评估直接口服抗凝剂在伴有瓣膜性心脏病的心房颤动患者中的安全性和有效性。

Evaluation of the Safety and Effectiveness of Direct-Acting Oral Anticoagulants in Patients with Atrial Fibrillation and Coexisting Valvular Heart Disease.

机构信息

Missouri Baptist Medical Center, St. Louis, MO, USA.

St. Louis College of Pharmacy, St. Louis, MO, USA.

出版信息

Am J Cardiovasc Drugs. 2020 Dec;20(6):611-617. doi: 10.1007/s40256-020-00398-x.

DOI:10.1007/s40256-020-00398-x

PMID:32043243

Abstract

BACKGROUND

Current guidelines recommend direct-acting oral anticoagulants (DOACs) over warfarin in patients with atrial fibrillation (AF) and valvular heart disease (VHD) without a mechanical valve or moderate to severe mitral stenosis. However, real-world data to support the safety and efficacy of DOACs in this patient population are lacking.

OBJECTIVE

Our objective was to assess the safety and effectiveness of DOACs in patients with AF and VHD.

METHODS

This retrospective chart review evaluated patients aged ≥ 18 years with a diagnosis of AF and at least moderate VHD on echocardiogram. Patients were included if they received ≥ 1 month of DOAC therapy from December 2016 to December 2018. Patients were excluded if they received dual antiplatelet therapy or had additional indications for anticoagulation. The primary outcomes were incidence of stroke or systemic embolism (SSE) and major bleeding.

RESULTS

In total, 200 patients were included (disease type: aortic, n = 50; mitral, n = 50; tricuspid, n = 50; multivalve, n = 50). Most patients received apixaban (n = 133 [66.5%]) followed by rivaroxaban (n = 50 [25%]) and dabigatran (n = 17 [8.5%]). No patients received edoxaban. The mean CHADS-VASc score was 4.25 and was similar among DOAC cohorts (p = 0.380). The overall SSE rate was 3.5% and was highest for dabigatran (n = 3 [17.6%]) compared with the other DOACs (apixaban, n = 1 [0.8%]; rivaroxaban, n = 3 [6%]; p = 0.001). Rates were similar among different valve types (aortic, n = 3 [6%]; mitral, n = 1 [2%]; tricuspid, n = 2 [4%]; multivalve, n = 1 [2%]; p = 0.653). The overall rate of major bleeding was 5.5% and did not differ among the DOACs (apixaban, n = 5 [3.8%]; rivaroxaban, n = 4 [8%]; dabigatran, n = 2 [11.8%]; p = 0.264) or valve type (aortic, n = 3 [6%]; mitral, n = 2 [4%]; tricuspid, n = 2 [4%]; multivalve, n = 4 [8%]; p = 0.787).

CONCLUSIONS

In patients with AF and VHD, rates of major bleeding were similar among the DOACs and valve types; however, more patients receiving dabigatran experienced SSE. Further studies are needed to validate these findings.

摘要

背景

目前的指南建议在有房颤（AF）和瓣膜性心脏病（VHD）且无机械瓣或中重度二尖瓣狭窄的患者中使用直接口服抗凝剂（DOAC）代替华法林。然而，缺乏支持 DOAC 在这一患者人群中安全性和有效性的真实世界数据。

目的

我们的目的是评估 DOAC 在有 AF 和 VHD 的患者中的安全性和有效性。

方法

这项回顾性图表审查评估了年龄≥18 岁且超声心动图显示至少有中度 VHD 的 AF 患者。如果患者在 2016 年 12 月至 2018 年 12 月期间接受了至少 1 个月的 DOAC 治疗，则将其纳入研究。如果患者接受双联抗血小板治疗或有其他抗凝指征，则将其排除。主要结局为卒中或全身性栓塞（SSE）和大出血的发生率。

结果

共有 200 名患者入选（疾病类型：主动脉瓣，n=50；二尖瓣，n=50；三尖瓣，n=50；多瓣膜，n=50）。大多数患者接受阿哌沙班（n=133[66.5%]）治疗，其次是利伐沙班（n=50[25%]）和达比加群（n=17[8.5%]）。没有患者接受依度沙班治疗。平均 CHADS-VASc 评分为 4.25，且在 DOAC 组间相似（p=0.380）。总的 SSE 发生率为 3.5%，达比加群最高（n=3[17.6%]），与其他 DOAC 相比（阿哌沙班，n=1[0.8%]；利伐沙班，n=3[6%]；p=0.001）。不同瓣膜类型之间的发生率相似（主动脉瓣，n=3[6%]；二尖瓣，n=1[2%]；三尖瓣，n=2[4%]；多瓣膜，n=1[2%]；p=0.653）。总的大出血发生率为 5.5%，且在 DOAC 之间无差异（阿哌沙班，n=5[3.8%]；利伐沙班，n=4[8%]；达比加群，n=2[11.8%]；p=0.264）或瓣膜类型（主动脉瓣，n=3[6%]；二尖瓣，n=2[4%]；三尖瓣，n=2[4%]；多瓣膜，n=4[8%]；p=0.787）。