Dutch iliac stent trial: long-term results in patients randomized for primary or selective stent placement.
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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ABSTRACT: To measure changes in claudicant's quality of life after surgery, angioplasty or unsupervised exercise. To explore the relationship between clinical indicators of limb perfusion and patient's perception of health change. Prospective study. University Hospital vascular outpatients. 202 claudicants referred for Duplex of lower limb arterial disease over a 12 month period. The short form 36 questionnaire was used to determine quality of life. Ankle pressures and walking distances were determined. The SF-36 was completed by 186 patients (92%) before and after treatment (34 operative patients, 74 angioplasty and 78 treated by exercise alone). Baseline quality of life was worse in surgical patients. Unsupervised exercise produced minimal changes in quality of life. Angioplasty and operation produced similar, significant improvements in physical functioning and pain. Changes in physical function or pain scores were unrelated to changes in ankle pressure. Unsupervised exercise programs are unlikely to significantly improve patient's quality of life. The benefits of surgery and angioplasty support a relaxation in the indications for investigation and treatment of claudicants. Patients with impaired perceived health should not be denied treatment on the basis of preintervention ankle pressure or walking distance alone.European Journal of Vascular and Endovascular Surgery 11/1995; 10(3):356-61. · 2.82 Impact Factor
Article: The RAND 36-Item Health Survey 1.0.[show abstract] [hide abstract]
ABSTRACT: Recently, Ware and Sherbourne published a new short-form health survey, the MOS 36-Item Short-Form Health Survey (SF-36), consisting of 36 items included in long-form measures developed for the Medical Outcomes Study. The SF-36 taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, general mental health, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. The SF-36 items and scoring rules are distributed by MOS Trust, Inc. Strict adherence to item wording and scoring recommendations is required in order to use the SF-36 trademark. The RAND 36-Item Health Survey 1.0 (distributed by RAND) includes the same items as those in the SF-36, but the recommended scoring algorithm is somewhat different from that of the SF-36. Scoring differences are discussed here and new T-scores are presented for the 8 multi-item scales and two factor analytically-derived physical and mental health composite scores.Health Economics 11/1993; 2(3):217-27. · 2.23 Impact Factor
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ABSTRACT: To determine differences between PTA and conventional medical treatment in treadmill distance until onset of claudication, treadmill maximum walking distance, patient reported maximum walking distance, ankle brachial pressure index (ABPI), quality of life (Nottingham Health Profile, NHP) and Duplex measured extent of occlusive disease. Randomised controlled clinical trial. Six hundred claudicants were screened. Fifty-one men and 11 women with intermittent claudication due to short femoral stenoses or occlusions (n = 47) and iliac stenoses (n = 15) were randomised to either PTA plus medical treatment (PTA group, n = 30) or to medical treatment alone (control group, n = 32). Medical treatment consisted of daily low dose aspirin and advice on smoking and exercise. At 6 month follow up: In the PTA group more patients reported no claudication (p < or = 0.05) and were asymptomatic on the treadmill (p < or = 0.01) compared to the control group. The ABPI was significantly higher in the PTA group. More of the PTA group reported lower NHP pain scores (p < or = 0.05). In the control group there were more occluded arteries (p < or = 0.001), and the stenosis velocity ratio of patient arteries was significantly higher (p < or = 0.001). Only 10% of claudicants had discrete lesions suitable for PTA. Treatment of these patients with PTA produces a greater short-term improvement in walking and quality of life than medical treatment alone and is associated with less progression of disease.European Journal of Vascular and Endovascular Surgery 09/1996; 12(2):167-72. · 2.82 Impact Factor