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心房颤动或心房扑动患者左心房血栓溶解情况:利伐沙班前瞻性研究(X-TRA)及提供基线数据的回顾性观察登记研究(CLOT-AF)结果

Left atrial thrombus resolution in atrial fibrillation or flutter: Results of a prospective study with rivaroxaban (X-TRA) and a retrospective observational registry providing baseline data (CLOT-AF).

作者信息

Lip Gregory Y H, Hammerstingl Christoph, Marin Francisco, Cappato Riccardo, Meng Isabelle Ling, Kirsch Bodo, van Eickels Martin, Cohen Ariel

机构信息

University of Birmingham Institute of Cardiovascular Sciences, City Hospital, Birmingham, United Kingdom; Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.

Department of Medicine II, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.

出版信息

Am Heart J. 2016 Aug;178:126-34. doi: 10.1016/j.ahj.2016.05.007. Epub 2016 May 17.

Abstract

BACKGROUND

Data on left atrial/left atrial appendage (LA/LAA) thrombus resolution after non-vitamin K antagonist (VKA) oral anticoagulant treatment are scarce. The primary objective of X-TRA was to explore the use of rivaroxaban for the resolution of LA/LAA thrombi in patients with nonvalvular atrial fibrillation (AF) or atrial flutter, with the CLOT-AF registry providing retrospective data after standard-of-care therapy in this setting.

METHODS

X-TRA was a prospective, single-arm, open-label, multicenter study that investigated rivaroxaban treatment for 6 weeks for LA/LAA thrombus resolution in patients with nonvalvular AF or atrial flutter and LA/LAA thrombus confirmed at baseline on a transesophageal echocardiogram (TEE). CLOT-AF retrospectively collected thrombus-related patient outcome data after standard-of-care anticoagulant treatment for 3 to 12 weeks in patients with nonvalvular AF or atrial flutter who had LA/LAA thrombi on TEE recorded in their medical file.

RESULTS

In X-TRA, patients were predominantly (95.0%) from Eastern European countries. The adjudicated thrombus resolution rate was 41.5% (22/53 modified intention-to-treat [mITT] patients, 95% CI 28.1%-55.9%) based on central TEE assessments. Resolved or reduced thrombus was evident in 60.4% (32/53 mITT patients, 95% CI 46.0%-73.6%) of patients. In CLOT-AF, the reported thrombus resolution rate was 62.5% (60/96 mITT patients, 95% CI 52.0%-72.2%) and appeared better in Western European countries (34/50; 68.0%) than in Eastern European countries (26/46; 56.5%).

CONCLUSION

X-TRA is the first prospective, multicenter study examining LA/LAA thrombus resolution with a non-VKA oral anticoagulant in VKA-naïve patients or in patients with suboptimal VKA therapy. Rivaroxaban could be a potential option for the treatment of LA/LAA thrombi.

摘要

背景

关于非维生素K拮抗剂(VKA)口服抗凝治疗后左心房/左心耳(LA/LAA)血栓溶解的数据较少。X-TRA研究的主要目的是探讨利伐沙班用于非瓣膜性心房颤动(AF)或心房扑动患者LA/LAA血栓溶解的效果,CLOT-AF注册研究提供了在此情况下标准治疗后的回顾性数据。

方法

X-TRA是一项前瞻性、单臂、开放标签、多中心研究,调查了利伐沙班治疗6周对非瓣膜性AF或心房扑动且经食管超声心动图(TEE)在基线时确诊有LA/LAA血栓的患者的LA/LAA血栓溶解情况。CLOT-AF回顾性收集了在医疗档案中记录有TEE显示LA/LAA血栓的非瓣膜性AF或心房扑动患者在接受3至12周标准抗凝治疗后的血栓相关患者结局数据。

结果

在X-TRA研究中,患者主要(95.0%)来自东欧国家。根据中心TEE评估,判定的血栓溶解率为41.5%(53例改良意向性治疗[mITT]患者中的22例,95%CI 28.1%-55.9%)。60.4%(53例mITT患者中的32例,95%CI 46.0%-73.6%)的患者血栓溶解或缩小。在CLOT-AF研究中,报告的血栓溶解率为62.5%(96例mITT患者中的60例,95%CI 52.0%-72.2%),并且在西欧国家(34/50;68.0%)似乎比东欧国家(26/46;56.5%)更好。

结论

X-TRA是第一项前瞻性、多中心研究,在未使用VKA的患者或VKA治疗效果欠佳的患者中,研究非VKA口服抗凝剂对LA/LAA血栓溶解的情况。利伐沙班可能是治疗LA/LAA血栓的一个潜在选择。

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