Women and men derive comparable benefits from an ultra-low-profile endograft: 1-year results of the European OVATION registry

作者：Storck Martin^*; Nolte Thomas; Tenholt Matthias; Maene Lieven; Maleux Geert; Scheinert Dierk

来源：The Journal of Cardiovascular Surgery, 2017, 58(5): 658-664.

DOI：10.23736/S0021-9509.16.09304-6

• Abdominal aortic aneurysm
• Endovascular procedures
• Sex
• Registries
• Stents

BACKGROUND: Female patients are underrepresented in most stent-graft (EVAREVAR) trials due to a reduced anatomical eligibility for endovascular treatment. The purpose of this analysis was to determine the performance of the Ovation (R) and Ovation Prime (R) stent graft in women versus men for elective abdominal aortic aneurysm (AAA) repair.
METHODS: From May 2011 to December 2013, 501 patients (86% men, mean age 73 years) from 30 sites were prospectively enrolled in the OVATION Registry and electively treated with endovascular aneurysm repair. Patients returned for clinical and imaging follow-up at 1 month, 6 months, and 1 year. A post-hoc analysis was performed to assess the influence of gender on patient outcomes.
RESULTS : Women were older (median 77 vs. 73 years, P<0.01) although men reported a higher frequency of ASA class III/IV (54% vs. 34%), coronary artery disease (43% vs. 29%), diabetes mellitus (19% vs. 7%), and history of tobacco use (50% vs. 33%). Median external iliac diameter was 6.4 mm in women and 7.5 mm in men (P<0.001). Proximal neck diameter was larger in men versus women (24 vs. 22 mm). Technical success was 100% in women and 99.5% in men. Type I endoleak was identified in 5 men (1.5%) and a type III leak was identified in 1 (0.3%) man. No woman presented with type I or III endoleak at 1 year. The rate of AAA enlargement was similar in women (2.5%) and men (2.7%). Freedom from aneurysm-related mortality through 1 year was 100% in women and 99.3% in men (log-rank P=0.49). Freedom from all-cause mortality through 1 year was 94.0% in women and 95.8% in men (log-rank P=0.51). One contained AAA rupture was reported in a male patient. One female patient underwent conversion to open surgery. Freedom from a secondary intervention through 1 year was 88.2% in women and 93.7% in men (log-rank P= 0.11). C
CONCLUSIONS: Women and men derive similarly favorable benefits with the Ovation stent graft through 1-year follow-up. Longer-term follow-up will be required to determine the durability of these outcomes.

• 出版日期2017-10