A new approach to ticagrelor-based de-escalation of antiplatelet therapy after acute coronary syndrome. A rationale for a randomized, double-blind, placebo-controlled, investigator-initiated, multicenter clinical study

© 2021 Via Medica. This article is available in open access under Creative Common Attribution-Non-Commercial-No Derivatives 4.0 International (CC BY-NC-ND 4.0) license. https://creativecommons.org/licenses/by/4.0/The risk of ischemic events gradually decreases after acute coronary syndrome (ACS), reaching a stable level after 1 month, while the risk of bleeding remains steady during the whole period of dual antiplatelet treatment (DAPT). Several de-escalation strategies of antiplatelet treatment aiming to enhance safety of DAPT without depriving it of its efficacy have been evaluated so far. We hypothesized that reduction of the ticagrelor maintenance dose 1 month after ACS and its continuation until 12 months after ACS may improve adherence to antiplatelet treatment due to better tolerability compared with the standard dose of ticagrelor. Moreover, improved safety of treatment and preserved anti-ischemic benefit may also be expected with additional acetylsalicylic acid (ASA) withdrawal. To evaluate these hypotheses, we designed the Evaluating Safety and Efficacy of Two Ticagrelor-based De-escalation Antiplatelet Strategies in Acute Coronary Syndrome — a randomized clinical trial (ELECTRA-SIRIO 2), to assess the influence of ticagrelor dose reduction with or without continuation of ASA versus DAPT with standard dose ticagrelor in reducing clinically relevant bleeding and main-taining anti-ischemic efficacy in ACS patients. The study was designed as a phase III, randomized, multicenter, double-blind, investigator-initiated clinical study with a 12-month follow-up.Peer reviewedFinal Published versio

Antiarrhythmic drugs for pharmacological cardioversion of atrial fibrillation and sex differences: Insights from the CANT II Study

Background: Data on sex differences in terms of action of antiarrhythmic agents (AADs) are limited. This study aimed to evaluate the clinical profile of patients with atrial fibrillation (AF), and efficacy and safety of AADs used for pharmacological cardioversion (PCV) of AF.Methods: This research was a sub-analysis of the retrospective multicenter Cardioversion with ANTazoline II (CANT) registry, which comprised 1365 patients with short-duration AF referred for urgent PCV with the use of AAD. Patients were categorized according to and compared in terms of clinical parameters and PCV outcomes. The primary endpoint was return of sinus rhythm within 12 hours after drug infusion, and the composite safety endpoint involved bradycardia <45 bpm, hypotension, syncope, or death.Results: The sex distribution of patients qualified for PCV was even (men, n = 725; 53.1%). Females were older and more symptomatic and had higher CHA2DS2-VASc scores, higher prevalence of tachyarrhythmia, and higher use of chronic anticoagulation. The overall efficacy (71.4% vs. 70.1%; P = 0.59) and safety (5.2% vs. 4.6%; P = 0.60) of PCV was comparable in men and women. Amiodarone (68.3% vs. 65.9%; P = 0.66) and antazoline (77.1% vs. 80.0%; P = 0.19) had similar efficacy in men and women, but propafenone had a lower rate of rhythm conversion in men (64.7% vs. 79.3%; P = 0.046). None of the assessed AADs differed in terms of safety profile in both sexes.Conclusion: Female patients with AF have different clinical profiles but similar efficacy and safety of AADs as compared to male participants. Propafenone has significantly lower efficacy in men, which requires further investigation

