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Introduction: The Fourth Universal Definition of Myocardial Infarction Global Taskforce recommends the use of high sensitive troponin (hs-Tn) assays in the diagnosis of acute myocardial infarction. We evaluated the analytical performance of the Atellica IM High-sensitivity Troponin I Assay (hs-TnI) (Siemens Healthcare Diagnostics Inc., Tarrytown, USA) and compared its performance to other hs-TnI assays (Siemens Advia Centaur, Dimension Vista, Dimension EXL, and Abbott Architect (Wiesbaden, Germany)) at one or more sites across Europe. Materials and methods: Precision, detection limit, linearity, method comparison, and interference studies were performed according to Clinical and Laboratory Standards Institute protocols. Values in 40 healthy individuals were compared to the manufacturer's cut-offs. Sample turnaround time (TAT) was examined. Results: Imprecision repeatability CVs were 1.1-4.7% and within-lab imprecision were 1.8-7.6% (10.0-25,000 ng/L). The limit of blank (LoB), detection (LoD), and quantitation (LoQ) aligned with the manufacturer's values of 0.5 ng/L, 1.6 ng/L, and 2.5 ng/L, respectively. Passing-Bablok regression demonstrated good correlations between Atellica IM analyser with other systems; some minor deviations were observed. All results in healthy volunteers fell below the 99th percentile URL, and greater than 50% of each sex demonstrated values above the LoD. No interference was observed for biotin (≤ 1500 µg/L), but a slight bias at 5.0 g/L haemoglobin and 50 ng/L Tn was observed. TAT from was fast (mean time = 10.9 minutes) and reproducible (6%CV). Conclusions: Real-world analytical and TAT performance of the hs-TnI assay on the Atellica IM analyser make this assay fit for routine use in clinical laboratories.
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Bioensayo , Troponina I , Pruebas de Coagulación Sanguínea , Europa (Continente) , Humanos , LaboratoriosRESUMEN
AIM: During pregnancy, thyroid homeostasis is physiologically modified, leading to altered levels of thyrotropin (TSH): hence, the adoption of pregnancy-related, population- and method-specific reference ranges is recommended. This monocentric and retrospective study was conducted to establish local pregnancy-related reference intervals for serum TSH in singleton pregnant women using real-life clinical data. METHODS: We included women who measured serum TSH during pregnancy at our Laboratory over six years, excluding pregnant women with current or past history of thyroid disease, pituitary or autoimmune diseases, use of medications known to influence thyroid function, multiple and/or pathological pregnancies, BMI >30 Kg/m2. RESULTS: We retrieved a total of 3744 TSH results. Reference limits (90% confidence intervals) for TSH (in mIU/L) are: first trimester 0.09 (0.06-0.12) - 3.16 (3.05-3.29); second trimester 0.25 (0.11-0.30) - 3.55 (3.34-3.73); third trimester 0.42 (0.15-0.48) - 3.93 (3.80-4.08). CONCLUSION: In conclusion, real-life clinical data could be used to establish or verify local reference intervals for TSH in pregnant women: this may reduce the risk of misclassification of pregnant women undergoing thyroid function testing.
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Trimestres del Embarazo/sangre , Embarazo/sangre , Tirotropina/sangre , Adulto , Femenino , Humanos , Valores de ReferenciaRESUMEN
INTRODUCTION: Haematological malignancies often escape the standard information flows of cancer registries because diagnosis is not always based on bone marrow histology but, rather, on other laboratory tests. OBJECTIVE: To quantify incident haematological malignancies identified exclusively through the laboratory information system and to measure the impact of that source on the sensitivity and accuracy of registering these malignancies. METHODS: We collected data from the only provincial laboratory of Reggio Emilia on molecular biology, flow cytometry tests and bone marrow smears to detect specific markers of some chronic haematological malignancies. We carried out a record linkage between laboratory reports (period 2013-2017) of patients resident in the province of Reggio Emilia and the Cancer Registry of Reggio Emilia. RESULTS: Of the 303 patients who underwent at least one of these tests, 85 were not included in our Cancer Registry. Of these 85 patients, 42 had received a diagnosis of cancer: 34 myeloproliferative neoplasms, 3 chronic myeloid leukaemias, 3 myelodysplastic neoplasms, 1 multiple myeloma and 1 chronic lymphocytic leukaemia. We recovered 4.2% of the total number of chronic haemolymphopoietic cancers registered in the study period, accounting for 15% of myeloproliferative neoplasms. For 30% of prelinkage cases, the specificity of the morphological code improved. CONCLUSIONS: Although the laboratory information system's contribution to the completeness of Cancer Registry incident cases was modest, it is useful to add laboratory data to routine cancer registry information flows due to the increasing use of molecular characterisation and to the phenomenon of dehospitalisation.
