Gender Analysis of Medtronic's VALOR Trial Results Published

August 8, 2011—In the Journal of Vascular Surgery, Benjamin M. Jackson, MD, et al published findings from a study that evaluated the differences between male and female patients undergoing thoracic endovascular aneurysm repair (TEVAR) in the pivotal VALOR (The Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System [Medtronic, Inc. Minneapolis, MN] for the Treatment of Thoracic Aortic Aneurysms) trial (2011;54:358–363). VALOR was a prospective, nonrandomized, multicenter, pivotal trial conducted in the United States. Patients were enrolled between December 2003 and June 2005. Follow-up was conducted at 30 days and 1 year.

According to the investigators, VALOR enrolled 115 men (58.9%; 69.3 ± 11.7 years old), and 80 women (41.1%; 71.6 ± 10.1 years old). Iliac conduits were used more often in women, who had smaller-diameter external iliac arteries than in men (38.8% vs 8.8%; P < .001). Women required more blood transfusions and had a longer hospital stay. At 30 days, more major adverse events occurred in women than in men (52.5% vs 33%; P = .008), with more vascular access-related and respiratory complications. No gender-based differences were seen in all-cause mortality or in aneurysm-related death. The composite endpoint of 1-year “successful aneurysm treatment,” defined as no aneurysm growth > 5 mm at the 1-year follow-up visit compared with the 30-day follow-up visit and absence of any type I endoleak requiring a secondary procedure, favored women over men (98.2% vs 82.4%; P = .004).

The investigators concluded that TEVAR with the Talent device provided similar rates of 1-year mortality and morbidity for men and women, and that although female patients had higher rates of periprocedural complications, they also more often had successful aneurysm treatment at the 1-year follow-up.