Self-expanding stent treatment in patients with iliac artery occlusive disease resulted in lower 12-month restenosis and target lesion revascularization rates vs. balloon-expandable stents, according to results of the ICE trial, published in JACC: Cardiovascular Interventions.
“Atherosclerosis is common in iliac arteries,” Hans Krankenberg, MD, from the department of angiology at Asklepios Klinikum Harburg, Germany, and colleagues wrote. “Autopsy studies have revealed severe atherosclerosis in 15% of men and 5% of women, increasing with age. Iliac arteries, in their role as inflow vessels, affect the entire downstream blood flow and are therefore of great clinical relevance.”
Krankenberg and colleagues conducted the prospective, multicenter, block-randomized, nonmasked, investigator-initiated trial to assess acute and midterm effectiveness and safety of primary stenting with self-expanding vs. balloon-expandable stents.
The researchers randomly assigned 660 patients with 660 lesions and moderate to severe claudication from common or external iliac artery occlusion disease to a balloon-expandable stent (Visi-Pro, ev3 Endovascular) or a self-expanding stent (Protégé, ev3 Endovascular). Patients were enrolled at 18 German and Swiss sites from August 2010 to June 2013.
The primary endpoint of the study was binary restenosis at 12 months, which was determined by duplex ultrasound and the secondary endpoints included walking impairment, freedom from TLR, hemodynamic success, target limb amputation and all-cause death.
Of those enrolled, 24.8% of patients were diabetic and 57.4% were active smokers, according to the data.
The common iliac artery was affected in 58.9% of patients.
Total occlusion and heavily calcification occurred in 109 lesions (16.5%), the researchers wrote.
At 1 year, incidence of restenosis was 6.1% after self-expanding stent implantation and 14.9% after balloon-expandable stent implantation (P = .006).
The researchers determined a Kaplan-Meier estimate of freedom from TLR of 97.2% for self-expanding implantation and 93.6% for balloon-expandable implantation (P = .042).
The study showed no difference in walking impairment, hemodynamic success, amputation rate, all-cause death or periprocedural complications among the two groups.
In a related editorial, Dmitry M. Feldman, MD, from the division of cardiology, interventional cardiology and endovascular laboratory at Weill Cornell Medical College in New York, and Andrew J.P. Klein, MD, from the division of interventional cardiology, vascular and endovascular medicine at Piedmont Heart Institute in Atlanta, wrote: “The findings of the ICE trial that [self-expanding] stents may be superior to [balloon-expandable] stents in the treatment of iliac arterial disease are intriguing. Let us continue investigations to identify subsets of patients who benefit from particular type of stent and not ‘fall through the ice’ by fully adopting [self-expanding] stent-first strategy or all iliac endovascular revascularization procedures.” – by Dave Quaile
Disclosures: The study was funded from a grant by ev3 Europe SAS (Paris). Feldman, Klein and Krankenberg report no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.