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

• Published in: Journal of vascular and interventional radiology Vol. 25; no. 5; pp. 685 - 692.e5
• Main Authors: Matsumoto, Alan H., MD, Angle, John F., MD, Secic, Michelle, MS, Carlson, Grace A., MD, MS, Fisher, Lois, BS, Fairman, Ronald M., MD
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.05.2014
• Subjects: Adult; Aged; Aortic Aneurysm, Thoracic - surgery; Female; Humans; Longitudinal Studies; Male; Middle Aged; Postoperative Complications - epidemiology; Prevalence; Radiology; Reoperation - statistics & numerical data; Risk Factors; Stents - statistics & numerical data; Treatment Outcome; United States - epidemiology; Vascular Grafting - statistics & numerical data; Vascular Surgical Procedures - statistics & numerical data; United States; OR; CI; odds ratio; Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms; SVS; thoracic endovascular aortic repair; thoracic aortic aneurysm; Society for Vascular Surgery; TAA; VALOR II; TEVAR; Evaluation of the Clinical Performance of the Valiant Thoracic Stent Graft System in the Treatment of Descending Thoracic Aneurysms of Degenerative Etiology; confidence interval; VALOR
• ISSN: 1051-0443; 1535-7732
• DOI: 10.1016/j.jvir.2013.12.012

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.