BackgroundAtrial fibrillation is associated with higher mortality. Identification of causes of death and contemporary risk factors for all‐cause mortality may guide interventions.Methods and ResultsIn the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) study, patients with nonvalvular atrial fibrillation were randomized to rivaroxaban or dose‐adjusted warfarin. Cox proportional hazards regression with backward elimination identified factors at randomization that were independently associated with all‐cause mortality in the 14 171 participants in the intention‐to‐treat population. The median age was 73 years, and the mean CHADS 2 score was 3.5. Over 1.9 years of median follow‐up, 1214 (8.6%) patients died. Kaplan–Meier mortality rates were 4.2% at 1 year and 8.9% at 2 years. The majority of classified deaths (1081) were cardiovascular (72%), whereas only 6% were nonhemorrhagic stroke or systemic embolism. No significant difference in all‐cause mortality was observed between the rivaroxaban and warfarin arms (P=0.15). Heart failure (hazard ratio 1.51, 95% CI 1.33–1.70, P<0.0001) and age ≥75 years (hazard ratio 1.69, 95% CI 1.51–1.90, P<0.0001) were associated with higher all‐cause mortality. Multiple additional characteristics were independently associated with higher mortality, with decreasing creatinine clearance, chronic obstructive pulmonary disease, male sex, peripheral vascular disease, and diabetes being among the most strongly associated (model C‐index 0.677).ConclusionsIn a large population of patients anticoagulated for nonvalvular atrial fibrillation, ≈7 in 10 deaths were cardiovascular, whereas <1 in 10 deaths were caused by nonhemorrhagic stroke or systemic embolism. Optimal prevention and treatment of heart failure, renal impairment, chronic obstructive pulmonary disease, and diabetes may improve survival.Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00403767.
Aim To study features of diagnosis and treatment of acute myocardial infarction (AMI) in Russian hospitals, results of the treatment, and early and late outcomes (6 and 12 months after AMI diagnosis); to evaluate the consistence of the treatment with clinical guidelines; and to evaluate patients’ compliance with the treatment.Material and methods The program was designed for 3 years, including 24 months for recruitment of patients to the study. The study will include 10, 000 patients hospitalized with a confirmed diagnosis (I21 according to ICD-10) of ST segment elevation acute myocardial infarction (MI) (STEMI) or non-ST segment elevation MI (NSTEMI) based on criteria of the European Society of Cardiology Guidelines on Forth Universal Definition of Myocardial Infarction (2018). The follow-up period was divided into three stages: observation during the stay in the hospital and at 6 and 12 months following inclusion into the registry. The primary endpoint included cardiac death, nonfatal MI during the hospitalization and after one-year follow-up. Secondary endpoints were 6-months and one-year incidence of repeated MI, heart failure, ischemic stroke, clinically significant hemorrhage, unscheduled revascularization after discharge from the hospital, and the proportion of patients who continue on statins, antiplatelet drugs, and drugs of other groups for 6 months and 1 year.Results The inclusion of patients into the registry started in 2020 and will continue for 24 months. By the time of the article publication (June, 2021), more than 2,000 patients will be included.Conclusion REGION-MI (Russian rEGIstry Of acute myocardial iNfarction) is a multicenter, retrospective and prospective observational cohort study that excludes any interference with the clinical practice. Results of the registry will help to analyze a real picture of medical care provided to patients with myocardial infarction and to schedule ways to improve the situation.
Aim To study specific features of the parenteral anticoagulant therapy for acute myocardial infarction (MI) in the Russian Federation and to evaluate the consistency of the prescribed parenteral anticoagulant therapy with the effective clinical guidelines.Material and methods REGION-MI, the Russian rEGIstry for acute myOcardial iNfarction, is a multicenter observational study. This registry includes all patients admitted to hospitals with a documented diagnosis of ST-elevation acute MI (STEMI) and non-ST-elevation acute MI (NSTEMI) based on the criteria of the Forth Universal Definition of MI of the European Society of Cardiology. Risk of bleeding was assessed with the Academic Research Consortium for High Bleeding Risk (ARC-HBR) scale, and risk of major bleeding in patients with NSTEMI was additionally assessed with the CRUSADE scale.Results From November 01, 2020 through April 03, 2022, 5025 patients were included into the REGION-MI registry. At primary vascular departments, 70.5% of patients were administered unfractionated heparin (NFH); at regional vascular centers, 37.1 % of patients were administered NFH, 29.6 % enoxaparin, 20,2% NFH in combination with enoxaparin, 6.8 % fondaparinux, 4.2 % NFH in combination with fondaparinux, and 1.9 % nadroparin. At the prehospital stage, NFH was used as an anticoagulant support for the thrombolytic therapy (TLT) in 84% of patients, and low-molecular heparins (LMH) were used in 16 %. At the hospital stage, UFH was administered to 64.4 % of patients, and enoxaparin was administered to 23.9 % of patients. Among the patients who had undergone primary percutaneous coronary intervention (PCI), 40 % received NFH, 25 % enoxaparin, 22 % NFH in combination with enoxaparin, 7 % fondaparinux, and 4 % NFH in combination with fondaparinux. In conservative and invasive tactics of therapy for NSTEMI, NFH was also administered more frequently (43 and 43 %, respectively), followed by (according to frequency of administration) enoxaparin (36 and 34 %, respectively), NFH in combination with enoxaparin (10 and 16 %, respectively), fondaparinux (7 and 6 %, respectively), and NFH in combination with fondaparinux (3 and 1 %, respectively).Conclusion According to the Russian registry of acute MI, REGION-MI, with all strategies for the treatment of MI, parenteral anticoagulants are not prescribed in full consistency with clinical guidelines. The most frequently used parenteral anticoagulant is NFH. Despite the high efficacy and safety of fondaparinux, the frequency of its administration remains unjustifiably low not only in the Russian Federation but also in other countries. The same can be said about the administration of enoxaparin to patients who had received TLT. Attention should be paid to physicians’ awareness of recent clinical guidelines, to minimize the prehospital treatment with parenteral anticoagulants, to limit this treatment to the TLT support, and to provide continuity between all stages of medical care.
Aim Improvement of quality of life is one of the most important goals for the treatment of patients with chronic heart failure (CHF). This study searched for ways to increase the efficiency of CHF treatment based on parameters of quality of life in CHF patients during and after the treatment with exogenous phosphocreatine (EP).Material and methods The effect of a single course of EP treatment on quality of life of patients with functional class (FC) II-IV CHF with reduced or mid-range left ventricular ejection fraction was studied as a part of the all-Russia prospective observational study BYHEART. The presence of FC II-IV CHF and a left ventricular ejection fraction <50 % were confirmed by results of 6-min walk test (6MWT) and findings of echocardiography after stabilization of the background therapy.Results An interim data analysis showed that the course of EP treatment was associated with a significant improvement of quality-of-life indexes as determined by the Minnesota Living with Heart Failure Questionnaire (LHFQ) total score. These indexes significantly increased and remained at a satisfactory level for 6 mos. following completion of the treatment course. Also, the treatment significantly beneficially influenced the clinical condition of patients (heart failure severity scale), results of 6MWT, and the increase in left ventricular ejection fraction.Conclusion The conclusions based on results of the interim analysis should be confirmed by results of the completed study. Complete results are planned to be published in 2022.
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