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Neoplasias Hematológicas/diagnóstico , Laboratorios/estadística & datos numéricos , Sistema de Registros/estadística & datos numéricos , Estudios de Seguimiento , Neoplasias Hematológicas/epidemiología , Humanos , Incidencia , Italia/epidemiología , Pronóstico , Estudios RetrospectivosRESUMEN
Background The Atellica Solution comprises chemistry (CH) and immunoassay (IM) analyzers. Recently, six early adopter clinical laboratories across Europe evaluated the analytical performance of 20 CH and IM assays. To measure analytical performance quality, Sigma metrics were calculated for individual-site and pooled-site results. Methods Precision, detection capability, linearity, and method comparison studies were performed according to Clinical Laboratory Standards Institute protocols. Global Sigma metrics across sites were calculated from pooled data at the medical decision level using total allowable error (TEa) goals from CLIA for CH assays, and TEa goals from RiliBÄK for IM assays; and, the equation: Sigma metrics=%TEa-%bias/%CV. A pooled %CV was calculated by combining the imprecision obtained from individual sites. Bias calculations were performed against the ADVIA Chemistry system or ADVIA Centaur system using Deming regression analysis (Passing-Bablok regression for electrolytes) on the pooled-site data. The 103 individual-site Sigma metric calculations used individual-site imprecision and pooled-bias. Results The limits of blank and detection results agreed with the manufacturer's claims. Most assays were linear across the assay range tested. Pooled Sigma metrics were good or better (>4 Sigma) for 18 of 20 assays; and, acceptable for urea nitrogen (3.1) and sodium (3.9), the latter values attributable to higher imprecision at one of five sites. Conclusions Sigma metrics for data generated across multiple real-world sites evaluating the Atellica Solution demonstrated good or better performance of greater than 4 Sigma for 18 of 20 assays tested. Overall, results verified the manufacturer's claims that methods were fit for use in clinical laboratories.
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Técnicas de Química Analítica/normas , Inmunoensayo/normas , Límite de Detección , Modelos Lineales , Control de CalidadRESUMEN
Bicycloalkyl groups have been previously described as phenyl group bioisosteres. This article describes the synthesis of new building blocks allowing their introduction into complex molecules, and explores their use as a means to modify the physicochemical properties of drug candidates and improve the quality of imaging agents. In particular, the replacement of an aromatic ring with a bicyclo[1.1.1]pentane-1,3-diyl (BCP) group improves aqueous solubility by at least 50-fold, and markedly decreases nonspecific binding (NSB) as measured by CHI(IAM), the chromatographic hydrophobicity index on immobilized artificial membranes. Structural variations with the bicyclo[2.2.2]octane-1,4-diyl group led to more lipophilic molecules and did not show the same benefits regarding NSB or solubility, whereas substitutions with cubane-1,4-diyl showed improvements for both parameters. These results confirm the potential advantages of both BCP and cubane motifs as bioisosteric replacements for optimizing para-phenyl-substituted molecules.
