most often apixaban) at discharge. AF/non-HF patients more often converted from AF at admission to sinus rhythm at discharge compared to AF/HF patients (55% vs. 30%), despite cardioversion performed as often in both groups. Class I antiarrhythmics were more often prescribed in AF/non-HF than in AF/HF group (13% vs. 8%), but still as many as 15% of HFpEF patients received them. CONCLUSIONS: Over 70% of hospitalized AF patients have coexisting HF. A significant number of AF patients does not receive the recommended OAC.

Antithrombotic therapy in patients with atrial fibrillation undergoing percutaneous coronary intervention, including compliance with current guidelines-data from the POLish Atrial Fibrillation (POL-AF) Registry.

BACKGROUND: Although triple antithrombotic therapy (TAT) is recommended in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), guidelines allow an option of dual antithrombotic therapy (DAT). This study assesses the everyday practice of 10 cardiology departments in antithrombotic therapy in AF patients undergoing PCI and its agreement with current guidelines. METHODS: This analysis included medical data of AF patients enrolled in the prospective, observational registry (The POLish Atrial Fibrillation-POL-AF) that underwent PCI [elective or due to acute coronary syndrome (ACS)]. RESULTS: Of the 3,999 consecutive subjects included, a final analysis was performed on 359 patients that underwent PCI: 148 with urgent PCI due to ACSand 211 patients with elective PCI. Eighty patients in the ACS-group and 120 patients in the elective-PCI group were treated with TAT, although guidelines also allowed DAT. Of 316 patients treated with oral anticoagulants as a part of combination therapy, 275 were on non-vitamin K antagonist oral anticoagulant (NOAC). Reduced doses of NOAC were used in 74 patients treated with rivaroxaban, 60 patients with dabigatran, and 54 patients with apixaban. The proportion of patients treated with reduced NOAC doses adequately to the guidelines was 29%, 100%, and 33% for rivaroxaban, dabigatran, and apixaban, respectively. Inappropriate low doses of NOACs were used in 71% of subjects on rivaroxaban and 67% on apixaban. CONCLUSIONS: In patients with AF undergoing PCI, NOACs are definitely preferred over vitamin-K antagonists (VKAs) in TAT/DAT, and an aggressive antithrombotic strategy with TAT is frequently chosen even if DAT is permissible by the guidelines. Label adherence of using reduced NOAC dose during combination therapy is not satisfactory for apixaban and rivaroxaban and probably results from too cautious an approach to the known indications for reduced therapy. The study is registered in the database Clinical Trials-NCT04419012.

Trends in the Prescription of Non-Vitamin K Antagonist Oral Anticoagulants for Atrial Fibrillation: Results of the Polish Atrial Fibrillation (POL-AF) Registry.

BACKGROUND: Current guidelines do not suggest in which groups of patients with atrial fibrillation (AF) individual non-vitamin K antagonist oral anticoagulants (NOACs) should be used for the prevention of thromboembolic complications. The aim of this study was to evaluate the frequency of use of apixaban, dabigatran, and rivaroxaban, and attempt to identify factors predisposing their administration. METHODS: The Polish Atrial Fibrillation (POL-AF) registry is a prospective, non-interventional study, including consecutive patients with AF hospitalized in ten Polish cardiology centers during the period ranging from January to December 2019. In this study, all patients were treated with NOACs. RESULTS: Among the 2971 patients included in the analysis, 40.4% were treated with rivaroxaban, 32% with apixaban, and 27.6% with dabigatran. The mean age of the total population was 72 ± 11.5 years and 43% were female. A reduced dose of NOAC was used in 35% of patients treated with apixaban, 39.7% of patients treated with dabigatran, and 34.4% of patients treated with rivaroxaban. Independent predictors of the use of apixaban were previous bleeding (OR 2.37, CI 1.67­3.38), GFR < 60 mL/min (OR 1.38, CI 1.25­1.64), heart failure (OR 1.38, CI 1.14­1.67) and age (per 5 years) (OR 1.14, CI 1.09­1.19). GFR < 60 mL/min (OR 0.79, CI 0.66­0.95), female (OR 0.8, CI 0.67­0.96) and age (per 5 years) (OR 0.95, CI 0.91­0.99) diminished the chance of using dabigatran. Previous bleeding (OR 0.43, CI 0.28­0.64), vascular disease (OR 0.84, CI 0.70­0.99), and age (per 5 years) (OR 0.94, CI 0.90­0.97) diminished the chance of choosing rivaroxaban. CONCLUSIONS: In hospitalized patients with AF, the most frequently chosen NOAC was rivaroxaban. Apixaban was chosen more often in patients after bleeding, and in those who were advanced in years, with heart failure and impaired renal function. Impaired renal function and female gender were factors that diminished the chance of using dabigatran. Previous bleeding and vascular disease was the factor that diminished the chance of using rivaroxaban. Dabigatran and rivaroxaban have been used less frequently in elderly patients.

Evaluation of the recommended prevention of thrombosis in hospitalised patients with atrial fibrillation and high thromboembolism risk.

BACKGROUND: According to the applicable guidelines for stroke prevention, patients with a high risk of thromboembolic com-plications should receive oral anticoagulants. AIM: The objective of the present study is to evaluate the prevention of thrombosis in patients with diagnosed atrial fibrillation (AF) on discharge and a high risk of stroke. METHODS: The present study is a retrospective single-centre registry. The analysis was carried out on the basis of the data on 4099 patients with non-valvular AF, who were discharged from the cardiology department in the years 2004-2012. 276 (67.3%) of those patients were reported to have a high thromboembolism risk. RESULTS: Oral anticoagulants in monotherapy or in combination were administered to 65% of patients with AF and high risk of stroke. Oral anticoagulants were recommended for 69.7% of patients with a low risk of bleeding and 59.3% of patients with a high risk of bleeding. The number of patients treated with oral anticoagulants within nine years of analysis was increasing: 61.7% in the years 2004-2006, 63.3% in the years 2007-2010, and 71.5% in the years 2011-2012. Factors that affected a decision to not introduce oral anticoagulants in patients with AF and high risk of stroke were hospitalisation in the years 2004-2006 (hazard ratio [HR] 0.72), high risk of bleeding (HR 0.70), vascular disease (HR 0.68), age ≥ 80 years (HR 0.52), history of bleeding (HR 0.55), and paroxysmal AF (HR 0.51). CONCLUSIONS: Oral anticoagulants were indicated on discharge for 2/3 of patients with AF and high risk of stroke, and more often in patients with low risk of bleeding events. An increase in the number of indications for oral anticoagulation has been observed in the past nine years. The factors which led to no use of oral anticoagulation among AF patients with high stroke risk were: hospitalisation in the years 2004-2006, high risk of bleeding, vascular disease, age ≥ 80 years, paroxysmal AF, and previous bleeding.