主动脉夹层检测风险评分加 D-二聚体对急性主动脉综合征的诊断准确性：ADvISED 前瞻性多中心研究。
Diagnostic Accuracy of the Aortic Dissection Detection Risk Score Plus D-Dimer for Acute Aortic Syndromes: The ADvISED Prospective Multicenter Study.
机构信息
Department of Emergency Medicine, Careggi University Hospital, Firenze, Italy (P.N., S.V., S.G.).
Cardiovascular Research Institute, University Hospital of Basel, Switzerland (C.M., K.G.).
出版信息
Circulation. 2018 Jan 16;137(3):250-258. doi: 10.1161/CIRCULATIONAHA.117.029457. Epub 2017 Oct 13.
BACKGROUND
Acute aortic syndromes (AASs) are rare and severe cardiovascular emergencies with unspecific symptoms. For AASs, both misdiagnosis and overtesting are key concerns, and standardized diagnostic strategies may help physicians to balance these risks. D-dimer (DD) is highly sensitive for AAS but is inadequate as a stand-alone test. Integration of pretest probability assessment with DD testing is feasible, but the safety and efficiency of such a diagnostic strategy are currently unknown.
METHODS
In a multicenter prospective observational study involving 6 hospitals in 4 countries from 2014 to 2016, consecutive outpatients were eligible if they had ≥1 of the following: chest/abdominal/back pain, syncope, perfusion deficit, and if AAS was in the differential diagnosis. The tool for pretest probability assessment was the aortic dissection detection risk score (ADD-RS, 0-3) per current guidelines. DD was considered negative (DD-) if <500 ng/mL. Final case adjudication was based on conclusive diagnostic imaging, autopsy, surgery, or 14-day follow-up. Outcomes were the failure rate and efficiency of a diagnostic strategy for ruling out AAS in patients with ADD-RS=0/DD- or ADD-RS ≤1/DD-.
RESULTS
A total of 1850 patients were analyzed. Of these, 438 patients (24%) had ADD-RS=0, 1071 patients (58%) had ADD-RS=1, and 341 patients (18%) had ADD-RS >1. Two hundred forty-one patients (13%) had AAS: 125 had type A aortic dissection, 53 had type B aortic dissection, 35 had intramural aortic hematoma, 18 had aortic rupture, and 10 had penetrating aortic ulcer. A positive DD test result had an overall sensitivity of 96.7% (95% confidence interval [CI], 93.6-98.6) and a specificity of 64% (95% CI, 61.6-66.4) for the diagnosis of AAS; 8 patients with AAS had DD-. In 294 patients with ADD-RS=0/DD-, 1 case of AAS was observed. This yielded a failure rate of 0.3% (95% CI, 0.1-1.9) and an efficiency of 15.9% (95% CI, 14.3-17.6) for the ADD-RS=0/DD- strategy. In 924 patients with ADD-RS ≤1/DD-, 3 cases of AAS were observed. This yielded a failure rate of 0.3% (95% CI, 0.1-1) and an efficiency of 49.9% (95% CI, 47.7-52.2) for the ADD-RS ≤1/DD- strategy.
CONCLUSIONS
Integration of ADD-RS (either ADD-RS=0 or ADD-RS ≤1) with DD may be considered to standardize diagnostic rule out of AAS.
CLINICAL TRIAL REGISTRATION
URL: https://www.clinicaltrials.gov. Unique identifier: NCT02086136.
背景
急性主动脉综合征（AAS）是一种罕见且严重的心血管急症，症状不具特异性。对于 AAS，误诊和过度检查都是关键问题，而标准化的诊断策略可能有助于医生平衡这些风险。D-二聚体（DD）对 AAS 具有高度敏感性，但作为单一检测手段并不充分。将预先评估概率与 DD 检测相结合是可行的，但这种诊断策略的安全性和效率目前尚不清楚。
方法
在 2014 年至 2016 年间，6 家医院的 4 个国家参与了一项多中心前瞻性观察性研究，符合以下条件的连续门诊患者具有纳入资格：胸痛/腹痛/背痛、晕厥、灌注不足和 AAS 在鉴别诊断中。预先评估概率的工具是现行指南中的主动脉夹层检测风险评分（ADD-RS，0-3）。DD 被认为是阴性（DD-），如果<500ng/mL。最终的病例判断是基于明确的诊断性影像学检查、尸检、手术或 14 天的随访。结果是在 ADD-RS=0/DD-或 ADD-RS ≤1/DD-的患者中，排除 AAS 的诊断策略的失败率和效率。
结果
共分析了 1850 名患者。其中，438 名患者（24%）ADD-RS=0，1071 名患者（58%）ADD-RS=1，341 名患者（18%）ADD-RS>1。241 名患者（13%）患有 AAS：125 名患者为 A 型主动脉夹层，53 名患者为 B 型主动脉夹层，35 名患者为壁内主动脉血肿，18 名患者为主动脉破裂，10 名患者为穿透性主动脉溃疡。DD 检测阳性的总体敏感性为 96.7%（95%置信区间[CI]，93.6-98.6），特异性为 64%（95%CI，61.6-66.4），用于诊断 AAS；8 名患有 AAS 的患者 DD-。在 294 名 ADD-RS=0/DD-的患者中，观察到 1 例 AAS。这导致了 0.3%（95%CI，0.1-1.9）的失败率和 15.9%（95%CI，14.3-17.6）的 ADD-RS=0/DD-策略效率。在 924 名 ADD-RS ≤1/DD-的患者中，观察到 3 例 AAS。这导致了 0.3%（95%CI，0.1-1）的失败率和 49.9%（95%CI，47.7-52.2）的 ADD-RS ≤1/DD-策略效率。
结论
将 ADD-RS（无论是 ADD-RS=0 还是 ADD-RS ≤1）与 DD 相结合，可用于标准化排除 AAS 的诊断。
临床试验注册
网址：https://www.clinicaltrials.gov。唯一标识符：NCT02086136。
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