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Compuestos Bicíclicos con Puentes/química , Membranas Artificiales , Compuestos de Anilina/química , Compuestos Bicíclicos con Puentes/síntesis química , Ácidos Carboxílicos/química , Interacciones Hidrofóbicas e Hidrofílicas , Ligandos , SolubilidadRESUMEN
OBJECTIVES/HYPOTHESIS: Sudden sensorineural hearing loss (SSHL) is an otologic emergency that affects five to 30 subjects per 100,000/year. The cause of SSHL remains unknown or uncertain in 70% to 90% of cases, and treatment decisions are usually made without knowing the etiology. STUDY DESIGN: Prospective case-control study. METHODS: One hundred thirty-one idiopathic SSHL patients were recruited from January 2014 to June 2015 in concordance with the Statements of Clinical Practice Guideline and divided into groups according to the disease severity. A clinical laboratory assessment was completed on blood samples collected from SSHL patients and control subjects. Multivariable regression analysis was performed to investigate the association between laboratory data and SSHL basis. RESULTS: Only a few SSHL patients were positive for autoimmunity or viral infection. Statistically significant (P < .05) higher levels of blood glucose, glycated hemoglobin (HbA1C), lipoprotein (a), and factor VIII were found in SSHL patients compared to controls. Furthermore, blood glucose, HbA1C, uric acid, factor VIII, and homocysteine were significantly associated to disease severity. CONCLUSIONS: Gluco-metabolic, lipidic, and coagulative laboratory data support the vascular hypothesis for SSHL and its severity. LEVEL OF EVIDENCE: 3b Laryngoscope, 127:2375-2381, 2017.
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Biomarcadores/sangre , Pérdida Auditiva Sensorineural/sangre , Pérdida Auditiva Súbita/sangre , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Audiometría , Estudios de Casos y Controles , Ensayo de Inmunoadsorción Enzimática , Femenino , Pérdida Auditiva Sensorineural/diagnóstico , Pérdida Auditiva Súbita/diagnóstico , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Reproducibilidad de los Resultados , Factores de Riesgo , Adulto JovenRESUMEN
BACKGROUND: Whether cyclosporine A (CsA) has beneficial effects in reperfused myocardial infarction (MI) is debated. OBJECTIVES: This study investigated whether CsA improved ST-segment resolution in a randomized, multicenter phase II study. METHODS: The authors randomly assigned 410 patients from 31 cardiac care units, age 63 ± 12 years, with large ST-segment elevation MI within 6 h of symptom onset, Thrombolysis In Myocardial Infarction (TIMI) flow grade 0 to 1 in the infarct-related artery, and committed to primary percutaneous coronary intervention, to 2.5 mg/kg intravenous CsA (n = 207) or control (n = 203) groups. The primary endpoint was incidence of ≥70% ST-segment resolution 60 min after TIMI flow grade 3. Secondary endpoints included high-sensitivity cardiac troponin T (hs-cTnT) on day 4, left ventricular (LV) remodeling, and clinical events at 6-month follow-up. RESULTS: Time from symptom onset to first antegrade flow was 180 ± 67 min; a median of 5 electrocardiography leads showed ST-segment deviation (quartile [Q]1 to Q3: 4 to 6); 49.8% of MIs were anterior. ST-segment resolution ≥70% was found in 52.0% of CsA patients and 49.0% of controls (p = 0.55). Median hs-cTnT on day 4 was 2,160 (Q1 to Q3: 1,087 to 3,274) ng/l in CsA and 2,068 (1,117 to 3,690) ng/l in controls (p = 0.85). The 2 groups did not differ in LV ejection fraction on day 4 and at 6 months. Infarct site did not influence CsA efficacy. There were no acute allergic reactions or nonsignificant excesses of 6-month mortality (5.7% CsA vs. 3.2% controls, p = 0.17) or cardiogenic shock (2.4% CsA vs. 1.5% controls, p = 0.33). CONCLUSIONS: In the CYCLE (CYCLosporinE A in Reperfused Acute Myocardial Infarction) trial, a single intravenous CsA bolus just before primary percutaneous coronary intervention had no effect on ST-segment resolution or hs-cTnT, and did not improve clinical outcomes or LV remodeling up to 6 months. (CYCLosporinE A in Reperfused Acute Myocardial Infarction [CYCLE]; NCT01650662; EudraCT number 2011-002876-18).
