Cappato Riccardo, Marchlinski Francis E, Hohnloser Stefan H, Naccarelli Gerald V, Xiang Jim, Wilber David J, Ma Chang-Sheng, Hess Susanne, Wells Darryl S, Juang George, Vijgen Johan, Hügl Burkhard J, Balasubramaniam Richard, De Chillou Christian, Davies D Wyn, Fields L Eugene, Natale Andrea
Arrhythmia and Electrophysiology Center, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy Gavazzeni Hospital, Second Arrhythmia and EP Unit, Bergamo, Italy.
Section of Cardiac Electrophysiology, Hospital of the University of Pennsylvania, Philadelphia, PA, USA.
Eur Heart J. 2015 Jul 21;36(28):1805-11. doi: 10.1093/eurheartj/ehv177. Epub 2015 May 14.
VENTURE-AF is the first prospective randomized trial of uninterrupted rivaroxaban and vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation (NVAF) undergoing catheter ablation (CA).
Trial size was administratively set at 250, the protocol-specified target. Events were independently and blindly adjudicated. We randomly assigned 248 NVAF patients to uninterrupted rivaroxaban (20 mg once-daily) or to an uninterrupted VKA prior to CA and for 4 weeks afterwards. The primary endpoint was major bleeding events after CA. Secondary endpoints included thromboembolic events (composite of stroke, systemic embolism, myocardial infarction, and vascular death) and other bleeding or procedure-attributable events. Patients were 59.5 ± 10 years of age, 71% male, 74% paroxysmal AF, and had a CHA2DS2-VASc score of 1.6. The average total heparin dose used to manage activated clotting time (ACT) was slightly higher (13 871 vs. 10 964 units; P < 0.001) and the mean ACT level attained slightly lower (302 vs. 332 s; P < 0.001) in rivaroxaban and VKA arms, respectively. The incidence of major bleeding was low (0.4%; 1 major bleeding event). Similarly, thromboembolic events were low (0.8%; 1 ischemic stroke and 1 vascular death). All events occurred in the VKA arm and all after CA. The number of any adjudicated events (26 vs. 25), any bleeding events (21 vs. 18), and any other procedure-attributable events (5 vs. 5) were similar.
In patients undergoing CA for AF, the use of uninterrupted oral rivaroxaban was feasible and event rates were similar to those for uninterrupted VKA therapy.
Clinicaltrials.gov trial registration number is NCT01729871.
VENTURE - AF是第一项针对接受导管消融术（CA）的非瓣膜性心房颤动（NVAF）患者进行不间断利伐沙班与维生素K拮抗剂（VKA）对比的前瞻性随机试验。
试验规模根据管理规定设定为方案指定的目标值250例。事件由独立且盲法判定。我们将248例NVAF患者随机分为两组，一组在CA术前及术后4周接受不间断利伐沙班治疗（每日一次，20毫克），另一组接受不间断VKA治疗。主要终点是CA术后的大出血事件。次要终点包括血栓栓塞事件（中风、全身性栓塞、心肌梗死和血管性死亡的复合事件）以及其他出血或与手术相关的事件。患者年龄为59.5±10岁，男性占71%，阵发性房颤占74%，CHA2DS2 - VASc评分为1.6。在利伐沙班组和VKA组中，用于控制活化凝血时间（ACT）的平均总肝素剂量略高（分别为13871单位和10964单位；P<0.001），而达到的平均ACT水平略低（分别为302秒和332秒；P<0.001）。大出血发生率较低（0.4%；1例大出血事件）。同样，血栓栓塞事件发生率也较低（0.8%；1例缺血性中风和1例血管性死亡）。所有事件均发生在VKA组，且均在CA术后。经判定的任何事件（26例对25例）、任何出血事件（21例对18例）以及任何其他与手术相关的事件（5例对5例）数量相似。
对于接受CA治疗的房颤患者，使用不间断口服利伐沙班是可行的，且事件发生率与不间断VKA治疗相似。
Clinicaltrials.gov试验注册号为NCT01729871。
