Format

Send to

Choose Destination
See comment in PubMed Commons below
J Vasc Interv Radiol. 2014 May;25(5):685-692.e5. doi: 10.1016/j.jvir.2013.12.012. Epub 2014 Feb 12.

Secondary procedures following thoracic aortic stent grafting in the first 3 years of the VALOR test and VALOR II trials.

Author information

1
Department of Radiology and Medical Imaging, University of Virginia Health System, 1215 Lee St., Box 800170, Room 1839, Charlottesville, VA 22908. Electronic address: ahm4d@virginia.edu.
2
Department of Radiology and Medical Imaging, University of Virginia Health System, 1215 Lee St., Box 800170, Room 1839, Charlottesville, VA 22908.
3
Secic Statistical Consulting, Chardon, Ohio.
4
Office of Medical Affairs, Medtronic Vascular, Santa Rosa, California.
5
Division of Vascular Surgery and Endovascular Therapy, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.

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.

PMID:
24529546
DOI:
10.1016/j.jvir.2013.12.012
[Indexed for MEDLINE]
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Elsevier Science
    Loading ...
    Support Center