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De La Torre Hernandez J.M.,Hospital Marques Of Valdecilla | Baz Alonso J.A.,Hospital Meixoeiro | Gomez Hospital J.A.,Hospital Bellvitge | Alfonso Manterola F.,Hospital Clinico San Carlos | And 16 more authors.
JACC: Cardiovascular Interventions | Year: 2014

Objectives: This study sought to investigate the clinical impact of the use of intravascular ultrasound (IVUS) during revascularization of patients with left main coronary artery (LM) disease with drug-eluting stents (DES). Background: Whether the use of IVUS during the procedure adds a clinical benefit remains unclear. There is only 1 previous observational study, with relevant limitations, supporting the value of this strategy. Methods: We performed a patient-level pooled analysis of 4 registries of patients with LM disease treated with DES in Spain. A propensity score-matching method was used to obtain matched pairs of patients with and without IVUS guidance. Results: A total of 1,670 patients were included, and 505 patients (30.2%) underwent DES implantation under IVUS guidance (IVUS group). By means of the matching method, 505 patients without the use of IVUS during revascularization were selected (no-IVUS group). Survival free of cardiac death, myocardial infarction, and target lesion revascularization at 3 years was 88.7% in the IVUS group and 83.6% in the no-IVUS group (p = 0.04) for the overall population, and 90% and 80.7%, respectively (p = 0.03), for the subgroups with distal LM lesions. The incidence of definite and probable thrombosis was significantly lower in the IVUS group (0.6% vs. 2.2%; p = 0.04). Finally, IVUS-guided revascularization was identified as an independent predictor for major adverse events in the overall population (hazard ratio: 0.70, 95% confidence interval: 0.52 to 0.99; p = 0.04) and in the subgroup with distal lesions (hazard ratio: 0.54, 95% confidence interval: 0.34 to 0.90; p = 0.02). Conclusions: The results of this pooled analysis show an association of IVUS guidance during percutaneous coronary intervention with better outcomes in patients with LM disease undergoing revascularization with DES. © 2014 by the American College of Cardiology Foundation.


Gluer C.-C.,Universitatsklinikum Schleswig Holstein | Marin F.,Lilly Research Center | Ringe J.D.,Klinikum Leverkusen | Hawkins F.,Hospital 12 Of Octubre | And 17 more authors.
Journal of Bone and Mineral Research | Year: 2013

Data on treatment of glucocorticoid-induced osteoporosis (GIO) in men are scarce. We performed a randomized, open-label trial in men who have taken glucocorticoids (GC) for ≥3 months, and had an areal bone mineral density (aBMD) T-score ≤ -1.5 standard deviations. Subjects received 20 μg/d teriparatide (n = 45) or 35 mg/week risedronate (n = 47) for 18 months. Primary objective was to compare lumbar spine (L1-L3) BMD measured by quantitative computed tomography (QCT). Secondary outcomes included BMD and microstructure measured by high-resolution QCT (HRQCT) at the 12th thoracic vertebra, biomechanical effects for axial compression, anterior bending, and axial torsion evaluated by finite element (FE) analysis from HRQCT data, aBMD by dual X-ray absorptiometry, biochemical markers, and safety. Computed tomography scans were performed at 0, 6, and 18 months. A mixed model repeated measures analysis was performed to compare changes from baseline between groups. Mean age was 56.3 years. Median GC dose and duration were 8.8 mg/d and 6.4 years, respectively; 39.1% of subjects had a prevalent fracture, and 32.6% received prior bisphosphonate treatment. At 18 months, trabecular BMD had significantly increased for both treatments, with significantly greater increases with teriparatide (16.3% versus 3.8%; p = 0.004). HRQCT trabecular and cortical variables significantly increased for both treatments with significantly larger improvements for teriparatide for integral and trabecular BMD and bone surface to volume ratio (BS/BV) as a microstructural measure. Vertebral strength increases at 18 months were significant in both groups (teriparatide: 26.0% to 34.0%; risedronate: 4.2% to 6.7%), with significantly higher increases in the teriparatide group for all loading modes (0.005 < p < 0.015). Adverse events were similar between groups. None of the patients on teriparatide but five (10.6%) on risedronate developed new clinical fractures (p = 0.056). In conclusion, in this 18-month trial in men with GIO, teriparatide showed larger improvements in spinal BMD, microstructure, and FE-derived strength than risedronate. Copyright © 2013 American Society for Bone and Mineral Research.


