Kar Saibal, Doshi Shephal K, Alkhouli Mohamad, Camm A John, Coylewright Megan, Gibson Michael C, Granger Christopher B, Gurol Mahmut E, Huber Kenneth, Mansour Moussa, Nair Devi G, Natale Andrea, Pocock Stuart J, Reddy Vivek R, Saliba Walid, Christen Thomas, Allocco Dominic J, Ellenbogen Kenneth A, Leon Martin B
Los Robles Medical Center, Thousand Oaks, CA.
Pacific Heart Institute, Santa Monica, CA.
Am Heart J. 2023 Oct;264:123-132. doi: 10.1016/j.ahj.2023.05.022. Epub 2023 Jun 4.
Percutaneous left atrial appendage (LAA) closure (LAAC) was developed as a nonpharmacologic alternative to oral anticoagulants (OACs) in patients with atrial fibrillation (AF) who are at an increased risk for stroke or systemic embolism. The Watchman device permanently seals off the LAA to prevent thrombi from escaping into the circulation. Previous randomized trials have established the safety and efficacy of LAAC compared to warfarin. However, direct OACs (DOACs) have become the preferred pharmacologic strategy for stroke prevention in patients with AF, and there is limited data comparing Watchman FLX to DOACs in a broad AF patient population. CHAMPION-AF is designed to prospectively determine whether LAAC with Watchman FLX is a reasonable first-line alternative to DOACs in patients with AF who are indicated for OAC therapy.
A total of 3,000 patients with a CHA2DS2-VASc score ≥2 (men) or ≥3 (women) were randomized to Watchman FLX or DOAC in a 1:1 allocation at 142 global clinical sites. Patients in the device arm were to be treated with DOAC and aspirin, DOAC alone, or DAPT for at least 3 months postimplant followed by aspirin or P2Y12 inhibitor for 1-year. Control patients were required to take an approved DOAC for the duration of the trial. Clinical follow-up visits are scheduled at 3- and 12-months, and then annually through 5 years; LAA imaging is required at 4 months in the device group. Two primary end points will be evaluated at 3 years: (1) composite of stroke (ischemic/hemorrhagic), cardiovascular death, and systemic embolism compared for noninferiority, and (2) nonprocedural bleeding (International Society on Thrombosis and Haemostasis [ISTH] major and clinically relevant nonmajor bleeding) tested for superiority in the device arm against DOACs. The third primary noninferiority end point is the composite of ischemic stroke and systemic embolism at 5 years. Secondary end points include 3- and 5-year rates of (1) ISTH-defined major bleeding and (2) the composite of cardiovascular death, all stroke, systemic embolism, and nonprocedural ISTH bleeding.
This study will prospectively evaluate whether LAAC with the Watchman FLX device is a reasonable alternative to DOACs in patients with AF.
NCT04394546.
经皮左心耳（LAA）封堵术（LAAC）是作为房颤（AF）患者中风或全身性栓塞风险增加时口服抗凝剂（OAC）的非药物替代方案而开发的。Watchman装置可永久性封闭左心耳，以防止血栓逸入循环系统。既往随机试验已证实LAAC与华法林相比的安全性和有效性。然而，直接口服抗凝剂（DOAC）已成为房颤患者预防中风的首选药物策略，在广泛的房颤患者群体中，比较Watchman FLX与DOAC的资料有限。CHAMPION-AF旨在前瞻性地确定，对于有OAC治疗指征的房颤患者，使用Watchman FLX进行LAAC是否是DOAC合理的一线替代方案。
共有3000例CHA2DS2-VASc评分≥2（男性）或≥3（女性）的患者在142个全球临床地点按1:1比例随机分配至Watchman FLX组或DOAC组。器械组患者在植入后至少3个月接受DOAC和阿司匹林治疗、单独使用DOAC或双联抗血小板治疗（DAPT），随后1年服用阿司匹林或P2Y12抑制剂。对照组患者在试验期间需服用已获批的DOAC。临床随访安排在3个月和12个月时进行，然后每年随访直至5年；器械组在4个月时需进行左心耳成像检查。3年时将评估两个主要终点：（1）比较中风（缺血性/出血性）、心血管死亡和全身性栓塞的复合终点是否非劣效，（2）器械组相对于DOAC组，检测非手术相关出血（国际血栓与止血协会[ISTH]定义的大出血和临床相关非大出血）是否具有优效性。第三个主要非劣效终点是5年时缺血性中风和全身性栓塞的复合终点。次要终点包括3年和5年时（1）ISTH定义的大出血发生率，以及（2）心血管死亡、所有中风、全身性栓塞和非手术相关ISTH出血的复合终点发生率。
本研究将前瞻性评估对于房颤患者，使用Watchman FLX装置进行LAAC是否是DOAC的合理替代方案。
NCT04394546。
