Secondary Procedures following Thoracic Aortic Stent Grafting in the First 3 Years of the VALOR Test and VALOR II Trials
Abstract 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 te...
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Published in | Journal of vascular and interventional radiology Vol. 25; no. 5; pp. 685 - 692.e5 |
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Main Authors | , , , , , |
Format | Journal Article |
Language | English |
Published |
United States
Elsevier Inc
01.05.2014
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Subjects | |
Online Access | Get full text |
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Summary: | Abstract 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 of 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 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). 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. |
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Bibliography: | ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23 |
ISSN: | 1051-0443 1535-7732 |
DOI: | 10.1016/j.jvir.2013.12.012 |