PubMed | Thomas Jefferson University, University of Pennsylvania, Clinic of Sagrado Corazon, University Pompeu Fabra and 7 more.
Type: | Journal: Epilepsy research | Year: 2017

We assessed the outcome of patients with drug resistant epilepsy and neuronal antibodies who underwent epilepsy surgery. Retrospective study, information collected with a questionnaire sent to epilepsy surgery centers. Thirteen patients identified, with antibodies to GAD (8), Ma2 (2), Hu (1), LGI1 (1) or CASPR2 (1). Mean age at seizure onset: 23 years. Five patients had an encephalitic phase. Three had testicular tumors and five had autoimmune diseases. All had drug resistant temporal lobe epilepsy (median: 20 seizures/month). MRI showed unilateral temporal lobe abnormalities (mainly hippocampal sclerosis) in 9 patients, bilateral abnormalities in 3, and was normal in 1. Surgical procedures included anteromesial temporal lobectomy (10 patients), selective amygdalohippocampectomy (1), temporal pole resection (1) and radiofrequency ablation of mesial structures (1). Perivascular lymphocytic infiltrates were seen in 7/12 patients. One year outcome available in all patients, at 3 years in 9. At last visit 5/13 patients (38.5%) (with Ma2, Hu, LGI1, and 2 GAD antibodies) were in Engels classes I or II. Epilepsy surgery may be an option for patients with drug resistant seizures associated with neuronal antibodies. Outcome seems to be worse than that expected in other etiologies, even in the presence of unilateral HS. Intracranial EEG may be required in some patients.


Bueno H.,Hospital General Universitario Gregorio Maran | Betriu A.,Hospital Clnic | Heras M.,Hospital Clnic | Alonso J.J.,Hospital Of Fuenlabrada | And 5 more authors.
European Heart Journal | Year: 2011

Aims To compare primary percutaneous coronary intervention (pPCI) and fibrinolysis in very old patients with ST-segment elevation myocardial infarction (STEMI), in whom head-to-head comparisons between both strategies are scarce. Methods and resultsPatients <75 years old with STEMI <6 h were randomized to pPCI or fibrinolysis. The primary endpoint was a composite of all-cause mortality, re-infarction, or disabling stroke at 30 days. The trial was prematurely stopped due to slow recruitment after enroling 266 patients (134 allocated to pPCI and 132 to fibrinolysis). Both groups were well balanced in baseline characteristics. Mean age was 81 years. The primary endpoint was reached in 25 patients in the pPCI group (18.9) and 34 (25.4) in the fibrinolysis arm [odds ratio (OR), 0.69; 95 confidence interval (CI) 0.381.23; P 0.21]. Similarly, non-significant reductions were found in death (13.6 vs. 17.2, P 0.43), re-infarction (5.3 vs. 8.2, P 0.35), or disabling stroke (0.8 vs. 3.0, P 0.18). Recurrent ischaemia was less common in pPCI-treated patients (0.8 vs. 9.7, P< 0.001). No differences were found in major bleeds. A pooled analysis with the two previous reperfusion trials performed in older patients showed an advantage of pPCI over fibrinolysis in reducing death, re-infarction, or stroke at 30 days (OR, 0.64; 95 CI 0.450.91). Conclusion Primary PCI seems to be the best reperfusion therapy for STEMI even for the oldest patients. Early contemporary fibrinolytic therapy may be a safe alternative to pPCI in the elderly when this is not available.Clinicaltrials.gov NCT00257309. © 2010 The Author.


