Rinfret Félix, Gu Chu-Shu, Vedantham Suresh, Kahn Susan R
Department of Medicine McGill University Montreal Quebec Canada.
Centre for Regulatory Excellence, Statistics and Trials Ottawa Ontario Canada.
Res Pract Thromb Haemost. 2022 Aug 29;6(6):e12796. doi: 10.1002/rth2.12796. eCollection 2022 Aug.
Postthrombotic syndrome (PTS) remains associated with significant clinical and economic burden. This study aimed to investigate known and novel predictors of the development of PTS in participants of the ATTRACT (Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis) trial.
We used multivariable logistic regression to identify baseline and postbaseline factors that were predictive of the development of PTS during study follow-up, as defined by a Villalta score of 5 or greater or the development of a venous ulcer from 6 to 24 months after enrollment.
Among 691 patients in the study cohort (all had proximal deep vein thrombosis [DVT] that extended above the popliteal vein, of which 57% had iliofemoral DVT), 47% developed PTS. Further, we identified that Villalta score at baseline (odds ratio [OR], 1.09 [95% confidence interval [CI], 1.05-1.13] per one-unit increase) and employment status (unemployed due to disability: OR, 3.31 [95% CI, 1.72-6.35] vs. employed more than 35 hours per week) were predictive of PTS. In terms of postbaseline predictors, leg pain severity at day 10 (OR, 1.28 [95% CI, 1.13-1.45] per 1-point increase in a 7-point scale) predicted PTS. Also, patients receiving rivaroxaban on day 10 following randomization had lower rates of PTS (OR, 0.53 [95% CI, 0.33-0.86]) than patients on warfarin.
Novel predictors for PTS identified in our study include baseline Villalta score, leg pain severity at 10 days, and unemployed due to disability. Our findings also suggest that the initial choice of anticoagulant to treat DVT may have an impact on the development of PTS.
血栓形成后综合征(PTS)仍然伴随着巨大的临床和经济负担。本研究旨在调查ATTRACT(急性静脉血栓形成:辅助导管定向溶栓清除血栓)试验参与者中PTS发生的已知和新的预测因素。
我们使用多变量逻辑回归来确定在研究随访期间预测PTS发生的基线和基线后因素,PTS的定义为Villalta评分为5分或更高,或在入组后6至24个月出现静脉溃疡。
在研究队列的691名患者中(所有患者均有腘静脉以上的近端深静脉血栓形成[DVT],其中57%患有髂股DVT),47%发生了PTS。此外,我们确定基线时的Villalta评分(比值比[OR],每增加一个单位为1.09[95%置信区间[CI],1.05-1.13])和就业状况(因残疾失业:OR,3.31[95%CI,1.72-6.35]与每周工作超过35小时的就业者相比)可预测PTS。就基线后预测因素而言,第10天时腿部疼痛严重程度(7分制中每增加1分,OR为1.28[95%CI,1.13-1.45])可预测PTS。此外,随机分组后第10天接受利伐沙班治疗的患者发生PTS的比率(OR,0.53[95%CI,0.33-0.86])低于接受华法林治疗的患者。
我们的研究中确定的PTS新预测因素包括基线Villalta评分、第10天时腿部疼痛严重程度和因残疾失业。我们的研究结果还表明,治疗DVT的初始抗凝剂选择可能会对PTS的发生产生影响。