Centre for Big Data Research in Health, UNSW Sydney, Australia.
Centre for Big Data Research in Health, UNSW Sydney, Australia; Biostatistics Training Program, NSW Ministry of Health, Sydney, Australia.
Eur J Vasc Endovasc Surg. 2023 Feb;65(2):272-280. doi: 10.1016/j.ejvs.2022.11.005. Epub 2022 Nov 9.
To compare rates of mortality, rupture, and secondary intervention following endovascular repair (EVAR) of intact abdominal aortic aneurysms (AAA) using contemporary endograft devices from three major manufacturers.
This was a retrospective cohort study using linked clinical registry (Australasian Vascular Audit) and all payer administrative data. Patients undergoing EVAR for intact AAA between 2010 and 2019 in New South Wales, Australia were identified. Rates of all cause death, secondary rupture, and secondary intervention (subsequent aneurysm repair; other secondary aortic intervention) were compared for patients treated with Cook, Medtronic, and Gore standard devices. Inverse probability of treatment weighted proportional hazards and competing risk regression were used to adjust for patient, clinical, and aneurysm characteristics, using Cook as the referent device.
This study identified 2 874 eligible EVAR patients, with a median follow up of 4.1 (maximum 9.5) years. Mortality rates were similar for patients receiving different devices (ranging between 7.0 and 7.3 per 100 person years). There was no statistically significant difference between devices in secondary rupture rates, which ranged between 0.4 and 0.5 per 100 person years. Patients receiving Medtronic and Gore devices tended to have higher crude rates of subsequent aneurysm repair (1.5 per 100 person years) than patients receiving Cook devices (0.8 per 100 person years). This finding remained in the adjusted analysis, but was only statistically significant for Medtronic devices (HR 1.57, 95% CI 1.02 - 2.47; HR 1.73, 95% CI 0.94 - 3.18, respectively).
Major endograft devices have similar overall long term safety profiles. However, there may be differences in rates of secondary intervention for some devices. This may reflect endograft durability, or patient selection for different devices based on aneurysm anatomy. Continuous comparative assessments are needed to guide evidence for treatment decisions across the range of available devices.
比较使用三大制造商生产的当代血管内移植物治疗完整腹主动脉瘤（AAA）的死亡率、破裂和二次干预的发生率。
这是一项回顾性队列研究，使用了相关临床登记（澳大利亚血管审计）和所有支付者管理数据。在澳大利亚新南威尔士州，确定了 2010 年至 2019 年间接受 EVAR 治疗的完整 AAA 患者。比较使用 Cook、Medtronic 和 Gore 标准设备治疗的患者的全因死亡、二次破裂和二次干预（随后的动脉瘤修复；其他二次主动脉干预）的发生率。使用 Cook 作为参考设备，采用逆概率治疗加权比例风险和竞争风险回归来调整患者、临床和动脉瘤特征。
这项研究确定了 2874 名符合条件的 EVAR 患者，中位随访时间为 4.1（最长 9.5）年。接受不同设备治疗的患者死亡率相似（范围在每 100 人年 7.0 至 7.3 之间）。在二次破裂率方面，各设备之间无统计学差异，范围在每 100 人年 0.4 至 0.5 之间。接受 Medtronic 和 Gore 设备的患者随后进行动脉瘤修复的粗率（每 100 人年 1.5 次）高于接受 Cook 设备的患者（每 100 人年 0.8 次）。这一发现仍存在于调整后的分析中，但仅在 Medtronic 设备上具有统计学意义（HR 1.57，95%CI 1.02-2.47；HR 1.73，95%CI 0.94-3.18）。
主要的血管内移植物设备具有相似的长期总体安全性特征。然而，某些设备的二次干预率可能存在差异。这可能反映了移植物的耐久性，或者根据动脉瘤解剖结构选择不同的设备进行患者治疗。需要进行持续的比较评估，以指导在各种可用设备范围内的治疗决策的证据。
