Author + information
- Received February 6, 2017
- Revision received April 28, 2017
- Accepted May 4, 2017
- Published online August 21, 2017.
- Hans Krankenberg, MDa,∗ (, )
- Thomas Zeller, MDb,
- Maja Ingwersen, DVMa,
- Josefin Schmalstieg, MDc,
- Hans Martin Gissler, MDd,
- Sigrid Nikol, MDe,
- Iris Baumgartner, MDf,
- Nicolas Diehm, MDg,
- Estell Nickling, MDa,
- Stefan Müller-Hülsbeck, MDh,
- Rainer Schmiedel, MDi,
- Giovanni Torsello, MDj,
- Willibald Hochholzer, MDk,
- Christian Stelzner, MDl,
- Klaus Brechtel, MDm,
- Wulf Ito, MDn,
- Ralph Kickuth, MDo,
- Erwin Blessing, MDp,
- Marcus Thieme, MDq,
- Jaroslaw Nakonieczny, MDr,
- Thomas Nolte, MDs,
- Ragnar Gareis, MDt,
- Harald Boden, MDu and
- Sebastian Sixt, MDf
- aDepartment of Angiology, Asklepios Klinikum Harburg, Hamburg, Germany
- bDepartment of Angiology, University Heart Center Freiburg–Bad Krozingen, Bad Krozingen, Germany
- cDepartment of Anesthesiology, Intensive Care and Pain Medicine, BG Klinikum Unfallkrankenhaus Berlin, Berlin, Germany
- dDepartment of Radiology, Kantonsspital Aarau, Aarau, Switzerland
- eDepartment of Angiology, Asklepios Klinik St. Georg, Hamburg, Germany
- fDepartment of Angiology, Inselspital, Universitätsspital Bern, Bern, Switzerland
- gZentrum für Gefäßmedizin Mittelland, Aarau, Switzerland
- hDepartment of Radiology, Diakonissenkrankenhaus Flensburg, Flensburg, Germany
- iPraxis für Interventionelle Angiology, Kaiserslautern, Germany
- jDepartment of Vascular Surgery, St. Franziskus-Hospital Münster, Münster, Germany
- kDepartment of Cardiology and Angiology II, University Heart Center Freiburg - Bad Krozingen, Bad Krozingen, Germany
- lDepartment of Angiology, Städtisches Klinikum Dresden-Friedrichstadt, Dresden, Germany
- mJoint Practice for Radiology, Berlin, Germany
- nCardiovascular Center Oberallgäu-Kempten, Hospital Immenstadt, Immenstadt, Germany
- oDepartment of Diagnostic and Interventional Radiology, Universitätsklinikum Würzburg, Würzburg, Germany
- pDepartment of Internal Medicine, Klinikum SRH Karlsbad, Karlsbad, Germany
- qDepartment of Angiology, Cardiology and Diabetology, MEDINOS Klinik Sonneberg, Sonneberg, Germany
- rDepartment of Vascular Surgery, GPR Klinikum Rüsselsheim, Rüsselsheim am Main, Germany
- sDepartment of Vascular Surgery, Herz- und Gefäßzentrum Bad Bevensen, Bad Bevensen, Germany
- tCardiologicum Stuttgart, Stuttgart, Germany
- uDepartment of Internal Medicine, Ilm-Kreis-Klinikum, Ilmenau, Germany
- ↵∗Address for correspondence:
Dr. Hans Krankenberg, Department of Angiology, Asklepios Klinikum Harburg, Eißendorfer Pferdeweg 52, 21075 Hamburg, Germany.
Objectives Atherosclerosis of iliac arteries is widespread. As inflow vessels, they are of great clinical significance and increasingly being treated by endovascular means. Most commonly, stents are implanted.
Background So far, due to a lack of comparative data, no guideline recommendations on the preferable stent type, balloon-expandable stent (BE) or self-expanding stent (SE), have been issued.
Methods In this randomized, multicenter study, patients with moderate to severe claudication from common or external iliac artery occlusive disease were assigned 1:1 to either BE or SE. 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.
Results Six hundred sixty patients with 660 lesions were enrolled at 18 German and Swiss sites over 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%. One hundred nine (16.5%) lesions were totally occluded and 25.6% heavily calcified. Twelve-month incidence of restenosis was 6.1% after SE implantation and 14.9% after BE implantation (p = 0.006). Kaplan-Meier estimate of freedom from TLR was 97.2% and 93.6%, respectively (p = 0.042). There was no between-group difference in walking impairment, hemodynamic success, amputation rate, all-cause death, or periprocedural complications.
Conclusions The treatment of iliac artery occlusive disease with SE as compared with BE resulted in a lower 12-month restenosis rate and a significantly reduced TLR rate. No safety concerns arose in both groups. (Iliac, Common and External [ICE] Artery Stent Trial; NCT01305174)
- balloon-expandable stent(s)
- common iliac artery
- external iliac artery
- peripheral artery disease
- randomized trial
- self-expanding stent(s)
The work was funded from a grant by ev3 Europe SAS (Paris, France). Dr. Gissler has received modest honoraria from Covidien and Abbott. Dr. Baumgartner has received research and educational grants from Abbott Vascular, Cook, Optimed, Terumo, Promedics, Amgen, Boston Scientific, Bayer, AstraZeneca, and Sanofi. Dr. Diehm has received a significant research grant from Biotronik; a modest research grant from Medtronic; significant expert witness fees from Biotronik; and modest expert witness fees from Medtronic and Genae; and has owned significant ownership interest in MediCut/BBraun. Dr. Hochholzer has received consulting and lecture fees from AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, and The Medicines Company. Dr. Kickuth has received modest honoraria from Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Krankenberg and Zeller contributed equally to this work.
- Received February 6, 2017.
- Revision received April 28, 2017.
- Accepted May 4, 2017.
- 2017 American College of Cardiology Foundation