ICE Trial Compares Stent Types in Iliac Artery Occlusive Disease
August 23, 2017—Twelve-month results from the Iliac, Common and External (ICE) Artery Stent Trial were published by Hans Krankenberg, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2017;10:1694–1704).
According to the investigators, the background of this study is that there have not been guideline recommendations issued on the preferable stent type (balloon-expandable [BE] or self-expanding [SE]) due to the lack of comparative data.
As summarized in JACC: Cardiovascular Interventions, in the randomized, multicenter ICE trial, patients with moderate to severe claudication from common or external iliac artery occlusive disease were assigned 1:1 to either BE or SE stents. The primary endpoint was binary restenosis at 12 months as determined by duplex ultrasound. Key secondary endpoints were walking impairment, freedom from target lesion revascularization (TLR), hemodynamic success, target limb amputation, and all-cause death.
ICE enrolled 660 patients with 660 lesions at 18 German and Swiss sites during a period of 34 months; 24.8% of the patients had diabetes and 57.4% were current smokers. The common iliac artery was affected in 58.9% of patients. One hundred nine (16.5%) lesions were totally occluded and 25.6% were heavily calcified.
The investigators reported that the 12-month incidence of restenosis was 6.1% after SE stent implantation and 14.9% after BE stent implantation (P = .006). The Kaplan-Meier estimate of freedom from TLR was 97.2% and 93.6%, respectively (P = .042). There was no between-group difference in walking impairment, hemodynamic success, amputation rate, all-cause death, or periprocedural complications.
The treatment of iliac artery occlusive disease with SE stents as compared with BE stents resulted in a lower 12-month restenosis rate and a significantly reduced TLR rate, with no safety concerns in either group, concluded the investigators in JACC: Cardiovascular Interventions.