ACTIVE Results Demonstrate Safety and Efficacy of Cobalt Chromium Stent in Treatment of PVD

SAN FRANCISCO, CALIF.—The Assurant Cobalt Iliac Balloon-Expandable Stent System was linked to favorable safety outcomes and a 100% primary patency rate at 9 months, according to data from the ACTIVE trial presented here.

The ACTIVE trial looked at 123 patients at 17 U.S. sites with claudication/rest pain who received the Assurant stent (Medtronic).

William A. Gray MD, of Columbia University Medical Center, New York, noted that the stent performed well for the primary and secondary endpoints (see Tables 1 and 2).

“The stent demonstrated a remarkable safety profile associated with high technical, procedural and clinical success and efficacy,” Gray said. “This translated into marked and durable improvements in clinical status, walking capacity and ankle-brachial index.”

Walking distance improved significantly from baseline to 9 months (22.9 ± 30.6 feet vs. 53.6 ± 39.8 feet; P=.001).

Additional PVD results

Gray also presented results of several studies that led to the FDA approval of the cobalt chromium balloon-expandable iliac stent, including the MELODIE and CRISP-U.S. trials and data from the Complete Iliac SE registry from Medtronic.

Results of the MELODIE registry of the Express LD Vascular Stent (Boston Scientific) indicated a 12-month target lesion revascularization rate of 10.9% in 151 patients with 163 total lesions. The CRISP-US trial involved 203 patients randomly assigned to either the SMART Iliac Stent (Cordis/Johnson & Johnson) or the Wallstent (Boston Scientific). Twelve-month primary patency was 94.7% for the SMART stent and 91.1% for the Wallstent.

Gray provided a broader overview of the Complete SE Iliac registry from Medtronic. He highlighted a 9-month major adverse event rate of 5.9%, a 3.9% TLR rate, and a 5.9% target vessel revascularization rate.

ICARUS

Twelve-month results of the ICARUS trial of the iCast stent (Atrium) to treat PVD were slated to be presented by John R. Laird Jr., MD, of the Vascular Center at University of California Davis Health System, but he said the data were “undergoing final analysis and not quite ready for prime time.”

Nevertheless, Laird expressed hope for the future of covered stents. “The drawback of the first generation of this stent was that it was rigid,” he said. “Now we have a more flexible version of this device.”

Laird also suggested that the stent may be versatile, and highlighted a number of case subjects who demonstrated benefit from the device. “The stent may be useful for patients with complex disease, including Trans-Atlantic Inter-Society Consensus C and D patients,” he said. Other patients who may benefit from this form of intervention are those with aortoiliac bifurcation disease, in-stent restenosis, rupture or perforation, or an iliac pseudoaneurysm or aneurysm, according to Laird.