Large endometriosis – case report

Endometriosis develops in about 10% of women in their fertile age, it is estrogen-dependent and is an important clinical problem. The main symptoms are: chronic pain of the minor pelvis, dysmenorrhea, and dyspareunia, with about 50% of patients being infertile; relapses of the disease are frequent. There are many theories linked to the etiopathogenesis: 1) implantation of the endometrium through salpinges to the abdominal cavity and organs located in the minor pelvis, 2) local immunodeficiency, 3) changes in cellular adhesion and cytokine profile, 4) environmental factors, 5) angiogenesis disorders, 6) genetic predispositions. In our report, we described a case of a patient, age 46, nullipara. The patient’s examination revealed a mass that was palpable in the abdomen and could be felt up to the level of four fingers below the navel. Serum CA-125 was 40.4 U/mL. The ultrasound examination per rectum showed a slightly enlarged uterus with normal endometrium, the right ovary without any pathological changes, and the left ovary changed into a cyst of 15 centimeters in diameter with the superior border not clearly visible. Typical clinical symptoms for endometriosis, like persistent pain in the abdomen, flatulence, bloating, dysmenorrhea, urinary incontinence were not observed in that patient. Surgery was performed in which 1000 mL of fluid were evacuated from the endometrial cyst.Endometrioza rozwija się u około 10% kobiet, głównie w wieku rozrodczym, jest chorobą estrogenozależną i stanowi istotny problem kliniczny. Dominującymi objawami są: przewlekły ból w miednicy mniejszej, bolesne miesiączkowanie i współżycie płciowe, a około 50% kobiet jest niepłodnych; często występują nawroty choroby. Istnieje wiele teorii związanych z jej etiopatogenezą: 1) implantacja endometrium poprzez jajowody do jamy otrzewnej i narządów miednicy mniejszej, 2) osłabienie układu immunologicznego (głównie lokalnego), 3) zmiany w adhezji komórkowej, profilu cytokin, macierzy komórkowej, 4) czynniki środowiskowe, 5) zaburzenia w procesie angiogenezy, 6) predyspozycje genetyczne. W pracy opisano przypadek 46-letniej pacjentki, nieródki. W badaniu palpacyjnym brzucha stwierdzono opór sięgający cztery palce poniżej pępka. Poziom CA-125 w osoczu wynosił 40,4 U/ml. Badanie ultrasonograficzne per rectum wykazało macicę nieco powiększoną z linijnym endometrium, jajnik prawy prawidłowej wielkości, lewy zmieniony w około 15-centymetrową torbiel, której górny biegun nie był dokładnie widoczny. U pacjentki nie występowały typowe objawy kliniczne dla endometriozy, takie jak pobolewanie, bolesne miesiączki czy też nietrzymanie moczu. Przeprowadzono zabieg operacyjny, w którym ewakuowano 1000 ml płynu z torbieli

Ulipristal acetate in the treatment of uterine fibroids – a bridge between pharmacology and surgery

Myomas are a common cause of infertility and miscarriages. Their pathogenesis is muftifactorial. It includes sex-hormones and their receptors, change of expression of cytokines and growth factors as well as epigenetics. Sex-hormones, mainly estrogens, play a key role in the development of myomas, which can be observed by their development in the fertility period and their regression during menopause. Other research has shown that myomas can be hereditary. The clinical symptoms of myomas vary depending on their localization and size. Submucosal myomas may cause massive menstrual bleeding and may be the cause of anemia. Enlarged myomas can be the source of pain and pressure symptoms within the pelvis; they may also be responsible for infertility and miscarriages. There are many options for the treatment of myomas – uterine artery embolization, operative myomectomy or pharmacological treatment (gonadoliberin analogues, anti-estrogens and antiprogestagens). With more treatment options available, clinical decisions are harder. A new drug – ulipristal acetate – has been registered for the preoperative treatment of uterine fibroids. It is already present in more than 30 countries, registered as Esmya, Inisia or Fibristal. The first reports of pregnancies after using this drug have been described. The article presents a case of a 30-year-old woman, gravida 0, para 0, who was admitted for myomectomy. A three-month Esmya treatment was administered followed by a successful myomectomy – we present the results of this treatment.Mięśniaki są jedną z najczęstszych przyczyn niepłodności i poronień. Z patogenezą tych łagodnych nowotworów wiąże się wiele czynników – przede wszystkim hormony płciowe i ich receptory, zmiany ekspresji pewnych cytokin i czynników wzrostu oraz czynniki genetyczne. Hormony płciowe, zwłaszcza estrogeny, odgrywają kluczową rolę w rozwoju mięśniaków, o czym świadczy ich rozwój w okresie rozrodczym kobiet i regresja w menopauzie. Inne badania wykazały, że mięśniaki mogą być dziedziczne. Objawy kliniczne są różne, zależą od lokalizacji i rozmiaru guza. Mięśniaki podśluzówkowe mogą powodować masywne krwawienia miesiączkowe i być przyczyną niedokrwistości, zaś powiększone mięśniaki bywają źródłem bólu i uczucia ucisku w obrębie miednicy. Istnieje wiele możliwości leczenia mięśniaków: embolizacja tętnic macicznych, zabieg miomektomii, leczenie farmakologiczne (analogi gonadoliberyny, antyestrogeny i antyprogestageny). Ze względu na rosnącą liczbę opcji terapeutycznych decyzje kliniczne dotyczące rodzaju leczenia stają się coraz trudniejsze. Octan uliprystalu został zarejestrowany w leczeniu przedoperacyjnym mięśniaków macicy. Jest już dostępny w ponad 30 krajach, występuje pod nazwami Esmya, Inisia czy Fibristal. Opublikowano pierwsze doniesienia o porodach po leczeniu tą nową substancją. W artykule przedstawiono przypadek 30-letniej nieródki, u której po trzymiesięcznym leczeniu octanem uliprystalu udało się wykonać całkowitą miomektomię

