Study Evaluates Secondary Procedures After Implantation With Medtronic's Talent and Valiant TEVAR Grafts

April 21, 2014—In the Journal of Vascular and Interventional Radiology (JVIR), Alan H. Matsumoto, MD, et al published findings on secondary procedures following thoracic aortic stent grafting in the first 3 years of the VALOR Test and VALOR II trials (2014;25:685–692).

As noted in JVIR, the purpose of this study is 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 arms 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.

The VALOR clinical study evaluated the Talent thoracic stent graft system (Medtronic, Inc., Santa Rosa, CA). VALOR II evaluated Medtronic’s Valiant thoracic stent graft system. The investigators reported in JVIR that a total of 127 and 96 patients were available for a minimum of 3 years of follow-up in the test arms 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 compared to 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. Estimated freedom from secondary procedures at 3 years was 85.1% (95% CI, 78.5%–89.8%) in the VALOR test arm and 94.9% (95% CI, 88.8%–97.7%) in the VALOR II test arm (P < .001).

The finding that 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—suggests significant benefit from advances in some combination of operator experience, imaging systems, treatment planning, and device design, concluded the investigators in JVIR.