Results of the VALOR II trial of the Medtronic Valiant Thoracic Stent Graft

Abstract

Background: The 1-year results of endovascular exclusion of degenerative descending thoracic aortic aneurysms (DTA) with the Valiant Thoracic Stent Graft (Medtronic Vascular, Santa Rosa, Calif) have been previously reported. With long-term follow-up now complete, the 5-year results are reported.

Methods: The VALOR II trial (Evaluation of the Clinical Performance of the Valiant Thoracic Stent Graft System in the Treatment of Descending Thoracic Aneurysms of Degenerative Etiology in Subjects Who Are Candidates for Endovascular Repair) was a prospective, nonrandomized trial of the Valiant Thoracic Stent Graft system in patients with degenerative DTA. The trial involved 24 sites in the United States and enrolled patients between December 2006 and September 2009. Standard follow-up included physical examination, computed tomography, and chest radiography through 5 years.

Results: The study enrolled 160 patients. The average age was 72.2 years (range, 36-85 years), 95 (59%) were men, 150 (94%) had hypertension, and 26 (16%) had renal insufficiency. There were 50 patients (31%) who presented with symptoms; back pain was the most common (34 [68%]). The average aneurysm diameter was 57 mm (range, 32-96 mm). There were 103 patients (64%) with a fusiform aneurysm and 57 (36%) with a saccular aneurysm or penetrating ulcer. Two or more devices were implanted in 126 patients (79%), and the maximum number of grafts implanted was four. There were 54 deaths during the study. The 5-year actuarial survival was 64%. There were eight aneurysm-related deaths (5 deaths ≤30 days of implant), and the 5-year freedom from aneurysm-related death was 95%. There was one conversion to open repair at 36 months. Eleven patients underwent 13 secondary procedures (9 for endoleak, 3 for aneurysm expansion, and 1 rupture). Follow-up imaging was available at 5 years for 56 patients. The average aortic diameter decreased >5 mm in 27 patients (48%), increased >5 mm in 6 patients (11%), and remained unchanged in 23 (41%).

Conclusions: The VALOR II 5-year results demonstrate that the reintervention and aneurysm-related death rates are low. The Valiant Thoracic Stent Graft is an effective treatment of degenerative DTA.

Trial registration: ClinicalTrials.gov NCT00413231.