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

Impact of proton pump inhibitors on efficacy of antiplatelet strategies with ticagrelor or aspirin after percutaneous coronary intervention : insights from the GLOBAL LEADERS trial

Background Several studies have suggested that proton pump inhibitors (PPIs) may reduce the antiplatelet effects of clopidogrel and/or aspirin, possibly leading to cardiovascular events. Aims We aimed to investigate the association between PPI and clinical outcomes in patients treated with ticagrelor monotherapy or conventional antiplatelet therapy after percutaneous coronary intervention (PCI). Methods This is a subanalysis of the randomized GLOBAL LEADERS trial, comparing the experimental antiplatelet arm (23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy [DAPT]) with the reference arm (12-month aspirin monotherapy following 12-month DAPT) after PCI. Patient-oriented composite endpoints (POCEs: all-cause mortality, myocardial infarction, stroke, or repeat revascularization) and its components were assessed stratified by PPI use as a time-dependent covariate in patients with the experiment or reference antiplatelet arm. Results Among 15,839 patients, 2115 patients (13.5%) experienced POCE at 2 years. In the reference arm, the use of PPIs was independently associated with POCE (hazard ratio [HR]: 1.27; 95% confidence interval [CI]: 1.12–1.44) and its individual components, whereas it was not in the experimental arm (HR: 1.04; 95% CI: 0.92–1.19; pinteraction = 0.035). During the second-year follow-up, patients taking aspirin with PPIs had a significantly higher risk of POCE compared to those on aspirin without PPIs (HR: 1.57; 95% CI: 1.27–1.94), whereas the risk did not differ significantly irrespective of PPI in ticagrelor monotherapy group (HR: 1.03; 95% CI: 0.83–1.28; pinteraction = 0.008). Conclusions In contrast to conventional antiplatelet strategy, there were no evidence suggesting the interaction between ticagrelor monotherapy and PPIs on increased cardiovascular events, which should be confirmed in further studies. Clinical Trial Registration URL: https://clinicaltrials.go

Safety management and the problem of participation of employees in enterprise

W artykule zajęto się problemem partycypacji pracowników w systemie zarządzania bezpieczeństwem w przedsiębiorstwie. Przedstawiono zagadnienie partycypacji, a także wyniki badań empirycznych obrazujących badany problem. Pokazano także korzyści wynikające z partycypacji pracowników w systemie zarządzania bezpieczeństwem.This article dealt with the problem of employee involvement in a safety management system. The article describes the issue of participation, as well as empirical studies illustrating the above mentioned problem in a selected company. The benefits of the employee involvement in the safety management system are also shown

Causes and effects of occupational burnout

W artykule zajęto się problemem wypalenia zawodowego. Przedstawiono charakterystykę wypalenia zawodowego. Pokazano także przyczyny powstania tego niekorzystnego zjawiska oraz jego skutki.The article dealt with the problem of burnout. Shows the characteristics of burnout. Shows the causes resulting in the emergence of this negative phenomenon and its effects

The system of training and adaptation of employees in achieving the improvement of work safety in the mine

W niniejszym artykule przedstawiono system szkoleń i adaptacji pracowników na stanowiskach robotniczych w kopalni. W opisywanym przedsiębiorstwie położono nacisk na podnoszenie bezpieczeństwa pracy między innymi poprzez rozwijanie i doskonalenie umiejętności pracowników, w tym dogłębne przeszkolenie i zapoznanie ich z zagrożeniami środowiska pracy.This article describes the system of training and the adaptation of workers to blue-collar jobs in the mine. In this enterprise focused on improving safety, inter alia through the development and improvement of skills of staff, including in-depth training and familiarizing them with threats of the working environment

Need for training the scope of health and safety in enterprises in the assessment of workers

Artykuł odnosi się do problemu szkoleń z zakresu bezpieczeństwa i higieny pracy. W pracy przedstawiono badania empiryczne obrazujące ocenę samych pracowników dotyczącą przeprowadzanych szkoleń w badanym przedsiębiorstwie. Przedstawiono korzyści płynące ze szkoleń.The article deals with the problem of training in the field of occupational health and safety. The article presents the empirical evaluation showing the employees about the training in the audited company. It shows the benefits of training

Znajomość przepisów przeciw pożarowych oraz zasad udzielenia pierwszej pomocy w wyniku zaistnienia pożaru wśród studentów Politechniki Śląskiej. Raport z badań

The following report is the result of the surveys conducted among students of Silesian University of Technology. Respondents provided answers to questions about fire regulations and how to react in case of fire. The questionnaire was meant to check students' knowledge in these particular areas. Every year thousands of people die or get burnt as a result of uncontrolled fires. Therefore, it is extremely important to know the fire regulations, to react properly in case of fire and to be able to give first aid when it is necessary.Przedstawiony raport jest wynikiem przeprowadzonych badań ankietowych wśród studentów Politechniki Śląskiej. Respondenci udzielali odpowiedzi na pytania dotyczące przepisów przeciw pożarowych oraz zasad postępowania w wyniku zaistnienia pożaru. Zaprojektowana ankieta sprawdzała wiedzę studentów odnośnie tych właśnie dziedzin. W pożarach każdego roku giną tysiące ludzi, a znacznie większa liczba ulega poparzeniom. Dlatego tak ważne jest to, aby każdy człowiek znał podstawowe przepisy przeciwpożarowe, wiedział jak się zachować w sytuacji wystąpienia pożaru oraz co najważniejsze by potrafił udzielić pierwszej pomocy gdy zaistnieje taka potrzeba

