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Leuven, Belgium

Stone G.W.,Columbia University Medical Center | Teirstein P.S.,Scripps Research Institute | Meredith I.T.,Monash Medical Center | Farah B.,Clinique Pasteur | And 6 more authors.
Journal of the American College of Cardiology

Objectives: We sought to evaluate the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients undergoing percutaneous coronary intervention (PCI). Background: Randomized trials have demonstrated an excellent safety and efficacy profile for the CoCr-EES. The PtCr-EES uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance. Methods: A total of 1,530 patients undergoing PCI of 1 or 2 de novo native lesions were randomized at 132 worldwide sites to CoCr-EES (n = 762) or PtCr-EES (n = 768). The primary endpoint was the 12-month rate of target lesion failure (TLF), the composite of target vessel-related cardiac death, target vessel-related myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR) in the per-protocol population (patients who received <1 assigned study stent), powered for noninferiority. Results: The 12-month rate of TLF in the per-protocol population occurred in 2.9% versus 3.4% of patients assigned to CoCr-EES versus PtCr-EES, respectively (difference: 0.5%, 95% confidence interval: -1.3% to 2.3%, pnoninferiority = 0.001, psuperiority = 0.60). By intention-to-treat, there were no significant differences between CoCr-EES and PtCr-EES in the 12-month rates of TLF (3.2% vs. 3.5%, p = 0.72), cardiac death or MI (2.5% vs. 2.0%, p = 0.56), TLR (1.9% vs. 1.9%, p = 0.96), or Academic Research Consortium definite or probable stent thrombosis (0.4% vs. 0.4%, p = 1.00). Conclusions: In this large-scale, prospective, single-blind randomized trial, a novel PtCr-EES was noninferior to the predicate CoCr-EES for TLF, with nonsignificant differences in measures of safety and efficacy through 12-month follow-up after PCI. (A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System [PROMUS Element] for the Treatment of up to Two De Novo Coronary Artery Lesions: NCT00823212) © 2011 American College of Cardiology Foundation. Source

Hermans M.P.,Cliniques Universitaires St Luc | Elisaf M.,University of Ioannina | Michel G.,Center Hospitalier Of Luxembourg | Muls E.,UZ Gasthuisberg | And 3 more authors.
Diabetes Care

OBJECTIVE-To assess prospectively the effect of benchmarking on quality of primary care for patients with type 2 diabetes by using three major modifiable cardiovascular risk factors as critical quality indicators. RESEARCH DESIGN ANDMETHODSdPrimary care physicians treating patients with type 2 diabetes in six European countries were randomized to give standard care (control group) or standard care with feedback benchmarked against other centers in each country (benchmarking group). In both groups, laboratory tests were performed every 4 months. The primary end point was the percentage of patients achieving preset targets of the critical quality indicators HbA1c, LDL cholesterol, and systolic blood pressure (SBP) after 12 months of follow-up. RESULTS-Of 4,027 patients enrolled, 3,996 patients were evaluable and 3,487 completed 12 months of follow-up. Primary end point of HbA1c target was achieved in the benchmarking group by 58.9 vs. 62.1% in the control group (P = 0.398) after 12 months; 40.0 vs. 30.1% patients met the SBP target (P < 0.001); 54.3 vs. 49.7% met the LDL cholesterol target (P = 0.006). Percentages of patients meeting all three targets increased during the study in both groups, with a statistically significant increase observed in the benchmarking group. The percentage of patients achieving all three targets at month 12 was significantly larger in the benchmarking group than in the control group (12.5 vs. 8.1%; P < 0.001). CONCLUSIONS-In this prospective, randomized, controlled study, benchmarking was shown to be an effective tool for increasing achievement of critical quality indicators and potentially reducing patient cardiovascular residual risk profile. © 2013 by the American Diabetes Association. Source

