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)
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)
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DOI：
10.1016/j.ahj.2016.05.007
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发表时间：
2016-08-01
影响因子：
4.8
通讯作者：
Cohen, Ariel
中科院分区：
文献类型：
--
作者：
Lip, Gregory Y. H.;Hammerstingl, Christoph;Cohen, Ariel
背景：关于非维生素K拮抗剂（VKA）口服抗凝治疗后左房/左房附件（LA/LAA）血栓溶解的数据很少。X-TRA的主要目的是探索利伐沙班在非瓣膜性心房颤动（AF）或心房扑动患者的LA/LAA血栓消退中的应用，在这种情况下，CLOT-AF登记提供了标准治疗后的回顾性数据。方法X-TRA是一项前瞻性、单组、开放标签、多中心研究，研究了利伐沙班治疗6周对经食管超声心动图（TEE）基线证实有LA/LAA血栓的非瓣膜性房颤或心房颤振患者LA/LAA血栓溶解的作用。CLOT-AF回顾性收集非瓣膜性房颤或心房扑动患者经标准治疗抗凝治疗3至12周后与血栓相关的患者预后数据，这些患者在TEE上有LA/LAA血栓，并记录在其医疗档案中。结果X-TRA患者主要（95.0%）来自东欧国家。根据中心TEE评估，确定的血栓溶解率为41.5%（22/53例修改意向治疗[mITT]患者，95% CI 28.1% -55.9%）。60.4%（32/53例mITT患者，95% CI 46.0%-73.6%）的患者血栓溶解或缩小。在CLOT-AF中，报告的血栓溶解率为62.5%(60/96例mITT患者，95% CI为52.0%-72.2%)，西欧国家（34/50;68.0%）优于东欧国家（26/46;56.5%）。结论X-TRA是首个前瞻性、多中心研究，在VKA初发患者或VKA治疗次优患者中，使用非VKA口服抗凝剂检测LA/LAA血栓溶解。利伐沙班可能是治疗LA/LAA血栓的潜在选择。
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-naive patients or in patients with suboptimal VKA therapy. Rivaroxaban could be a potential option for the treatment of LA/LAA thrombi.