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Ciclosporina/administración & dosificación , Electrocardiografía , Infarto del Miocardio/terapia , Reperfusión Miocárdica/métodos , Función Ventricular Izquierda/fisiología , Remodelación Ventricular/efectos de los fármacos , Angiografía Coronaria , Relación Dosis-Respuesta a Droga , Ecocardiografía , Femenino , Estudios de Seguimiento , Humanos , Inmunosupresores/administración & dosificación , Inyecciones Intravenosas , Masculino , Persona de Mediana Edad , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/fisiopatología , Estudios Prospectivos , Resultado del TratamientoRESUMEN
Objective of this study was to assess the clinical performance of bioresorbable vascular scaffold (BVS) compared to everolimus-eluting stent (EES) in subjects with ST-segment elevation myocardial infarction (STEMI). We included all consecutive patients with STEMI who underwent percutaneous coronary intervention (PCI) with BVS implantation in centers participating to the Italian ABSORB Prospective Registry (BVS-RAI) and PCI with EES in the same centers during the same period. The 2 groups were compared. The primary end point was patient-oriented composite end point (POCE) including cardiac death, myocardial infarction, and target lesion revascularization (TLR) at the longest available follow-up. BVS or EES thrombosis at follow-up was also evaluated. Of the 563 patients with STEMI included, 122 received BVS and 441 EES. Procedural success was obtained in 549 (97.5%) cases without significant differences between the 2 groups (BVS 99.3% vs EES 97.0%, p = 0.2). At a median of 220-day (interquartile range 178 to 369) follow-up, no significant differences were observed in terms of POCE (BVS 4.9% vs EES 7.0%, p = 0.4); death (BVS 0.8%, EES 2.0%, p = 0.4), MI (BVS 4.1%, EES 2.0%, p = 0.2), TLR (BVS 4.1%, EES 4.5%, p = 0.8), device thrombosis (BVS 2.5%, EES 1.4%, p = 0.4). All TLR cases were successfully managed with re-PCI in both groups. A propensity matching of the study populations showed no significant differences regarding POCE at the longest available follow-up (odds ratio 0.53, 0.1 to 4.3). In conclusion, in this direct prospective comparison, BVS was associated with similar clinical results compared to EES in the STEMI setting. Larger and adequately powered randomized trials are needed to fully assess the potential clinical benefit of BVS versus the current standard of care in patients with STEMI.
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Implantes Absorbibles , Stents Liberadores de Fármacos , Infarto del Miocardio/cirugía , Intervención Coronaria Percutánea/métodos , Sirolimus/análogos & derivados , Andamios del Tejido , Anciano , Antineoplásicos , Angiografía Coronaria , Electrocardiografía , Everolimus , Femenino , Estudios de Seguimiento , Humanos , Inmunosupresores/farmacología , Incidencia , Italia/epidemiología , Masculino , Persona de Mediana Edad , Infarto del Miocardio/diagnóstico , Complicaciones Posoperatorias/epidemiología , Estudios Prospectivos , Diseño de Prótesis , Sirolimus/farmacología , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: The purpose of this study was to collect information to understand how citizens perceive the National Health System (NHS), and what is the degree of confidence they have in the NHS. METHODS: We carried out an opinion poll with the Demos & Pi group on the perception of the NHS by Italian citizens, with particular reference to the activities related to cardiology, by interviewing 2311 people with a set of 33 questions, about the perception of their health status, lifestyles, the propensity to use public or private services, consideration of the level of the NHS, and the trust in the medical profession. The subjects included were also preliminarily stratified according to the presence or absence of heart disease. RESULTS: Overall, Italian citizens express a high level of satisfaction for the NHS (on average, 65% of approval rating), including the whole professional staff, hoping that the NHS will be kept appropriately funded. The result is even better in the subset of interviewed citizens, who suffered from cardiovascular disease. People also consider the NHS an essential requirement to ensure equity in access to medical treatment and to keep costs competitive, even compared to private healthcare. The NHS major weakness remains the waiting lists, which are considered too long for diagnostic procedures and ordinary interventions. CONCLUSIONS: There is a widespread positive feeling among Italian citizens concerning the role and functioning of the NHS. Such opinion, shared by the whole country, should be taken into account when the time will come to define strategies for health policy of the Italian society in the near future.
