Results From the VISIBILITY Iliac Study: Primary and Cohort Outcomes at 9 Months

John H Rundback, Patrick Peeters, Jon C George, Michael R Jaff, Peter L Faries, John H Rundback, Patrick Peeters, Jon C George, Michael R Jaff, Peter L Faries

Abstract

Purpose: To evaluate the safety and effectiveness of primary stenting of the common (CIA) or external iliac artery (EIA) using the Visi-Pro Balloon-Expandable Peripheral Stent System for treatment of stenotic, restenotic, or occluded lesions.

Methods: Between 2011 and 2012, 75 patients (mean age 64.2±8.9 years; 46 men) with Rutherford category 2-4 ischemia and atherosclerotic lesions ≤10 cm in length underwent iliac artery stenting at 17 centers in the United States and Europe. The primary outcome of the study was the major adverse event (MAE) rate at 9 months postprocedure [composite of periprocedural death, in-hospital myocardial infarction, clinically driven target lesion revascularization (CD-TLR), and amputation of the treated limb]. Secondary outcomes included 30-day MAE rate, 9-month primary patency, changes in ankle-brachial index (ABI) and the Walking Impairment Questionnaire at 30 days and 9 months postprocedure, device success, and clinically driven target vessel revascularization (CD-TVR) at 30 days and 9 months. Outcomes in specific patient cohorts (ie, gender, stent location, calcification severity, and lesion grade) were analyzed.

Results: Eighty-one stents were implanted in 61 CIA and 15 EIA lesions (41 with moderate/severe calcification). The mean lesion treated length was 29.3±13.9 mm. All devices were successfully deployed. MAE occurred in 3 (4.0%) of 75 subjects at 9 months. Primary patency and freedom from CD-TVR at 9 months were both 95.8%. ABI improved from 0.67±0.14 at baseline to 0.94±0.14 and 0.96±0.16 at 30 days and 9-month follow-up, respectively (p<0.001 for both). There were no differences with respect to any of the analyzed patient characteristics, including gender.

Conclusion: Nine-month results of the VISIBILITY Iliac stent study ( ClinicalTrials.gov identifier NCT01402700) demonstrated safety and effectiveness for the treatment of atherosclerotic CIA and EIA lesions with the Visi-Pro stent across all treated cohorts.

Keywords: balloon-expandable stent; claudication; common iliac artery; external iliac artery; iliac artery; peripheral artery disease; stent.

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: John H. Rundback is a paid consultant to Covidien/Medtronic. Jon C. George is a consultant to Covidien/Medtronic and received a research grant. Michael R. Jaff is a noncompensated advisor for Covidien Vascular and a board member of VIVA Physicians, a 501c not-for-profit education and research organization.

Figures

Figure 1.
Figure 1.
The Visi-Pro balloon-expandable peripheral stent is cut in an open lattice design and comes premounted onto a noncompliant balloon catheter, with tantalum markers at the proximal and distal ends of the stent. The stent is available in stent diameters of 5, 6, and 7 mm with corresponding stent lengths of 12, 17, 27, 37, and 57 mm and in larger diameters of 8, 9, and 10 with corresponding stent lengths of 17, 27, 37, and 57 mm.
Figure 2.
Figure 2.
Kaplan-Meier estimate of 9-month primary patency overall and by gender. The standard error did not exceed 10%.

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