Dutch Iliac Stent trial: COVERed versus uncovered balloon-expandable stents in the Common Iliac Artery
J.A. Bekken1, J.A. Vos2, R.A. Aarts3, J.P.P.M. de Vries3, B. Fioole1
1. Department of Vascular Surgery, St. Antonius Hospital, Nieuwegein, The Netherlands
2. Department of Interventional Radiology, St. Antonius Hospital, Nieuwegein, The Netherlands
3. Department of Interventional Radiology, Maasstad Hospital, Rotterdam, The Netherlands
4. Department of Vascular Surgery, Maasstad Hospital, Rotterdam, The Netherlands
Iliac artery atherosclerotic disease may cause intermittent claudication and critical limb ischemia. It can lead to serious complications such as infection, amputation and even death. Revascularization relieves symptoms and prevents these complications. Historically, open surgical repair, in the form of endarterectomy of bypass, was used. Over the last decade, endovascular repair has become the first choice of treatment for iliac arterial occlusive disease. No definitive consensus has emerged about the best endovascular strategy and which type of stent, if any, to use. However, in more advanced disease, that is, long or multiple stenoses or occlusions, literature is most supportive of primary stenting with a balloon-expandable stent in the common iliac artery. Recently, a PTFE-covered balloon-expandable stent (Advanta V12, Atrium Medical Inc., Hudson, NH) has been introduced for the iliac artery. Covering stents with PTFE has been shown to lead to less neo-intimal hyperplasia and this might lower restenosis rates. However, only one RCT of mediocre quality has been published on this stent in the common iliac artery. Our hypothesis is that covered balloon-expandable stents lead to better results when compared to uncovered balloon-expandable stents.
The DISCOVER study is a prospective, randomized, controlled, double-blind, multi-center trial. A total of 174 human volunteers will be included, with symptomatic advanced atherosclerotic disease of the common iliac artery,defined as stenoses longer than 3 cm and occlusions. The control group will undergo endovascular dilatation or revascularization of the common iliac artery, followed by placement of one or more uncovered balloon-expandable stents. The study group will undergo the same treatment, however one or more PTFE-covered balloon-expandable stents will be placed. When necessary, the aorta, external iliac artery, common femoral artery, superficial femoral artery and deep femoral artery will be treated, using the standard treatment. The primary endpoints is absence of binary restenosis rate. Secondary endpoints are reocclusion rate, target-lesion revascularization rate, clinical success, procedural success, hemodynamic success, major amputation rate, complication rate and mortality rate. Main study parameters are age, gender, relevant co-morbidity, and several patient, disease and procedure related parameters. Follow up is 2 years, and consists of 4 visits in which ankle-brachial indices (ABI) and duplex ultrasound (DUS) is performed. Quality of life and burden of disease will be scored using the RAND-36 and Walking Impairment Questionnaire. The DISCOVER study will provide evidence if using PTFE-covered stent reduces binary restenosis rates in advanced atherosclerotic lesions in the Common Iliac Artery, when compared with uncovered stents. This trial is registered in the Dutch Trial Register under number NTR3381.