RESUMEN
Delftia sp. strain JD2 is a plant-growth-promoting bacterium that enhances legume nodulation and growth, acting as nodule-assisting bacterium during the co-inoculation of plants with rhizobial strains. In this work, we evaluate how the co-inoculation of alfalfa with Sinorhizobium meliloti U143 and JD2 increases plant yield under greenhouse conditions and we analyze the pattern of secreted bioactive compounds which may be involved in the microbe-plant communication. The chemical composition of extracellular cultures (EC) produced in hydroponic conditions (collected 4, 7, and 14 days after bacterial treatment) were characterized using different chromatographic and elucidation techniques. In addition, we assessed the effect that plant irrigation with cell-free EC, produced during co-inoculation experiments, would have on plant yield. Results showed increased alfalfa shoot and root matter, suggesting that U143-JD2 co-inoculation might be a beneficial agricultural practice. The pattern of secreted secondary metabolites among treatments showed important differences. Qualitative and quantitative changes in phenolic compounds (including flavonoids), organic acids, and volatile compounds were detected during the early microbe-plant interaction, suggesting that the production of some molecules positively affects the microbe-plant association. Finally, the irrigation of co-inoculated plants with cell-free EC under greenhouse conditions increased plant yield over agronomic expectations. This effect might be attributed to the bioactive secondary metabolites incorporated during the irrigation.
Asunto(s)
Delftia/fisiología , Medicago sativa/crecimiento & desarrollo , Medicago sativa/microbiología , Sinorhizobium meliloti/fisiología , Simbiosis/fisiología , Metabolismo de los Hidratos de Carbono , Regulación de la Expresión Génica de las Plantas/fisiología , Metabolismo de los Lípidos , Medicago sativa/metabolismo , Proteínas de Plantas/genética , Proteínas de Plantas/metabolismoRESUMEN
Vitamin B12 deficiency can lead to serious haematological and neurological signs in infants. The reported clinical cases of vitamin B12 deficiency were found in exclusively breast-fed infants whose asymptomatic mothers were diagnosed later with pernicious anaemia. For the infants, the diagnosis required urinary methylmalonic acid quantification (grossly elevated in these two cases) and treatment rapidly improved the clinical signs. These cases underline the serious consequences of vitamin B12 deficiency in infants and the helpful role of early methylmalonic acid quantification for diagnosis.
Asunto(s)
Lactancia Materna , Ácido Metilmalónico/orina , Deficiencia de Vitamina B 12/diagnóstico , Vitamina B 12/orina , Biomarcadores/orina , Humanos , Lactante , Deficiencia de Vitamina B 12/orinaRESUMEN
The objective of this work was to study the natural history of dystrophinopathies and the genotype-phenotype correlations made possible by the development of the clinical part of the French DMD database. The collection of 70,000 clinical data for 600 patients with an average longitudinal follow-up of 12years enabled clarification of the natural history of Duchenne and Becker muscular dystrophies and clinical presentations in symptomatic females. We were able to specify the phenotypic heterogeneity of motor, orthopedic and respiratory involvements (severe, standard and intermediary form), of the cardiac disorder (severe, standard or absent cardiomyopathy, absence of correlation between motor and cardiac involvements), and of brain function (mental deficiency in the patients with Becker muscular dystrophy, psychopathological disorders in dystrophinopathies). Phenotypic variability did not correlate with a specific mutational spectrum. We propose a model of phenotypic analysis based on the presence or not of muscular and cardiac involvements (described by age at onset and rate of progression) and brain involvement (described by the type and the severity of the cognitive impairment and of the psychological disorders). The methodology developed for the DMD gene can be generalized and used for other databases dedicated to genetic diseases. Application of this model of phenotypic analysis for each patient and further development of the database should contribute substantially to clinical research providing useful tools for future clinical trials.
