左心耳封堵术与直接口服抗凝剂在伴有心房颤动的高危患者中的比较。

Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation.

机构信息

Cardiocenter, Third Faculty of Medicine, Charles University Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic.

出版信息

J Am Coll Cardiol. 2020 Jun 30;75(25):3122-3135. doi: 10.1016/j.jacc.2020.04.067.

DOI:10.1016/j.jacc.2020.04.067

PMID:32586585

Abstract

BACKGROUND

Percutaneous left atrial appendage closure (LAAC) is noninferior to vitamin K antagonists (VKAs) for preventing atrial fibrillation (AF)-related stroke. However, direct oral anticoagulants (DOACs) have an improved safety profile over VKAs, and their effect on cardiovascular and neurological outcomes relative to LAAC is unknown.

OBJECTIVES

This study sought to compare DOACs with LAAC in high-risk patients with AF.

METHODS

Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation (PRAGUE-17) was a multicenter, randomized, noninferiority trial comparing LAAC with DOACs. Patients were eligible to be enrolled if they had nonvalvular AF; were indicated for oral anticoagulation (OAC); and had a history of bleeding requiring intervention or hospitalization, a history of a cardioembolic event while taking an OAC, and/or a CHADS-VASc of ≥3 and HAS-BLED of >2. Patients were randomized to receive LAAC or DOAC. The primary composite outcome was stroke, transient ischemic attack, systemic embolism, cardiovascular death, major or nonmajor clinically relevant bleeding, or procedure-/device-related complications. The primary analysis was by modified intention to treat.

RESULTS

A high-risk patient cohort (CHADS-VASc: 4.7 ± 1.5) was randomized to receive LAAC (n = 201) or DOAC (n = 201). LAAC was successful in 181 of 201 (90.0%) patients. In the DOAC group, apixaban was most frequently used (192 of 201; 95.5%). At a median 19.9 months of follow-up, the annual rates of the primary outcome were 10.99% with LAAC and 13.42% with DOAC (subdistribution hazard ratio [sHR]: 0.84; 95% confidence interval [CI]: 0.53 to 1.31; p = 0.44; p = 0.004 for noninferiority). There were no differences between groups for the components of the composite endpoint: all-stroke/TIA (sHR: 1.00; 95% CI: 0.40 to 2.51), clinically significant bleeding (sHR: 0.81; 95% CI: 0.44 to 1.52), and cardiovascular death (sHR: 0.75; 95% CI: 0.34 to 1.62). Major LAAC-related complications occurred in 9 (4.5%) patients.

CONCLUSIONS

Among patients at high risk for stroke and increased risk of bleeding, LAAC was noninferior to DOAC in preventing major AF-related cardiovascular, neurological, and bleeding events. (Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation [PRAGUE-17]; NCT02426944).

摘要

背景

经皮左心耳封堵术（LAAC）在预防房颤（AF）相关卒中方面不劣于维生素 K 拮抗剂（VKA）。然而，直接口服抗凝剂（DOAC）的安全性优于 VKA，其相对于 LAAC 的心血管和神经结局的影响尚不清楚。

目的

本研究旨在比较 DOAC 与 AF 高危患者的 LAAC。

方法

左心耳封堵与新型抗凝药物在房颤中的比较（PRAGUE-17）是一项多中心、随机、非劣效性试验，比较 LAAC 与 DOAC。如果患者患有非瓣膜性 AF；需要口服抗凝治疗（OAC）；并且有需要干预或住院治疗的出血史、在服用 OAC 时发生心源性栓塞事件的病史，和/或 CHADS-VASc 评分≥3 分和 HAS-BLED 评分＞2 分，则有资格被纳入。患者被随机分配接受 LAAC 或 DOAC。主要复合终点是卒中、短暂性脑缺血发作、全身性栓塞、心血管死亡、大出血或非大出血、或与手术/器械相关的并发症。主要分析采用改良意向治疗。

结果

一个高危患者队列（CHADS-VASc：4.7±1.5）被随机分配接受 LAAC（n=201）或 DOAC（n=201）。201 例患者中有 181 例（90.0%）LAAC 成功。在 DOAC 组中，阿哌沙班是最常使用的药物（192/201；95.5%）。在中位 19.9 个月的随访中，LAAC 的主要结局年发生率为 10.99%，DOAC 为 13.42%（亚分布危险比[ sHR ]：0.84；95%置信区间[CI]：0.53 至 1.31；p=0.44；p=0.004 用于非劣效性）。两组之间复合终点的各组成部分无差异：所有卒中/TIA（sHR：1.00；95%CI：0.40 至 2.51）、临床显著出血（sHR：0.81；95%CI：0.44 至 1.52）和心血管死亡（sHR：0.75；95%CI：0.34 至 1.62）。9 例（4.5%）患者发生主要 LAAC 相关并发症。