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Cardiología , Atención a la Salud , Política de Salud , Programas Nacionales de Salud , Satisfacción del Paciente , Adolescente , Adulto , Anciano , Femenino , Encuestas de Atención de la Salud , Cardiopatías/diagnóstico , Cardiopatías/terapia , Humanos , Italia , Masculino , Persona de Mediana Edad , Medicina Estatal , Encuestas y CuestionariosRESUMEN
AIMS: In this multicentre prospective registry we sought to evaluate the immediate and midterm clinical outcomes following single or multiple overlapping bioresorbable vascular scaffold (BVS) implantation in the STEMI setting. METHODS AND RESULTS: A prospective cohort analysis was performed on all STEMI patients who underwent primary PCI with BVS implantation. Between December 2012 and February 2014, 1,232 STEMI patients underwent primary PCI at the participating centres. Of these, 74 (6.0%) received a BVS, 18 (24.3%) of them were multiple and overlapping. Procedural success was obtained in 72 (97.3%) cases without differences between the groups (overlapping BVS 100% vs. single BVS 96.4%, p=0.5). One patient experienced a reinfarction due to subacute BVS thrombosis which was successfully managed with balloon-only PCI while the other patient had a "slow-flow" phenomenon (final TIMI flow 2). At six-month follow-up, two non-fatal MI (2.7%), three target lesion revascularisations (4.1%), and one subacute BVS thrombosis were reported in three patients (one [5.6%] overlapping BVS and two [3.6%] in the single BVS group, p=0.5). All the events were successfully managed with re-PCI. CONCLUSIONS: BVS implantation in STEMI patients can be successfully performed with a high procedural success rate and encouraging midterm outcomes. Larger randomised trials and longer follow-up are needed to assess the potential clinical benefit of BVS versus new-generation DES in this setting.
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Implantes Absorbibles , Stents Liberadores de Fármacos , Everolimus/uso terapéutico , Infarto del Miocardio/cirugía , Intervención Coronaria Percutánea , Adolescente , Adulto , Anciano , Estudios de Cohortes , Femenino , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/métodos , Estudios Prospectivos , Sistema de Registros , Resultado del Tratamiento , Adulto JovenRESUMEN
OBJECTIVES: To obtain further, and more focused, information on the efficacy and safety of the antithrombotic regimens, including triple therapy (TT) of warfarin, aspirin, and clopidogrel; dual therapy (DT) of warfarin and single antiplatelet agent (aspirin or clopidogrel); and dual-antiplatelet therapy (DAPT) of aspirin and clopidogrel, prescribed to patients on oral anticoagulation (OAC) undergoing percutaneous coronary intervention with stent (PCI-S). BACKGROUND: The true efficacy and safety of TT, DT, and DAPT in OAC patients undergoing PCI-S is largely undefined. METHODS: We analyzed the database of the prospective, multicenter WARfarin and coronary STENTing (WAR-STENT) registry (ClinicalTrials.gov identifier NCT00722319), only including the post-discharge period. RESULTS: Of the 401 patients discharged alive from index hospitalization, 339 (85%), 20 (5%), and 42 (10%) were prescribed TT, DT, and DAPT, respectively. Throughout a mean follow-up of 368.3 ± 22.8 days, major adverse cardiovascular events (MACE) (including cardiovascular death, myocardial infarction, repeat revascularization, stent thrombosis, and thromboembolism), total bleeding, major bleeding, and combination of MACE plus total bleeding were comparable across the three treatment groups. The absolute rate of major bleeding with TT was 4%. The antithrombotic treatment actually ongoing at major bleeding was TT in 44%, DT in 50%, and DAPT in 6% of cases. CONCLUSION: In the real-world population of OAC patients undergoing PCI-S in the WAR-STENT registry, the three antithrombotic regimens of TT, DT, and DAPT showed comparable efficacy and safety. Due to several limitations, our data cannot be considered conclusive in confuting the current recommendations to prescribe TT. Further properly designed and sized studies are warranted.
