Results
Among the 510 patient enrolled in this study, 164 patients were excluded
due to the usage of inappropriate dose of edoxaban. Accordingly, data on
346 patients, who were receiving recommended dosages of edoxaban, were
used for the analysis. The median age of the included patients was 73
years (range, 34-93 years), and there were 168 (48.6%) females. Thirty
two patients (9.2%) experienced bleeding complications after taking
edoxaban. Among them, 16 patients experienced major bleeding
complications. Two and eight patients experienced intracranial
hemorrhage and gastrointestinal bleeding complications, respectively.
Six patients showed urological bleeding and 11 had unclassified bleeding
outcomes. Eleven patients experienced stroke or recurrent DVT/PE.
As shown in Table 1, patients less than or equal to 60 kg had more
bleeding complications than those who were heavier than 60 kg (p=0.018).
Also, patients with cancer had more bleeding outcomes than those without
cancer (p=0.030).
Multivariable analysis (Table 2) included sex, age, CrCl, and factors
with p<0.05 in univariate analysis (weight and cancer). After
adjusting for related covariates, patients with cancer or weights less
than or equal to 60 kg showed approximately 3.4-fold higher bleeding
complications than patients without cancer or with weights higher than
60 kg. The Hosmer–Lemeshow test showed that the fitness of the
multivariable analysis model was satisfactory
(χ2=11.335, 6 degrees of freedom, p=0.079).
Since more than 10% of patients had bleeding complications even after
dose reduction, we performed subgroup analysis to investigate factors on
bleeding complications in high-risk patients receiving a low dose of
edoxaban. We found that weight was a significant factor for bleeding
outcomes in both univariate and multivariable analysis (Table 3 and
Table 4). Patients with weight ≤60 kg showed 3.3-times higher bleeding
complications even with low dose of edoxaban compared to those with
weight >60 kg. Hosmer–Lemeshow test showed that the
fitness of the multivariable analysis model was satisfactory
(χ2=3.636, 6 degrees of freedom, p=0.726).