Gender analysis of the pivotal results of the Medtronic Talent Thoracic Stent Graft System (VALOR) trial

Abstract

Purpose: This study evaluated the differences between male and female patients undergoing thoracic endovascular aneurysm repair (TEVAR) in a pivotal Food and Drug Administration (FDA)-approved trial.

Methods: The Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms (VALOR) study 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 and 365 days.

Results: 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 length of stay. At 30 days, more major adverse events occurred in women than in men (52.5% vs 33.0%, 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 end point of 365-day "successful aneurysm treatment," defined as no aneurysm growth >5 mm at the 365-day 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).

Conclusions: TEVAR with the Talent device provided similar rates of 365-day mortality and morbidity for men and women. Although female patients had higher rates of periprocedural complications, they also more often had successful aneurysm treatment at the 1-year follow-up.