Kuwahara Taishi, Abe Mitsunori, Yamaki Masaru, Fujieda Hiroyuki, Abe Yumiko, Hashimoto Katsushi, Ishiba Misako, Sakai Hirotsuka, Hishikari Keiichi, Takigawa Masateru, Okubo Kenji, Takagi Katsumasa, Tanaka Yasuaki, Nakajima Jun, Takahashi Atsushi
Cardiovascular Center, Yokosuka Kyousai Hospital, Yokosuka, Kanagawa, Japan.
Yotsuba Circulation Clinic, Matsuyama, Ehime, Japan.
J Cardiovasc Electrophysiol. 2016 May;27(5):549-54. doi: 10.1111/jce.12928. Epub 2016 Feb 12.
Stroke can be a life-threatening complication of atrial fibrillation (AF) catheter ablation. Uninterrupted warfarin treatment contributes to minimizing the risk of stroke complications.
This was a prospective, open-label, randomized, multicenter study assessing the safety and efficacy of apixaban for the prevention of cerebral thromboembolism complicating AF catheter ablation. Two hundred patients with drug-resistant AF were equally assigned to take either apixaban (5 mg or 2.5 mg twice daily) or warfarin (target international normalized ratio, 2-3) for at least 1 month before AF ablation. Neither drug regimen was interrupted throughout the operative period. Diffusion-weighted magnetic resonance imaging was performed for all patients to detect silent cerebral infarction (SCI) after the ablation. Primary outcomes were defined as the occurrence of stroke, transient ischemic attack, SCI, or major bleeding that required intervention. The secondary outcome was minor bleeding. The groups did not statistically differ in patients' backgrounds or procedural parameters. During AF ablation, the apixaban group required administration of more heparin to maintain an activated clotting time > 300 seconds than the warfarin group (apixaban, 14,000 ± 4,000 units; warfarin, 9,000 ± 3,000 units). Three primary outcome events occurred in each group (apixaban, 2 SCI and 1 major bleed; warfarin, 3 SCI, P = 1.00), and 3 and 4 secondary outcome events occurred in the apixaban and warfarin groups (P = 0.70), respectively.
Apixaban has similar safety and effectiveness to warfarin for the prevention of cerebral thromboembolism during the periprocedural period of AF ablation.
中风可能是心房颤动（AF）导管消融术的一种危及生命的并发症。不间断的华法林治疗有助于将中风并发症的风险降至最低。
这是一项前瞻性、开放标签、随机、多中心研究，评估阿哌沙班预防AF导管消融术并发脑栓塞的安全性和有效性。200例耐药性AF患者在AF消融术前至少1个月被平均分配服用阿哌沙班（5毫克或2.5毫克，每日两次）或华法林（目标国际标准化比值为2 - 3）。在整个手术期间，两种药物治疗方案均未中断。对所有患者进行弥散加权磁共振成像，以检测消融术后的无症状性脑梗死（SCI）。主要结局定义为中风、短暂性脑缺血发作、SCI或需要干预的大出血的发生。次要结局为小出血。两组患者的背景或手术参数在统计学上无差异。在AF消融术中，与华法林组相比，阿哌沙班组需要更多的肝素给药以维持活化凝血时间>300秒（阿哌沙班，14,000±4,000单位；华法林，9,000±3,000单位）。每组均发生3例主要结局事件（阿哌沙班组，2例SCI和1例大出血；华法林组，3例SCI，P = 1.00），阿哌沙班组和华法林组分别发生3例和4例次要结局事件（P = 0.70）。
在AF消融术围手术期预防脑栓塞方面，阿哌沙班与华法林具有相似的安全性和有效性。
