CARDIOVASCULAR JOURNAL OF AFRICA • Volume 34, No 3, July/August 2023 182 AFRICA period of follow up. Moreover, no differences were observed in the incidence of bleeding complications (Table 1). Similar results were obtained in the ENSURE-AF study for edoxaban, which enrolled 2 199 patients with AF with a duration Table 1. Effectiveness and safety of oral anticoagulants among non-valvular AF patients who underwent ECV (data from randomised, controlled trials) Trial Trial design NOAC No of patients Sample size, n Observation period after randomisation Outcomes Efficacy, n (%) Safety, n (%) NOAC VKA NOAC VKA NOAC VKA X-VeRT RCT to determine events after CV Rivaroxaban 1504 1167 cardioverted 1002 502 30 days Stroke 2 (0.20) Stroke 2 (0.41) MB 6 (0.61) MB 4 (0.80) HS 2 (0.20) HS 0 FB 1 (0.10) FB 2 (0.40) IS 0 IS 2 (0.41) ICH 2 (0.20) ICH 1 (0.20) SE 0 SE 1 (0.20) CvD 4 (0.41) CvD 2 (0.41) All-cD 5 (0.51) All-cD 3 (0.61) ENSURE-AF RCT to determine events after CV Endoxaban 2199 2149 recieived study drug 1095 1067 1104 1082 28 days to asses efficacy and 28 + 30 days to asses safety Stroke 2 (0.18) Stroke 3 (0.27) MB 3 (0.28) MB 5 (0.46) HS 0 HS 0 CRNMB 14 (1.31) CRNMB 7 (0.65) IS 2 (0.18) IS 2 (0.18) SE 1 (0.09) SE 1 (0.09) CvD 1 (0.09) CvD 5 (0.45) EMANATE RCT to determine events after CV Apixaban 1500 753 747 30 days cardioverted Stroke 0 Stroke 6 (0.80) MB 3 (0.40) MB 6 (0.83) 1338 cardioverted HS 0 HS 1 (0.13) CRNMB 11 (1.49) CRNMB 13 (1.80) 90 days noncardioverted IS 0 IS 5 (0.67) SE 0 SE 0 All-cD 2 (0.26) All-cD 1 (0.13) RELY subgroup Post hoc analysis of an open-label RCT Dabigatran 1270 from 18 113 413 – D110 436 30 days Stroke and SEa Stroke and SEa 4 (0.60) MBa MBa 4 (0.60) D110 5 (0.77) D110 11 (1.70) D150 2 (0.30) D150 4 (0.60) 1983 cardioversions 421 – D150 Stroke and SEb Stroke and SEb 2 (0.46) MBb MBb 2 (0.46) D110 2 (0.48) D110 11 (2.66) D150 2 (0.48) D150 2 (0.48) ROCET AF subgroup Post hoc analysis of an open-label RCT Rivaroxaban 321 from 14 264 underwent ECV, PCV, catheter ablation 160 161 During studyc Stroke and SE 3 (1.88) Stroke and SE 3 (1.86) MB or CRNMB 30 (18.75) MB or CRNMB 21 (13.04) CvD 2 (1.25) CvD 4 (2.48) All-cD 3 (1.88) All-cD 6 (3.73) ARISTOTLE subgroup Post hoc analysis of an open-label RCT Apixaban 540 from 18 201 265 275 30 days Stroke and SEa 0 Stroke and SEa 0 MBa 1 (0.3) MBa 1 (0.2) 743 cardioversions All-cD 2 (0.6) All-cD 2 (0.5) ENGAGE AF-TIMI 48 Post hoc analysis of an open-label RCT Endoxaban 365 from 21 105 632 cardioversions 140 – E60/30 114 30 days Stroke and SEb Stroke and SEb 0 MBb MBb 0 111 – E30/15 E 30/15 2 (1.81) E 30/15 0 E 60/30 0 E 60/30 0 All-cD E 30/15 0 E 60/30 1 (0.71) aFor all cardioversions, bfor first-time cardioversions (n = 1 270), cmedian follow up of 2.1 years. RCT, randomised controlled trial; NOAC, novel oral anticoagulant; VKA, vitamin K antagonist; CV, cardioversion; All-cD, all-cause death; CRNMB, clinically relevant non-major bleeding; CvD, cardiovascular death; D110, dabigatran 110 mg; D150, dabigatran 150 mg; E30, endoxaban 30 mg; E60, endoxaban 60 mg; ECV, electrical cardioversion; FB, fatal bleeding; HS, haemorrhagic stroke; IS, ischaemic stroke; MB, major bleeding; PCV, pharmacological cardioversion; SE, systemic embolism.
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