HCC is one of the leading causes of death worldwide. Liver transplantation including living donor transplantation is the best available treatment. We have analyzed our experience with LDLT (living donor liver transplantation) in patients with HCC and HCV in order to determine if alpha feto-protein (AFP) is a better predictor of recurrence than the tumor burden. We have identified all patients with HCV related liver disease and HCC who have undergone LDLT in one center during the period from December 2000 to December 2014. Outcomes from the prospective database were compared for patients who met Milan criteria (single tumor ≤5 cm, maximum of 3 total tumors with none >3 cm) or not. Uni-and multi-variable analyses of factors influencing recurrence free survival (RFS) were performed. A total of 142 patients with HCC and HCV associated liver disease underwent LDTL during the study period. RFS was 96.4% at 1 year, 91.8% at 3 years and 91.8% at 5 years. Gender, Model for End-stage Liver Disease (MELD), pre-transplant therapy, AFP level, tumor number, total tumor size were predictors of recurrence in univariable analysis. In multivariable analysis MELD score (Hazard ratio (HR) 1.16) and Log10 AFP (HR 3.14) were predictors of RFS. In the ROC curve analysis with an AUC of 0.76 the optimal cutoff value of AFP was 26 ng/mL. In conclusion, MELD score and pre-transplant AFP predict recurrence after LDLT for HCC with HCV infection.

Background As populations age, prevalence of atrial fibrillation (AF) and ensuing need for oral anticoagulation increase. Benefits and risks of nonvitamin K antagonist oral anticoagulants such as edoxaban in the frail, elderly population with AF in regular clinical care is of special interest. Purpose Data from Global ETNA-AF capturing almost 2ehz745.1164 patients treated with edoxaban in Europe, Japan, and Korea/Taiwan, was analyzed to compare outcomes in patients <75 years, elderly (≥75 years), and very elderly (≥85 years) patients. Methods Global ETNA-AF is a multinational, multicentre, prospective, noninterventional program (EU: NCT02944019, Japan: UMINehz745.116417011, Korea/Taiwan: NCT02951039). Demographics, baseline characteristics, and 1-year outcome data were reported for 19416 patients classified into 3 age categories. Results At 1-year follow-up, rates of major bleeding (including intracranial haemorrhage [ICH]) and ischaemic stroke were generally low. All-cause and CV mortality increased with age; CV mortality was a minor proportion of all-cause mortality in all age groups. Rates of major bleeding and ischaemic stroke increased slightly with age, but to a lesser extent than all-cause and CV mortality. There was no increase in the rate of ICH with age. <75 yrs (N=9725) ≥75 yrs (N=9687) ≥85 yrs (N=2186) Age, median (IQR) 68.0 (63.0, 72.0) 80.0 (77.0, 84.0) 87.0 (86.0, 89.0) Gender, male % 65.8 51.5 41.4 BMI, median (IQR) 25.6 (22.9, 29.0) 24.5 (21.9, 27.5) 23.4 (20.8, 26.1) Weight, median (IQR) kg 71.0 (60.0, 84.5) 62.5 (52.9, 75.0) 55.4 (47.6, 67.0) CHA2DS2-VASc, mean (SD) 2.4 (1.28) 4.1 (1.27) 4.4 (1.34) CrCl [mL/min], median (IQR) 78.4 (63.6, 95.9) 52.0 (41.1, 64.5) 40.3 (32.2, 49.4) Edoxaban 60/30 mg, % 64.0/36.0 34.3/65.7 15.8/84.2 1-year outcome, n (%/year)   Major bleeding (ISTH) 57 (0.71) 93 (1.19) 25 (1.53)   Intracranial hemorrhage 22 (0.27) 22 (0.28) 3 (0.18)   Major GI* bleeding 18 (0.22) 36 (0.46) 16 (0.98)   CRNMB** 126 (1.57) 212 (2.73) 56 (3.45)   Ischaemic stroke 53 (0.66) 83 (1.06) 23 (1.41)   All-cause/CV mortality 95 (1.18)/25 (0.31) 224 (2.86)/55 (0.70) 89 (5.44)/23 (1.41) *Gastrointestinal. **Clinically relevant nonmajor bleeding. Conclusion Global data from this set of unselected patients support the use of edoxaban as a safe and effective treatment in elderly and very elderly patients with AF in regular clinical care. Acknowledgement/Funding Daiichi Sankyo

