Hospital of the University of Pennsylvania, Philadelphia, Pa 19104, USA.
J Vasc Surg. 2012 Nov;56(5):1222-31.e1. doi: 10.1016/j.jvs.2012.04.062. Epub 2012 Jul 24.
We report 30-day and 12-month results of endovascular treatment with the Valiant Thoracic Stent Graft System (Medtronic Vascular, Santa Rosa, Calif) in patients with descending thoracic aortic aneurysms of degenerative etiology. The Valiant stent graft is an evolution of the Talent thoracic stent graft (Medtronic Vascular).
The VALOR II (Evaluation of the Clinical Performance of the Valiant Thoracic Stent Graft System in the Treatment of Descending Thoracic Aneurysms of Degenerative Etiology in Subjects Who Are Candidates for Endovascular Repair) was a prospective, nonrandomized, pivotal trial conducted at 24 U.S. sites with enrollment between December 2006 and September 2009. Standard follow-up examinations, including physical examination, computed tomography, and chest radiography, were at 1, 6, and 12 months, and annually through 5 years. VALOR II outcomes were compared with those from the pivotal VALOR (Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms) trial of the Talent stent graft, which enrolled 195 patients with similar enrollment criteria.
VALOR II enrolled 160 patients. Compared with VALOR patients, VALOR II patients had similar age and sex distribution but higher rates of cardiovascular risk factors and significantly more severe modified Society for Vascular Surgery/American Association for Vascular Surgery risk scores. Stent graft delivery and deployment were successful in 154 patients (96.3%). Outcomes at 30 days in VALOR II were perioperative mortality, 3.1%; major adverse events, 38.1%; paraplegia, 0.6%; paraparesis, 1.9%; and stroke, 2.5%. At 12 months, after the minimum sample size was reached, 151 patients were evaluated: aneurysm-related mortality was 4.0%, stent graft migration was 2.9%, and endoleak was 13.0%. Through 12 months, there were no ruptures, conversions to open surgery, secondary procedures due to endoleak >30 days, or loss of stent graft patency. The Valiant stent graft was statistically noninferior to the Talent stent graft in 12-month all-cause mortality (12.6% vs 16.1%) and exceeded the primary effectiveness goal of 12-month successful aneurysm treatment, defined as absence of aneurysm growth >5 mm and of secondary procedures for type I/III endoleak (97.4% vs 80.0%).
The VALOR II 12-month results demonstrate that the Medtronic Valiant thoracic stent graft is a safe and effective treatment for patients with descending thoracic aortic aneurysms of degenerative etiology.
我们报告了 30 天和 12 个月的血管内治疗结果，使用的是 Valiant 胸主动脉覆膜支架系统（美敦力血管，加利福尼亚州圣罗莎）治疗退行性病因的降主动脉瘤。Valiant 支架移植物是 Talent 胸主动脉支架移植物（美敦力血管）的进化。
VALOR II（评价在候选血管内修复的退行性病因的降主动脉瘤患者中使用 Valiant 胸主动脉支架移植物系统的临床性能）是一项前瞻性、非随机、主要在美国 24 个地点进行的试验，于 2006 年 12 月至 2009 年 9 月期间进行招募。标准随访检查包括体格检查、计算机断层扫描和胸部 X 线检查，在 1、6 和 12 个月，以及 5 年内每年进行一次。VALOR II 的结果与 Talent 支架移植物的主要 VALOR（评估美敦力血管 Talent 胸主动脉支架移植物系统治疗胸主动脉瘤的效果）试验的结果进行了比较，该试验招募了 195 名具有类似入组标准的患者。
VALOR II 招募了 160 名患者。与 VALOR 患者相比，VALOR II 患者的年龄和性别分布相似，但心血管危险因素的发生率更高，改良的血管外科学会/血管外科学会风险评分明显更严重。154 名患者（96.3%）的支架移植物输送和部署成功。VALOR II 术后 30 天的结果为围手术期死亡率 3.1%；主要不良事件 38.1%；截瘫 0.6%；偏瘫 1.9%；中风 2.5%。在 12 个月时，达到最小样本量后，对 151 名患者进行了评估：动脉瘤相关死亡率为 4.0%，支架移植物迁移率为 2.9%，内漏率为 13.0%。通过 12 个月，没有破裂、转为开放手术、因内漏>30 天而进行的二次手术，或支架移植物闭塞。Valiant 支架移植物在 12 个月时的全因死亡率（12.6%比 16.1%）方面统计学上不劣于 Talent 支架移植物，并且超过了 12 个月时成功治疗动脉瘤的主要有效性目标，定义为动脉瘤生长>5 毫米和因 I/III 型内漏而进行二次手术的情况不存在（97.4%比 80.0%）。
VALOR II 12 个月的结果表明，美敦力血管 Valiant 胸主动脉支架移植物是退行性病因的降主动脉瘤患者的一种安全有效的治疗方法。
