Dutch Iliac Stent Trial: Long-term Results in Patients Randomized for Primary or Selective Stent Placement 1

Utrecht University, Utrecht, Utrecht, Netherlands
Radiology (Impact Factor: 6.87). 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.

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    • "The reviewed literature shows that stent placement, whether primary or selective, is a valuable tool in the treatment of iliac atherosclerotic disease; however, long-term results could still be improved by improved stent design and delivery.5,6,8–10,14,15,18 Abbott’s stent design for the Absolute Pro was aimed at overcoming some of the shortcomings in the design of previously available stent and deployment systems. "
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    ABSTRACT: Management of iliac artery disease has evolved over the years, from a surgical-only approach to a primarily endovascular-only approach as the first line treatment option. This has been continuously improved upon with the advent of new devices and applied technologies. Most recently in particular, the literature has shown good, reliable outcomes with the use of self-expandable stents in iliac artery atherosclerotic lesions. Nevertheless, no device is without its limitations, and the Absolute Pro® Vascular Self-Expanding Stent System was designed with the intent of overcoming some of the shortcomings of other available stents while maintaining acceptable postprocedural outcomes. Based on preliminary industry-acquired data, it has achieved these goals and appears to be an emergent competitor for the treatment of both focal and complex iliac artery lesions.
    Medical Devices: Evidence and Research 09/2013; 6(1):147-150. DOI:10.2147/MDER.S31696
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    • "However, a randomized controlled trial conducted by the same group, published in 1998, showed, after 5 to 8 years of follow-up, no significant difference in iliac patency and ABI. A small, but significant, difference in symptomatic success was found, in favor of selective stenting [25,26]. These results are equivocal, due to a low technical success rate (approximately 80%) and the exclusion of advanced disease. "
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    ABSTRACT: Background 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 or 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 (Jongkind V et al., J Vasc Surg 52:1376-1383,2010). Recently, a PTFE-covered balloon-expandable stent (Advanta V12, Atrium Medical Inc., Hudson, NH, USA) 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 (Dolmatch B et al. J Vasc Interv Radiol 18:527-534,2007, Marin ML et al. J Vasc Interv Radiol 7:651-656,1996, Virmani R et al. J Vasc Interv Radiol 10:445-456,1999). However, only one RCT, of mediocre quality has been published on this stent in the common iliac artery (Mwipatayi BP et al. J Vasc Surg 54:1561-1570,2011, Bekken JA et al. J Vasc Surg 55:1545-1546,2012). Our hypothesis is that covered balloon-expandable stents lead to better results when compared to uncovered balloon-expandable stents. Methods/Design This is a prospective, randomized, controlled, double-blind, multi-center trial. The study population consists of human volunteers aged over 18 years, with symptomatic advanced atherosclerotic disease of the common iliac artery, defined as stenoses longer than 3 cm and occlusions. A total of 174 patients will be included. 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 endpoint 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. Trial registration Dutch Trial Register, NTR3381.
    Trials 11/2012; 13(1):215. DOI:10.1186/1745-6215-13-215 · 1.73 Impact Factor
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    ABSTRACT: There is a large body of evidence supporting the safety and efficacy of the endovascular treatment of iliac arterial lesions under the appropriate clinical circumstances. Although debate continues, it seems a reasonable strategy to perform angioplasty for iliac stenosis, employing stents where angioplasty alone has failed. Iliac occlusions, however, should be managed by primary stent insertion to avoid the high risk of distal embolisation. The results of iliac artery angioplasty or stenting are comparable to those of surgery, and despite the TASC recommendations, a majority of surgeons and interventional radiologists seem to favour the endovascular option wherever possible. Serious complications are relatively uncommon, but procedures should always be performed with very careful technique, including maintaining the guidewire positioned across the lesion until a satisfactory result has been confirmed. This allows the management of any complication endovascularly, meaning that it should only rarely be necessary to resort to surgery.
    Vascular Interventional Radiology, 12/2006: pages 29-39;
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