Dutch iliac stent trial: long-term results in patients randomized for primary or selective stent placement.

Department of Radiology and Julius Center of Health Sciences and Primary Care, University Medical Center Utrecht, Room E.01.132, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands.
Radiology (Impact Factor: 6.34). 03/2006; 238(2):734-44. DOI: 10.1148/radiol.2382041053
Source: PubMed

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

  • [Show abstract] [Hide abstract]
    ABSTRACT: These guidelines are intended for use in assessing the standard for technical success and safety in aorto-iliac percutaneous endovascular interventions. Any recommendation contained in the text comes from the highest level and extension of literature review available to date. The success of endovascular procedures is strictly related to an accurate planning based mainly on CT- or MR-angiography. TASC II A through C lesions have an endovascular-first option Pre-procedure ASA antiplatelet therapy is advisable in all cases. The application of stents improves the immediate hemodynamic and most likely long-term clinical results. Cumulative mean complication rate is 7.51 % according to the most relevant literature. Most of the complications can be managed by means of percutaneous techniques. The design and quality of devices, as well as the easy and accuracy of performing these procedures, have improved over the last decades, leading to the preferential treatment of aorto-iliac steno-obstructive disease via endovascular means, often as first-line therapy, with high technical success rate and low morbidity. This is mirrored by the decreasing number of patients undergoing surgical grafts over the last years with patency, limb salvage, and survival rates equivalent to open reconstruction.
    CardioVascular and Interventional Radiology 11/2013; · 2.09 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: To evaluate the 2-year results obtained with self-expandable stent for chronic total occlusion (CTO) of the iliac artery, a retrospective study was performed of patients who underwent endovascular therapy (EVT) for chronic iliac artery CTO who presented from April 2007 to September 2012. 82 patients with 86 occluded iliac arteries underwent successful recanalization and stenting with a self-expandable stent. The primary equivalence end point was a composite of restenosis, mortality, target vessel revascularization, and limb salvage rates. Patients were followed up with the presence of a palpable femoral artery pulse, resolution of symptoms, and noninvasive vascular laboratory testing reviewed at 1, 3, and 6 months after EVT and then were evaluated at 6-month intervals. In patients who gave consent, repeat angiography was done in sixty-one of 86 lesions (70.1 %) for follow-up. The mean follow-up was at 27.6 ± 17.8 months (range 3-60 months). All stents were placed in the true lumen under intravascular ultrasound (IVUS) guidance. There were no cases of peripheral embolization or iliac artery rupture after the procedure. The ankle-brachial index increased significantly from 0.55 ± 0.19 to 0.88 ± 0.17 (P < 0.001). The primary patency rate was 96.5 % at 2 years. The MLD immediately after the procedure was 5.10 ± 0.26 mm and increased significantly to 5.40 ± 0.28 mm at the period of follow-up angiography. The 2-year outcome of endovascular therapy with self-expandable stents for CTO of the iliac artery had an acceptable result.
    Cardiovascular intervention and therapeutics. 09/2013;
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Subintimal angioplasty (SA) is becoming increasingly accepted as a revascularization technique for chronic arterial occlusive disease. However, its efficacy in iliac artery occlusions has not been established. Therefore, we investigated the procedural and clinical outcomes of subintimal angioplasty in long iliac artery occlusions and compared them with those of intraluminal angioplasty (IA) in nonocclusive stenotic iliac artery lesions. We retrospectively analyzed data from 151 consecutive patients with long (>5 cm) iliac artery lesions (204 limbs) who underwent angioplasty with primary stent implantation from October 2004 through July 2008. Among them, 100 lesions in 100 patients were treated with intentional SA, and 104 lesions in 82 patients were treated with IA. We compared the baseline characteristics and immediate and long-term outcomes of iliac artery lesions treated with SA versus IA. Baseline characteristics showed that longer lesions and critical limb ischemia were found more frequently in the SA group, whereas diabetes and combined femoropopliteal lesions were present more often in the IA group. The technical success rate of SA was lower than that of IA (93.0% vs 99.0%; P = .048). However, there was no significant difference in the procedure-related complications between the SA and IA groups (4.0% vs 4.8%; P = .779). Primary patency rates for SA and IA were 96.8% and 98.0% at 1 year, and 93.9% and 90.6% at 2 years, respectively (log rank P = .656). Stent-supported SA in occlusive iliac lesions was safe and showed a high long-term patency rate comparable to that of IA performed in nonocclusive iliac lesions despite longer lesion length. Thus, SA with implantation of stents is an effective technique for the treatment of chronic long iliac artery occlusion.
    Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter 02/2011; 54(1):116-22. · 3.52 Impact Factor