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GREAT 登记研究:血管内动脉瘤修复后 5 年瘤囊演变:糖尿病患者的新认识——倾向评分匹配对照研究

Five Year Post-Endovascular Aneurysm Repair Aneurysm Sac Evolution in the GREAT Registry: an Insight in Diabetics Using Propensity Matched Controls.

机构信息

Servicio de Angiología y Cirugía Vascular, Hospital Universitario Central de Asturias (HUCA), Oviedo, Spain; Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo, Spain.

Servicio de Angiología y Cirugía Vascular, Hospital Universitario Central de Asturias (HUCA), Oviedo, Spain.

出版信息

Eur J Vasc Endovasc Surg. 2024 Jun;67(6):912-922. doi: 10.1016/j.ejvs.2023.10.033. Epub 2023 Oct 26.

Abstract

OBJECTIVE

To assess differences in the five year abdominal aortic aneurysm (AAA) sac regression rate after endovascular aneurysm repair (EVAR) in patients with and without diabetes mellitus (DM).

METHODS

An international prospective registry (Europe, USA, Brazil, Australia, and New Zealand) of patients treated with the GORE EXCLUDER endograft. All scheduled EVARs for infrarenal AAA between 2014 and 2016 with complete five year imaging follow up were included. Emergency procedures, ancillary proximal procedures, and inflammatory and infectious aetiologies were excluded. Descriptive and inferential statistics, and Cox proportional hazards survival models were used. A control group of patients without DM with similar age and comorbidities was selected using propensity scores, matched in a 1:2 scheme.

RESULTS

A total of 2 888 patients (86.1% male; mean age 73.5 ± 8 years) was included, of whom 545 (18.9%) had DM. Patients with DM had higher rates of hypertension (89.2% vs. 78.4%), dyslipidaemia (76.0% vs. 60.7%), coronary artery disease (52.3% vs. 37.9%), and chronic renal impairment (20.9% vs. 14.0%) (all p < .001). The mean pre-procedural AAA diameter was 58.1 ± 10 mm. Five years post-EVAR, the type 1A endoleak rate was 1.1% (0.6% DM vs. 1.2% non-DM), the endograft related re-intervention rate was 7.3% (6.2% vs. 7.6%), the major adverse cardiovascular event (MACE) rate was 1.4% (1.1% vs. 1.5%), and aortic related mortality rate was 1.0% (0.6% vs. 1.2%), without statistically significant differences between groups. The overall five year mortality rate was higher in diabetics (36.3% vs. 30.5%; hazard ratio [HR] 1.30, 95% confidence interval [CI] 1.07 - 1.58; p = .001). No statistically significant differences were found in sac regression rate (≥ 5 mm) between diabetics and non-diabetics 70.0% vs. 73.1%; HR 0.88, 95% CI 0.75-1.04; p = .131. These differences remained statistically non-significant after excluding patients performed out of instructions for use (p = .61) and patients with types 1, 2 or 3 endoleaks (p = .39).

CONCLUSION

The paradoxical relationship between DM and AAA does not appear to result in differences in post-EVAR sac regression rates. However, even when controlling for other comorbidities, patients with DM undergoing EVAR may have a higher five year mortality rate.

摘要

目的

评估血管内动脉瘤修复术(EVAR)后 5 年内合并和不合并糖尿病(DM)的腹主动脉瘤(AAA)瘤囊消退率的差异。

方法

这是一项针对 Gore EXCLUDER 血管内移植物进行治疗的国际前瞻性登记研究(欧洲、美国、巴西、澳大利亚和新西兰)。纳入 2014 年至 2016 年期间因肾下型 AAA 行计划性 EVAR 治疗,且具有完整 5 年影像学随访的患者。排除急诊手术、辅助近端手术、炎症和感染性病因。使用描述性和推断性统计学以及 Cox 比例风险生存模型进行分析。使用倾向评分选择无 DM 的、年龄和合并症相似的患者作为对照组,并按 1:2 的比例进行匹配。

结果

共纳入 2888 例患者(86.1%为男性;平均年龄 73.5 ± 8 岁),其中 545 例(18.9%)患有 DM。DM 患者高血压(89.2% vs. 78.4%)、血脂异常(76.0% vs. 60.7%)、冠心病(52.3% vs. 37.9%)和慢性肾功能不全(20.9% vs. 14.0%)的发生率更高(均 p <.001)。AAA 术前平均直径为 58.1 ± 10 mm。EVAR 术后 5 年,1 型 A 内漏发生率为 1.1%(DM 组为 0.6%,非 DM 组为 1.2%),移植物相关再干预率为 7.3%(DM 组为 6.2%,非 DM 组为 7.6%),主要不良心血管事件(MACE)发生率为 1.4%(DM 组为 1.1%,非 DM 组为 1.5%),主动脉相关死亡率为 1.0%(DM 组为 0.6%,非 DM 组为 1.2%),两组间无统计学差异。糖尿病患者的总体 5 年死亡率较高(36.3% vs. 30.5%;HR 1.30,95%置信区间 [CI] 1.07-1.58;p =.001)。DM 患者与非 DM 患者之间的瘤囊消退率(≥5mm)差异无统计学意义(70.0% vs. 73.1%;HR 0.88,95%CI 0.75-1.04;p =.131)。排除超出说明书使用的患者(p =.61)和存在 1 型、2 型或 3 型内漏的患者(p =.39)后,差异仍无统计学意义。

结论

DM 与 AAA 之间的矛盾关系似乎并未导致 EVAR 后瘤囊消退率的差异。然而,即使在控制其他合并症的情况下,接受 EVAR 治疗的糖尿病患者可能具有更高的 5 年死亡率。

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