根据先前口服抗凝药物使用情况，房颤患者的阿哌沙班或阿森地仙：OCEANIC-AF随机临床试验的亚组分析

IF 14.8 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JAMA cardiology Pub Date : 2025-06-01 DOI:10.1001/jamacardio.2025.0277

John H Alexander, Elizabeth J Lydon, Jonathan P Piccini, Thomas Viethen, Jonas Oldgren, Shaun G Goodman, Jan Steffel, Andrea M Russo, Isabelle C van Gelder, Keith C Ferdinand, Renato D Lopes, Hardi Mundl, Bela Benczur, Juan José Gómez-Doblas, Michael Glikson, Assen Goudev, Erik L Grove, Sigrun Halvorsen, Tuomas Kiviniemi, Anne-Céline Martin, Roopinder K Sandhu, Dragos Vinereanu, Frank W Rockhold, Valeria Caso, Rosa Coppolecchia, Manesh R Patel

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引用次数: 0

摘要

重要性：在房颤（AF）患者中，口服抗凝剂（OACs）可降低卒中风险。目的：研究先前接触较少OAC的患者与接触较多OAC的患者是否对新的OAC有不同的反应。设计、环境和参与者：在口服因子11a抑制剂Asundexian作为新型抗血栓性房颤（ocean - af）随机临床试验的预先指定的探索性亚组分析中，参加ocean - af试验的患者根据他们是否有6周或更短的OAC使用时间或超过6周的OAC使用时间，被分类为OAC初始或OAC经验。然后比较亚森地西安和阿哌沙班对OAC初发和OAC经验患者预后的影响。研究环境包括38个国家的1035个地点，参与者是那些参加了OCEANIC-AF试验的人。数据分析时间为2024年6月至7月。干预措施：将Asundexian（一种新型的XIa因子抑制剂）与阿哌沙班（apixaban）在af患者中的疗效进行比较。主要结局和测量：主要疗效结局为卒中或全身性栓塞。主要安全指标为大出血。结果：在OCEANIC-AF试验的患者中，2493例（17%）为OAC初发患者(平均[SD]年龄72.6[8.6]岁；1464名男性[59%])和12 317名（83%）有OAC经历(平均[SD]年龄74.2[7.5]岁；8132名男性[66%])。在asd组中，初始OAC患者的卒中或全身性栓塞率为0.8%（1238例中有10例），而有OAC经验的患者为1.4%（6177例中有88例）。在阿哌沙班组中，初始OAC患者的卒中或全身性栓塞率为0.6%（1255例中有7例），而有OAC经验的患者为0.3%（6140例中有19例）。因此，与阿哌沙班相比，未接受OAC治疗的患者阿森地安卒中或全身性栓塞的增加较小(风险比[HR]， 1.42；95% CI, 0.54-3.73)比经历过OAC的患者(HR, 4.66；95% ci, 2.84-7.65；P为相互作用=.03)。oac初始患者（0.2%[1228例中2例]）和oac经验患者（0.2%[6145例中15例]）的出血率均低于oac初始患者（1.0%[1249例中13例]）和oac经验患者（0.7%[6115例中40例]）分配阿哌沙班的出血率。结论和相关性：在OCEANIC-AF随机临床试验中，与有OAC经验的患者相比，OAC初始的AF患者卒中或全身性栓塞的增加较小，与阿哌沙班相比，asdexian的出血率也较低。这些发现的机制尚不清楚，值得进一步研究。试验注册：ClinicalTrials.gov标识符：NCT05643573。

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

Importance: In patients with atrial fibrillation (AF), oral anticoagulants (OACs) reduce the risk of stroke.

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

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

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

Main outcomes and measures: The primary efficacy outcome was stroke or systemic embolism. The main safety outcome was major bleeding.

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%]). 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. 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. 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). 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.

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

Trial registration: ClinicalTrials.gov Identifier: NCT05643573.

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来源期刊

JAMA cardiology Medicine-Cardiology and Cardiovascular Medicine

CiteScore

45.80

自引率

1.70%

发文量

264

期刊介绍： JAMA Cardiology, an international peer-reviewed journal, serves as the premier publication for clinical investigators, clinicians, and trainees in cardiovascular medicine worldwide. As a member of the JAMA Network, it aligns with a consortium of peer-reviewed general medical and specialty publications. Published online weekly, every Wednesday, and in 12 print/online issues annually, JAMA Cardiology attracts over 4.3 million annual article views and downloads. Research articles become freely accessible online 12 months post-publication without any author fees. Moreover, the online version is readily accessible to institutions in developing countries through the World Health Organization's HINARI program. Positioned at the intersection of clinical investigation, actionable clinical science, and clinical practice, JAMA Cardiology prioritizes traditional and evolving cardiovascular medicine, alongside evidence-based health policy. It places particular emphasis on health equity, especially when grounded in original science, as a top editorial priority.