Hans Krankenberg1, Thomas Zeller2, Maja Ingwersen3, Josefin Schmalstieg4, Hans Martin Gissler5, Sigrid Nikol6, Iris Baumgartner7, Nicolas Diehm8, Estell Nickling3, Stefan Müller-Hülsbeck9, Rainer Schmiedel10, Giovanni Torsello11, Willibald Hochholzer12, Christian Stelzner13, Klaus Brechtel14, Wulf Ito15, Ralph Kickuth16, Erwin Blessing17, Marcus Thieme18, Jaroslaw Nakonieczny19, Thomas Nolte20, Ragnar Gareis21, Harald Boden22, Sebastian Sixt7. 1. Department of Angiology, Asklepios Klinikum Harburg, Hamburg, Germany. Electronic address: h.krankenberg@asklepios.com. 2. Department of Angiology, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany. 3. Department of Angiology, Asklepios Klinikum Harburg, Hamburg, Germany. 4. Department of Anesthesiology, Intensive Care and Pain Medicine, BG Klinikum Unfallkrankenhaus Berlin, Berlin, Germany. 5. Department of Radiology, Kantonsspital Aarau, Aarau, Switzerland. 6. Department of Angiology, Asklepios Klinik St. Georg, Hamburg, Germany. 7. Department of Angiology, Inselspital, Universitätsspital Bern, Bern, Switzerland. 8. Zentrum für Gefäßmedizin Mittelland, Aarau, Switzerland. 9. Department of Radiology, Diakonissenkrankenhaus Flensburg, Flensburg, Germany. 10. Praxis für Interventionelle Angiology, Kaiserslautern, Germany. 11. Department of Vascular Surgery, St. Franziskus-Hospital Münster, Münster, Germany. 12. Department of Cardiology and Angiology II, University Heart Center Freiburg - Bad Krozingen, Bad Krozingen, Germany. 13. Department of Angiology, Städtisches Klinikum Dresden-Friedrichstadt, Dresden, Germany. 14. Joint Practice for Radiology, Berlin, Germany. 15. Cardiovascular Center Oberallgäu-Kempten, Hospital Immenstadt, Immenstadt, Germany. 16. Department of Diagnostic and Interventional Radiology, Universitätsklinikum Würzburg, Würzburg, Germany. 17. Department of Internal Medicine, Klinikum SRH Karlsbad, Karlsbad, Germany. 18. Department of Angiology, Cardiology and Diabetology, MEDINOS Klinik Sonneberg, Sonneberg, Germany. 19. Department of Vascular Surgery, GPR Klinikum Rüsselsheim, Rüsselsheim am Main, Germany. 20. Department of Vascular Surgery, Herz- und Gefäßzentrum Bad Bevensen, Bad Bevensen, Germany. 21. Cardiologicum Stuttgart, Stuttgart, Germany. 22. Department of Internal Medicine, Ilm-Kreis-Klinikum, Ilmenau, Germany.
Abstract
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).
RCT Entities:
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).
Authors: Dmitriy N Feldman; Ehrin J Armstrong; Herbert D Aronow; Subhash Banerjee; Larry J Díaz-Sandoval; Michael R Jaff; Sasanka Jayasuriya; Safi U Khan; Andrew J Klein; Sahil A Parikh; Kenneth Rosenfield; Mehdi H Shishehbor; Rajesh V Swaminathan; Christopher J White Journal: Catheter Cardiovasc Interv Date: 2020-05-14 Impact factor: 2.692
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