School of Clinical Medicine, South Western Sydney Clinical School, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia.
Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, Liverpool, New South Wales, Australia.
JAMA Netw Open. 2023 Jun 1;6(6):e2317838. doi: 10.1001/jamanetworkopen.2023.17838.
Ischemic heart disease remains the leading cause of mortality following hip and knee arthroplasty. Due to its antiplatelet and cardioprotective properties, aspirin has been proposed as an agent that could reduce mortality when used as venous thromboembolism (VTE) prophylaxis following these procedures.
To compare aspirin with enoxaparin in reducing 90-day mortality for patients undergoing hip or knee arthroplasty procedures.
DESIGN, SETTING, AND PARTICIPANTS: This study was a planned secondary analysis of the CRISTAL cluster randomized, crossover, registry-nested trial performed across 31 participating hospitals in Australia between April 20, 2019, and December 18, 2020. The aim of the CRISTAL trial was to determine whether aspirin was noninferior to enoxaparin in preventing symptomatic VTE following hip or knee arthroplasty. The primary study restricted the analysis to patients undergoing total hip or knee arthroplasty for a diagnosis of osteoarthritis only. This study includes all adult patients (aged ≥18 years) undergoing any hip or knee arthroplasty procedure at participating sites during the course of the trial. Data were analyzed from June 1 to September 6, 2021.
Hospitals were randomized to administer all patients oral aspirin (100 mg daily) or subcutaneous enoxaparin (40 mg daily) for 35 days after hip arthroplasty and 14 days after knee arthroplasty procedures.
The primary outcome was mortality within 90 days. The between-group difference in mortality was estimated using cluster summary methods.
A total of 23 458 patients from 31 hospitals were included, with 14 156 patients allocated to aspirin (median [IQR] age, 69 [62-77] years; 7984 [56.4%] female) and 9302 patients allocated to enoxaparin (median [IQR] age, 70 [62-77] years; 5277 [56.7%] female). The mortality rate within 90 days of surgery was 1.67% in the aspirin group and 1.53% in the enoxaparin group (estimated difference, 0.04%; 95% CI, -0.05%-0.42%). For the subgroup of 21 148 patients with a nonfracture diagnosis, the mortality rate was 0.49% in the aspirin group and 0.41% in the enoxaparin group (estimated difference, 0.05%; 95% CI, -0.67% to 0.76%).
In this secondary analysis of a cluster randomized trial comparing aspirin with enoxaparin following hip or knee arthroplasty, there was no significant between-group difference in mortality within 90 days when either drug was used for VTE prophylaxis.
http://anzctr.org.au Identifier: ACTRN12618001879257.
背景：在髋关节和膝关节置换术后，缺血性心脏病仍然是导致死亡的主要原因。由于其抗血小板和心脏保护特性，阿司匹林被提议作为一种可以降低这些手术后静脉血栓栓塞症（VTE）预防死亡率的药物。
目的：比较阿司匹林和依诺肝素在降低髋关节或膝关节置换术后 90 天死亡率方面的效果。
设计、地点和参与者：本研究是对澳大利亚 31 家参与医院于 2019 年 4 月 20 日至 2020 年 12 月 18 日期间进行的 CRISTAL 集群随机、交叉、登记嵌套试验的二次分析。CRISTAL 试验的目的是确定阿司匹林在预防髋关节或膝关节置换术后症状性 VTE 方面是否不劣于依诺肝素。主要研究将分析仅限于因骨关节炎而接受全髋关节或全膝关节置换术的患者。本研究包括在试验过程中参与地点接受任何髋关节或膝关节置换术的所有成年患者（年龄≥18 岁）。数据于 2021 年 6 月 1 日至 9 月 6 日进行分析。
干预措施：医院被随机分配给所有患者口服阿司匹林（每天 100 毫克）或皮下依诺肝素（每天 40 毫克），用于髋关节置换术后 35 天和膝关节置换术后 14 天。
主要结局和测量：主要结局是 90 天内的死亡率。使用群组汇总方法估计组间死亡率差异。
结果：共纳入了 31 家医院的 23458 名患者，其中 14156 名患者被分配到阿司匹林组（中位数[IQR]年龄，69[62-77]岁；7984[56.4%]为女性），9302 名患者被分配到依诺肝素组（中位数[IQR]年龄，70[62-77]岁；5277[56.7%]为女性）。手术 90 天内的死亡率在阿司匹林组为 1.67%，在依诺肝素组为 1.53%（估计差异，0.04%；95%CI，-0.05%-0.42%）。对于 21148 名非骨折诊断的亚组，阿司匹林组的死亡率为 0.49%，依诺肝素组为 0.41%（估计差异，0.05%；95%CI，-0.67%-0.76%）。
结论和相关性：在髋关节或膝关节置换术后比较阿司匹林和依诺肝素的这项二次分析的集群随机试验中，当使用任何一种药物进行 VTE 预防时，90 天内的死亡率在组间没有显著差异。
试验注册：http://anzctr.org.au 标识符：ACTRN12618001879257.
