Two-year clinical evaluation of the Zilver vascular stent for symptomatic iliac artery disease.
OBJECTIVE
To evaluate the 2-year outcomes of safety and effectiveness for iliac artery stent placement and examine the effects of placement in the common iliac artery (CIA) and external iliac artery (EIA), the degree of initial stenosis, and patient gender on success.


METHODS
Zilver vascular stents (Cook Inc., Bloomington, Indiana) were placed in 151 consecutive patients whose iliac arteries remained stenotic after percutaneous transluminal angioplasty (PTA). Success at 2 years was determined by patency, ankle-brachial index (ABI) scores, and Walking Impairment Questionnaire (WIQ) scores.


RESULTS
Patency, ABI measurements, and WIQ scores showed improvement at 2 years, compared with preprocedure measurements. Kaplan-Meier estimate of overall patency at 2 years was 90% (n = 117). Significant improvement in ABI and WIQ scores was seen at 2 years, compared with preprocedural values (P < .01). The 2-year overall success rate was 91%. The degree of initial stenosis, stent location, and patient gender did not affect the success of the Zilver stent (P = .65, P = .58, and P = .77). The Kaplan-Meier estimate of the probability of experiencing a major adverse event (MAE) related to the device or stent placement procedure by the 2-year follow-up was 2.7%.


CONCLUSIONS
The Zilver vascular stent remains durable at 2 years in regard to safety and clinical effectiveness, and is effective in the CIA and EIA both in male and female patients.
Jaff
Michael R
MR
Massachusetts General Hospital Vascular Center, 55 Fruit Street, GB 800, Boston, MA 02114, USA. mjaff@partners.org
Katzen
Barry T
BT
D000368:Aged; D001807:Blood Vessel Prosthesis / Q000706:statistics & numerical data*; D001900:Boston / Q000453:epidemiology; D019544:Equipment Failure Analysis; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007083:Iliac Artery / Q000601:surgery*; D015994:Incidence; D008297:Male; D008404:Massachusetts; D058729:Peripheral Arterial Disease / Q000453:epidemiology* / Q000601:surgery*; D011183:Postoperative Complications / Q000209:etiology*; D011474:Prosthesis Design; D017678:Sex Distribution; D015607:Stents / Q000706:statistics & numerical data*; D016896:Treatment Outcome