DOACs in pacemaker or defibrillator surgery 77 in accordance with the landmark BRUISE CONTROL trials.(4,16) The secondary endpoint was any systemic thromboembolic complication (i.e., transient ischemic attack, stroke) < 30 days after surgery. 2.4. 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). 2.5. Ethics The Medical Ethics Committee reviewed the study (MEC-2020–0299), and this 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. 3. Results 3.1. Study population A total of 1,033 elective CIED procedures were performed during the study period. After exclusion of patients who did not fulfil the criteria, the final study population consisted of 283 patients (Fig. 1). The VKA group comprised 202 patients (71%) and the DOAC group comprised 81 patients (29%). In the VKA group, most patients used acenocoumarol (Fig. 2A). In the DOAC group, most patients used dabigatran (43%) or apixaban (24%) (Fig. 2B). Patients who used a lower dose of DOAC had a lower mean eGFR in comparison to those with a normal dose of DOAC (50 ± 23 mL/min vs 74 ± 18 mL/min, p= < 0.001). The use of DOAC in the study population increased over the years, increasing from 15% in 2016 to 42% in 2019 (Fig. 3). Baseline patient characteristics are depicted in Table 1. In comparison to the VKA group, patients using DOACs were younger, had a lower median HAS-BLED score, 5
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