Al Rawahi Mohamed N, Al-Maqbali Juhaina S, Al Noumani Jawahar, Al Alawi Abdullah M, Essebag Vidal
Medicine, Sultan Qaboos University Hospital, Muscat, OMN.
Clinical Pharmacy, Department of Pharmacy, Sultan Qaboos University Hospital, Muscat, OMN.
Cureus. 2023 Jan 1;15(1):e33222. doi: 10.7759/cureus.33222. eCollection 2023 Jan.
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.
不推荐在中重度二尖瓣狭窄（MS）合并心房颤动（AF）的患者中使用新型口服抗凝药（NOAC）。我们旨在评估与维生素K拮抗剂（VKA）相比，NOAC在中重度MS合并AF患者中的疗效和安全性。我们进行了一项系统评价，以确定在中重度MS合并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）符合我们的检索标准，共报道了7529例MS合并AF患者，其中4138例接受了NOAC治疗。在两项观察性研究中，MS的严重程度未确定，且MS病因存在异质性。尽管如此，两项研究均显示，在该人群中，与VKA相比，NOAC在疗效和安全性方面有积极信号。对中重度MS患者进行了一项随机试点试验（n = 40），结果显示利伐沙班的疗效和安全性进一步可接受。然而，一项更大规模的随机对照试验（n = 4531）显示，VKA（华法林）导致的心血管事件或死亡率综合发生率显著低于利伐沙班，且大出血而非致命性出血的发生率没有更高。我们的系统评价提供了关于NOAC在MS患者中的安全性和有效性的探索性信息；它也不鼓励在中重度MS患者中使用NOAC，并支持当前的治疗指南。然而，更多专门评估NOAC在中重度MS中使用的临床试验正在进行中。它们将明确确定NOAC在这一高危人群中的安全性和临床有效性。
