Medtronic's Self-Expanding and Balloon-Expandable Stents Compared to Treat Iliac Artery Stenosis

November 2, 2015—An analysis comparing the safety and effectiveness outcomes of stenting using self-expanding versus balloon-expandable stents for the treatment of iliac artery stenosis was presented by John Runback, MD, during the first of two Late-Breaking Trials sessions at VIVA 15, the 13th annual Vascular InterVentional Advances meeting. The meeting, which is sponsored by VIVA Physicians, Inc., is being held November 2–5, 2015, at the Wynn Las Vegas in Las Vegas, Nevada. The session moderators are Michael R. Jaff, DO, and Krishna Rocha-Singh, MD.

As summarized in the VIVA press release, the analysis was composed of the 150 patients with symptomatic iliac stenoses who were enrolled in the DURABILITY Iliac (n = 75) and VISIBILITY Iliac (n = 75) studies. Patients in the DURABILITY Iliac trial were treated with either the EverFlex or Protégé GPS self-expanding stents (Medtronic plc). Patients in the VISIBILITY Iliac study were treated with Medtronic’s Visi-Pro balloon-expandable stent system.

Identical outcomes were assessed for both studies. The primary study outcome was major adverse event (MAE) rate at 9 months, defined as a composite of periprocedural death, in-hospital myocardial infarction, clinically driven target lesion revascularization, and amputation of the treated limb. Secondary outcomes included assessment of device success, patency by duplex ultrasonography, ankle-brachial index, and Walking Impairment Questionnaire.

DURABILITY Iliac and VISIBILITY Iliac patients presented with iliac disease at a comparable age (62 vs 64 years). VISIBILITY Iliac patients were more likely to be diabetic (36% vs 17%; P = .0158) and hyperlipidemic (77.3% vs 61.3%; P = .0508). Lesions treated with the self-expanding stents were significantly longer (45 cm vs 29 cm; P = .0001), stenosed (74.3% vs 68.3%; P = .0255), and more occluded (22.1% vs 7.9%; P = .0144). In comparison, lesions treated with a balloon-expandable stent were more likely to be eccentric (73.7% vs 57.1%; P = .0413).

The 9-month MAE rate was 1.3% for DURABILITY Iliac versus 4% for VISIBILITY Iliac (P = .081), and the 9-month primary patency rate in both studies was 95.8%. There were no significant differences in MAE and patency rates between the DURABILITY Iliac and VISIBILITY Iliac study groups at 9 months, despite differences between study groups. These data confirm the safety and effectiveness and comparative utilization patterns for balloon-expandable stents and self-expanding stents in the treatment of iliac artery atherosclerosis.