Okayama Heart Clinic, Okayama, Japan.
Clin Drug Investig. 2013 Jun;33(6):409-18. doi: 10.1007/s40261-013-0081-1.
The usefulness of dabigatran etexilate for the prevention of stroke in patients with atrial fibrillation (AF) has been reported.
In this study the efficacy and safety of dabigatran etexilate for anticoagulation for AF ablation were examined.
Patients were divided into three groups: Group 1, interrupted warfarin bridged by heparin between pre- and post-ablation; Group 2, continuous warfarin therapy; and Group 3, dabigatran etexilate therapy. Anticoagulation therapy with warfarin or dabigatran etexilate was performed from 30 days before to at least 90 days after AF ablation. Dabigatran etexilate was administered at 110 or 150 mg twice daily, depending on renal function and age.
Patients' clinical characteristics, associated disorders, echocardiographic parameters and arrhythmia status were not different among the three groups. Procedural parameters such as procedural time and radiofrequency energy supply were also not different among the three groups. The dabigatran etexilate group and the warfarin groups had no embolic complications (stroke, cerebral transient ischaemic attack, deep venous thrombosis or pulmonary embolism). No pericardial tamponade was observed in the dabigatran etexilate group, while two patients in each of Group 1 (2/194, 1.0 %) and Group 2 (2/203, 0.98 %) developed cardiac tamponade, though the differences were not significant. Pericardial effusion and groin haematoma were observed in one patient each (1/105, 0.9 %) in the dabigatran etexilate group, and the incidences were not different from the warfarin group (Group 1: 4/194, 2.1 % and 2/194, 1.0 %; Group 2: 3/203, 1.5 % and 2/203, 1.0 %, respectively). As a whole, the safety outcomes did not differ among the three groups.
Dabigatran etexilate is an effective and safe anticoagulation therapy for AF ablation. Thus, dabigatran etexilate appears to be useful as an alternative anticoagulant therapy to warfarin for AF ablation.
达比加群酯在预防心房颤动(AF)患者中风方面的有效性已得到证实。
本研究旨在检验达比加群酯在 AF 消融抗凝治疗中的疗效和安全性。
患者分为三组:组 1,在消融前后用肝素桥接华法林;组 2,持续华法林治疗;组 3,达比加群酯治疗。华法林或达比加群酯抗凝治疗从 AF 消融前 30 天开始,至少持续 90 天。根据肾功能和年龄,达比加群酯的剂量为 110 或 150 mg,每日两次。
三组患者的临床特征、合并症、超声心动图参数和心律失常状态无差异。三组患者的手术参数(手术时间和射频能量供应)也无差异。达比加群酯组和华法林组均未发生栓塞并发症(中风、短暂性脑缺血发作、深静脉血栓形成或肺栓塞)。达比加群酯组未发生心包填塞,而组 1 中有 2 例(2/194,1.0%)和组 2 中有 2 例(2/203,0.98%)发生心包填塞,差异无统计学意义。达比加群酯组有 1 例(1/105,0.9%)出现心包积液,1 例(1/105,0.9%)出现腹股沟血肿,与华法林组无差异(组 1:4/194,2.1%和 4/194,2.1%;组 2:3/203,1.5%和 3/203,1.5%)。总的来说,三组的安全性结局无差异。
达比加群酯是一种有效的、安全的 AF 消融抗凝治疗方法。因此,达比加群酯似乎可以作为 AF 消融的华法林替代抗凝治疗药物。