Transfer of knowledge about innovative technical solutions on example chosen coal mine

W kopalniach węgla kamiennego istotne znaczenie ma zastosowanie nowoczesnych urządzeń typu klimatyzacyjnych i odpylających, zapewniających komfort pracy. Klimatyzacja w kopalniach, aby mogła spełniać swoją funkcję, musi być odpowiednio zaprojektowana tak aby nie stanowiła zagrożenia dla pracy górników. Najczęściej stosowane są scentralizowane systemy chłodzenia coraz częściej projektowane zgodnie z ustaleniami automatyki, dzięki której możliwa jest bezawaryjna praca z ograniczonym udziałem człowieka. Obok temperatury, innym istotnym zagrożeniem środowiska pracy w górnictwie jest zapylenie powietrza. W polskich kopalniach stosuję się głównie odpylacze suche i mokre. Celem artykułu jest przedstawienie współczesnych zagadnień związanych z urządzeniami klimatyzacyjnymi i odpylającymi w kopalniach węgla kamiennego, tj. badania rynku produkcji urządzeń klimatyzacyjnych i odpylających, ocena zagrożenia klimatycznego. W artykule przedstawiono również badania własne przeprowadzone w formie kwestionariusza ankiety na temat oceny możliwości transferu wiedzy na temat nowoczesnych urządzeń chłodniczych i odpylających.In hard coal mines great importance has use of modern air-conditioners as well as dedusters, that assuring comfort of work. Air-conditioners in mines, in order to grant functionality, it must be designed properly so that it did not present threat for work of miners. Most often centralized systems of cooling are used. More frequently are designed automatic systems securing work without emergency for operators’. Beside temperature, there is other important threat of working environment in mining industry, it is ambient air quality. In polish mines mainly dry and wet dedusters are in use. The aim of this paper is to present recent aspects connected to air conditioning and dedusting devices, among them are research of market of producers and assessment of working climate. In the paper are presented results of research carried with use of questionnaire related to workers knowledge about modern air conditioners and dedusters

A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial

Background MiStent is a drug-eluting stent with a fully absorbable polymer coating containing and embedding a microcrystalline form of sirolimus into the vessel wall. It was developed to overcome the limitation of current durable polymer drug-eluting stents eluting amorphous sirolimus. The clinical effect of MiStent sirolimus-eluting stent compared with a durable polymer drug-eluting stents has not been investigated in a large randomised trial in an all-comer population. Methods We did a randomised, single-blind, multicentre, phase 3 study (DESSOLVE III) at 20 hospitals in Germany, France, Netherlands, and Poland. Eligible participants were any patients aged at least 18 years who underwent percutaneous coronary intervention in a lesion and had a reference vessel diameter of 2.50-3.75 mm. We randomly assigned patients (1: 1) to implantation of either a sirolimus-eluting bioresorbable polymer stent (MiStent) or an everolimus-eluting durable polymer stent (Xience). Randomisation was done by local investigators via web-based software with random blocks according to centre. The primary endpoint was a non-inferiority comparison of a device-oriented composite endpoint (DOCE)-cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation-between the groups at 12 months after the procedure assessed by intention-to-treat. A margin of 4.0% was defined for non-inferiority of the MiStent group compared with the Xience group. All participants were included in the safety analyses. This trial is registered with ClinicalTrials. gov, number NCT02385279. Findings Between March 20, and Dec 3, 2015, we randomly assigned 1398 patients with 2030 lesions; 703 patients with 1037 lesions were assigned to MiStent, of whom 697 received the index procedure, and 695 patients with 993 lesions were asssigned to Xience, of whom 690 received the index procedure. At 12 months, the primary endpoint had occurred in 40 patients (5.8%) in the sirolimus-eluting stent group and in 45 patients (6.5%) in the everolimus-eluting stent group (absolute difference -0.8% [95% CI -3.3 to 1.8], p(non-inferiority) = 0.0001). Procedural complications occurred in 12 patients (1.7%) in the sirolimus-eluting stent group and ten patients (1.4%) in the everolimus-eluting stent group; no clinical adverse events could be attributed to these dislodgements through a minimum of 12 months of follow-up. The rate of stent thrombosis, a safety indicator, did not differ between groups and was low in both treatment groups. Interpretation The sirolimus-eluting bioabsorbable polymer stent was non-inferior to the everolimus-eluting durable polymer stent for a device-oriented composite clinical endpoint at 12 months in an all-comer population. MiStent seems a reasonable alternative to other stents in clinical practic