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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.

journal_name

J Vasc Surg

journal_title

Journal of vascular surgery

authors

Jackson BM,Woo EY,Bavaria JE,Fairman RM

doi

10.1016/j.jvs.2010.12.064

subject

Has Abstract

pub_date

2011-08-01 00:00:00

pages

358-63, 363.e1

issue

2

eissn

0741-5214

issn

1097-6809

pii

S0741-5214(11)00099-1

journal_volume

54

pub_type

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