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非维生素 K 拮抗剂口服抗凝剂在心房颤动和生物瓣心脏瓣膜/既往手术瓣膜修复患者中的应用:一项多中心临床实践经验。

Nonvitamin K Antagonist Oral Anticoagulants Use in Patients with Atrial Fibrillation and Bioprosthetic Heart Valves/Prior Surgical Valve Repair: A Multicenter Clinical Practice Experience.

机构信息

Chair of Cardiology, University of Campania "Luigi Vanvitelli," Monaldi Hospital, Naples, Italy.

Department of Cardiology, Fatebenefratelli Hospital, Naples, Italy.

出版信息

Semin Thromb Hemost. 2018 Jun;44(4):364-369. doi: 10.1055/s-0037-1615261. Epub 2018 Jan 5.

Abstract

This is an observational study to investigate the efficacy and safety of nonvitamin K antagonist oral anticoagulants (NOACs) in atrial fibrillation (AF) patients with bioprosthetic valves or prior surgical valve repair in clinical practice. A total of 122 patients (mean age: 74.1 ± 13.2; 54 females) with bioprosthetic heart valve or surgical valve repair and AF treated with NOACs were included in the analysis. The mean CHADS-VASc (Congestive heart failure, Hypertension, Age >75 years, Diabetes mellitus, prior Stroke or transient ischemic attack, Vascular disease) and HAS-BLED (Hypertension, Abnormal renal and liver function, Stroke, Bleeding, Labile INR [international normalized ratio], Elderly, Drugs or alcohol) score values were 3.6 ± 1.2 and 2.6 ± 1.4, respectively. Of the total study population, 28.6% was taking apixaban 5 mg twice daily (BID), 24.5% apixaban 2.5 mg BID, 18% dabigatran 150 mg BID, 13% dabigatran 110 mg BID, 9.8% rivaroxaban 20 mg daily (QD), and 5.7% rivaroxaban 15 mg QD. Also, 92% of the study population previously had warfarin replaced with NOACs due to lack compliance and labile INR control (time in therapeutic range < 60%). NOAC therapy for AF was started on average 934 ± 567 days after bioprosthetic heart valve implantation or surgical repair for an average duration of 835 ± 203 days. The study population included 24 (19.6%) patients with bioprosthetic mitral valve, 52 (43%) patients with bioprosthetic aortic valve, 41 (33.6%) patients with previous surgical mitral repair, 5 (4%) patients with previous surgical aortic repair, and concomitant use of NOACs. All patients were evaluated for thromboembolic events (ischemic stroke, transient ischemic attack, systemic embolism) as well as major bleeding events during the follow-up period. In our study population, we recorded a low mean annual incidence of thromboembolism (0.8%) and major bleeding (1.3%). According to our data, anticoagulation therapy with NOACs seems to be an effective and a safe treatment strategy for nonvalvular AF patients with bioprosthetic valves or prior surgical valve repair.

摘要

这是一项观察性研究,旨在调查非维生素 K 拮抗剂口服抗凝剂(NOACs)在生物瓣或既往心脏瓣膜修复术后的心房颤动(AF)患者中的疗效和安全性。共纳入 122 例(平均年龄:74.1±13.2;54 例女性)接受 NOACs 治疗的生物瓣或心脏瓣膜修复术后的 AF 患者。平均 CHADS-VASc(充血性心力衰竭、高血压、年龄>75 岁、糖尿病、既往卒中和短暂性脑缺血发作、血管疾病)和 HAS-BLED(高血压、肾功能和肝功能异常、卒中和短暂性脑缺血发作、出血、INR 不稳定、年龄较大、药物或酒精)评分分别为 3.6±1.2 和 2.6±1.4。在总研究人群中,28.6%的患者服用 5mg 每日两次的阿哌沙班(BID),24.5%的患者服用 2.5mg BID,18%的患者服用 150mg BID 的达比加群,13%的患者服用 110mg BID 的达比加群,9.8%的患者服用 20mg 每日一次的利伐沙班(QD),5.7%的患者服用 15mg QD 的利伐沙班。此外,92%的研究人群因依从性差和 INR 不稳定(治疗范围内时间<60%)而将华法林替换为 NOACs。NOAC 治疗 AF 的起始时间平均为生物瓣植入或心脏瓣膜修复术后 934±567 天,平均持续时间为 835±203 天。研究人群包括 24 例(19.6%)二尖瓣生物瓣患者、52 例(43%)主动脉瓣生物瓣患者、41 例(33.6%)既往二尖瓣修复术患者、5 例(4%)既往主动脉瓣修复术患者和同时使用 NOACs 的患者。在随访期间,所有患者均评估了血栓栓塞事件(缺血性卒中、短暂性脑缺血发作、全身性栓塞)和大出血事件的发生情况。在我们的研究人群中,我们记录了较低的平均年血栓栓塞发生率(0.8%)和大出血发生率(1.3%)。根据我们的数据,NOACs 的抗凝治疗似乎是一种有效的、安全的治疗策略,适用于生物瓣或既往心脏瓣膜修复术后的非瓣膜性 AF 患者。

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