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Dutch Iliac Stent Trial: Long-term Results in Patients Randomized for Primary or Selective Stent Placement¹

¹ From the Department of Radiology (W.M.K., W.P.T.M.M.) and Julius Center of Health Sciences and Primary Care (Y.v.d.G., E.B.), University Medical Center Utrecht, Room E.01.132, Heidelberglaan 100, 3584 CX Utrecht, the Netherlands; Departments of Vascular Surgery (J.S.) and Interventional Radiology (J.H.S.), Slingeland Hospital, Doetinchem, the Netherlands; Department of Vascular Surgery, Twenteborg Hospital, Almelo, the Netherlands (J.G.v.B.); Department of Vascular Surgery, Catharina Hospital, Eindhoven, the Netherlands (J.B.); Departments of Vascular Surgery (F.L.M.) and Interventional Radiology (T.T.C.O.), St Antonius Hospital, Nieuwegein, the Netherlands; and Department of Vascular Surgery, Erasmus Medical Center Rotterdam, Rotterdam, the Netherlands (M.R.H.M.v.S.). A complete list of centers that participated in the Dutch Iliac Stent Trial Study Group is included in the Acknowledgments. Received June 14, 2004; revision requested August 25; final revision received February 25, 2005; accepted March 18; final version accepted May 3. Supported by Cordis. Address correspondence to W.P.T.M.M. (e-mail: W.Mali{at}azu.nl).

Purpose: To determine long-term results of the prospective Dutch Iliac Stent Trial.

Materials and Methods: The study protocol was approved by local institutional review boards. All patients gave written informed consent. Two hundred seventy-nine patients (201 men, 78 women; mean age, 58 years) with iliac artery disease were randomly assigned to undergo primary stent placement (143 patients) or percutaneous transluminal angioplasty (PTA) with selective stent placement in cases in which the residual mean pressure gradient was greater than 10 mm Hg across the treated site (136 patients). Before and at 3, 12, and 24 months and 5–8 years after treatment, all patients underwent assessment, which included duplex ultrasonography (US), ankle-brachial index (ABI) measurement, Fontaine classification of symptoms, and completion of the Rand 36-Item Health survey for quality-of-life assessment. Treatment was considered successful for symptoms if symptoms increased at least one Fontaine grade, for ABI if ABI increased more than 0.10, for patency if peak systolic velocity ratio at duplex US was less than 2.5, and for quality of life if the RAND 36-Item Health Survey score increased more than 15 points. Effects of both treatments on symptoms, quality of life, patency, and ABI were compared by using survival analyses.

Results: Patients who underwent PTA and selective stent placement had better improvement of symptoms (hazard ratio [HR], 0.8; 95% confidence limits [CLs]: 0.6, 1.0) than did patients treated with primary stent placement, whereas ABI (HR, 0.9; 95% CLs: 0.7, 1.3), iliac patency (HR, 1.3; 95% CLs: 0.8, 2.1), and score for quality of life for nine survey dimensions did not support a difference between treatment groups.

Conclusion: Patients treated with PTA and selective stent placement in the iliac artery had a better outcome for symptomatic success compared with patients treated with primary stent placement, whereas data about iliac patency, ABI, and quality of life did not support a difference between groups.

© RSNA, 2005