Stockx L.,Limburgs Vaatcentrum Ziekenhuis Oost Limburg |
Poncyljusz W.,Vascular Imaging |
Krzanowski M.,University Hospital of Cracow |
Schroe H.,Limburgs Vaatcentrum Ziekenhuis Oost Limburg |
And 2 more authors.
Journal of Endovascular Therapy | Year: 2010
Purpose: To report the 2-year results of the MELODIE trial, which evaluated the safety and effectiveness of the balloon-expandable Express LD Vascular stent for the treatment of atherosclerotic iliac artery disease. Methods: This prospective, multicenter, single-arm trial enrolled 151 patients (113 men; mean age 60.1±8.4 years) with 163 de novo or restenotic iliac lesions. The primary endpoint, 6-month angiographic mean percent loss of luminal diameter, was compared to an objective performance criterion (OPC) based on published results with the Palmaz stent. Follow-up included ankle-brachial index (ABI) measurement and symptom assessment (Fontaine classification) at discharge, 30 days, and 6, 12, and 24 months. Arteriography was performed at 6 months and computed tomographic angiography (CTA) at 1 and 2 years. Results: The primary endpoint of 6-month mean percent luminal diameter loss was 16.2% (upper 95% confidence boundary of 19.1%) and non-inferior to the 20% OPC (p=0.006). Primary patency was 92.1% at 6 months and 87.8% at 2 years. The rate of major adverse events (MAE) was 6.3% at 6 months and 10.2% at 2 years. Of the 3 event types included in the definition of MAE, only target lesion revascularization occurred; no distal embolization or device- or procedure-related deaths were recorded. The percent of patients with Fontaine stage IIb symptoms or worse improved from 84.1% before the procedure to 16.8% at 2 years (p<0.0001). The 2-year ABI remained significantly improved compared to baseline (0.85 versus 0.63, p<0.0001). Conclusion: The Express LD Vascular stent is safe, effective, and non-inferior to the Palmaz stent for treatment of iliac artery stenosis. © 2010 by the International Society of Endovascular Specialists.
Witek P.W.,University Hospital of Cracow |
Wolkow P.,Jagiellonian University |
Stancel-Mozwillo J.,University Hospital of Cracow |
Wojtyczek K.,University Hospital of Cracow |
And 4 more authors.
Diabetologia Kliniczna | Year: 2012
Background. Over the years 2006-2009 a pilot project of the Polish Diabetes Registry for Adults financed by the Polish Ministry of Health was performed. The objective was to assess outpatient diabetes care a few years after joining the European Union. Material and methods. Questionnaires for randomly enrolled patients were completed by diabetologists in 39 outpatient diabetes centers in different parts of Poland. Data concerning age, sex, BMI, diabetes type and duration, hypoglycemic treatment, glycated haemoglobin (HbA1c), lipids levels, blood pressure (BP), diabetes complications, concomitant diseases and their treatment, and other aspects of medical care were collected. The questionnaires were analysed centrally. Results. Data on 7606 individuals were available: 15.0% with type 1 diabetes (T1DM); 80.9% with type 2 diabetes (T2DM); 1.9% with other types of diabetes; and 2.2% with gestational diabetes. T1DM and T2DM cohorts consisted of 1134 (52.4% women) and 6119 (55.5% women) patients, mean age 40.9 and 63.8 years, mean diabetes duration 14.6 and 9.7 years, respectively. Mean HbA1c for T1DM and T2DM was 7.69 and 7.25%. Lipid parameters for T1DM and T2DM were as followed: mean total cholesterol (TC) 4.84 and 5.06 mmol/l; mean LDL-cholesterol (LDL) 2.73 and 2.90 mmol/l; mean HDL-cholesterol (HDL) 1.58 and 1.30 mmol/l; mean triglycerides (TG) 1.26 and 1.95 mmol/l; mean blood pressure (BP) 127.4//77.7 and 139.8/81.8 mmHg. The following proportion of the patients within target were recorded: for HbA1c (≤ 7.0% and ≤ 6.5%): T1DM 39.4 and 22.6%, T2DM 52.1 and 32.8%; for TC levels (< 4.5 mmol/l): T1DM 40.1%, T2DM 32.6%; for TG levels (< 1.7 mmol/l): T1DM 82.1%, T2DM 53.2%; for BP (< 130/80 mm Hg): T1DM 31.9%, T2DM 12.9%, respectively. Prevalence of microvascular complications among T1DM and T2DM was as followed: retinopathy 38,4 and 23,4%; nephropathy 15,2 and 8,5%; peripheral neuropathy 25.3 and 25.4%; autonomic neuropathy 9,6 and 5,4%. Conclusions. The data show the current quality of diabetes care in Poland, which seems to show some improvement as compared to the DEPAC survey performed at the accession to EU (2004). Nevertheless, the current Registry also indicates that most patients still do not meet the criteria of diabetes control defined by the local and international guidelines. © 2012 Via Medica.