Matsumoto Alan H, Angle John F, Secic Michelle, Carlson Grace A, Fisher Lois, Fairman Ronald M
Department of Radiology and Medical Imaging, University of Virginia Health System, 1215 Lee St., Box 800170, Room 1839, Charlottesville, VA 22908.
Department of Radiology and Medical Imaging, University of Virginia Health System, 1215 Lee St., Box 800170, Room 1839, Charlottesville, VA 22908.
J Vasc Interv Radiol. 2014 May;25(5):685-692.e5. doi: 10.1016/j.jvir.2013.12.012. Epub 2014 Feb 12.
To compare the durability of thoracic endovascular aortic repair (TEVAR) in two similar clinical trials that used early- and later-generation stent grafts.
Secondary procedures from the prospective, nonrandomized, multicenter, clinical trial databases of the test arm of the VALOR and VALOR II trials were analyzed at 3 years. Descriptive and statistical analyses were employed to compare the rate of and potential predictors for secondary procedures.
A total of 127 and 96 patients were available for a minimum of 3 years of follow-up in the test arm of VALOR and VALOR II, respectively. By the first year after the index procedure, VALOR II patients were significantly less likely to have undergone a secondary procedure versus patients in the test arm of VALOR (odds ratio [OR], 0.08; 95% confidence interval [CI], 0.01-0.63; P = .02), with most procedures performed for type I endoleak. Multivariate predictors at 3 years for the need for a secondary procedure in the VALOR test arm were maximum aneurysm diameter (P = .002) and aneurysm length (P = .01), both of which remained significant at the end of the study period. The estimated freedoms from secondary procedures in the VALOR test arm and VALOR II at 3 years were 85.1% (95% CI, 78.5%-89.8%) and 94.9% (95% CI, 88.8%-97.7%), respectively (P < .001).
The rate of secondary procedures after TEVAR differed between the two cohorts, being substantially lower in the VALOR II trial at 1 year of follow-up. This finding suggests significant benefit from advances in some combination of operator experience, imaging systems, treatment planning, and device design.
在两项使用早期和新一代支架移植物的相似临床试验中比较胸主动脉腔内修复术（TEVAR）的耐久性。
对VALOR和VALOR II试验测试组的前瞻性、非随机、多中心临床试验数据库中的二次手术进行3年分析。采用描述性和统计分析来比较二次手术的发生率及潜在预测因素。
VALOR和VALOR II试验测试组分别有127例和96例患者至少随访了3年。在首次手术后的第一年，与VALOR试验测试组的患者相比，VALOR II试验的患者进行二次手术的可能性显著降低（优势比[OR]为0.08；95%置信区间[CI]为0.01 - 0.63；P = 0.02），大多数手术是针对I型内漏进行的。VALOR试验测试组中3年时二次手术需求的多变量预测因素为最大动脉瘤直径（P = 0.002）和动脉瘤长度（P = 0.01），在研究期结束时这两个因素仍具有显著性。VALOR试验测试组和VALOR II试验3年时二次手术的估计无发生率分别为85.1%（95% CI为78.5% - 89.8%）和94.9%（95% CI为88.8% - 97.7%）（P < 0.001）。
TEVAR术后二次手术的发生率在两个队列中有所不同，在VALOR II试验随访1年时显著更低。这一发现表明，在术者经验、成像系统、治疗规划和器械设计的某些组合方面取得进展具有显著益处。
