Asundexian or Apixaban in Patients With Atrial Fibrillation According to Prior Oral Anticoagulant Use: A Subgroup Analysis of the OCEANIC-AF Randomized Clinical Trial.

Background

To investigate if patients with less prior OAC exposure respond differently to a new OAC than patients with more OAC exposure.

研究旨在调查那些之前较少接触口服抗凝药物（OAC）的患者，对于新型口服抗凝药物的反应是否与那些接触较多的患者有所不同。

DESIGN, SETTING, AND PARTICIPANTS: In this prespecified exploratory subgroup analysis of the Oral Factor 11a Inhibitor Asundexian as Novel Antithrombotic-Atrial Fibrillation (OCEANIC-AF) randomized clinical trial, patients enrolled in the OCEANIC-AF trial were categorized as OAC naive or OAC experienced based on whether they had 6 or fewer weeks or more than 6 weeks of prior OAC use.

在OCEANIC-AF随机临床试验的预先指定的探索性亚组分析中，根据患者是否曾经使用过6周或更少的口服抗凝药物（OAC），将OCEANIC-AF试验中的患者分类为OAC初治或OAC经验者。

The effect of asundexian vs apixaban was then compared on outcomes among patients who were OAC naive and OAC experienced.

然后比较了asundexian与阿哌沙班在OAC初治和OAC经验患者中的效果差异。

The study setting included 1035 sites in 38 countries, and participants were those enrolled in the OCEANIC-AF trial. Data were analyzed from June to July 2024.

研究设置涵盖了38个国家的1035个地点，参与者是OCEANIC-AF试验中注册的患者。数据在2024年6月至7月期间进行了分析。

Methods

Asundexian, a novel factor XIa inhibitor, was compared with apixaban in patients with AF.

Asundexian，一种新型的因子XIa抑制剂，与阿哌沙班在房颤患者中进行了比较。

main_outcomes_and_measures

The primary efficacy outcome was stroke or systemic embolism.

主要疗效终点是中风或全身性栓塞。

The main safety outcome was major bleeding.

主要安全性终点是重大出血。

Results

Of patients in the OCEANIC-AF trial, 2493 (17%) were OAC naive (mean [SD] age, 72.6 [8.6] years; 1464 male [59%]) and 12 317 (83%) were OAC experienced (mean [SD] age, 74.2 [7.5] years; 8132 male [66%]).

在OCEANIC-AF试验中，2493名患者（17%）为OAC初治（平均年龄[标准差]为72.6[8.6]岁；1464名为男性[59%]），12317名患者（83%）为OAC经验者（平均年龄[标准差]为74.2[7.5]岁；8132名为男性[66%]）。

In the asundexian arm, patients who were OAC naive had a stroke or systemic embolism rate of 0.8% (10 of 1238) compared with 1.4% (88 of 6177) in those who were OAC experienced.

在阿松德沙星组中，OAC初治患者的中风或全身性栓塞发生率为0.8%（1238名患者中有10例），而在OAC经验者中这一比例为1.4%（6177名患者中有88例）。

In the apixaban arm, patients who were OAC naive had a stroke or systemic embolism rate of 0.6% (7 of 1255) compared with 0.3% (19 of 6140) in those who were OAC experienced.

在阿哌沙班组中，未接受过口服抗凝治疗（OAC）的患者发生中风或全身性栓塞的比率为0.6%（7/1255），而有OAC经验的患者为0.3%（19/6140）。

Thus, patients who were OAC naive had a smaller increase in stroke or systemic embolism with asundexian compared with apixaban (hazard ratio[HR], 1.42; 95% CI, 0.54-3.73) than patients who were OAC experienced (HR, 4.66; 95% CI, 2.84-7.65; P for interaction =.03).

因此，与阿哌沙班相比，未接受过OAC治疗的患者使用阿桑德塞安后发生中风或全身性栓塞的增加较小（风险比[HR]，1.42；95%置信区间，0.54-3.73），而有OAC经验的患者则较大（HR，4.66；95%置信区间，2.84-7.65；交互作用P值=.03）。

Bleeding rates were lower among both OAC-naive patients (0.2% [2 of 1228]) and OAC-experienced patients (0.2% [15 of 6145]) assigned asundexian than among OAC-naive patients (1.0% [13 of 1249]) and OAC-experienced patients (0.7% [40 of 6115]) assigned apixaban.

在OAC未使用患者中（0.2% [1228人中有2人]）和OAC使用经验患者中（0.2% [6145人中有15人]）被分配到asundexian的出血率低于OAC未使用患者（1.0% [1249人中有13人]）和OAC使用经验患者（0.7% [6115人中有40人]）被分配到apixaban。

conclusions_and_relevance

In the OCEANIC-AF randomized clinical trial, patients with AF who were OAC naive had a smaller increase in stroke or systemic embolism and a similar lower rate of bleeding with asundexian compared with apixaban than patients who were OAC experienced.

在OCEANIC-AF随机临床试验中，与OAC使用经验患者相比，OAC未使用患者使用asundexian时，中风或全身性栓塞的增加较小，且出血率相似地较低，与apixaban相比。

The mechanism of these findings is unknown and deserves further research.

这些发现的机制尚不明确，值得进一步研究。

trial_registration

ClinicalTrials.gov Identifier: NCT05643573.

ClinicalTrials.gov 注册号：NCT05643573。