BACKGROUND One third of patients undergoing transcatheter aortic-valve implantation (TAVI) have an indication for oral anticoagulation owing to concomitant diseases. Interruption of oral anticoagulation during TAVI may decrease the risk of bleeding, whereas continuation may decrease the risk of thromboembolism. METHODS We conducted an international, open-label, randomized, noninferiority trial involving patients who were receiving oral anticoagulants and were planning to undergo TAVI. Patients were randomly assigned in a 1:1 ratio to periprocedural continuation or interruption of oral anticoagulation. The primary outcome was a composite of death from cardiovascular causes, stroke from any cause, myocardial infarction, major vascular complications, or major bleeding within 30 days after TAVI. RESULTS A total of 858 patients were included in the modified intention-to-treat population: 431 were assigned to continuation and 427 to interruption of oral anticoagulation. A primary-outcome event occurred in 71 patients (16.5%) in the continuation group and in 63 (14.8%) in the interruption group (risk difference, 1.7 percentage points; 95% confidence interval [CI], -3.1 to 6.6; P = 0.18 for noninferiority). Thromboembolic events occurred in 38 patients (8.8%) in the continuation group and in 35 (8.2%) in the interruption group (risk difference, 0.6 percentage points; 95% CI, -3.1 to 4.4). Bleeding occurred in 134 patients (31.1%) in the continuation group and in 91 (21.3%) in the interruption group (risk difference, 9.8 percentage points; 95% CI, 3.9 to 15.6). CONCLUSIONS In patients undergoing TAVI with a concomitant indication for oral anticoagulation, periprocedural continuation was not noninferior to interruption of oral anticoagulation during TAVI with respect to the incidence of a composite of death from cardiovascular causes, stroke, myocardial infarction, major vascular complications, or major bleeding at 30 days. (Funded by the Netherlands Organization for Health Research and Development and the St. Antonius Research Fund; POPular PAUSE TAVI ClinicalTrials.gov number, NCT04437303.).

中文翻译：

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TAVI 期间口服抗凝药物的继续与中断。


背景 三分之一接受经导管主动脉瓣植入术 (TAVI) 的患者由于伴随疾病而有口服抗凝药物的指征。 TAVI 期间中断口服抗凝药可能会降低出血风险，而继续服用可能会降低血栓栓塞的风险。方法 我们开展了一项国际性、开放标签、随机、非劣效性试验，受试者为正在接受口服抗凝剂并计划接受 TAVI 的患者。患者以 1:1 的比例随机分配至围手术期继续或中断口服抗凝药物。主要结局是心血管原因死亡、任何原因引起的中风、心肌梗死、主要血管并发症或 TAVI 后 30 天内大出血的复合结果。结果 修改后的意向治疗人群总共纳入了 858 名患者：431 名患者被分配至继续口服抗凝药治疗组，427 名患者被分配至中断口服抗凝药组。继续组有 71 名患者 (16.5%) 发生主要结果事件，中断组有 63 名患者 (14.8%) 发生主要结果事件（风险差异，1.7 个百分点；95% 置信区间 [CI]，-3.1 至 6.6；P = 0.18（非劣效性）。继续组有 38 名患者（8.8%）发生血栓栓塞事件，中断组有 35 名患者（8.2%）发生血栓栓塞事件（风险差异，0.6 个百分点；95% CI，-3.1 至 4.4）。继续组有 134 名患者（31.1%）发生出血，中断组有 91 名患者（21.3%）发生出血（风险差异，9.8 个百分点；95% CI，3.9 至 15.6）。 结论 在接受 TAVI 并伴有口服抗凝药物指征的患者中，就心血管原因死亡、卒中、心肌梗塞、主要血管并发症或重大并发症的综合发生率而言，围手术期继续治疗并不劣于 TAVI 期间中断口服抗凝药物。 30天时出血。 （由荷兰卫生研究与发展组织和圣安东尼研究基金资助；POPular PAUSE TAVI ClinicalTrials.gov 编号，NCT04437303。）。