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Title: Vascular Thoracic Stent Graft Proves Safe and Effective: Summary of the VALOR Trial
URL: http://www.pslgroup.com/dg/22A1EE.htm
Doctor's Guide
August 28, 2008

CHICAGO -- August 28, 2008 -- The Vascular Medtronic Talent Thoracic Stent Graft System (VALOR) is a safe and effective endovascular therapy, as an alternative to open surgery in patients with thoracic aortic aneurysms who were considered candidates for open surgical repair, according to a study published in the September 2008 Journal of Vascular Surgery.

Principal Investigator Ronald M. Fairman, MD, Division of Vascular Surgery, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, reported the results of the prospective, nonrandomised, multicentre, trial conducted at 38 sites.

A total of 195 patients were enrolled in the VALOR trial, and 189 patients were identified as retrospective open surgical subjects. Endovascular enrolment occurred between December 2003 and June 2005 and endovascular results were compared with retrospective open surgical data from 3 centres of excellence.

The mean number of thoracic stent graft components implanted was 2.7 +- 1.3 devices per patient. Of the proximal main thoracic stent graft components implanted 25% had diametres smaller than 26 mm or larger than 40 mm.

Left subclavian artery revascularisation was performed prior to the initial stent graft procedure in 5.2% of patients, and iliac conduits were utilised in 21.1% of patients.

Thirty-three percent of patients had the bare spring segment of the most proximally implanted device in zones 1 or 2 of the aortic arch. One hundred and ninety-four patients (99.55) had successful vessel access and deployment of the thoracic stent graft at the intended site.

The 12-month VALOR results included all-cause mortality (16.1%), aneurysm-related mortality (3.1%), conversion to open surgery (0.5%), target aneurysm rupture (0.5%), stent graft migration >10 mm (3.9%), endoleak (12.2%), stent graft patency (100%), stable or decreasing aneurysm diameter (91.5%), and loss of stent graft integrity (4 patients). There were no instances of deployment-related events or perforation of the aorta by a graft component.

"The Talent Thoracic Stent Graft showed statistically superior performance with respect to acute procedural outcomes, 30 day major adverse events, perioperative mortality, and 12 month aneurysm-related mortality when compared to open surgery," said Dr. Fairman.

The submission of these trial results lead to US Food and Drug Administration (FDA) approval of the Talent Thoracic Stent Graft System for treatment of thoracic aortic aneurysms in June 2008.

SOURCE: The Society for Vascular Surgery

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