目的:深静脉阻塞(DVO)对医疗保健系统和患者的生活质量(QoL)有很大的负担。病例系列显示支架置入是安全有效的;然而,大多数研究缺乏对照组,QoL变化未与常规治疗进行比较.目的是评估支架和常规治疗的DVO患者从基线到12个月的QoL变化差异。
方法:受试者>在三级医院中,由于血栓后(PTS)或非血栓性髂静脉病变(NIVL)导致的18岁的DVO被前瞻性随机分配到最佳药物治疗(BMT)或BMT以2:1的比例放置支架,进行PTS或NIVL分层。主要结果是从基线到治疗后12个月的VEINES-QoL评分变化的组间差异。次要结局包括EuroQoL5维度5级(EQ-5D-5L)的得分变化差异,疼痛残疾指数(PDI)静脉临床严重程度评分(VCSS),还有Villalta的分数.
背景:NCT03026049。
结果:三年后,纳入率降至几乎为零,因此,这项研究不得不停止。63例患者被随机分为支架组(n=42)或对照组(n=21)。总的来说,50例患者具有可用于主要结果分析的数据。VEINES-QoL和VEINES-Sym的12个月评分之间的调整平均差为8.07(95%CI3.04-13.09)和5.99(95%CI0.75-11.24)(p=.026),分别,支持支架组。差异很大,但尚未达到预定义的有意义的QoL改善14点。VCSS的12个月得分之间的平均差异为-2.93(95%CI-5.71-0.16,p=0.040),PDI的-11.83(95%CI-20.81-2.86,p=0.011),EQ-5D指数为0.015(95%CI-0.12-0.15,p=0.82),Villalta评分为-2.99(95%CI-7.28-1.30,p=.17)。
结论:接受专用静脉支架的有症状的DVO患者在12个月时的VEINES-QoL/Sym评分明显高于对照组,但组间差异低于预先规定的临床相关QoL差异至少14分.
OBJECTIVE: Deep venous obstruction (DVO) is a great burden on the healthcare system and patients\' quality of life (QoL). Case series show stenting is safe and effective, however most studies lack control groups and QoL changes have not been compared with conventional treatment. The aim was to assess the difference in QoL changes from baseline to 12 months between stent and conventionally treated patients with DVO.
METHODS: Subjects > 18 years old with DVO due to post-thrombotic (PTS) or non-thrombotic iliac vein lesions (NIVLs) in a tertiary hospital were prospectively randomised to best medical therapy (BMT) or stent placement with BMT in a ratio 2:1, stratified for PTS or NIVL. The primary outcome was the between group difference in VEINES-QoL scores change from baseline to 12 months after treatment. Secondary outcomes included the difference in score changes for EuroQoL 5-Dimension 5 Level (EQ-5D-5L), Pain Disability Index (PDI), Venous Clinical Severity Score (VCSS), and the Villalta score.
RESULTS: After three years, the inclusion rate dropped to almost zero, therefore the study had to be stopped. Sixty-three patients were randomised to either the stent (n = 42) or control group (n = 21). Overall, 50 patients had available data for primary outcome analysis. The adjusted mean difference between 12 month scores for VEINES-QoL and VEINES-Sym was 8.07 (95% CI 3.04 - 13.09) and 5.99 (95% CI 0.75 - 11.24) (p = .026), respectively, in favour of the stent group. The differences were significant, but a pre-defined meaningful 14 point improvement in QoL was not reached. The mean difference between 12 month scores for VCSS was -2.93 (95% CI -5.71 - 0.16, p = .040), -11.83 (95% CI -20.81 - 2.86, p = .011) for PDI, 0.015 (95% CI -0.12 - 0.15, p = .82) for the EQ-5D index, and -2.99 (95% CI -7.28 - 1.30, p = .17) for the Villalta score.
CONCLUSIONS: Symptomatic patients with DVO who received dedicated venous stents had significantly higher VEINES-QoL/Sym scores at 12 months compared with the control group, but the between group difference was lower than the pre-specified clinically relevant QoL difference of at least 14 points.
BACKGROUND: NCT03026049.