DURABILITY Iliac: Self-expanding stents safe, effective for iliac artery disease

New data from the DURABILITY Iliac trial confirm the safety and effectiveness of primary stenting with two self-expanding stent systems for the treatment of symptomatic iliac artery disease.

The prospective, multicenter, nonrandomized study included 75 patients (mean age, 62 years; 65.3% men) at 15 sites in the United States and Europe. Researchers performed primary stenting using the self-expanding EverFlex and Protégé GPS stent systems (Covidien).

All patients had lesions in the common and/or external iliac arteries, with moderate to severe ischemia and ≥50% stenosis, restenosis or occlusion. Target lesion length was ≤10 cm, and target vessel diameter was ≥4.5 mm and ≤11 mm. Whether patients were treated with the EverFlex or Protégé stent system was determined by the size of the vessel.

The primary endpoint was incidence of major adverse events within 9 months of the procedure, including periprocedural death or MI, clinically driven target lesion revascularization or amputation of the treated limb. Secondary outcomes included major adverse events at 30 days, primary patency at 9 months, postprocedural changes in ankle-brachial index, and changes in functional assessment based on walking impairment questionnaires administered at baseline, 30 days and 9 months after the procedure. Follow-up will continue at 1, 2 and 3 years following treatment.

No major adverse events were reported at 30 days. The major adverse event rate at 9 months was 1.3%. When components of the primary endpoint were examined individually, the rate of periprocedural death was 0%, in-hospital MI was 0% and amputation of the treated limb was 0%. One patient had clinically driven TLR (rate, 1.3%).

Device success, defined as the ability to deploy the stent as intended at the treatment site, was achieved in 100% of cases, with 82 treated lesions across the cohort. No device malfunctions were reported.

The primary patency rate at 9 months was 95.8%, and freedom from clinically driven TLR was 98.6%. Subgroup analysis indicated a similarly high primary patency at 9 months among patients with lesions in both the common (96.1%) and external iliac arteries (95.2%). Analysis according to severity of lesions by Trans-Atlantic Inter-Society Consensus (TASC) II classification indicated a primary patency of 92.2% among patients with Class A lesions and 100% among those with Class B, C or D lesions.

The researchers noted significant improvement in ankle-brachial index, with 96% of patients showing improvement from baseline at 30 days; this was maintained by 87% of patients at 9 months. Responses to the walking impairment questionnaire demonstrated improvement at both 30 days and 9 months, with patients reporting reductions in pain, greater walking speed and distance, and increased ability to climb stairs.

“This study demonstrated safety of the EverFlex and Protégé GPS stents in iliac lesions, with no major adverse events at 30 days,” said Peter Faries, MD, professor of surgery and radiology at Icahn School of Medicine at Mount Sinai. He also noted that the high primary patency within both common and external iliac arteries and the large percentage of patients free from TLR at 9 months indicated “outstanding” results for the stents.

For more information:

Faries P. Late-Breaking Clinical Trials. Presented at: VIVA 14; Nov. 4-7, 2014; Las Vegas.

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