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Angioplastia Coronaria con Balón , Aspirina/efectos adversos , Aspirina/uso terapéutico , Stents Liberadores de Fármacos , Ticlopidina/análogos & derivados , Warfarina/efectos adversos , Warfarina/uso terapéutico , Administración Oral , Clopidogrel , Bases de Datos Bibliográficas , Quimioterapia Combinada , Estudios de Seguimiento , Hemorragia/inducido químicamente , Estudios Prospectivos , Sistema de Registros , Ticlopidina/efectos adversos , Ticlopidina/uso terapéutico , Resultado del TratamientoRESUMEN
BACKGROUND: Hypertension continues to be a major burden of public health concern despite the recent advances and proven benefit of pharmacological therapy. A certain subset of patients has hypertension resistant to maximal medical therapy and appropriate lifestyle measures. A novel catheter-based technique for renal denervation (RDN) as a new therapeutic avenue has great promise for the treatment of refractory hypertension. SUMMARY: This review included the physiology of the renal sympathetic nervous system and the renal nerve anatomy. Furthermore, the RDN procedure, technology systems, and RDN clinical trials as well as findings besides antihypertensive effects were discussed. Findings on safety and efficacy seem to suggest that renal sympathetic denervation could be of therapeutic benefit in refractory hypertensive patients. Despite the fast pace of development in RDN therapies, only initial and very limited clinical data are available. Large gaps in knowledge concerning the long-term effects and consequences of RDN still exist, and solid, randomized data are warranted.
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BACKGROUND: Coronary bifurcation lesions represent a difficult problem regularly confronting interventional cardiologist, in part due to the lack of dedicated device. OBJECTIVE: To investigate the feasibility, safety and effectiveness of the Tryton Side Branch Stent (Tryton Medical, Durham, NC, USA), a dedicated bare metal stent deployed in conjunction with a standard drug-eluting stent to treat bifurcation lesions. METHODS: The SAFE-TRY is a prospective single arm multicenter registry including patients with de novo bifurcation lesions in native coronary arteries and syntax score <32. The primary endpoint was target vessel failure (TVF) at 30 days that comprised cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization. Secondary endpoints included device, angiographic and procedural success, 9-month major adverse cardiac and cerebrovascular event (MACCE), and stent thrombosis (ST) rates (ClinicalTrials.gov identifier: NCT01174433). RESULTS: Among 252 enrolled patients, 24% had diabetes and 35.3% unstable angina. True bifurcation lesions involving both branches occurred in 96.8% of cases with Medina classification 1.1.1 in 62%. The left anterior descending artery and the left main were treated in 70% and 8.3% of the patients, respectively. A 6 Fr guide catheter was used in 61% of the cases. Device, angiographic and procedural success rates were 99.6%, 99.6% and 97.2% respectively. The 30-day TVF was 2.8%; the 9-month MACCE rate was 13.7%, with target lesion revascularization being 4.4%. No definite ST occurred. CONCLUSIONS: This prospective, multicenter study confirmed the feasibility, safety and effectiveness of the Tryton Side Branch Stent to treat patients with de novo complex bifurcation lesions.
