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Aldo Lorenzetti M.D, Internal Medicine & Hepatology, Milano - SIMEDET Delegate
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#Edoxaban versus enoxaparin–warfarin in patients undergoing cardioversion of atrial #fibrillation (ENSURE-AF): a randomised, open-label, phase 3b trial

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)31474-X/fulltext

Interpretation
ENSURE-AF is the largest prospective randomised clinical trial of anticoagulation for cardioversion of patients with non-valvular atrial fibrillation. Rates of major and CRNM bleeding and thromboembolism were low in the two treatment groups.
#Edoxaban for the Prevention of Thromboembolism in Patients with AtrialFibrillation and Bioprosthetic #Valves

http://circ.ahajournals.org/content/early/2017/02/14/CIRCULATIONAHA.116.026714?papetoc=

Only one of the first three warfarin-controlled pivotal NOAC trials in AF included patients with bioprosthetic valves (n>80)3. The Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation Thrombolysis in Myocardial Infarction 48 (ENGAGE AF-TIMI 48) trial, which compared edoxaban (a direct oral factor Xa inhibitor) to warfarin in AF patients4, did not exclude patients with bioprosthetic valves, thus providing an opportunity to analyze this high-risk subgroup.
#Edoxaban for the Treatment of #Cancer-Associated Venous #Thromboembolism
http://www.nejm.org/doi/full/10.1056/NEJMoa1711948

Of the 1050 patients who underwent randomization, 1046 were included in the modified intention-to-treat analysis. A primary-outcome event occurred in 67 of the 522 patients (12.8%) in the edoxaban group as compared with 71 of the 524 patients (13.5%) in the dalteparin group (hazard ratio, 0.97; 95% confidence interval [CI], 0.70 to 1.36; P=0.006 for noninferiority; P=0.87 for superiority). Recurrent venous thromboembolism occurred in 41 patients (7.9%) in the edoxaban group and in 59 patients (11.3%) in the dalteparin group (difference in risk, −3.4 percentage points; 95% CI, −7.0 to 0.2). Major bleeding occurred in 36 patients (6.9%) in the edoxaban group and in 21 patients (4.0%) in the dalteparin group (difference in risk, 2.9 percentage points; 95% CI, 0.1 to 5.6).

CONCLUSIONS
Oral edoxaban was noninferior to subcutaneous dalteparin with respect to the composite outcome of recurrent venous thromboembolism or major bleeding. The rate of recurrent venous thromboembolism was lower but the rate of major bleeding was higher with edoxaban than with dalteparin.