Prostate cancer is the most common male malignancy. Radiation therapy and radical prostatectomy are the main curative treatment options for organ confined disease. Despite the good long-term oncologic outcomes, roughly 40% of patients undergoing surgery develop biochemical recurrence, manifested as a rising prostate-specific antigen (PSA). Those patients are at higher risk of developing a local or distant recurrence. The diagnosis of a nodal recurrence is challenging. This report is about a 66-year-old male, who had a radical prostatectomy in 2006. Postoperatively, the PSA was never undetectable. Radiotherapy was delivered in 2007, but the PSA rose again. Anti-androgen therapy was started, but he developed painful mastodynia. A (11C) choline PET-CT showed an enlarged suspicious lymph node at the left common iliac and a salvage pelvic lymphadenectomy was performed. Postoperatively, the PSA remained undetectable for the last 5 years. The use of lesion - targeted therapy for oligometastatic disease is a new concept in urology, aiming at reducing the tumor burden. Therefore, even though this surgical approach might not be associated with a durable response over time, the tumor load is decreased and further cancer progression might be delayed, allowing to postpone the delivery of hormone therapy. © 2014 S. Karger AG, Basel Copyright © 2014, S. Karger AG. All rights reserved. Source

Peene B.,Catholic University of Leuven | Benhalima K.,UZ Gasthuisberg
Therapeutic Advances in Endocrinology and Metabolism

Type 2 diabetes mellitus (T2DM) is increasing worldwide. Treatment of T2DM continues to present challenges, with a significant proportion of patients failing to achieve and maintain glycemic targets. Despite the availability of many oral antidiabetic agents, therapeutic efficacy is also offset by side effects such as weight gain and hypoglycemia. Therefore, the search for novel therapeutic agents with an improved benefit–risk profile continues. In the following review we focus on a novel class of oral antidiabetic drugs, the sodium glucose transporter protein 2 (SGLT2) inhibitors, which have unique characteristics. SGLT2 inhibitors focus on the kidney as a therapeutic target, where they inhibit the reabsorption of glucose in the proximal tubule, causing an increase in urinary glucose excretion. Doing this, they reduce plasma glucose independently of the β-cell function of the pancreas. SGLT2 inhibitors are effective at lowering hemoglobin A1c, but also induce weight loss and reduce blood pressure, with a low risk of hypoglycemia. In general, the SGLT2 inhibitors are well tolerated, with the most frequent adverse events being mild urinal and genital infections. Since their primary site of effect is the kidney, these drugs are less effective in patients with impaired kidney function but evidence is emerging that these drugs may also have a protective effect against diabetic nephropathy. This review focuses on the most extensively studied SGLT2 inhibitors dapagliflozin, canagliflozin and empagliflozin. Dapagliflozin and canagliflozin have already been approved for marketing by the US Food and Drug Administration. The European Medicines Agency has accepted all three drugs for marketing. © The Author(s), 2014. Source

Peeters K.,UZ Gasthuisberg | Sahai A.,Guys Hospital | De Ridder D.,UZ Gasthuisberg | De Ridder D.,Catholic University of Leuven | And 2 more authors.
BJU International

Objective To report our long-term experience of sacral neuromodulation (SNM) for various lower urinary tract dysfunctions but with a focus on efficacy, safety, re-interventions and degree of success. Patients and Methods This is a single tertiary referral centre study that included 217 patients (86% female) who received an implantable pulse generator (IPG) (Interstim™, Medtronic, Minneapolis, USA) between 1996 and 2010. Success was considered if the initial ≥50% improvement in any of primary voiding diary variables persisted compared with baseline, but was further stratified. Results The mean duration of follow-up was 46.88 months. Success and cure rates were ≈70% and 20% for urgency incontinence, 68% and 33% for urgency frequency syndrome and 73% and 58% for idiopathic retention. In those patients with an unsuccessful therapy outcome, the mean time to failure was 24.6 months after implantation. There were 88 (41%) patients who had at least one device or treatment related surgical re-intervention. The re-intervention rate was 1.7 per patient with most of them (47%) occurring ≤2 years of follow-up. Conclusions SNM appears effective in the long-term with a success rate after definitive IPG implant of ≈70% and complete cure rates ranging between 20% and 58% depending on indication. Patients with idiopathic retention appear to do best. The re-intervention rate is high with most occurring ≤2 years of implantation. It is likely that with the newer techniques used, efficacy and re-intervention rates will improve. © 2013 The Authors. BJU International © 2013 BJU International. Source

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