Asunto(s)
Distrofina/genética , Estudios de Asociación Genética , Heterogeneidad Genética , Distrofia Muscular de Duchenne/genética , Adolescente , Edad de Inicio , Niño , Preescolar , Estudios de Cohortes , Bases de Datos Factuales , Femenino , Francia/epidemiología , Técnicas Genéticas , Humanos , Masculino , Actividad Motora , Distrofia Muscular de Duchenne/epidemiología , FenotipoRESUMEN
A visual attention (VA) span disorder has been reported in dyslexic children as potentially responsible for their poor reading outcome. The purpose of the current paper was to identify the cerebral correlates of this VA span disorder. For this purpose, 12 French dyslexic children with severe reading and VA span disorders and 12 age-matched control children were engaged in a categorisation task under fMRI. Two flanked and isolated conditions were designed which both involved multiple-element simultaneous visual processing but taxed visual attention differently. For skilled readers, flanked stimuli processing activated a large bilateral cortical network comprising the superior and inferior parietal cortex, the inferior temporal cortex, the striate and extrastriate visual cortex, the middle frontal cortex and the anterior cingulate cortex while the less attention-demanding task of isolated stimuli only activated the inferior occipito-temporal cortex bilaterally. With respect to controls, the dyslexic children showed significantly reduced activation within bilateral parietal and temporal areas during flanked processing, but no difference during the isolated condition. The neural correlates of the processes involved in attention-demanding multi-element processing tasks were more specifically addressed by contrasting the flanked and the isolated conditions. This contrast elicited activation of the left precuneus/superior parietal lobule in the controls, but not in the dyslexic children. These findings provide new insights on the role of parietal regions, in particular the left superior parietal lobule, in the visual attention span and in developmental dyslexia.
Asunto(s)
Atención/fisiología , Mapeo Encefálico , Dislexia/fisiopatología , Lóbulo Parietal/fisiopatología , Niño , Femenino , Humanos , Interpretación de Imagen Asistida por Computador , Imagen por Resonancia Magnética , Masculino , LecturaRESUMEN
Mutations in the human X-linked cyclin-dependent kinase-like 5 (CDKL5) gene have been shown to cause infantile spasms as well as Rett syndrome-like phenotype. To date, fewer than 20 different mutations have been reported. So far, no clear genotype-phenotype correlation has been established. We screened the entire coding region of CDKL5 in 151 affected girls with a clinically heterogeneous phenotype ranging from encephalopathy with epilepsy to atypical Rett syndrome by denaturing high liquid performance chromatography and direct sequencing, and we identified three novel missense mutations located in catalytic domain (p.Ala40Val, p.Arg65Gln, p.Leu220Pro). Segregation analysis showed that p.Arg65Gln was inherited from the healthy father, which rules out the involvement of CDKL5 in the aetiology of the phenotype in this patient. However, the de novo occurrence was shown for p.Ala40Val and p.Leu220Pro. The p.Ala40Val mutation was observed in two unrelated patients and represented the first recurrent mutation in the CDKL5 gene. For the two de novo mutations, we analysed the cellular localisation of the wild-type and CDKL5 mutants by transfection experiments. We showed that the two CDKL5 mutations cause mislocalisation of the mutant CDKL5 proteins in the cytoplasm. Interestingly these missense mutations that result in a mislocalisation of the CDKL5 protein are associated with severe developmental delay which was apparent within the first months of life characterised by early and generalised hypotonia, and autistic features, and as well as early infantile spasms.