Background Patients with atrial fibrillation (AF) who survive an intracranial haemorrhage (ICH) are at high risk of stroke, death, and recurrent haemorrhage. Effectiveness and safety of the nonvitamin K antagonist oral anticoagulant (NOAC) edoxaban in this patient population has not been reported. Purpose This snapshot analysis from the global ETNA-AF program compared 1-year outcomes in AF patients with and without history of ICH treated with edoxaban from Europe, Japan, and Korea/Taiwan. Methods Global ETNA-AF (EU: NCT02944019, Japan: UMINehz745.116117011, Korea/Taiwan: NCT02951039) is a multinational, multicentre, prospective, noninterventional program of AF patients receiving edoxaban in regular clinical care. Demographics, baseline characteristics, and outcomes at 1-year follow-up were reported for 19416 patients with and without a history of ICH. Results Of the 19416 patients, 297 had a history of ICH. At 1-year follow-up, incidences of International Society on Thrombosis and Haemostasis (ISTH) major bleeding (including ICH) and clinically relevant nonmajor bleeding (CRNMB) were generally low. The rate of ischaemic stroke was higher in patients with a history of ICH than in those without prior ICH. Europe (N=7672) Korea/Taiwan (N=1701) Japan (N=10043) History of ICH, n (%) Yes No Yes No Yes No 36 (0.5) 636 (99.5) 27 (1.6) 1674 (98.4) 234 (2.3) 9809 (97.7) Age, median (IQR) 75 (69, 78) 74 (68, 80) 70 (66, 76) 72 (66, 77) 76 (71, 82) 75 (68, 81) Gender, male % 72.2 57.4 70.4 59.9 60.7 59.3 Weight, median (IQR) kg 80.0 (75.0, 88.0) 80.0 (70.0, 92.0) 68.0 (54.0, 77.0) 65.0 (58.0, 73.0) 57.0 (50.0, 65.0) 59.0 (51.0, 68.0) CHA2DS2-VASc, mean (SD) 4.2 (1.44) 3.1 (1.38) 3.9 (1.63) 3.0 (1.43) 4.0 (1.56) 3.4 (1.64) HAS-BLED, mean (SD) 4.3 (1.23) 2.6 (1.12) 3.9 (1.55) 2.4 (10.7) 3.7 (1.07) 2.3 (1.12) CrCl [mL/min], median (IQR) 70.5 (58.8, 85.1) 70.4 (53.8, 90.1) 63.7 (45.8, 84.2) 61.6 (48.4, 78.1) 58.5 (46.0, 73.2) 60.2 (46.1, 77.0) Edoxaban 60/30 mg, % 83.3 / 16.7 77.1 / 22.9 55.6 / 44.4 50.2 / 49.8 21.8 / 78.2 27.8 / 72.2 1-year outcome, n (%/year)   Major bleeding (ISTH) 2 (5.94) 66 (0.92) 0 (0) 13 (0.82) 3 (1.92) 66 (0.96)   Intracranial haemorrhage 1 (2.91) 19 (0.26) 0 (0) 5 (0.32) 1 (0.64) 18 (0.26)   Major GI* bleeding 0 (0.00) 20 (0.28) 0 (0) 2 (0.13) 2 (1.28) 30 (0.43)   CRNMB 0 (0.00) 102 (1.43) 0 (0) 11 (0.70) 6 (3.82) 219 (3.20)   Ischaemic stroke 1 (2.93) 41 (0.57) 1 (4.04) 11 (0.70) 4 (2.57) 78 (1.13) *Gastrointestinal. Conclusion Our data underpin the need for effective stroke prevention. In AF patients with a history of ICH, data suggest that edoxaban can be safely and effectively administered in patients with and without prior ICH in regular clinical care. Acknowledgement/Funding Daiichi Sankyo

Background Heart failure (HF) occurs in approximately 26% of patients with atrial fibrillation (AF). Real-world data of oral anticoagulation with edoxaban in AF patients with HF history are limited. Purpose To compare edoxaban effectiveness and safety in AF patients with or without HF history. Methods The Global ETNA-AF programme (EU: NCT02944019, Japan: UMIN000017011, South Korea/Taiwan: NCT02951039) integrates data from multiple prospective, observational, noninterventional regional studies of AF patients receiving edoxaban for stroke prevention. This snapshot analysis summarises baseline characteristics and 2-year annualised rates of all-cause death, cardiovascular (CV) death, stroke (haemorrhagic, ischaemic, any), and bleeding (major bleeding [MB], major gastrointestinal [GI] bleeding, intracranial haemorrhage [ICH], clinically relevant nonmajor bleeding [CRNMB], and any bleeding) in patients with or without HF history. Univariate Cox regression models assessed clinical outcomes. Results Data from 27,333 patients (5258 with HF history) from Europe, Japan, South Korea, and Taiwan were analysed. Patients with HF history were significantly older and had lower mean body weight and creatinine clearance (P&lt;0.0001 all; Table). Patients with HF history had significantly higher baseline stroke (CHA2DS2-VASc) and bleeding (HAS-BLED) risk scores (P&lt;0.0001 both; Table). Significantly more patients with HF history reported previous experiences with MB (P=0.001) and major GI bleeding (P=0.007); these patients were also more likely to receive 30 mg edoxaban vs 60 mg edoxaban (P&lt;0.0001; Table). Patients with HF history had significantly (P&lt;0.0001 both) higher rates of all-cause (6.1% vs 2.5%; hazard ratio [HR] (95% confidence interval [CI]), 2.41 [2.17–2.68]) and CV death (2.8% vs 1.2%; HR [95% CI], 2.39 [2.05–2.80]), and fatal bleeding (0.3% vs 0.2%; HR [95% CI], 1.86 [1.20–2.89]; Figure). The proportion of all-cause deaths that were fatal bleeding events was 6% and 7% for patients with and without HF, respectively. Additionally, patients with HF history had significantly (P&lt;0.0001 both) higher rates of MB (1.7% vs 0.9%; HR [95% CI], 1.87 [1.53–2.28]) and major GI bleeding (1.1% vs 0.4%; HR [95% CI], 2.69 [2.07–3.49]), with a greater proportion of MB events classified as major GI bleeding (64.5% vs 44.8%; P&lt;0.0001). Patients with HF history also had significantly (P&lt;0.0001 both) higher rates of CRNMB (HR [95% CI], 1.87 [1.58–2.21]) and any bleeding (HR [95% CI], 1.49 [1.34–1.65]). Rates of ICH and haemorrhagic stroke were similar in both groups. Conclusions In AF patients receiving edoxaban, the rates of MB, major GI bleeding, and CV or all-cause death were higher when comparing those with versus without HF history. The higher incidence of MB and major GI bleeding in patients with HF history did not lead to proportionally higher fatal bleeding rates among all-cause deaths. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Daiichi Sankyo