Makaroun Michel S, Dillavou Ellen D, Wheatley Grayson H, Cambria Richard P
Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA 15213, USA.
J Vasc Surg. 2008 May;47(5):912-8. doi: 10.1016/j.jvs.2007.12.006. Epub 2008 Mar 19.
Report the results of a phase II multicenter, prospective trial comparing endovascular treatment of descending thoracic aneurysm (TEVAR) with the TAG device to surgical controls after 5 years of follow-up.
The Gore TAG trial compared the TAG endograft patients (n = 140) with standard open surgical controls (n = 94) with enrollment from September of 1999 to May of 2001. An additional 51 patients were enrolled in 2003 after revision of the endograft. Follow-up consisted of patient visits, computed tomography (CT) scans and x-rays at 1, 6, and 12 months and yearly. Significant sac size change was defined as >or=5 mm increase or decrease from the 1 month baseline measurement. Migration was defined as >or=10 mm cranial or caudal movement of the device inside the aorta. Significance was determined as P <or= .05.
At 5 years, aneurysm-related mortality was lower for TAG patients at 2.8% compared with open controls at 11.7% (P = .008). No differences in all-cause mortality were noted, with 68% of TAG patients and 67% of open controls surviving to 5 years (P = .43). Major adverse events at 5 years were significantly reduced in the TAG group; 57.9% vs 78.7% (P = .001). Endoleaks in the TAG group decreased from 8.1% at 1 month to 4.3% at 5 years. Five TAG patients have undergone major aneurysm-related re-interventions at 5 years (3.6%), including one arch aneurysm repair for type 1 endoleak and migration, one open conversion and five endovascular procedures for endoleaks in three patients. There were fewer secondary procedures not directly related to aneurysm repair in the TAG vs the open repair group at 5 years, 15.0% vs 31.9%, (P = .01). For TAG patients, sac size at 60 months decreased in 50% and increased in 19% compared with the 1-month baseline. Comparison with the modified low-porosity device at 24 months showed sac increase in 12.9% of original vs 2.9% in modified grafts (P = .11). At 5 years, there have been no ruptures, one migration, no collapse, and 20 instances of fracture in 19 patients, all before the revision of the TAG graft.
In anatomically suitable patients, TAG treatment of thoracic aneurysms is superior to surgical repair at 5 years. Although sac enlargement is concerning, early modified device results indicate this issue may be resolved.
报告一项II期多中心前瞻性试验的结果，该试验比较了使用TAG装置进行胸降主动脉瘤腔内治疗（TEVAR）与手术对照组在5年随访后的情况。
戈尔TAG试验将TAG血管内支架移植物患者（n = 140）与标准开放手术对照组（n = 94）进行比较，入组时间为1999年9月至2001年5月。2003年血管内支架移植物修订后又纳入了51例患者。随访包括患者就诊、在1、6和12个月以及每年进行的计算机断层扫描（CT）和X线检查。显著的瘤体大小变化定义为与1个月基线测量值相比增加或减少≥5 mm。移位定义为装置在主动脉内向上或向下移动≥10 mm。显著性判定为P≤0.05。
5年时，TAG患者的动脉瘤相关死亡率为2.8%，低于开放手术对照组的11.7%（P = 0.008）。全因死亡率无差异，68%的TAG患者和67%的开放手术对照组患者存活至5年（P = 0.43）。TAG组5年时的主要不良事件显著减少；分别为57.9%和78.7%（P = 0.001）。TAG组的内漏从1个月时的8.1%降至5年时的4.3%。5年时有5例TAG患者因动脉瘤相关进行了重大再次干预（3.6%），包括1例因I型内漏和移位进行的弓部动脉瘤修复、1例开放手术转换以及3例患者因内漏进行的5次血管内手术。5年时，与开放修复组相比，TAG组中与动脉瘤修复无直接关系的二次手术较少，分别为15.0%和31.9%（P = 0.01）。对于TAG患者，与1个月基线相比，60个月时瘤体大小减小的占50%，增大的占19%。与24个月时的改良低孔隙率装置相比，原始装置组瘤体增大的占12.9%，改良移植物组为2.9%（P = 0.11）。5年时，未发生破裂，1例移位，无塌陷，19例患者中有20例发生骨折，均在TAG移植物修订前。
在解剖结构合适的患者中，TAG治疗胸主动脉瘤5年时优于手术修复。尽管瘤体增大令人担忧，但早期改良装置的结果表明这个问题可能会得到解决。
