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.
Klinikum Karlsruhe, Karlsruhe, Germany - gefaesschirurgie@klinikum-karlsruhe.de.
Martin
M
Storck
Bad Bevensen Heart and Vascular Center, Bad Bevensen, Germany.
Thomas
T
Nolte
Theresienwiese Hospital, Mannheim, Germany.
Matthias
M
Tenholt
OLV Hospital Aalst, Aalst, Belgium.
Lieven
L
Maene
Leuven University Hospitals, Leuven, Belgium.
Geert
G
Maleux
Leipzig University Hospital, Leipzig, Germany.
Dierk
D
Scheinert
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017544:Aortic Aneurysm, Abdominal / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D001019:Aortic Rupture / Q000209:etiology; D001027:Aortography / Q000379:methods; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D000072226:Computed Tomography Angiography; D018450:Disease Progression; D018572:Disease-Free Survival; D017558:Elective Surgical Procedures; D057867:Endoleak / Q000209:etiology; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005060:Europe; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D012307:Risk Factors; D012737:Sex Factors; D013997:Time Factors; D016896:Treatment Outcome