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Angioplastia Coronaria con Balón/instrumentación , Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos/efectos adversos , Stents/efectos adversos , Anciano , Angioplastia Coronaria con Balón/estadística & datos numéricos , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/epidemiología , Reestenosis Coronaria/epidemiología , Trombosis Coronaria/epidemiología , Vasos Coronarios/patología , Stents Liberadores de Fármacos/estadística & datos numéricos , Estudios de Factibilidad , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Sistema de Registros/estadística & datos numéricos , Stents/estadística & datos numéricos , Resultado del TratamientoRESUMEN
OBJECTIVES: This study sought to investigate the efficacy and performance of the XIENCE V everolimus-eluting stent (EES) (Abbott Vascular, Santa Clara, California) in the treatment of de novo coronary lesions in patients with 2- to 3-vessel multivessel coronary artery disease (MV-CAD). BACKGROUND: Drug-eluting stents (DES) have emerged as an alternative to conventional coronary artery bypass surgery in patients with MV-CAD although first-generation DES yielded inferior efficacy and safety compared with surgery. METHODS: Prospective, randomized (1:1), multicenter feasibility trial was designed to assess angiographic efficacy of EES compared with the TAXUS paclitaxel-eluting stent (PES) in 200 patients, and a prospective, open-label, single-arm, controlled registry was designed to analyze the clinical outcome of EES at 1-year follow-up in 400 MV-CAD patients. For the randomized trial, the primary endpoint was in-stent late loss at 9 months. For the registry, the primary endpoint was a composite of all-cause death, myocardial infarction, and ischemia-driven target vessel revascularization at 12 months. RESULTS: The primary endpoint per single lesion was significantly lower in the EES group compared with the PES group (-0.03 ± 0.49 mm vs. 0.23 ± 0.51 mm, p = 0.001). Similar results were observed when analyzing all lesions (0.05 ± 0.51 mm vs. 0.24 ± 0.50 mm, p < 0.001). Clinical outcome at 1 year yielded a composite of major adverse cardiac events of 9.2% in the single-arm registry, and 11.1% and 16.5% in the EES and PES randomized groups, respectively (p = 0.30). CONCLUSIONS: The EXECUTIVE trial was a randomized pilot trial dedicated to the comparison of the efficacy of 2 different DES among patients with 2- to 3-vessel MV-CAD. The study shows lower in-stent late loss at 9 months with the EES XIENCE V compared with the PES TAXUS Libertè, and a low major adverse cardiac event rate at 1 year in patients with 2-to 3-vessel MV-CAD. (EXECUTIVE [EXecutive RCT: Evaluating XIENCE V in a Multi Vessel Disease]; NCT00531011).
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Fármacos Cardiovasculares/administración & dosificación , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/terapia , Vasos Coronarios/efectos de los fármacos , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea/instrumentación , Sirolimus/análogos & derivados , Anciano , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Enfermedad de la Arteria Coronaria/fisiopatología , Reestenosis Coronaria/etiología , Reestenosis Coronaria/prevención & control , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/fisiopatología , Everolimus , Estudios de Factibilidad , Femenino , Humanos , Italia , Masculino , Persona de Mediana Edad , Infarto del Miocardio/etiología , Infarto del Miocardio/prevención & control , Paclitaxel/administración & dosificación , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Valor Predictivo de las Pruebas , Estudios Prospectivos , Diseño de Prótesis , Sistema de Registros , Sirolimus/administración & dosificación , Factores de Tiempo , Resultado del TratamientoRESUMEN
A synthesis of all four stereoisomers of 3-(tert-butoxycarbonyl)-3-azabicyclo[3.1.0]hexane-2-carboxylic acid has been developed, thereby significantly shortening the known literature procedures for the syntheses of these unnatural amino acids. With a simple adjustment of the reaction conditions, we were able to obtain either pure cis or trans acid. Optical resolution was accomplished via diastereomeric salt formation or alternatively via chromatography on a chiral stationary phase. Finally, ab initio calculations gave an explanation for the observed cis selectivity in the initial step.
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Aminoácidos/síntesis química , Compuestos Bicíclicos Heterocíclicos con Puentes/síntesis química , Ciclohexanos/síntesis química , Aminoácidos/química , Compuestos Bicíclicos Heterocíclicos con Puentes/química , Ciclohexanos/química , Estructura Molecular , Teoría Cuántica , EstereoisomerismoRESUMEN
The purpose of this survey is to assess the prevalence of intestinal parasites in a population of Mozambican students. Ninety five faecal samples were collected at the three schools in Marrere, Mozambique, for a period of about one week. Observations of fresh and Giemsa-stained samples were performed at the laboratory of the Geral de Marrere Hospital; observation after concentration (FEA) was performed later at the Microbiology Laboratory of the S. Maria Nuova Hospital (Reggio Emilia, Italy). The results show a high rate of intestinal parasites among the subjects examined, supported mainly by helminths (Strongyloides stercoralis and Ancylostoma/Necator americanus), and protozoa (Dientamoeba fragilis and Giardia intestinalis). Analysis of data shows that the search for pathogenic parasites with the formalin-ethyl acetate (FEA) stool concentration technique shows higher sensitivity than the observation of fresh samples (60% vs 30%) and in some cases allows the presence of a second or third parasite to be detected. The high rate of parasitosis in endemic areas underlines the importance of lending greater attention to immigrant patients in Italy, due also to the fact that parasitosis is often found in asymptomatic forms.
