Dabigatran for stroke prevention in real life in a sample of population from Turkey: D-SPIRIT registry.

OBJECTIVE: The D-SPIRIT registry is designed to investigate the safety and effectiveness of dabigatran etexilate in patients with atrial fibrillation in routine clinical practice. METHODS: D-SPIRIT is the first national, multicenter, prospective, observational, postmarketing registry that investigates the usage of dabigatran in real life. A total of 326 noveloral anticoagulant-eligible patients with atrial fibrillation who have been taking dabigatran etexilate therapy for stroke prevention at least 6 months from 9 different centers were enrolled into the registry. Patients were followed up for 2 years to evaluate the effectiveness and safety of the treatment. All adverse clinical events including bleeding, thromboembolic events, stroke, systemic embolism, transient ischemic attack, myocardial infarction, and all-cause death were recorded. RESULTS: The mean age was 71.1±9.6 years, and 57.4% of the study participants were female. The mean CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke or transient ischemic attack [TIA], vascular disease, age 65-74 years, sex category) score was 3.4±1.6. The cumulative adverse clinical events rate was 6.30% per year. The rate for embolic events including TIA, ischemic stroke, and peripheral embolism was 1.26% per year. The rate for major bleeding was 2.20% per year, and the mortality rate was 0.94% per year. CONCLUSION: This registry obtained an important overview of the current safety and effectiveness of the dabigatran etexilate in Turkey. Our results indicate similar rates of thromboembolic and bleeding events with pivotal phase 3 trial and other real-life registries. However, rate of undertreatment usage of dabigatran etexilate in real life was found to be considerable.

Heart failure with preserved ejection fraction, atrial fibrillation, and increased NT­proBNP levels : An emergent clinical dilemma.

BACKGROUND: The co-presence of atrial fibrillation (AF) in patients with heart failure with preserved ejection fraction (HFpEF) may cause some diagnostic difficulties, because AF itself is associated with elevated levels of N­terminal pro-B-type natriuretic peptide (NT-proBNP). In the present study we aimed to investigate NT-proBNP levels of patients with HFpEF and AF. METHODS: This was a retrospective cohort study. Outpatient data were reviewed through the hospital data management system. Consecutive patients with the diagnosis of HFpEF and AF, who had at least one NT-proBNP measurement, were included in the study. RESULTS: The study population comprised 235 patients. Median NT-proBNP levels were 1242 pg/ml in the stable phase and 2321.5 pg/ml during decompensation. NT-proBNP was correlated positively with age, CHA2DS2 and CHA2DS2VASc scores, left atrial diameter (LAD), tricuspid annulus diameter, and systolic pulmonary artery pressure but negatively correlated with left ventricular ejection fraction (LVEF) and hemoglobin level. The change in NT-proBNP was positively correlated with heart rate and LAD. CONCLUSION: Patients with HFpEF and AF have higher levels of NT-proBNP, which may exceed the upper limits defined in guidelines. This study underlines the importance of measuring NT-proBNP levels in the stable phase and proposes a rule-in level for the decompensated phase.

Clinical characteristics and in-hospital outcomes of acute decompensated heart failure patients with and without atrial fibrillation.

OBJECTIVE: Atrial fibrillation (AF) and heart failure (HF) are common cardiovascular diseases. The impact of AF on in-hospital outcomes in acute decompensated heart failure (ADHF) is controversial. The aim of this study is to determine the prevalence of AF among hospitalized patients with ADHF and describe the clinical characteristics and in-hospital outcomes of these patients with and without AF. METHODS: We examined the multicenter, observational data from the real-life data of hospitalized patients with HF: Journey HF-TR study in Turkey that studied the clinical characteristics and in-hospital outcomes of hospitalized patients with ADHF between September 2015 and September 2016. RESULTS: Of the 1,606 patients hospitalized with ADHF, 626 (39%) had a history of AF or developed new-onset AF during hospitalization. The patients with AF were older (71±12 vs. 65±13 years; p<0.001) and more likely to have a history of hypertension, valvular heart disease, and stroke. The AF patients were less likely to have coronary artery disease and diabetes. In-hospital adverse event rates and length of in-hospital stay were similar in ADHF patients, both with and without AF. In-hospital all-cause mortality rate was higher in patients with AF than in patients without AF, although the difference was not statistically significant (8.9% vs. 6.8%; p=0.121). CONCLUSION: AF has been found in more than one-third of the patients hospitalized with ADHF, and it has varied clinical features and comorbidities. The presence of AF is not associated with increased adverse events or all-cause mortality during the hospitalization time.

Resistant hypertension in elderly: a clinical manifestation of heart failure with preserved ejection fraction? retrospective single-center analysis.

Background: Resistant hypertension (RHT) is defined as high blood pressure despite three antihypertensive medications one being a diuretic. RHT is a common clinical problem and as a subgroup has not been studied widely. The present study has investigated patient demographics and if the RHT might be a clinical presentation of heart failure with preserved ejection fraction (HFPEF) in elderly. Method: The outpatient data between January and June 2015 of Izmir Kemalpasa State hospital's hypertension specialty clinic has been reviewed retrospectively. The patients with pseudo-RHT are excluded. Among 957 patients, 68 patients have been identified as true RHT with a left ventricle ejection fraction ≥50%. HFPEF is defined according to the latest guideline. Instead of a common cut-off level for NT-proBNP, age and gender-related cut-off levels have been used. Results: The mean age was 63.24 ± 12.05 years. Among 68 patients, 49 were female. While only 3 patients in younger group (8.8%) had elevated levels of NT-proBNP, 22 of older RHT patients (64.7%) had high levels. NT-proBNP levels were disproportionally high in elderly (p < 0.001) and high levels in RHT patients were related to a larger left atrial diameter (p < 0.001). Conclusion: The underlying mechanism might be different in RHT according to age. Hypervolemia might be the key factor in older RHT patients but not in younger patients. The current study suggests RHT in elderly can be a clinical presentation of HFPEF, and they should be investigated and treated accordingly. Because of single-center results and limited patients, further studies are needed.

Design and rationale of dabigatran's stroke prevention in real life in Turkey (D-SPIRIT).

OBJECTIVE: The D-SPIRIT registry is designed to investigate the safety and efficacy of dabigatran etexilate in patients with nonvalvular atrial fibrillation (NVAF) and to collect data on outcomes in clinical practice. METHODS: The D-SPIRIT is a national, prospective, observational, post-marketing registry involving patients with NVAF who have been taking dabigatran etexilate therapy for stroke prevention for a minimum of 6 months prior to enrollment. The registry will collect and analyze data from routine care, enrolling up to 600 patients in 9 centers. Patients will be followed up for 2 years to evaluate effectiveness and safety. A sample size of 600 subjects is proposed based on the following assumptions; Two-sided significance level of 0.05 (1-sided significance level of 0.025), ischemic stroke incidence rate of 0.768%-1.111%, hemorrhagic stroke incidence rate of 0.109%-0.130%, transient ischemic attack incidence rate of 0.722%-0.623%, therapy discontinuation incidence rate of 40% at day 730, and duration of enrollment period of 12 months with non-uniformed enrollment rate. Ethics approval was given by Dokuz Eylül University Ethics Committee of Clinical Research (2014/54) and approved by the Turkish Ministry of Health. CONCLUSION: Potential results of D-SPIRIT registry will add data from clinical practice to those from the RE-LY trial to expand knowledge of dabigatran etexilate treatment in patients with NVAF.