Flechner S.M.,Cleveland Clinic | Glyda M.,Szpital Wojewodzki | Cockfield S.,University of Alberta | Grinyo J.,Hospital Bellvitge | And 5 more authors.
American Journal of Transplantation | Year: 2011

Safety and efficacy of two sirolimus (SRL)-based regimens were compared with tacrolimus (TAC) and mycophenolate mofetil (MMF). Renal transplantation recipients were randomized to Group 1 (SRL+TAC; week 13 TAC elimination [n = 152]), Group 2 (SRL + MMF [n = 152]) or Group 3 (TAC + MMF [n = 139]). Group 2, with higher-than-expected biopsy-confirmed acute rejections (BCARs), was sponsor-terminated; therefore, Group 2 two-year data were limited. At 1 and 2 years, respectively, graft (Group 1: 92.8%, 88.5%; Group 2: 90.6%, 89.9%; Group 3: 96.2%, 95.4%) and patient (Group 1: 97.3%, 94.4%; Group 2: 95.2%, 94.5%; Group 3: 97.0%, 97.0%) survival rates were similar. One- and 2-year BCAR incidence was: Group 1, 15.2%, 17.4%; Group 2, 31.3%, 32.8%; Group 3, 8.2%, 12.3% (Group 2 vs. 3, p < 0.001). Mean 1- and 2-year modified intent-to-treat glomerular filtration rates (mL/min) were similar. Primary reason for discontinuation was adverse events (Group 1, 34.2%; Group 2, 33.6%; Group 3, 22.3%; p < 0.05). In Groups 1 and 2, delayed wound healing and hyperlipidemia were more frequent. One-year post hoc analysis of new-onset diabetes posttransplantation was greater in TAC recipients (Groups 1 and 3 vs. 2, 17% vs. 6%; p = 0.004). Between-group malignancy rates were similar. The SRL-based regimens were not associated with improved outcomes for kidney transplantation patients. © 2011 The American Society of Transplantation and the American Society of Transplant Surgeons.


Nelson M.,Chelsea and Westminster Hospital | Stellbrink H.-J.,Infektionsmedizinisches Centrum | Podzamczer D.,Hospital Bellvitge | Banhegyi D.,Szt Laszlo Hospital | And 6 more authors.
AIDS | Year: 2011

Background: Although efavirenz is a universally recommended treatment for naive HIV-infected individuals, neuropsychiatric adverse events are common. Methods: The Study of Efavirenz NeuropSychiatric Events versus Etravirine (SENSE) trial is a double-blind, placebo-controlled study in which 157 treatment-naive individuals with HIV-RNA higher than 5000 copies/ml were randomized to etravirine 400 mg once daily (n = 79) or to efavirenz 600 mg once daily (n = 78), with two investigator-selected nucleoside reverse transcriptase inhibitors (NRTIs). The primary end point was the percentage of patients with grade 1-4 drug-related treatment-emergent neuropsychiatric adverse events up to week 12. Results: The study population were 81% men and 85% whites, with a median age of 36 years, baseline CD4 cell counts of 302 cells/μl and HIV-RNA of 4.8 log10 copies/ml. In the intent-to-treat analysis, 13 of 79 individuals (16.5%) in the etravirine arm and 36 of 78 individuals (46.2%) in the efavirenz arm showed at least one grade 1-4 drug-related treatment-emergent neuropsychiatric adverse event (P < 0.001). The number with at least one grade 2-4 drug-related treatment-emergent neuropsychiatric adverse event was four of 79 individuals (5.1%) in the etravirine arm and 13 of 78 individuals (16.7%) in the efavirenz arm (P = 0.019). The change in HIV-RNA to week 12 was -2.9 log10 in both treatment arms. The median rise in CD4 cell counts was 146 cells/μl in the etravirine arm and 121 cells/μl in the efavirenz arm. Conclusions: After 12 weeks, first-line treatment with etravirine 400 mg once daily with two NRTIs was associated with significantly fewer neuropsychiatric adverse events when compared with efavirenz with two NRTIs. The virological and immunological efficacy profile was similar between the two arms. © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins.


