A new dosage form of lappaconitine hydrobromide has been created – the long-acting drug Allaforte®, which has fewer side effects compared to the traditional dosage form (Allapinin®). Objective. To evaluate the effectiveness, safety and tolerability of Allaforte® therapy in comparison with the drug Rytmonorm® in patients with paroxysmal atrial fibrillation (AF). Material and methods. Patients who met the inclusion criteria and those who did not meet the non-inclusion criteria were randomized into 2 groups: 1st (n=50) – patients received Allaforte® 25 mg 3 times a day with an increase in dose to 50 mg 2 times a day when detected attack of AF; 2nd (n=50) – patients received Rytmonorm® 150 mg 3 times a day with an increase in dose to 300 mg 2 times a day if an attack of AF was detected. Results. The average time from the first dose of the drug to the development of AF paroxysm in the 1st group (Allaforte®) was 98.877±6.022 days, in the 2nd group (Rytmonorm®) – 98.808±5.876 days, the average time from the first dose of the drug to the completion of the study – 105.740±5.032 and 103.732±5.353 days, respectively. The drugs Allaforte® and Rytmonorm® equally improved the quality of life of patients. A comparative analysis in groups according to the severity of adverse events and their cause-and-effect relationship with the drug did not show significant differences. Conclusion. The study drugs showed comparable effectiveness in preventing attacks of AF with similar safety and tolerability.
© Коллектив авторов, 2019 терапии. Обязательным элементом любых катетерных вмешательств является транссосудистый доступ, включающий в себя пункцию бедренных и, реже, подключичных, кубитальных или яремных вен. В настоящее время для внутрисосудистого доступа обычно пунктируют правую и/или левую бедренные вены [1]. Как известно, любое катетерное вмешательство сопряжено с определенным риском осложнений со стороhttps://doi.org/10.17116/Cardiobulletin20191401112
AIM:to compare two anticoagulant therapy (ACT) regimens in the treatment of venous thrombosis (VT) in patients after catheter interventions - electrophysiological studies (EFIs) and ablations: enoxaparin followed by warfarin, and rivaroxaban monotherapy.MATERIALS AND METHODS:The study included patients from 18 years and older with heart rhythm disorders and planned catheter ablation. When parietal venous thrombosis (VT) were detected at the femoral vein puncture site, all patients were randomly assigned to two treatment groups. In group I enoxaparin 1 mg/kg was prescribed every 12 hours with switching to warfarin after 7 days with maintenance of the target INR values (2.0-3.0). In group II rivaroxaban therapy was started at a dose of 15 mg twise/day for 21 days with a further transition to a dose of 20 mg/day. The total period of observation and treatment of patients was at least 3 months.RESULTS:408 patients were observed, 42 (10.3%) patients with parietal VT were divided into two treatment groups. In group I (n=16) complete lysis of VT was noted by the 7th day of treatment in 7 (58.3%) patients, however this scheme was associated with a greater risk of complications (р=0.003) at the puncture site in the form of arteriovenous fistulae (n=1; 8.3%) and intermuscular hematomas (n=4; 25%). In group II (n=26), no complications were noted, the lysis time of VT was on average 21 days (n=18; 69.2%). Complete lysis of VT was noted in both groups at the time of the control observation point (3rd month).CONCLUSION:The efficiency of the two VT treatment regimens was comparable. Enoxaparin therapy is associated with a high risk of local complications, namely intermuscular hematomas (n=4; 25%) and arteriovenous fistulas (n=1; 8.3%). Rivaroxaban monotherapy is safer (p=0.003); in Group II none of the patients had any complications.
Rationale: Thrombosis of the puncture site in the femoral veins is one of the potentially dangerous complications of intracardial catheter interventions associated with thromboembolic risk related to its proximal location. According to the literature, the incidence of symptomatic venous thrombosis (VT) is 1–3%. No special studies on the assessment of risk factors for this complication, its diagnosis and treatment have been conducted.Aim: To study the incidence, risk factors and special aspects of VT diagnosis in patients undergoing intracardial electrophysiological studies (EFI) and/or catheter ablation.Materials and methods: This prospective study included 408 patients (194 men and 214 women, with median age of 51±10.1 years), who were admitted to the hospital with various cardiac rhythm disorders for intracardial EFIs and/or catheter ablations from 2016 to 2018. Before the interventions, in addition to common laboratory and instrumental work-up, all the patients underwent ultrasound duplex scanning (USDS) of the iliac-femoral segment; in 269 patients the level of D-dimer was measured. Latest at 24 hours after the intervention, all patients underwent a control ultrasound scan of the femoral vein puncture site. In case of VT occurrence anticoagulant therapy was started in all patients and they were followed up till complete VT resolution and at least for 3 months (the study endpoint). The VT incidence and its risk factors including the prognostic value of D-dimer levels were evaluated.Results: The VT incidence after catheter interventions was 11.7% (n=48). There was a significant correlation between VT occurrence and such risk factors as diabetes mellitus (p=0.001) and obesity (p<0.001). No association between elevated baseline D-dimer values (>500 ng/mL) and subsequent VT development was found (p>0.05). The quartile analysis revealed an association between baseline D-dimer levels exceeding 434 ng/mL (which corresponds to the range of 75 to 100%) and the presence of the following risk factors: age over 65 years (p<0.001), female gender (p=0.001), arterial hypertension (p=0.003), chronic coronary heart disease (p=0.044).Conclusion: In this study, all VTs (11.7%) detected after catheter transvenous interventions by USDS were asymptomatic. VTs were most frequent in patients with diabetes mellitus and obesity. D-dimer had no predictive value in the development of VT; however, its increased baseline values were more common in women, patients over 65 years, and in patients with arterial hypertension and chronic coronary heart disease.