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

BACKGROUND

Female patients are underrepresented in most stent-graft (EVAR) trials due to a reduced anatomical eligibility for endovascular treatment. The purpose of this analysis was to determine the performance of the Ovation® and Ovation Prime® 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).

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.