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VALOR II: Thoracic stent graft safe, efficacious in patients with descending TAA

Issue: August 2011

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The Valiant thoracic stent graft produced favorable results at 1 year among patients with descending thoracic aortic aneurysms of degenerative etiology and proved to be noninferior to a predicate device, according to presented data.

The nonrandomized, prospective, pivotal VALOR II trial followed 160 patients with descending thoracic aortic aneurysms (TAA) of degenerative etiology who were treated with a thoracic stent graft (Valiant, Medtronic) at 24 US centers. Outcomes were compared with those obtained in the VALOR pivotal trial, a study that examined a precursor thoracic stent graft (Talent, Medtronic) among 195 patients with the same inclusion criteria.

Overall, 96.3% of VALOR II patients had successful stent graft delivery and deployment. At 30 days, perioperative mortality was 3.1% with a major adverse event rate of 38.1%. At 1 year, among 94.4% of patients from the VALOR II trial who were available for follow-up, rates of aneurysm-related mortality was 3.3%, 2.9% for stent-graft migration and 13% for endoleak, with no cases of rupture, conversion to open surgery or loss of stent-graft patency.

In all, the Valiant stent graft proved to be statistically noninferior to the Talent stent graft in 12-month all-cause mortality (12.6% vs. 16.1%) and exceeded the primary effectiveness goal of 12-month successful aneurysm treatment (97.4% vs. 80%), which was defined as the absence of aneurysm growth of more than 5 mm and of secondary procedures for type I/III endoleak.

For more information:

• Fairman RM. LB1. Presented at: 2011 Vascular Annual Meeting; June 16-18, 2011; Chicago.

Disclosure: Several trial investigators report relevant financial disclosures, including receiving research grants and/or consulting fees and other payment from Medtronic.

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