Using Thermal Monitoring and Fibre Optic Measurements to Verify Numerical Models, Soil Parameters and to Determine the Impact of the Implemented Investment on Neighbouring Structures

Numerical modelling using Finite Element Method (FEM) is currently a standard procedure for engineering complex structures and determining structure–subsoil cooperation conditions. It is used for, among others, forecasting displacements, which are the calculation results most easily verified. Numerical modelling is also used to identify the impact on neighbouring structures and design a monitoring system and determine expected values, e.g., displacements. A numerical model enables one to optimally design the monitoring system for a facility under construction and the neighbouring structures through selecting a measurement technology, matching the scope of obtained results or choosing sensor and measurement point locations. The implemented monitoring may be based on various technologies, from thermal monitoring, laser scanning, fibre optic measurements, to classic surveying measurements. The walls must protect the soil from excessive displacement and protect the excavation against groundwater inflow. If the wall is not watertight, deepening the excavation may cause a sudden water inflow. Leak and erosion process thermal monitoring is a proven leak detection method. It is based on the tests utilizing heat and water transfer process relations, which are coupled processes. Another tool for verifying numerical models is the installation of DFOS (Distributed Fibre Optic Sensors) at the stage of executing structural elements (e.g., diaphragm walls, barrettes, foundation slab). It allows one to permanently monitor both temperature and displacements during element execution (concrete curing), and following facility construction and operation stages. The paper presents methods for designing selected monitoring elements of engineering objects, based on calculations using the Finite Element Method. The verification of numerical models, based on data obtained from DFOS, classic surveying measurements and thermal monitoring, is also presented

Correlation of Oxidative and Antioxidative Processes in the Blood of Patients with Cervical Spinal Cord Injury

The effect of cervical spinal cord injury (CSCI) on oxidative stress parameters was assessed. The study was conducted in 42 patients with CSCI (studied group), 15 patients with cerebral concussion, without CSCI (Control II), and 30 healthy volunteers (Control I). Blood was taken from the basilic vein: before and seven days after the spinal cord decompression surgery (mean time from CSCI to surgery: 8 hours) in the studied group and once in the controls. Thiobarbituric acid reactive substances (TBARS) and conjugated dienes (CD) concentrations, and glutathione peroxidase (GPx), catalase (CAT), and creatine kinase (CK) activities before the surgery were higher in the studied group than in the controls. Reduced glutathione concentration was similar in all groups. Superoxide dismutase (SOD) in the studied group was 16% lower (P≤0.001) than in Control I. Lipid peroxidation products, and GPx and CAT activities in erythrocytes seven days after the surgery were lower (P≤0.001), while SOD was 25% higher (P≤0.001) than before the surgery. CK in blood plasma after the surgery was 34% lower (P≤0.001) than before it. CSCI is accompanied by oxidative stress. Surgical and pharmacological treatment helps to restore the oxidant-antioxidant balance

Improvement in Scoliosis Top View: Evaluation of Vertebrae Localization in Scoliotic Spine-Spine Axial Presentation

Morphological analysis of the scoliotic spine is based on two-dimensional X-rays: coronal and sagittal. The three-dimensional character of scoliosis has raised the necessity for analyzing scoliosis in three planes. We proposed a new user-friendly method of graphical presentation of the spine in the third plane–the Spine Axial Presentation (SAP). Eighty-five vertebrae of patients with scoliosis were analyzed. Due to different positions during X-rays (standing) and computer tomography (CT) (supine), the corresponding measurements cannot be directly compared. As a solution, a software creating Digital Reconstructed Radiographs (DRRs) from CT scans was developed to replace regular X-rays with DRRs. Based on the measurements performed on DRRs, the coordinates of vertebral bodies central points were defined. Next, the geometrical centers of vertebral bodies were determined on CT scans. The reproducibility of measurements was tested with Intraclass Correlation Coefficient (ICC), using p = 0.05. The intra-observer reproducibility and inter-observer reliability for vertebral body central point’s coordinates (x, y, z) were high for results obtained based on DRRs and CT scans, as well as for comparison results obtained based on DRR and CT scans. Based on two standard radiographs, it is possible to localize vertebral bodies in 3D space. The position of vertebral bodies can be present in the Spine Axial Presentation