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Heces/parasitología , Helmintiasis/diagnóstico , Parasitosis Intestinales/diagnóstico , Infecciones por Protozoos/diagnóstico , Estudiantes/estadística & datos numéricos , Adolescente , Ancylostoma/aislamiento & purificación , Animales , Niño , Dientamoeba/aislamiento & purificación , Femenino , Giardia lamblia/aislamiento & purificación , Encuestas Epidemiológicas , Helmintiasis/epidemiología , Humanos , Incidencia , Parasitosis Intestinales/epidemiología , Parasitosis Intestinales/parasitología , Masculino , Mozambique/epidemiología , Necator americanus/aislamiento & purificación , Parasitología/métodos , Prevalencia , Infecciones por Protozoos/epidemiología , Factores de Riesgo , Muestreo , Instituciones Académicas , Strongyloides stercoralis/aislamiento & purificaciónAsunto(s)
Adhesión a Directriz , Revascularización Miocárdica/normas , Guías de Práctica Clínica como Asunto , Síndrome Coronario Agudo/fisiopatología , Síndrome Coronario Agudo/cirugía , Enfermedad Coronaria/complicaciones , Enfermedad Coronaria/cirugía , Humanos , Educación del Paciente como AsuntoRESUMEN
The purpose of this survey is to assess the prevalence of intestinal parasites in Reggio Emilia during 2009. We analyzed 1961 samples from 1503 subjects: a copro-parasitological standard examination was performed in 1416 of the subjects and the scotch-test in the remaining 87. Of the 1503 subjects examined, 111 (7.4%) were positive for one or more parasites. Pathogenic parasites were found in 44 subjects (39.6% of all positive subjects) and non-pathogenic protozoa were found in 67 subjects (60.4% of all positive subjects). The most commonly found species were, of the protozoa, Blastocystis hominis, Dientamoeba fragilis and Giardia intestinalis and, of the helminths, Enterobius vermicularis and Taenia Spp. This epidemiological survey shows the need to pay more attention to immigrants and travellers to endemic areas as potential carriers of major parasitic infections in the community.
Asunto(s)
Parasitosis Intestinales/epidemiología , Adulto , Animales , Niño , Comorbilidad , Emigrantes e Inmigrantes/estadística & datos numéricos , Heces/parasitología , Femenino , Helmintiasis/epidemiología , Humanos , Italia/epidemiología , Masculino , Prevalencia , Infecciones por Protozoos/epidemiología , Estudios Retrospectivos , ViajeRESUMEN
Adjunctive therapy with abciximab during primary percutaneous coronary intervention (PPCI) in patients with ST-elevation myocardial infarction (STEMI) determines a better short-term outcome compared to placebo. Tirofiban and eptifibatide represent a valid option with lower cost, but these have been less studied. The aim of the present study was to combine all randomized trials and registries to demonstrate the noninferiority of tirofiban and eptifibatide compared to abciximab in patients with STEMI treated with PPCI. We identified 6 randomized trials and 4 registries. Overall, 4,653 received small molecules and 2,696 abciximab, and the rate of combined death and nonfatal reinfarction did not differ (4.6% vs 4.5%, odds ratio 0.99, 95% confidence interval [CI] 0.78 to 1.27, p = 0.95) up to 30 days of follow-up, with an absolute difference of 0.1% (95% CI -1.06 to 0.8). Because the noninferiority limit was set at +1.5%, and because the upper point estimate (0.8%) of the 95% CI did not cross the prespecified limit, the noninferiority of the small molecules was documented. In-hospital major bleeding was also similar (8.8% vs 6.1%, odds ratio 0.92, 95% CI 0.75 to 1.13, p = 0.43). Sensitivity analysis comparing randomized trials to registries and tirofiban or eptifibatide to abciximab did not show any significant differences. In conclusion, our results documented noninferiority of "small molecules" compared to abciximab and, therefore, support their alternative use as adjunctive therapy during PPCI for patients with STEMI.