Abstract Aims It is recommended to perform atrial fibrillation ablation with continuous anticoagulation. Continuous apixaban has not been tested. Methods and results We compared continuous apixaban (5 mg b.i.d.) to vitamin K antagonists (VKA, international normalized ratio 2–3) in atrial fibrillation patients at risk of stroke a prospective, open, multi-centre study with blinded outcome assessment. Primary outcome was a composite of death, stroke, or bleeding (Bleeding Academic Research Consortium 2–5). A high-resolution brain magnetic resonance imaging (MRI) sub-study quantified acute brain lesions. Cognitive function was assessed by Montreal Cognitive Assessment (MoCA) at baseline and at end of follow-up. Overall, 674 patients (median age 64 years, 33% female, 42% non-paroxysmal atrial fibrillation, 49 sites) were randomized; 633 received study drug and underwent ablation; 335 undertook MRI (25 sites, 323 analysable scans). The primary outcome was observed in 22/318 patients randomized to apixaban, and in 23/315 randomized to VKA {difference −0.38% [90% confidence interval (CI) −4.0%, 3.3%], non-inferiority P = 0.0002 at the pre-specified absolute margin of 0.075}, including 2 (0.3%) deaths, 2 (0.3%) strokes, and 24 (3.8%) ISTH major bleeds. Acute small brain lesions were found in a similar number of patients in each arm [apixaban 44/162 (27.2%); VKA 40/161 (24.8%); P = 0.64]. Cognitive function increased at the end of follow-up (median 1 MoCA unit; P = 0.005) without differences between study groups. Conclusions Continuous apixaban is safe and effective in patients undergoing atrial fibrillation ablation at risk of stroke with respect to bleeding, stroke, and cognitive function. Further research is needed to reduce ablation-related acute brain lesions.

中文翻译：

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阿哌沙班在接受房颤消融的中风风险患者中的应用

摘要 目的 推荐在持续抗凝的情况下进行房颤消融。连续阿哌沙班尚未经过测试。方法和结果 我们比较了连续性阿哌沙班（5 mg bid）与维生素 K 拮抗剂（VKA，国际标准化比率 2-3）在有中风风险的房颤患者中的一项前瞻性、开放、多中心研究，并进行了盲法结果评估。主要结果是死亡、中风或出血的综合结果（出血学术研究联盟 2-5）。高分辨率脑磁共振成像 (MRI) 子研究量化了急性脑损伤。在基线和随访结束时通过蒙特利尔认知评估 (MoCA) 评估认知功能。总体而言，674 名患者（中位年龄 64 岁，33% 女性，42% 非阵发性心房颤动，49 个部位）被随机分组​​；633 人接受了研究药物并接受了消融；335 人进行了 MRI（25 个部位，323 次可分析扫描）。在随机分配至阿哌沙班的 22/318 名患者和随机分配至 VKA 的 23/315 名患者中观察到主要结果{差异 -0.38% [90% 置信区间 (CI) -4.0%, 3.3%]，非劣效性 P = 0.0002 0.075} 的预先指定的绝对界限，包括 2 例 (0.3%) 死亡、2 例 (0.3%) 中风和 24 例 (3.8%) ISTH 大出血。在每组相似数量的患者中发现急性小脑损伤 [阿哌沙班 44/162 (27.2%)；VKA 40/161 (24.8%)；P = 0.64]。随访结束时认知功能增加（中位数 1 MoCA 单位；P = 0.005），研究组之间没有差异。结论 对于有卒中风险的房颤消融患者，在出血、卒中、和认知功能。需要进一步的研究来减少与消融相关的急性脑损伤。