Clinical evaluation of the Zilver vascular stent for symptomatic iliac artery disease.
OBJECTIVE
To evaluate the safety and effectiveness of the Zilver vascular stent in the treatment of de novo or restenotic lesions in the external and common iliac arteries.


METHODS
Regardless of the results of an initial percutaneous transluminal angioplasty (PTA), 151 consecutive patients were implanted with Zilver vascular stents (Cook, Bloomington, Ind) in up to two stenotic (< or =10 cm) or occluded (< or =5 cm) atherosclerotic lesions of the external or common iliac arteries. The primary endpoint was the rate of major adverse events within 9 months after the procedure. Major adverse events were defined as death, myocardial infarction, target lesion revascularization, and limb loss. Secondary endpoints included acute procedural success, 30-day clinical success, 9-month patency rate, 9-month functional status (on the basis of the validated Walking Impairment Questionnaire), and ankle-brachial index (ABI).


RESULTS
of 1-, 6-, and 9-month follow-up are reported. Results The 9-month device and/or procedural-related major adverse event rate (adjudicated by an independent clinical events committee) was 2.7%. The all-cause major adverse event rate was 7.5%. Both rates were substantially below the prespecified objective performance criterion of 16%. The acute procedure success rate and 30-day clinical success rate were 98.0% and 94.0%, respectively. The 9-month patency rate, measured with duplex ultrasonography, was 92.9%. Significant improvement in the ABI and walking distance and walking speed scores, relative to preprocedural values, was seen at 1 month and was maintained through 9-month follow-up.


CONCLUSIONS
The Zilver vascular stent is safe and effective as an adjunct to PTA in the treatment of symptomatic disease of the iliac arteries.
Krol
Katharine L
KL
St Vincent Hospital & Health Care Center, Indianapolis, IN, USA.
Saxon
Richard R
RR
Farhat
Naim
N
Botti
Charles F
CF
Brown
O William
OW
Zemel
Gerald
G
Raabe
Rodney D
RD
Voorhees
William D
WD
Katzen
Barry T
BT
D000368:Aged; D000671:Amputation, Surgical; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D000842:Ankle / Q000098:blood supply; D001157:Arterial Occlusive Diseases / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D050197:Atherosclerosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D001794:Blood Pressure; D001916:Brachial Artery / Q000503:physiopathology; D002317:Cardiovascular Agents / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007083:Iliac Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality; D011446:Prospective Studies; D011474:Prosthesis Design; D011859:Radiography; D020127:Recovery of Function; D012008:Recurrence; D018570:Risk Assessment; D015607:Stents; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014654:Vascular Patency; D016138:Walking
D002317:Cardiovascular Agents