DOACs in elective electrical cardioversion 25 3.2 Primary endpoints In total, 8 patients (0.56%) had a thromboembolic event and 3 patients (0.21%) had an ISTH major bleeding event during the 60-day follow-up period. There were no differences in the primary efficacy and safety endpoints between both groups (Table 2). A detailed overview of endpoints is presented in Appendix B. A thromboembolic event occurred in 6 (0.64%) and 2 (0.41%) patients in the VKA and DOAC group, respectively (P=0.72). The timing of thromboembolic events was similar between groups (VKA: median 19 [10, 25] days; DOAC: 13 [4, 22] days, P=0.64). In the 8 patients with a thromboembolic event, 5 patients (63%) had a medical history of prior stroke or TIA (Appendix B). All patients with a TIA after ECV had an uneventful recovery. The patients who had experienced a stroke had a modified Rankin scale (20) ranging from 0 to 2. No SEE occurred in the study population. Major bleeding occurred in 1 (0.11%) and 2 (0.41%) patients in the VKA and DOAC group, respectively (P=0.27) (Table 2, Appendix B). One patient had a trauma-related subdural hematoma and had a modified Rankin scale of 4. The two other patients experienced a gastro-intestinal bleeding requiring blood transfusion and had an uneventful recovery. 3.3 Secondary endpoints In total, 8 patients (0.56%) died within 60 days after the ECV procedure. There were no differences in the all-cause mortality rate between both groups (Table 2, Appendix B). Also, when looking at the individual endpoints there was no difference between groups with regard to stroke, TIA or SEE. For comparison with RCTs, the composite endpoint of stroke and SEE was also presented. The 30-day rate of the composite endpoint of stroke and SEE and major bleeding after ECV was comparable to the results of the 3 RCTs focusing on the efficacy and safety of pericardioversion DOAC (Appendix C). 4. Discussion The present study demonstrates that DOACs are associated with low thromboembolic and bleeding rates (both <0.5%) in patients undergoing elective ECV for atrial tachyarrhythmia in the setting of a tertiary referral center. Furthermore, the study period was a transition time in our center where DOAC use pericardioversion increased from 5% in 2013 to 73% in 2020. 2
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