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首页> 外文期刊>Journal of endovascular therapy: an official journal of the International Society of Endovascular Specialists >Effects of Venous Angioplasty on Cerebral Lesions in Multiple Sclerosis: Expanded Analysis of the Brave Dreams Double-Blind, Sham-Controlled Randomized Trial
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Effects of Venous Angioplasty on Cerebral Lesions in Multiple Sclerosis: Expanded Analysis of the Brave Dreams Double-Blind, Sham-Controlled Randomized Trial

机译：静脉血管成形术对多发性硬化症中脑病变的影响：扩大勇敢梦想分析双盲，假手动随机试验

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Purpose: To evaluate if jugular vein flow restoration in various venographic defects indicative of chronic cerebrospinal venous insufficiency (CCSVI) in multiple sclerosis (MS) patients can have positive effects on cerebral lesions identified using magnetic resonance imaging (MRI). Materials and Methods: The Brave Dreams trial ( identifier NCT01371760) was a multicenter, randomized, parallel group, double-blind, sham-controlled trial to assess the efficacy of jugular venoplasty in MS patients with CCSVI. Between August 2012 and March 2016, 130 patients (mean age 39.9 +/- 10.6 years; 81 women) with relapsing/remitting (n=115) or secondary/progressive (n=15) MS were randomized 2:1 to venography plus angioplasty (n=86) or venography (sham; n=44). Patients and study personnel (except the interventionist) were masked to treatment assignment. MRI data acquired at 6 and 12 months after randomization were compared to the preoperative scan for new and/or >30% enlargement of T2 lesions plus new gadolinium enhancement of pre-existing lesions. The relative risks (RR) with 95% confidence interval (CI) were estimated and compared. In a secondary assessment, venograms of patients who underwent venous angioplasty were graded as "favorable" (n=38) or "unfavorable" (n=30) for dilation according to the Giaquinta grading system by 4 investigators blinded to outcomes. These subgroups were also compared. Results: Of the 130 patients enrolled, 125 (96%) completed the 12-month MRI follow-up. Analysis showed that the likelihood of being free of new cerebral lesions at 1 year was significantly higher after venoplasty compared to the sham group (RR 1.42, 95% CI 1.00 to 2.01, p=0.032). Patients with favorable venograms had a significantly higher probability of being free of new cerebral lesions than patients with unfavorable venograms (RR 1.82, 95% CI 1.17 to 2.83, p=0.005) or patients in the sham arm (RR 1.66, 95% CI 1.16 to 2.37, p=0.005). Conclusion: Expanded analysis of the Brave Dreams data that included secondary/progressive MS patients in addition to the relapsing/remitting patients analyzed previously showed that venoplasty decreases new cerebral lesions at 1 year. Secondary analysis confirmed the efficacy of the Giaquinta grading system in selecting patients appropriate for venoplasty who were more likely to be free from accumulation of new cerebral lesions at MRI.
机译：目的：评估在多发性硬化症（MS）患者中指示慢性脑脊髓静脉内部（CCSVI）的各种静脉缺陷中的颈静脉流量恢复，可以对使用磁共振成像（MRI）鉴定的脑病变具有积极作用。材料和方法：勇敢的梦想试验（标识符NCT01371760）是一种多中心，随机，并行组，双盲，假对照试验，以评估颈静脉术在MS患者中CCSVI患者的疗效。 2012年8月至2016年3月期间，130名患者（平均39.9 +/- 10.6岁; 81名女性）随着复发/饲养（n = 115）或次要/渐进（n = 15）MS被随机分配2：1至静脉成形血管成形术（n = 86）或静脉注册（假; n = 44）。患者和研究人员（除介入主义者除外）被掩盖到治疗任务。将随机化6和12个月获得的MRI数据与新的和/或> 30％的T2病变扩大的术前扫描加上了新的钆增强了预先存在的病变。估计和比较了95％置信区间（CI）的相对风险（RR）。在二次评估中，根据吉亚昆塔分级系统对结果进行扩张，接受静脉血管成形术的患者的静脉血管成形术患者或“有利”（n = 38）或“不利的”（n = 30）。这些亚组也被比较了。结果：130名患者注册，125名（96％）完成了12个月的MRI随访。分析表明，与假手术组（RR 1.42,95％CI 1.00至2.01，P = 0.032）相比，静脉成形术后，在venoplasty之后，1年内没有新的脑病变的可能性显着高。有利静脉图的患者比不合适的静脉图（RR 1.82,95％CI 1.17-2.83，P = 0.005）或假手臂（RR 1.66,95％CI 1.16的患者而言，没有新的脑病变的概率显着更高2.37，p = 0.005）。结论：除了先前分析的复发/饲养患者外，还扩增了包括二次/逐步MS患者的勇敢梦想数据，所述患者患者分析的复发/饲养患者表明venoplasty在1年内降低了新的脑病变。二次分析证实了胶质肿分级系统在选择适合于venoplasty的患者中的疗效，这些患者更容易免于在MRI上积累新的脑病变。

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