Study population
This was a prospective study performed in the atrial fibrillation (AF)
clinic of the Second Affiliated Hospital of Soochow University in China
between January 2018 and June 2019. A total of 86 patients treated with
110 mg DE twice daily were recruited for this study. All patients
included in our study had received dabigatran for at least 18 continuous
months and visited the clinic at least once a month for long-term
follow-up. This study was approved by the Ethics Review Board of the
Second Affiliated Hospital of Soochow University and was performed in
accordance with the Declaration of Helsinki. All patients signed
informed consent prior to this study.
The inclusion criteria were14: (1) diagnosed with
NVAF; (2) receiving anticoagulant therapy with oral DE for a minimum of
eighteen months; and (3) provided at least one valid blood sample for
SNP detection. We excluded patients who were pregnant, younger than 18
years of age, suffered severe vascular heart disease, severe liver
damage or cancer, had prior kidney transplant or long-term dialysis, or
were unable to fulfill the follow-up visits.
Baseline characteristics were collected for all enrolled patients (shown
in Table 1). All bleeding and thromboembolic complications were recorded
during the 1.5 years of follow-up. Major bleeding was defined as a
reduction in the hemoglobin level of at least 20 g/L, transfusion of at
least 2 U blood, or symptomatic bleeding in a critical area or organ.
All other bleeding was considered minor14,15. Any
bleeding events were composed of major and minor bleeding events.