Secondary Procedures following Thoracic Aortic Stent Grafting in the First 3 Years of the VALOR Test and VALOR II Trials

作者：Matsumoto Alan H^*; Angle John F; Secic Michelle; Carlson Grace A; Fisher Lois; Fairman Ronald M

来源：Journal of Vascular and Interventional Radiology, 2014, 25(5): 685-692.

DOI：10.1016/j.jvir.2013.12.012

Purpose: To compare the durability of thoracic endovascular aortic repair (TEVAR) in two similar clinical trials that used early- and later-generation stent grafts.
Materials and Methods: 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 a and potential predictors for secondary procedures.
Results: 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 anti 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).
Conclusions: 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.

• 出版日期2014-5