PDF(Pubmed)
Abstract：
The use of novel oral anticoagulants (NOAC) in patients with moderate to severe mitral stenosis (MS) and atrial fibrillation (AF) is not recommended. We aimed to evaluate the efficacy and safety of NOAC usage compared to vitamin K antagonist (VKA) in patients with moderate to severe MS and AF. We conducted a systematic review to identify articles that compared warfarin to NOAC in patients with moderate to severe MS and AF. Only four studies (two observational studies and two trials) met our search criteria and reported a total of 7529 patients with MS and AF with MS and AF, 4138 of them treated with NOAC. In both observational studies, the severity of MS was not determined, and there was heterogeneity in MS etiology. Nevertheless, both studies showed a positive signal toward the efficacy and safety of NOAC compared to VKA in this population. A randomized pilot trial (n=40) was done on patients with moderate to severe MS, and it showed further acceptable efficacy and safety for rivaroxaban use. However, a larger randomized controlled trial (n=4531) disclosed that VKA (warfarin) led to a significantly lower rate of a composite of cardiovascular events or mortality than rivaroxaban, without a higher rate of major bleeding but not fatal bleeding. Our systematic review provides exploratory information on NOAC safety and effectiveness in patients with MS; it also discourages using NOACs for patients with moderate to severe MS and supports the current treatment guidelines. However, more dedicated clinical trials evaluating the use of NOACs in moderate to severe MS are underway. They will categorically establish the safety profile and clinical effectiveness of NOAC in this high-risk population.
摘要：
不建议在中度至重度二尖瓣狭窄（MS）和心房颤动（AF）的患者中使用新型口服抗凝剂（NOAC）。我们旨在评估NOAC与维生素K拮抗剂（VKA）在中度至重度MS和AF患者中的疗效和安全性。我们进行了系统评价，以确定在中度至重度MS和AF患者中比较华法林与NOAC的文章。只有四项研究（两项观察性研究和两项试验）符合我们的搜索标准，报告了总共7529例MS和AF患者。其中4138人用NOAC治疗。在两项观察性研究中，MS的严重程度尚未确定，MS病因存在异质性。然而，两项研究均显示,在该人群中,与VKA相比,NOAC的疗效和安全性呈正信号.对中度至重度MS患者进行了一项随机试点试验（n=40），它显示了利伐沙班使用的进一步可接受的疗效和安全性。然而,一项更大的随机对照试验（n=4531）显示，与利伐沙班相比，VKA（华法林）导致心血管事件或死亡率的复合比率显着降低，没有较高的大出血率，但不是致命性出血。我们的系统评价提供了有关NOAC在MS患者中的安全性和有效性的探索性信息；它也不鼓励对中度至重度MS患者使用NOAC，并支持当前的治疗指南。然而,正在进行更多专门的临床试验,以评估NOAC在中度至重度MS中的应用.他们将明确确定NOAC在这一高风险人群中的安全性和临床有效性。