Pascual J.,Hospital Del Mar | Del Castillo D.,Hospital Reina Sofia | Cabello M.,Hospital Carlos Haya | Pallardo L.,Hospital Dr Peset | And 2 more authors.
Transplantation | Year: 2010

Background. Clinical data are lacking concerning therapeutic action and systemic exposure of tacrolimus (TAC) and everolimus (EVL) in a combined regimen in renal transplantation. Methods. A prospective randomized phase II pharmacokinetic study was conducted comparing two fixed EVL dosages (0.75 mg two times per day (BID), group A, or 1.5 mg BID, group B) in combination with standard TAC dose. Complete 12-hr pharmacokinetic curves of both drugs were performed at days 4, 14, and 42 posttransplant. Results. A higher TACC min was observed with EVL dose of 0.75 mg BID (TAC 11.1±6.4 group A vs. 9.4±5.0 ng/mL group B, P=0.03), with equivalent TAC area under the curves (162±61 vs. 171±75). The exposure to TAC was lower in group B despite higher TAC doses were required to maintain target concentrations (day 14: 9.5 vs. 12.5 mg and day 42: 6 vs. 9 mg, P<0.05). Cmin-TAC/dose and area under the curve-TAC/dose ratios were significantly lower, from day 4 to day 42, in group B. Both groups achieved good graft function and acute rejection rate was similar (20% and 15%, respectively). Conclusions. We conclude that in adult renal transplant recipients, EVL significantly decreases TAC oral bioavailability in a dose-dependent manner. Doses higher than 1.5 mg BID would be probably needed for TAC-minimization strategies because 3 mg/day is not enough to achieve levels more than 3 ng/mL during the first 2 weeks. Therapeutic drug monitoring is mandatory to adjust the dose and prevent low TAC exposure. This regimen of low EVL exposure plus standard TAC exposure avoids wound healing problems with good efficacy. © 2010 by Lippincott Williams & Wilkins.


Iglesias P.,Hospital Ramon y Cajal | Bernal C.,Hospital Doce Of Octubre | Villabona C.,Hospital Bellvitge | Castro J.C.,Hospital General | And 2 more authors.
Clinical Endocrinology | Year: 2012

Aims To assess treatment outcome in male patients with micro- and macroprolactinomas. Design Multicentre and retrospective study. Patients Eighty-eight male patients (15 micro- and 73 macroprolactinomas), aged 40.3 ± 14.7 years, were studied. Time of follow-up ranged from 3 to 244 months. Methods Clinical, hormonal and radiological data were registered at diagnosis and follow-up. Treatment outcome was evaluated in relation to the modality of therapy (dopamine agonists, surgery and radiation therapy). Results Dopamine agonists normalized prolactin levels in 73.3% and 65.2% of patients with micro- and macroprolactinomas, respectively. Disappearance of tumour was reached in 53.3% and 28.3% of subjects with micro- and macroprolactinomas, respectively. Tumour absence at last visit was achieved in 7 of 14 patients with macroprolactinoma and treated by means of dual therapy (dopamine agonists and neurosurgery) and in 9 of 13 patients with macroprolactinoma managed with triple therapy (dopamine agonists, neurosurgery and radiation therapy). Normalization of prolactin levels at last visit was present in 68.9%, 79.6% and 69.2% of patients treated by medical therapy, dual therapy and triple therapy, respectively (differences not significant). Multivariate logistic regression analysis showed that the time on therapy was the only significant variable related to tumour disappearance. Conclusion We conclude that medical therapy normalizes prolactin and reduces tumour size in the majority of men with prolactinomas. The addition of pituitary surgery with or without radiation therapy does not offer significant advantages over medical therapy with dopamine agonists in male patients with macroprolactinomas. © 2012 Blackwell Publishing Ltd.


