Efficacy and safety of dabigatran versus warfarin for preventing stroke in elderly patients with atrial fibrillation:a randomized controlled trial
10.3760/cma.j.issn.1008-5734.2018.06.006
- VernacularTitle:达比加群酯与华法林预防老年房颤患者卒中的有效性和安全性随机对照试验
- Author:
Jingcheng CHEN
1
;
Yuan JI
1
;
Meng ZHU
1
;
Xuejun ZHOU
1
;
Aoshuang ZHU
1
Author Information
1. 213164,南京医科大学附属常州市第二人民医院阳湖院区心血管内科
- Publication Type:Journal Article
- Keywords:
Atrial fibrillation;
Dabigatran;
Warfarin;
Anticoagulants;
Stroke;
Hemorrhage
- From:
Adverse Drug Reactions Journal
2018;20(6):426-430
- CountryChina
- Language:Chinese
-
Abstract:
Objective To compare the efficacy and safety of long-term use of dabigatran and warfarin for prevention of stroke in elderly patients with atrial fibrillation. Methods The study was designed as a prospective randomized controlled trial. The subjects were outpatients or inpatients who were diagnosed as non-valvular atrial fibrillation and needed anticoagulant therapy in Changzhou No.2 People′s Hospital. The study started on March 20,2015. Patients in accordance with the inclusion criteria were randomly divided into the dabigatran group (dabigatran 110 mg,twice daily)and warfarin group (warfarin dose was adjusted by regular follow-up results to maintain INR in the range of 2.0-3.0). After two years of follow-up,effectiveness of preventing thromboembolism events and occurrence of hemorrhagic events were compared between the two groups;occurrence of extracranial hemorrhage was also compared in patients with different ages (＜60 years old group,60-＜80 years old group,≥80 years old group)between the two groups.Results Up to October 2015,a total of 180 patients were enrolled,including 114 males (63.3%) and 66 females (36.7%);65 patients (36.1%)were ＜60 years old,108 patients (60.0%)were 60-＜80 years old,and 7 (3.9%)were≥80 years old. There were 90 patients in the dabigatran group and in the warfarin group,respectively. During the period of 2-year follow-up,stroke and non-central nervous system embolism occurred in 6 patients and intracranial hemorrhage in 5 patients in each group,extracranial hemorrhage occurred respectively in 12 and 16 patients in the warfarin and dabigatran groups,without statistically significant differences (P ＞ 0. 05 for all comparisons ). Comparisons of the extracranial hemorrhage incidences in patients with different ages between the 2 groups showed that the incidence of extracranial hemorrhage in patients ＜60 years old in the dabigatran group was lower than that in the warfarin group (11.4% vs. 13.3%);the incidences of extracranial hemorrhage in patients aged 60-＜80 and ≥80 years in the dabigatran group were higher than those in the warfarin group (19.6% vs. 12.2%,50.0% vs. 33.3%,respectively ),without statistically significant differences (P ＞ 0. 05 for all comparisons ). Conclusions The effectivenessfor preventing stroke and the incidences of hemorrhagic events were respectively similar in elderly atrial fibrillation patients with long-term use of dabigatran and warfarin. The risk of extracranial hemorrhage in very elderly patients needs to be further studied by expanding the sample size.
