Sorbonne Université, ACTION Group, INSERM UMRS 1166, Hôpital Pitié-Salpêtrière (AP-HP), Institut de Cardiologie, Paris, France.
Sorbonne Université, Laboratoire Imagerie Biomédicale, ICAN, ACTION Group, Hôpital Pitié-Salpêtrière (AP-HP), Institut de Cardiologie, Paris, France.
JACC Cardiovasc Interv. 2022 Sep 26;15(18):1794-1804. doi: 10.1016/j.jcin.2022.07.014. Epub 2022 Aug 31.
Subclinical obstructive valve thrombosis after transcatheter aortic valve replacement (TAVR) is of uncertain frequency and clinical impact.
The aim of this study was to determine the effects of apixaban vs standard of care on post-TAVR valve thrombosis detected by 4-dimensional (4D) computed tomography.
The randomized ATLANTIS (Anti-Thrombotic Strategy to Lower All Cardiovascular and Neurologic Ischemic and Hemorrhagic Events After Trans-Aortic Valve Implantation for Aortic Stenosis) trial demonstrated that apixaban 5 mg twice daily was not superior to standard of care (vitamin K antagonists or antiplatelet therapy) after successful TAVR and was associated with similar safety but with more noncardiovascular deaths. Three months after randomization, 4D computed tomography was proposed to all patients to determine the percentage of patients with ≥1 prosthetic valve leaflet with grade 3 or 4 reduced leaflet motion or grade 3 or 4 hypoattenuated leaflet thickening (the primary endpoint) in the intention-to-treat population.
Seven hundred sixty-two participants had complete multiphase datasets and were included in the 4D computed tomographic analysis. The primary endpoint occurred in 33 (8.9%) and 51 (13.0%) patients in the apixaban and standard-of-care groups, respectively. It was reduced with apixaban vs antiplatelet therapy (OR: 0.51; 95% CI: 0.30-0.86) but not vs vitamin K antagonists (OR: 1.80; 95% CI: 0.62-5.25) (P = 0.037). The composite of death, myocardial infarction, any stroke, or systemic embolism at 1 year occurred in 10.7% (n = 9 of 84) and 7.1% (n = 48 of 178) of patients with and without subclinical valve thrombosis at 90 days, respectively (HR: 1.68; 95% CI: 0.82-3.44).
Apixaban reduced subclinical obstructive valve thrombosis in the majority of patients who underwent TAVR without having an established indication for anticoagulation. This study was not powered for clinical outcomes. (Anti-Thrombotic Strategy After Trans-Aortic Valve Implantation for Aortic Stenosis [ATLANTIS]; NCT02664649).
经导管主动脉瓣置换术（TAVR）后亚临床阻塞性瓣叶血栓形成的频率和临床影响尚不确定。
本研究旨在确定阿哌沙班与标准治疗对 4 维（4D）计算机断层扫描检测到的 TAVR 后瓣叶血栓形成的影响。
随机 ATLANTIS（经主动脉瓣植入术治疗主动脉瓣狭窄后抗血栓策略以降低所有心血管和神经缺血性和出血性事件）试验表明，阿哌沙班 5mg 每日两次与 TAVR 成功后标准治疗（维生素 K 拮抗剂或抗血小板治疗）相比并无优势，且安全性相似，但非心血管死亡率更高。随机分组后 3 个月，向所有患者提出进行 4D 计算机断层扫描，以确定意向治疗人群中≥1 个瓣叶有 3 级或 4 级瓣叶运动减少或 3 级或 4 级瓣叶低衰减增厚的患者比例（主要终点）。
762 名参与者有完整的多期数据集，包括在 4D 计算机断层扫描分析中。阿哌沙班组和标准治疗组分别有 33（8.9%）和 51（13.0%）名患者发生主要终点事件。与抗血小板治疗相比，阿哌沙班降低了该终点事件（OR：0.51；95%CI：0.30-0.86），但与维生素 K 拮抗剂相比并未降低（OR：1.80；95%CI：0.62-5.25）（P=0.037）。在 90 天时有亚临床瓣膜血栓形成的患者中，1 年时死亡、心肌梗死、任何卒中或全身性栓塞的复合终点事件发生率分别为 10.7%（n=9/84）和 7.1%（n=48/178）（HR：1.68；95%CI：0.82-3.44）。
阿哌沙班降低了大多数接受 TAVR 治疗且无抗凝指征的患者的亚临床阻塞性瓣叶血栓形成。本研究未对临床结局进行分析。（主动脉瓣狭窄经主动脉瓣植入术后抗血栓策略[ATLANTIS]；NCT02664649）。
