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.