Section of Interventional Cardiology (T.R., R.T., C. Shea, C.Z., P.C., I.B.-D., L.F.S., R.W.), MedStar Washington Hospital Center, WA.
Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (T.R.).
Circ Cardiovasc Interv. 2021 Jan;14(1):e009983. doi: 10.1161/CIRCINTERVENTIONS.120.009983. Epub 2021 Jan 11.
The optimal antithrombotic regimen after transcatheter aortic valve replacement remains unclear.
In this randomized open-label study, low-risk patients undergoing transfemoral transcatheter aortic valve replacement at 7 centers in the United States were randomized 1:1 to low-dose aspirin or warfarin plus low-dose aspirin for 30 days. Patients who could not be randomized were enrolled in a separate registry. Computed tomography or transesophageal echocardiography was performed at 30 days. The primary effectiveness end point was a composite of the following at 30 days: hypoattenuated leaflet thickening, at least moderately reduced leaflet motion, hemodynamic dysfunction (mean aortic valve gradient ≥20 mm Hg, effective orifice area ≤1.0 cm, dimensionless valve index <0.35, or moderate or severe aortic regurgitation), stroke, or transient ischemic attack.
Between July 2018 and October 2019, 94 patients were randomly assigned, 50 to aspirin and 44 to warfarin plus aspirin, and 30 were enrolled into the registry. In the intention-to-treat analysis of the randomized cohort, the composite primary effectiveness end point was met in 26.5% for aspirin versus 7.0% for warfarin plus aspirin (=0.014; odds ratio, 4.8 [95% CI, 1.3-18.3]). The rate of hypoattenuated leaflet thickening was 16.3% for aspirin versus 4.7% for warfarin plus aspirin (=0.07; odds ratio, 4.0 [95% CI, 0.8-20.0]). There was no excess bleeding at 30 days with anticoagulation. In the as-treated analysis of pooled randomized and registry cohorts, the rate of hypoattenuated leaflet thickening was 16.7% for aspirin versus 3.1% for warfarin plus aspirin (=0.011; odds ratio, 6.3 [95% CI, 1.3-30.6]).
In low-risk transcatheter aortic valve replacement patients, anticoagulation with warfarin may prevent transcatheter heart valve dysfunction in the short term without excess bleeding. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03557242.
经导管主动脉瓣置换术后的最佳抗栓治疗方案仍不明确。
本随机、开放标签研究纳入美国 7 家中心的低危行经股动脉经导管主动脉瓣置换术患者，按 1:1 随机分为低剂量阿司匹林组或华法林+低剂量阿司匹林组，治疗 30 天。不能随机分组的患者纳入单独的登记处。在第 30 天进行计算机断层扫描或经食管超声心动图检查。主要有效性终点为 30 天时以下复合终点：瓣叶低衰减增厚、瓣叶运动至少中度降低、血流动力学功能障碍（平均主动脉瓣梯度≥20mmHg、有效瓣口面积≤1.0cm2、无量纲瓣指数＜0.35 或中度或重度主动脉瓣反流）、卒中和短暂性脑缺血发作。
2018 年 7 月至 2019 年 10 月期间，94 例患者被随机分配，50 例接受阿司匹林治疗，44 例接受华法林+阿司匹林治疗，30 例患者纳入登记处。在随机队列的意向治疗分析中，阿司匹林组复合主要有效性终点发生率为 26.5%，华法林+阿司匹林组为 7.0%（=0.014；比值比，4.8[95%CI，1.3-18.3]）。阿司匹林组瓣叶低衰减增厚发生率为 16.3%，华法林+阿司匹林组为 4.7%（=0.07；比值比，4.0[95%CI，0.8-20.0]）。抗凝治疗 30 天无过度出血。在随机和登记队列的治疗分析中，阿司匹林组瓣叶低衰减增厚发生率为 16.7%，华法林+阿司匹林组为 3.1%（=0.011；比值比，6.3[95%CI，1.3-30.6]）。
在低危经导管主动脉瓣置换术患者中，华法林抗凝治疗可在短期内预防经导管心脏瓣膜功能障碍，且无过度出血。注册：网址：https://www.clinicaltrials.gov。唯一标识符：NCT03557242。
