Loufopoulos Georgios, Nana Petroula, Dakis Konstantinos, Kouvelos George, Makaloski Vladimir, Donas Konstantinos P, Matsagkas Miltiadis, Giannoukas Athanasios, Spanos Konstantinos
Department of Vascular Surgery, University Hospital of Lausanne (CHUV), 1005 Lausanne, Switzerland.
Department of Vascular Surgery, Faculty of Medicine, School of Health Sciences, University Hospital of Larissa, University of Thessaly, 38221 Larissa, Greece.
J Clin Med. 2025 Sep 12;14(18):6453. doi: 10.3390/jcm14186453.
New endografts have improved clinical outcomes in patients with abdominal aortic aneurysm (AAA) treated with the endovascular approach (EVAR). The purpose of this study is to evaluate the Endurant endograft for EVAR. A systematic search was conducted in PubMed, Scopus, and Cochrane for studies including patients treated with EVAR for unruptured AAA. This meta-analysis follows PRISMA guidelines (PROSPERO: CRD42024621517). A Kaplan-Meier-derived individual patient data analysis assessed the survival, the freedom from reintervention, the freedom from type Ia endoleak (ETIa), and the aneurysm-related mortality rates. The analysis reflects aggregated survival data, and the at-risk population decreases over time due to censoring and loss to follow-up. Kaplan-Meier survival curves were digitized to extract survival/mortality values at specific time points, and number-at-risk tables or total events were used to improve time-to-event accuracy. A subgroup analysis compared the outcomes of treatment within versus outside the instructions for use (IFU). Twenty-six studies met our eligibility criteria, incorporating 5901 patients in terms of survival, with survival rates at 1, 5, and 10 years of follow-up at 94.4%, 71.6%, and 42.4%, respectively, while overall aneurysm-related mortality rates were 0.8%, 2.3%, and 7.6%, respectively. Freedom from secondary reintervention was 94.9% at 1 year, 81.9% at 5 years, and 43.7% at 10 years, while freedom from type Ia endoleak was 98.8%, 94.6%, and 85.6%, respectively. Comparing treatment within versus outside the IFU, in terms of survival (HR: 0.94, 95% CI: 0.75-1.16, = 0.53), freedom from reintervention (HR: 0.85, 95% CI: 0.63-1.15, = 0.29) and mortality due to aneurysm-related complication (HR: 0.79, 95% CI: 0.34-1.84, = 0.58) revealed no statistically significant difference. The Endurant endograft provides acceptable rates of survival, freedom from secondary intervention, aneurysm-related mortality rates, and freedom from ETIa; however, continuous long-term follow-up surveillance is necessary.
新型腔内移植物改善了采用血管腔内治疗方法（EVAR）治疗的腹主动脉瘤（AAA）患者的临床结局。本研究的目的是评估用于EVAR的Endurant腔内移植物。我们在PubMed、Scopus和Cochrane数据库中进行了系统检索，以查找包含接受EVAR治疗未破裂AAA患者的研究。本荟萃分析遵循PRISMA指南（PROSPERO：CRD42024621517）。采用Kaplan-Meier法进行个体患者数据分析，评估生存率、再次干预自由度、Ia型内漏（ETIa）自由度和动脉瘤相关死亡率。该分析反映了汇总的生存数据，由于删失和失访，处于风险中的人群随时间减少。对Kaplan-Meier生存曲线进行数字化处理，以提取特定时间点的生存/死亡值，并使用风险数表或总事件数来提高事件发生时间的准确性。亚组分析比较了在使用说明（IFU）范围内与范围外的治疗结局。26项研究符合我们的纳入标准，纳入了5901例生存方面的患者，随访1年、5年和10年的生存率分别为94.4%、71.6%和42.4%，而总体动脉瘤相关死亡率分别为0.8%、2.3%和7.6%。1年时再次干预自由度为94.9%，5年时为81.9%，10年时为43.7%，而Ia型内漏自由度分别为98.8%、94.6%和85.6%。比较IFU范围内与范围外的治疗，在生存率（HR：0.94，95%CI：0.75-1.16，P = 0.53）、再次干预自由度（HR：0.85，95%CI：0.63-1.15，P = 0.29）和动脉瘤相关并发症导致的死亡率（HR：0.79，95%CI：从0.34至1.84，P = 0.58）方面，未发现统计学上的显著差异。Endurant腔内移植物提供了可接受的生存率、再次干预自由度、动脉瘤相关死亡率和ETIa自由度；然而，持续的长期随访监测是必要的。