Granulation tissue of large size in the vagina after Manchester operation

We reported on a case of granulation tissue of large size in the vagina after Manchester operation. A 71-year-old patient was admitted with a tumor of 7 cm in diameter in the vagina. The patient had undergone Manchester operation a year before. Granulation of tissues in the vagina are an often complication after hysterectomy. Clinical symptoms are mucous or blood secretion and mild coital bleeding. In some cases it might also be asymptomatic. It was found that in more than 30% of women after hysterectomy there is granulation tissue in the vagina. It was observed that in more than 60% it is ≤5 mm in size and that it regresses more often than in cases where it is of >5 mm (72% and 33%, respectively). Granulation tissue of >10 mm is very rare. Double biopsies of the 7-centimeter tumor did not provide sufficient information on the tumor origin. There are different therapeutic options for granulation tissue depending on its size – from observation to laser and surgical treatment. In the presented case the only possible option was according to us cautious removal of the tumor from the anterior wall of the vagina to prevent bladder damage. Tumor excision was performed – immunohistochemical staining methods revealed granulation tissue.Opisano przypadek dużej ziarniny w pochwie po operacji manchesterskiej. Siedemdziesięciojednoletnia pacjentka została przyjęta z powodu 7-centymetrowego guza w pochwie. Chora przed rokiem przebyła operację manchesterską. Ziarnina w kikucie pochwy jest częstym powikłaniem po wycięciu macicy. Klinicznie przebiega z nieprawidłową wydzieliną z pochwy, niekiedy krwistą, krwawieniem przy współżyciu płciowym, choć może też nie powodować żadnych objawów. Ocenia się, że ziarnina w kikucie pochwy występuje u ponad 30% kobiet po operacjach wycięcia macicy. W ponad 60% ma ona rozmiary ≤5 mm i w takich przypadkach jej samoistna regresja jest częstszym zjawiskiem, niż kiedy ma wielkość >5 mm (odpowiednio w 72% i 33%). Ziarnina o wielkości >10 mm występuje rzadko. Dwukrotnie wykonane biopsje 7-centymetrowego guza nie wyjaśniły jednoznacznie jego pochodzenia. Metody postępowania z ziarniną są różne, w zależności od jej wielkości – od postawy wyczekującej po leczenie laserem i leczenie chirurgiczne. W sytuacji tak wielkiej ziarniny jedyną opcją wydaje się ostrożne chirurgiczne oddzielenie zmiany z przedniej ściany pochwy w celu uniknięcia okaleczenia pęcherza moczowego. Wycięto guz w całości – metody immunohistochemiczne potwierdziły rozpoznanie tkanki ziarninowej

How does cultural tourism focus on the subject?

Wiele współczesnych atrakcji turystycznych o charakterze kulturowym powstało dzięki inwencji, umiejętnościom, postawom i osiągnięciom osób z przeszłości. Ich istnienie jest wyrazem potrzeb, ambicji i osiągnięć ludzi żyjących na przestrzeni wieków, a przede wszystkim pomysłowości wybitnych jednostek oraz efektu wspólnej pracy społeczności na rzecz i dla dobra ogółu. Turystyka kulturowa może bazować na takiej osobowej, podmiotowej prezentacji dziedzictwa. Czy jednak taka opowieść o wybitnych osobach jest obecna w dzisiejszych atrakcjach turystycznych? Czy jest wykorzystywana przez przewodników, zarządców czy twórców w opowieści o konkretnym dziedzictwie materialnym lub niematerialnym? Czy prezentacja ludzkich dokonań ukazana jest w perspektywie interpretacji dziedzictwa i w umiejętny sposób trafia do odbiorców? Czy zatem turystyka kulturowa skupia się w wystarczający sposób na podmiocie? W jaki sposób to robi bądź dlaczego tego nie robi? Co można zrobić, żeby w szerszym zakresie ten wątek pojawił się w ofercie turystyki kulturowej? Pytamy zatem: W jaki sposób turystyka kulturowa skupia się na podmiocie