Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation.
Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation.
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DOI：
10.1093/eurheartj/ehy176
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发表时间：
2018-08-21
影响因子：
39.3
通讯作者：
Di Biase L
中科院分区：
文献类型：
--
作者：
Kirchhof P;Haeusler KG;Blank B;De Bono J;Callans D;Elvan A;Fetsch T;Van Gelder IC;Gentlesk P;Grimaldi M;Hansen J;Hindricks G;Al-Khalidi HR;Massaro T;Mont L;Nielsen JC;Nölker G;Piccini JP;De Potter T;Scherr D;Schotten U;Themistoclakis S;Todd D;Vijgen J;Di Biase L
建议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。我们对有中风风险的房颤患者进行连续阿哌沙班（5mg b.i.d.）与维生素 K 拮抗剂（VKA，国际标准化比率 2-3）的比较，这是一项前瞻性、开放、多中心研究，并进行了盲法结果评估。主要结局是死亡、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。蒙特利尔认知评估（MoCA）在基线和随访结束时对认知功能进行评估。总体而言，674 名患者（中位年龄 64 岁，33% 为女性，42% 为非阵发性房颤，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 人接受了 MRI（25 个部位，323 次可分析扫描）。在随机接受阿哌沙班的 22/318 名患者和随机接受 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 在预先指定的绝对边际 0.075}，包括 2 例 (0.3%) 死亡， 2 次 (0.3%) 中风，24 次 (3.8%) ISTH 大出血。每组中相似数量的患者均发现急性小脑损伤[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有所提高（中位 1 MoCA 单位；P = 0.005），研究组之间没有差异。持续阿哌沙班对于接受房颤消融且有中风风险的患者在出血、中风和认知功能方面是安全有效的。需要进一步的研究来减少与消融相关的急性脑损伤。
It is recommended to perform atrial fibrillation ablation with continuous anticoagulation. Continuous apixaban has not been tested. 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. 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.
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影响因子：
158.5
作者：
Kuck, Karl-Heinz;Brugada, Josep;Tondo, Claudio
通讯作者：
Tondo, Claudio
影响因子：
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January CT;Wann LS;Alpert JS;Calkins H;Cigarroa JE;Cleveland JC Jr;Conti JB;Ellinor PT;Ezekowitz MD;Field ME;Murray KT;Sacco RL;Stevenson WG;Tchou PJ;Tracy CM;Yancy CW;ACC/AHA Task Force Members
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通讯作者：
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