Additional file 1 of The point-of-care D-dimer test provides a fast and accurate differential diagnosis of Stanford Type A aortic syndrome and ST-elevated myocardial infarction in emergencies

Additional file 1

Study outcomes as reported in randomized controlled trials comparing edoxaban to warfarin.

<p>*Event rates were based on the intention-to-treat population unless otherwise specified.</p

Patient- and study-level characteristics of randomized controlled trials comparing edoxaban to warfarin.

<p>*measure as mean ±SD or median (interquartile range).</p><p>NVAF denotes nonvalvular atrial fibrillation; DVT deep vein thrombosis; PE pulmonary embolism; INR international normalized ratio ; QD que die; BID bis in die; NA not applicable; VKA vitamin K antagonist; TIA transient ischemic attack; HF heart failure; DM diabetes mellitus; HTN hypertension.</p

Flow Diagram of Selection Strategy.

<p>Flow diagram depicting the selection strategy for trials used in this meta-analysis. Please note that when we meant the phrase of ‘no available data’, we meant that there was no associated result that matched the end-point outcomes of our meta-analysis. <b>RCT</b> denotes randomized clinical trial, <b>SCIE</b> Science Citation Index Expanded databases.</p

Bleeding Risk and Mortality of Edoxaban: A Pooled Meta-Analysis of Randomized Controlled Trials

<div><p>Objective(s)</p><p>Edoxaban, a factor Xa inhibitor, is a new oral anticoagulant that has been developed as an alternative to vitamin K antagonists. However, its safety remains unexplored.</p><p>Methods</p><p>Medline, Embase and Web of Science were searched to March 8, 2014 for prospective, randomized controlled trials (RCTs) that assessed the safety profile of edoxaban with warfarin. Safety outcomes examined included bleeding risk and mortality.</p><p>Results</p><p>Five trials including 31,262 patients that met the inclusion criteria were pooled. Overall, edoxaban was associated with a significant decrease in major or clinically relevant nonmajor bleeding events [risk ratio (RR) 0.78, 95% confidence interval (CI) 0.74 to 0.82, p<0.001] and any bleeding events [RR 0.82, 95% CI 0.79 to 0.85, p<0.001]. Edoxaban also showed superiority to warfarin both in all-cause mortality [RR 0.92, 95% CI0.85 to0.99, p = 0.02] and cardiovascular mortality [RR 0.87, 95% CI0.79 to 0.96, p = 0.004]. Subgroup analyses indicated that RRs of edoxaban 30, 60 or 120 mg/d were 0.67 (p<0.001), 0.87 (p<0.001) and 3.3 (p = 0.004) respectively in major or clinically relevant nonmajor bleeding; 0.71 (p<0.001), 0.89 (p<0.001) and 2.29 (p = 0.002) respectively in any bleeding; as well as 0.86 (p = 0.01), 0.87 (p = 0.01) and 0.28 (p = 0.41) respectively in cardiovascular death… Meanwhile, paramount to note that pooled results other than the largest trial showed edoxaban was still associated with a decrease in the rate of major or clinically relevant nonmajor bleeding event (p = 0.02) and any bleeding (p = 0.002), but neither in all-cause death (p = 0.66) nor cardiovascular death (p = 0.70).</p><p>Conclusions</p><p>Edoxaban, a novel orally available direct factor Xa inhibitor, seems to have a favorable safety profiles with respect to bleeding risk and non-inferior in mortality when compared to warfarin. Further prospective RCTs are urgently needed to confirm the results of this meta-analysis.</p></div

Subgroup analyses of safety outcomes based on different fixed doses of edoxaban.

<p>*Dose measured as mg per day.</p><p>NA not application; RR risk ratio; CI confidence interval.</p

A series of forest plots of risk ratios of any bleeding event for comparison each fixed dose of edoxaban with warfarin.

<p>A series of forest plots of risk ratios (RRs) of any bleeding events for comparison each fixed dose of edoxaban (30, 60 or 120 mg/d) with warfarin if data were available. CI confidence interval.</p

Forest plots of risk ratios for events of cardiovascular death for comparison each fixed dose of edoxaban with warfarin.

<p>Forest plots of risk ratios (RRs) for events of cardiovascular death for comparison each fixed dose of edoxaban with warfarin. CI confidence interval.</p

Forest Plot of risk ratios of bleeding events for comparison edoxaban with warfarin.

<p>A series of forest plots of risk ratios (RRs) of bleeding events for comparison of given edoxaban or warfarin according to every trial were pooled. All five trials (n = 31,262) reported events of major or clinically relevant nonmajor bleeding event and any bleeding. CI confidence interval.</p

Risk of bias in included studies.

<p>Risk of bias in included studies were evaluated every element of study design: blinding description, randomization process, inclusion and exclusion criteria, concealed allocation, intention-to-treat analysis, and assessment of withdrawals and dropouts. <b>NR</b> =  not reported.</p