Sahlein D.H.,Hospital Bellvitge | Mora P.,Hospital Bellvitge | Mora P.,NYU Langone Medical Center | Becske T.,Hospital Bellvitge | And 5 more authors.
Stroke | Year: 2014

BACKGROUND AND PURPOSE - : Although there is generally thought to be a 2% to 4% per annum rupture risk for brain arteriovenous malformations (bAVMs), there is no way to estimate risk for an individual patient. METHODS - : In this retrospective study, patients were eligible who had nidiform bAVMs and underwent detailed pretreatment diagnostic cerebral angiography at our medical center from 1996 to 2006. All patients had superselective microcatheter angiography, and films were reviewed for the purpose of this project. Patient demographics, clinical presentation, and angioarchitectural characteristics were analyzed. A univariate analysis was performed, and angioarchitectural features with potential physiological significance that showed at least a trend toward significance were added to a multivariate logistic regression model. RESULTS - : One hundred twenty-two bAVMs met criteria for study entry. bAVMs with single venous drainage anatomy were more likely to present with hemorrhage. In addition, patients with multiple draining veins and a venous stenosis reverted to a risk similar to those with 1 draining vein, whereas those with multiple draining veins and without stenosis had diminished association with hemorrhage presentation. Those bAVMs with associated aneurysms were more likely to present with hemorrhage. These findings were robust in both univariate and multivariate models. CONCLUSIONS - : The results of this article lead to the first physiological, internally consistent model of individual bAVM hemorrhage risk, where 1 draining vein, venous stenosis, and associated aneurysms increase risk. © 2014 American Heart Association, Inc.


Macaya A.,Hospital Bellvitge
Cochrane database of systematic reviews (Online) | Year: 2012

Anal canal intraepithelial neoplasia (AIN) is a pre-malignant condition of the anal canal transitional epithelium that is associated with human papillomavirus (HPV) infection. The incidence and prevalence of AIN and anal cancer are increasing rapidly in HIV-positive men who have sex with men (MSM). Other groups like HIV-negative MSM, immunosuppressed patients and people affected by other HPV diseases like genital warts and cervical intraepithelial neoplasia (CIN) may also develop AIN. The condition is complicated by its multicentric and multifocal nature and high rates of relapse and morbidity. Targeted excisions using ablative treatments such as cautery, infrared coagulation (IRC) and cryotherapy have been used as first-line therapeutic strategies, and there are many other options. There is no consensus about the optimal management of AIN. To evaluate the effects of therapeutic interventions for anal canal intraepithelial neoplasia (AIN). We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2011, Issue 4), MEDLINE and EMBASE (to October 2011). We also searched registers of clinical trials, abstracts of scientific meetings and reference lists of included studies, and contacted experts in the field and manufacturers of any AIN and HPV-specific treatments. Randomized controlled trials (RCTs) that assessed any type of intervention for AIN. Two review authors independently abstracted data and assessed risk of bias. If it was possible, the data were synthesised in a meta-analysis. We found only one RCT, which included 53 patients, that met our inclusion criteria. This trial reported data on imiquimod versus placebo. There was no statistically significant difference in the risk of disease cure but there was a trend for imiquimod to downgrade the AIN to a low-risk stage. The lack of statistical power of the trial may be due to the small number of patients in each group. The risk of bias was estimated as moderate. The included trial failed to demonstrate any statistically significant efficacy of imiquimod in the management of anal intraepithelial neoplasia (AIN). The absence of reliable evidence for any of the interventions used in AIN precludes any definitive guidance or recommendations for clinical practice. Prospective cohort studies and retrospective studies have not been included in this review as they are considered to provide lower quality evidence. Well designed RCTs are needed.

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