DOACs in elective electrical cardioversion 23 performed with a biphasic shock of 200 Joules. For patients in atrial flutter a lower dose was used (usually 100 Joules). A cardioversion was repeated when necessary. 2.4 Study endpoints The primary efficacy endpoint was a composite of stroke, transient ischemic attack (TIA), and systemic embolic event (SEE) within 60 days. The primary safety endpoint was major bleeding within 60 days. Major bleeding was defined according to the International Society of Thrombosis and Haemostasis (ISTH) criteria and included clinically overt bleeding accompanied by a decrease in the haemoglobin level of at least 20 g/L (1.24 mmol/L) or transfusion of at least 2 units of packed red cells, occurring at a critical site, or resulting in death (19). TIA and stroke were diagnosed by a neurologist. The secondary efficacy endpoints were death from any cause, stroke, TIA, SEE, and a composite of stroke and SEE (excluding TIA). 2.5 Statistical analysis Continuous parameters were tested for normality before analysis and are expressed as mean ± standard deviation (SD) or median [interquartile range], as appropriate. Categorical data are presented as frequencies and percentages. Comparisons between groups were performed with an independent Student t test, chi-square tests, Fisher exact test, or a Mann-Whitney U test, as appropriate. All analyses were twotailed; a p-value<0.05 was considered statistically significant. Statistical analyses were performed using SPSS software (SPSS, version 25; IBM, Chicago, Illinois). 2.6 Ethics The Medical Ethics Committee reviewed the study (MEC-2019-0405), and this retrospective single-center study was not subjected to the Dutch Medical Research Involving Human Subjects Act. The study was carried out according to the ethical principles for medical research involving human subjects established by Declaration of Helsinki, protecting the privacy of all the participants and the confidentiality of their personal information. 2
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