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一项评估依度沙班对房颤患者左心房血栓溶解有效性的前瞻性研究。

A Prospective Study to Evaluate the Effectiveness of Edoxaban for the Resolution of Left Atrial Thrombosis in Patients with Atrial Fibrillation.

作者信息

Patti Giuseppe, Parato Vito Maurizio, Cavallari Ilaria, Calabrò Paolo, Russo Vincenzo, Renda Giulia, Gragnano Felice, Pengo Vittorio, D'Onofrio Antonio, Grimaldi Massimo, De Caterina Raffaele

机构信息

Maggiore della Carità Hospital, University of Eastern Piedmont, 28100 Novara, Italy.

Madonna del Soccorso Hospital, 63074 San Benedetto del Tronto, Italy.

出版信息

J Clin Med. 2022 Mar 31;11(7):1945. doi: 10.3390/jcm11071945.

DOI:10.3390/jcm11071945
PMID:35407553
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8999540/
Abstract

Available evidence on left atrial (LA) thrombus dissolution in patients with atrial fibrillation (AF) largely refers to the use of vitamin K antagonist oral anticoagulants (VKAs), showing >50% thrombus resolution over a 4-week to 12-month treatment period. Available data on non-vitamin K antagonist anticoagulants (NOACs) in this setting are limited and derive from isolated case reports or observational small-sized investigations with dabigatran, rivaroxaban or apixaban. The aim of this study was to investigate the extent of thrombus resolution with edoxaban therapy in patients with AF and LA thrombosis. We conducted a prospective, observational, open-label pilot study in seven Italian institutions. We included a total of 25 patients with non-valvular AF and LA (or left atrial appendage (LAA)) thrombosis, documented by transesophageal echocardiography (TEE). All patients received edoxaban OD treatment (n = 23 on 60 mg daily; n = 2 on 30 mg daily) and underwent TEE examination after 4 weeks. The primary endpoint was the percentage of patients with complete thrombus resolution by TEE imaging at 4 weeks. The mean age of the study population was 68.3 ± 10.8 years with a female population of 16%. AF was permanent in all cases, with a mean arrhythmia duration of 4.3 ± 1.7 years. CHA2DS2-VASc and HAS-BLED scores were 3.2 ± 1.5 and 1.9 ± 1.1, respectively. We were able to demonstrate a complete thrombus resolution in 14 patients (56%) at 4 weeks. In patients with residual atrial thrombosis (n = 11), we observed a 15.4 ± 14.9% reduction in the thrombus area from baseline. As compared with patients without thrombus dissolution, those with thrombus resolution had a numerically lower-indexed LA diameter (27.9 ± 9.3 vs 34.8 ± 16.1 mm/m2), a smaller maximum thrombus area at baseline (45.5 ± 44.6 vs 63.9 ± 43.5 mm2), a higher left ventricular ejection fraction (47.4 ± 21.0% vs 38.4 ± 20.6%) and higher maximum LAA flow velocities (26.3 ± 15.2 vs 19.3 ± 10.0 cm/s). Figures on the percentage of thrombus resolution in this study are comparable to those reported in the literature for the other OACs. We conclude that, in patients with AF, the use of edoxaban is associated with a >50% resolution of atrial thrombus at 4 weeks, similar to studies using VKAs and the other NOACs (ClinicalTrials.gov identifier number: NCT034899395).

摘要

关于心房颤动(AF)患者左心房(LA)血栓溶解的现有证据主要涉及维生素K拮抗剂口服抗凝剂(VKA)的使用,显示在4周至12个月的治疗期内血栓溶解率超过50%。在这种情况下,关于非维生素K拮抗剂抗凝剂(NOAC)的现有数据有限,且来自于使用达比加群、利伐沙班或阿哌沙班的个别病例报告或观察性小型研究。本研究的目的是调查依度沙班治疗AF和LA血栓形成患者时血栓溶解的程度。我们在意大利的七个机构进行了一项前瞻性、观察性、开放标签的试点研究。我们纳入了总共25例经食管超声心动图(TEE)证实患有非瓣膜性AF和LA(或左心耳(LAA))血栓形成的患者。所有患者接受依度沙班每日一次治疗(23例每日60mg;2例每日30mg),并在4周后接受TEE检查。主要终点是4周时通过TEE成像显示完全血栓溶解的患者百分比。研究人群的平均年龄为68.3±10.8岁,女性占16%。所有病例中AF均为永久性,平均心律失常持续时间为4.3±1.7年。CHA2DS2-VASc和HAS-BLED评分分别为3.2±1.5和1.9±1.1。我们能够证明14例患者(56%)在4周时完全血栓溶解。在有残余心房血栓的患者(n = 11)中,我们观察到血栓面积较基线减少了15.4±14.9%。与无血栓溶解的患者相比,有血栓溶解的患者在数值上有较低的LA直径指数(27.9±9.3 vs 34.8±16.1 mm/m2)、基线时较小的最大血栓面积(45.5±44.6 vs 63.9±43.5 mm2)、较高的左心室射血分数(47.4±21.0% vs 38.4±20.6%)和较高的最大LAA血流速度(26.3±15.2 vs 19.3±10.0 cm/s)。本研究中血栓溶解百分比的数据与文献中报道的其他口服抗凝剂的数据相当。我们得出结论,在AF患者中,使用依度沙班与4周时心房血栓溶解率>50%相关,类似于使用VKA和其他NOAC的研究(ClinicalTrials.gov标识符编号:NCT034899395)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c4d5/8999540/2576db835bf9/jcm-11-01945-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c4d5/8999540/2576db835bf9/jcm-11-01945-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c4d5/8999540/2576db835bf9/jcm-11-01945-g001.jpg

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