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评估连续 CT 监测下腹主动脉瘤直径的生长模式。

Evaluating Growth Patterns of Abdominal Aortic Aneurysm Diameter With Serial Computed Tomography Surveillance.

机构信息

Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison.

Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.

出版信息

JAMA Surg. 2021 Apr 1;156(4):363-370. doi: 10.1001/jamasurg.2020.7190.

Abstract

IMPORTANCE

Small abdominal aortic aneurysms (AAAs) are common in the elderly population. Their growth rates and patterns, which drive clinical surveillance, are widely disputed.

OBJECTIVE

To assess the growth patterns and rates of AAAs as documented on serial computed tomography (CT) scans.

DESIGN, SETTING, AND PARTICIPANTS: Cohort study and secondary analysis of the Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial (N-TA3CT), a randomized, double-blind placebo-controlled clinical trial conducted from 2013 to 2018, with CT imaging every 6 months for 2 years. The trial was a multicenter, observational secondary analysis, not related to treatment hypotheses of data collected in the N-TA3CT. Participants included 254 patients with baseline AAA diameter between 3.5 and 5.0 cm.

EXPOSURES

Patients received serial CT scan measurements, analyzed for maximum transverse diameter, at 6-month intervals.

MAIN OUTCOMES AND MEASURES

The primary study outcome was AAA annual growth rate. Secondary analyses included characterizing AAA growth patterns, assessing likelihood of AAA diameter to exceed sex-specific intervention thresholds over 2 years.

RESULTS

A total of 254 patients, 35 women with baseline AAA diameter 3.5 to 4.5 cm and 219 men with baseline diameter 3.5 to 5.0 cm, were included. Yearly growth rates of AAA diameters were a median of 0.17 cm/y (interquartile range [IQR], 0.16) and a mean (SD), 0.19 (0.14) cm/y. Ten percent of AAAs displayed minimal to no growth (<0.05 cm/y), 62% displayed low growth (0.05-0.25 cm/y), and 28% displayed high growth (>0.25 cm/y). Baseline AAA diameter accounted for 5.4% of variance of growth rate (P < .001; R2, 0.054). Most AAAs displayed linear growth (70%); large variations in interval growth rates occurred infrequently (3% staccato growth and 4% exponential growth); and some patients' growth patterns were not clearly classifiable (23% indeterminate). No patients with a maximum transverse diameter less than 4.25 cm exceeded sex-specific repair thresholds at 2 years (men, 0 of 92; 95% CI, 0.00-0.055; women, 0 of 25 ; 95% CI, 0.00-0.247). Twenty-six percent of patients with a maximum transverse diameter of at least 4.25 cm exceeded sex-specific repair thresholds at 2 years (n = 12 of 83 men with diameter ranging from 4.25 to <4.75 cm; 95% CI, 0.091-0.264; n = 21 of 44 men with diameter ranging from 4.75-5.0 cm; 95% CI, 0.362-0.669; n = 3 of 10 women with diameter ≥4.25 cm; 95% CI, 0.093-0.726).

CONCLUSIONS AND RELEVANCE

Most small AAAs showed linear growth; large intrapatient variations in interval growth rates were infrequently observed over 2 years. Linear growth modeling of AAAs in individual patients suggests smaller AAAs (<4.25 cm) can be followed up with a CT scan in at least 2 years with little chance of exceeding interventional thresholds.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT01756833.

摘要

重要性

小的腹主动脉瘤(AAA)在老年人群中很常见。它们的生长速度和模式决定了临床监测的方向,这方面存在广泛争议。

目的

评估连续计算机断层扫描(CT)扫描记录的 AAA 生长模式和速度。

设计、地点和参与者:这是一项队列研究和非侵入性治疗腹主动脉瘤临床试验(N-TA3CT)的二次分析,该试验于 2013 年至 2018 年进行,为随机、双盲、安慰剂对照临床试验,每 6 个月进行一次 CT 成像,持续 2 年。该试验是一项多中心、观察性二次分析,与 N-TA3CT 中收集的数据的治疗假设无关。参与者包括 254 名基线 AAA 直径在 3.5 至 5.0 厘米之间的患者。

暴露

患者接受连续 CT 扫描测量,每 6 个月分析一次最大横径。

主要结果和措施

主要研究结果是 AAA 年增长率。次要分析包括描述 AAA 生长模式,评估在 2 年内 AAA 直径超过性别特异性干预阈值的可能性。

结果

共有 254 名患者,35 名女性基线 AAA 直径为 3.5 至 4.5 厘米,219 名男性基线直径为 3.5 至 5.0 厘米,纳入研究。AAA 直径的年增长率中位数为 0.17cm/y(四分位距 [IQR],0.16)和平均值(SD)为 0.19(0.14)cm/y。10%的 AAA 显示出最小或无生长(<0.05cm/y),62%显示出低生长(0.05-0.25cm/y),28%显示出高生长(>0.25cm/y)。基线 AAA 直径占生长速度方差的 5.4%(P<0.001;R2,0.054)。大多数 AAA 显示出线性生长(70%);间隔生长速度的大变化很少发生(3%的不连续生长和 4%的指数生长);并且一些患者的生长模式无法明确分类(23%的不确定)。在 2 年内,没有最大横径小于 4.25cm 的患者超过性别特异性修复阈值(男性,0/92;95%CI,0.00-0.055;女性,0/25;95%CI,0.00-0.247)。在 2 年内,至少有 4.25cm 最大横径的 26%患者超过了性别特异性修复阈值(n=83 名直径从 4.25 至<4.75cm 的男性患者中的 12 名;95%CI,0.091-0.264;n=44 名直径从 4.75 至 5.0cm 的男性患者中的 21 名;95%CI,0.362-0.669;n=10 名直径≥4.25cm 的女性患者中的 3 名;95%CI,0.093-0.726)。

结论和相关性

大多数小的 AAA 表现为线性生长;在 2 年内,很少观察到患者间间隔生长速度的大变化。对个体患者的 AAA 进行线性生长建模表明,较小的 AAA(<4.25cm)可以在至少 2 年内通过 CT 扫描进行随访,超过干预阈值的可能性很小。

试验注册

ClinicalTrials.gov 标识符:NCT01756833。

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