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. 2020 Apr 26;22(8):1149–1161. doi: 10.1093/europace/euaa057

Table 3.

Large studies investigating NOACs vs. VKA in the cardioversion setting

Study (year) RE-LY (2011)96 undefined X-VeRT (2014)87 undefined ENSURE-AF (2016)88 undefined EMANATE (2018)100 undefined
Study type Multicentre, international, post hoc analysis Multinational, randomized, open-label, parallel-group Phase IIIb study Multicentre, prospective, randomized, open-label, parallel-group with blinded endpoint Multinational, prospective, randomized, open-label with blinded endpoint adjudication
NOAC Dabigatran Rivaroxaban Edoxaban Apixaban
Total number of patients (NOAC/warfarin) (N) 1270 (1319/664)a 1504 (1002/502) 2199 (1095/1104) 1500 (753/747)
Follow-up 30 days 30 days 58 days 30 days (90 days in patients not converted)
NOAC dosing 110 mg b.i.d. and 150 mg b.i.d. 20 mg o.d.b 60 mg o.d.c 5 mg b.i.d.d
Outcomes Primary: stroke, systemic embolism and major bleeding

  • Primary efficacy outcome: composite of stroke, TIA, peripheral embolism, MI, and cardiovascular death

  • Primary safety outcome: major bleeding

  • Primary efficacy endpoint: composite of stroke, systemic embolic event, MI, and cardiovascular mortality

  • Primary safety endpoint: major and clinically relevant non-major bleeding

  • Primary efficacy endpoint: stroke, systemic embolism, and all-cause death

  • Primary safety endpoint: major bleeding and clinically relevant non-major bleeding
Age (years) 71.5 ± 8.8 (dabigatran 150 mg), 71.4 ± 8.6 (dabigatran 110 mg), 71.6 ± 8.6 (warfarin)e 64.9 ± 10.6 (rivaroxaban), 64.7 ± 10.5 (VKA) 64.3 ± 10.3 (edoxa), 64.2 ± 10.8 (enoxaparin + warfarin) 64.7 ± 12.2 (apixaban), 64.5 ± 12.8 (heparin/warfarin)
CHA2DS2-VASc score ≥2 N/R 959/1504 (63.76%) 1707/2199 (77.63%) mean 2.4 ± 1.7
TTR in warfarin-treated patients (%) N/R N/R 70.8 ± 27.4 65% (beyond first 2 weeks of treatment)
TOE-guided cardioversion, n (%)

  • Dabigatran 150 mg: 162 (24.11%)

  • Dabigatran 110 mg: 165 (25.5%)

  • Warfarin: 88 (13.25%)

  • Rivaroxaban: 410 (40.92%)

  • VKA: 218 (43.42%)

  • Edoxaban: 589/1095 (53.8%)

  • Warfarin: 594/1104 (53.8%)

  • Apixaban: 418/753 (55.5%)

  • Heparin/warfarin: 437/747 (58.1%)
Patients with primary efficacy outcome, n (%)

  • Dabigatran 150 mg: 2 (0.3%)

  • Dabigatran 110 mg: 5 (0.77%)

  • Warfarin: 4 (0.6%)

  • Rivaroxaban: 5/978 (0.51%)

  • VKA: 5/492 (1.02%)

  • Edoxaban: 5/1095 (0.5%)

  • Warfarin: 11/1104 (1%)

  • Apixaban: 0 strokes and 2 death

  • Heparin/warfarin: 6 strokes and 1 death
Patients with primary safety outcome, n (%)

  • Dabigatran 150 mg: 4 (0.6%)

  • Dabigatran 110 mg: 11 (1.7%)

  • Warfarin: 4 (0.6%)

  • Rivaroxaban: 6/988 (0.61%)

  • VKA: 4/499 (0.8%)

  • Edoxaban: 16/1067 (1.5%)

  • Warfarin: 11/1082 (1%)

  • Apixaban: 3 major bleeds and 11 CRNM bleeds

  • Heparin/warfarin: 6 major bleeds and 13 CRNM bleeds

b.i.d., twice a day; CHA2DS2-VASc, Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, Stroke, Vascular disease, Age 65–74 years, Sex category (female); CRNM bleeds, clinically relevant non-major bleeds; EMANATE, Eliquis evaluated in acute cardioversion compared to usual treatments for anticoagulation in subjects with atrial fibrillation; ENSURE-AF, edoxaban vs. warfarin in subjects undergoing cardioversion of atrial fibrillation; MI, myocardial infarction; N/R, not reported; NOAC, non-vitamin K oral anticoagulant; o.d., once daily; RE-LY, Randomized Evaluation of Long-Term Anticoagulation Therapy; TIA, transient ischaemic attack; TOE, transoesophageal echocardiography; TTR, time in therapeutic range; VKA, vitamin K antagonist; X-VeRT, explore the efficacy and safety of once-daily oral rivaroxaban for the prevention of cardiovascular events in patients with non-valvular atrial fibrillation scheduled for cardioversion.

a

Total number of cardioversions.

b

15 mg o.d. in patients with CrCL of 30–49 mL/min.

c

30 mg o.d., if CrCl 15–50 mL/min, body weight ≤60 kg or use of P-gp inhibitors.

d

2.5 mg b.i.d., if at least two of the following: age ≥80 years, weight ≤60 kg, or serum creatinine ≥1.5 mg/dL (≥133 µmol/L). Cardioversion could be performed 2 h after a loading dose of 10 mg (5 mg, if at least two of the following: age ≥80 years, weight ≤60 kg, or serum creatinine ≥1.5 mg/dL [≥133 µmol/L]).

e

From main study.