Department of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Division of Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Am Heart J. 2024 Mar;269:167-178. doi: 10.1016/j.ahj.2023.12.006. Epub 2023 Dec 18.
The risks of leaflet thrombosis and the associated cerebral thromboembolism are unknown according to different anticoagulation dosing after transcatheter aortic valve replacement (TAVR). The aim was to evaluate the incidence of leaflet thrombosis and cerebral thromboembolism between low-dose (30 mg) or standard-dose (60 mg) edoxaban and dual antiplatelet therapy (DAPT) after TAVR.
In this prespecified subgroup analysis of the ADAPT-TAVR trial, the primary endpoint was the incidence of leaflet thrombosis on 4-dimensional computed tomography at 6-months. Key secondary endpoints were new cerebral lesions on brain magnetic resonance imaging and neurological and neurocognitive dysfunction.
Of 229 patients enrolled in this study, 118 patients were DAPT group and 111 were edoxaban group (43 [39.1%] 60 mg vs 68 [61.3%] 30 mg). There was a significantly lower incidence of leaflet thrombosis in the standard-dose edoxaban group than in the DAPT group (2.4% vs 18.3%; odds ratio [OR] 0.11; 95% confidence interval [CI], 0.01-0.55; P = .03). However, no significant difference was observed between low-dose edoxaban and DAPT (15.0% vs 18.3%; OR 0.79; 95% CI, 0.32-1.81; P = .58). Irrespective of different antithrombotic regiments, the percentages of patients with new cerebral lesions on brain MRI and worsening neurological or neurocognitive function were not significantly different.
In patients without an indication for anticoagulation after TAVR, the incidence of leaflet thrombosis was significantly lower with standard-dose edoxaban but not with low-dose edoxaban, as compared with DAPT. However, this differential effect of edoxaban on leaflet thrombosis was not associated with a reduction of new cerebral thromboembolism and neurological dysfunction.
根据经导管主动脉瓣置换术（TAVR）后不同的抗凝剂量，对于瓣叶血栓形成的风险及其相关的脑血栓栓塞，目前尚不清楚。目的是评估 TAVR 后低剂量（30 毫克）或标准剂量（60 毫克）依度沙班和双联抗血小板治疗（DAPT）之间瓣叶血栓形成和脑血栓栓塞的发生率。
在 ADAPT-TAVR 试验的这一预设亚组分析中，主要终点是 6 个月时 4 维计算机断层扫描上瓣叶血栓形成的发生率。关键次要终点是脑磁共振成像上新的脑损伤和神经和认知功能障碍。
在这项研究中，共纳入 229 例患者，其中 118 例为 DAPT 组，111 例为依度沙班组（43[39.1%]例 60mg 与 68[61.3%]例 30mg）。标准剂量依度沙班组瓣叶血栓形成的发生率明显低于 DAPT 组（2.4%比 18.3%；比值比[OR]0.11；95%置信区间[CI]，0.01-0.55；P=0.03）。然而，低剂量依度沙班与 DAPT 之间无显著差异（15.0%比 18.3%；OR 0.79；95%CI，0.32-1.81；P=0.58）。无论采用何种不同的抗血栓形成方案，脑 MRI 上有新脑损伤和神经或认知功能恶化的患者比例无显著差异。
在 TAVR 后无抗凝指征的患者中，标准剂量依度沙班的瓣叶血栓形成发生率明显低于 DAPT，但低剂量依度沙班则不然。然而，依度沙班对瓣叶血栓形成的这种差异作用与新的脑血栓栓塞和神经功能障碍的减少无关。
