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SOX-PTS 评分在近端深静脉血栓形成患者前瞻性多中心试验中的外部验证。

External validation of the SOX-PTS score in a prospective multicenter trial of patients with proximal deep vein thrombosis.

机构信息

Thrombosis and Hemostasis Unit, Hematology Institute, Soroka University Medical Center, Faculty of Health Sciences, Ben Gurion University of the Negev, Beer Sheva, Israel.

Department of Oncology, McMaster University, Hamilton, ON, Canada.

出版信息

J Thromb Haemost. 2020 Jun;18(6):1381-1389. doi: 10.1111/jth.14791. Epub 2020 Apr 9.

Abstract

BACKGROUND

Using data from the SOX Trial, we recently developed a clinical prediction model for occurrence of the postthrombotic syndrome (PTS) after proximal deep vein thrombosis (DVT), termed the SOX-PTS score. The score includes anatomical extent of DVT; body mass index; and baseline Villalta score.

OBJECTIVE

To externally validate the SOX-PTS score.

METHODS

Logistic regression analysis of data from the ATTRACT Trial that evaluated pharmacomechanical catheter directed thrombolysis in patients with proximal DVT. The primary outcome was the occurrence of PTS (defined as Villalta score ≥ 5) from 6 to 24 months after DVT. Secondary outcomes included moderate-severe PTS (Villalta scale ≥ 10) and severe PTS (Villalta scale ≥ 14). Predictive performance was assessed by discrimination and calibration. An updated score was evaluated in an exploratory analysis.

RESULTS

Six hundred and ninety-one ATTRACT patients were included, of whom 328 (47%) developed PTS. The c-statistic was 0.63; 95% confidence interval (CI) 0.59-0.67 for PTS. The model's performance appeared to be better for the outcomes moderate to severe PTS and severe PTS (c-statistic 0.67; 95% CI 0.62-0.72 for moderate-severe PTS and 0.70; 0.64-0.77 for severe PTS). An updated model with age as an additional variable performed similarly to the original model.

CONCLUSION

We externally validated the SOX-PTS score for estimating the risk of developing PTS, moderate to severe PTS, and severe PTS, in patients with proximal DVT. The score may be useful to predict PTS at the time of DVT diagnosis. Further external validation in different patient cohorts is required.

摘要

背景

我们最近利用 SOX 试验的数据,开发了一种预测近端深静脉血栓(DVT)后血栓后综合征(PTS)发生的临床预测模型,称为 SOX-PTS 评分。该评分包括 DVT 的解剖范围、体重指数和基线 Villalta 评分。

目的

外部验证 SOX-PTS 评分。

方法

对评估近端 DVT 患者药物机械导管溶栓的 ATTRACT 试验数据进行逻辑回归分析。主要结局是 DVT 后 6-24 个月 PTS 的发生(定义为 Villalta 评分≥5)。次要结局包括中重度 PTS(Villalta 量表≥10)和重度 PTS(Villalta 量表≥14)。预测性能通过区分度和校准度进行评估。在探索性分析中评估了更新的评分。

结果

共纳入 691 例 ATTRACT 患者,其中 328 例(47%)发生 PTS。C 统计量为 0.63;95%置信区间(CI)为 PTS 的 0.59-0.67。该模型的性能对于中重度 PTS 和重度 PTS 的结果似乎更好(中重度 PTS 的 C 统计量为 0.67;95%CI 为 0.62-0.72,重度 PTS 的为 0.70;0.64-0.77)。一个包含年龄作为附加变量的更新模型与原始模型表现相似。

结论

我们对 SOX-PTS 评分进行了外部验证,以评估近端 DVT 患者发生 PTS、中重度 PTS 和重度 PTS 的风险。该评分可能有助于在 DVT 诊断时预测 PTS。需要在不同的患者队列中进行进一步的外部验证。

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