Douketis James D, Li Na, St John Melanie, Nixon Joanne, Moffat Karen, Shaw Joseph, Syed Summer, Schulman Sam, Gross Peter L, Spyropoulos Alex C
Department of Medicine, St. Joseph's Healthcare Hamilton, Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada.
Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada; Department of Computing and Software, McMaster University, Hamilton, Ontario, Canada.
J Thromb Haemost. 2025 Jul;23(7):2226-2234. doi: 10.1016/j.jtha.2025.03.003. Epub 2025 Mar 12.
There is uncertainty about the perioperative management of patients who are receiving a direct oral anticoagulant (DOAC) and require elective high-bleed-risk surgery, including those who are undergoing a neuraxial or deep peripheral nerve block procedure.
The objectives of this pilot trial were to provide preliminary data as to pre-operative residual DOAC levels with different management strategies andro assess the feasibility of a larger trial.
The Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE)-2 pilot trial was a proof-of-concept, open-label, randomized controlled trial that assessed the feasibility of comparing perioperative DOAC management using an American Society of Regional Anesthesia (ASRA)-based or PAUSE-based approach in patients with atrial fibrillation who needed an elective high-bleed-risk surgery/procedure and/or any neuraxial anesthesia/procedure.
There were 159 patients enrolled (86 on apixaban, 12 on dabigatran, and 61 on rivaroxaban), of whom 141 had preoperative DOAC-level testing done. The median (IQR) residual DOAC level was 19 (19-24) ng/mL in the ASRA group and 20 (19-24) ng/mL in the PAUSE group (standardized difference = -0.02). The percentage of patients in the ASRA and PAUSE groups with preoperative residual DOAC levels < 30 ng/mL was 95.6% and 94.4%, respectively; the percentage with residual DOAC levels of 30 to 50 ng/mL was 1.4% and 2.8%, respectively, and the percentage with levels > 50 ng/mL was 2.9% and 2.8%, respectively.
In this pilot trial, we found that recruitment of DOAC-treated patients who needed an elective high-bleed-risk surgery or neuraxial procedure was feasible and that preoperative residual DOAC levels appeared similar according to ASRA-based and PAUSE-based management approaches, providing the foundation for a larger trial comparing ASRA- and PAUSE-based perioperative DOAC management.
对于正在接受直接口服抗凝剂（DOAC）治疗且需要进行择期高出血风险手术的患者，包括那些正在接受神经轴或深部周围神经阻滞手术的患者，围手术期管理存在不确定性。
本试点试验的目的是提供关于不同管理策略下术前DOAC残留水平的初步数据，并评估更大规模试验的可行性。
围手术期抗凝剂用于手术评估（PAUSE）-2试点试验是一项概念验证、开放标签、随机对照试验，评估了在需要进行择期高出血风险手术/操作和/或任何神经轴麻醉/操作的房颤患者中，使用基于美国区域麻醉学会（ASRA）或基于PAUSE的方法比较围手术期DOAC管理的可行性。
共纳入159例患者（86例使用阿哌沙班，12例使用达比加群，61例使用利伐沙班），其中141例进行了术前DOAC水平检测。ASRA组的中位（IQR）DOAC残留水平为19（19-24）ng/mL，PAUSE组为20（19-24）ng/mL（标准化差异=-0.02）。ASRA组和PAUSE组术前DOAC残留水平<30 ng/mL的患者百分比分别为95.6%和94.4%；残留DOAC水平为30至50 ng/mL的患者百分比分别为1.4%和2.8%，水平>50 ng/mL的患者百分比分别为2.9%和2.8%。
在本试点试验中，我们发现招募需要进行择期高出血风险手术或神经轴手术的DOAC治疗患者是可行的，并且根据基于ASRA和基于PAUSE的管理方法，术前DOAC残留水平似乎相似，这为比较基于ASRA和基于PAUSE的围手术期DOAC管理的更大规模试验奠定了基础。