Asunto(s)
Encefalopatías Metabólicas Innatas/enzimología , Encefalopatías Metabólicas Innatas/genética , Núcleo Celular/enzimología , Mutación Missense , Proteínas Serina-Treonina Quinasas/genética , Proteínas Serina-Treonina Quinasas/metabolismo , Secuencia de Aminoácidos , Sustitución de Aminoácidos , Animales , Secuencia de Bases , Encefalopatías Metabólicas Innatas/patología , Encefalopatías Metabólicas Innatas/fisiopatología , Células COS , Preescolar , Chlorocebus aethiops , Análisis Mutacional de ADN , Electroencefalografía , Femenino , Humanos , Lactante , Imagen por Resonancia Magnética , Fenotipo , Plásmidos/genética , ARN Mensajero/genética , Homología de Secuencia de Aminoácido , Transfección , Inactivación del Cromosoma XRESUMEN
BACKGROUND: Angiographic restenosis after percutaneous coronary interventional procedures is more common than recurrent angina. Clinical and angiographic factors associated with asymptomatic versus symptomatic restenosis after percutaneous coronary intervention were compared. METHODS AND RESULTS: All patients with angiographic restenosis from the BENESTENT I, BENESTENT II pilot, BENESTENT II, MUSIC, WEST 1, DUET, FINESS 2, FLARE, SOPHOS, and ROSE studies were analyzed. Multivariate analysis evaluated 46 clinical and angiographic variables, comparing those with and without angina. The 10 studies recruited 2690 patients who underwent percutaneous revascularization and 6-month follow-up angiography (86% of those eligible). Restenosis (>/=50% diameter stenosis) occurred in 607 patients and was clinically silent in 335 (55%). Male sex (P=0.008), absence of antianginal therapy with nitrates (P=0.0002) and calcium channel blockers (P=0.02) at 6 months, greater reference diameter after the procedure (P=0.04), greater reference diameter at follow-up (P=0.004), and lesser lesion severity (percent stenosis) at 6 months (P=0.0004) were univariate predictors of asymptomatic restenosis. By multivariate analysis, only male sex (P=0.04), greater reference diameter at follow-up (P=0.002), and lesser lesion severity at 6 months (P=0.0001) were associated with restenosis without angina. CONCLUSIONS: Approximately half of patients with angiographic restenosis have no symptoms. The only multivariate predictors of silent restenosis at 6 months were male sex, greater reference diameter at follow-up, and lesser lesion severity on follow-up angiography.
Asunto(s)
Angioplastia Coronaria con Balón , Ensayos Clínicos como Asunto/estadística & datos numéricos , Angiografía Coronaria/estadística & datos numéricos , Reestenosis Coronaria/diagnóstico , Angioplastia Coronaria con Balón/efectos adversos , Reestenosis Coronaria/epidemiología , Reestenosis Coronaria/etiología , Progresión de la Enfermedad , Femenino , Estudios de Seguimiento , Humanos , Masculino , Análisis Multivariante , Valor Predictivo de las Pruebas , Índice de Severidad de la Enfermedad , Factores Sexuales , Grado de Desobstrucción VascularRESUMEN
OBJECTIVES: This study sought to establish whether the early favorable results in the Benestent-I randomized trial comparing elective Palmaz-Schatz stent implantation with balloon angioplasty in 516 patients with stable angina pectoris are maintained at 5 years. BACKGROUND: The size of the required sample was based on a 40% reduction in clinical events in the stent group. Seven months and one-year follow-up in this trial showed a decreased incidence of restenosis and clinical events in patients randomized to stent implantation. METHODS: Data at five years were collected by outpatient visit, via telephone and via the referring cardiologist. Three patients in the stent group and one in the percutaneous transluminal coronary angioplasty (PTCA) group were lost to follow-up at five years. Major clinical events, anginal status and use of cardiac medication were recorded according to the intention to treat principle. RESULTS: No significant differences were found in anginal status and use of cardiac medication between the two groups. In the PTCA group, 27.3% of patients underwent target lesion revascularization (TLR) versus 17.2% of patients in the stent group (p = 0.008). No significant differences in mortality (5.9% vs. 3.1%), cerebrovascular accident (0.8% vs. 1.2%), myocardial infarction (9.4% vs. 6.3%) or coronary bypass surgery (11.7% vs. 9.8%) were found between the stent and PTCA groups, respectively. At five years, the event-free survival rate (59.8% vs. 65.6%; p = 0.20) between the stent and PTCA groups no longer achieved statistical significance. CONCLUSIONS: The original 10% absolute difference in TLR in favor of the stent group has remained unchanged at five years, emphasizing the long-term stability of the stented target site.
Asunto(s)
Angina de Pecho/cirugía , Angioplastia Coronaria con Balón/normas , Implantación de Prótesis/normas , Stents/normas , Angina de Pecho/clasificación , Angina de Pecho/complicaciones , Angina de Pecho/mortalidad , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/métodos , Causas de Muerte , Puente de Arteria Coronaria , Supervivencia sin Enfermedad , Estudios de Seguimiento , Humanos , Incidencia , Infarto del Miocardio/etiología , Modelos de Riesgos Proporcionales , Implantación de Prótesis/efectos adversos , Implantación de Prótesis/instrumentación , Implantación de Prótesis/métodos , Recurrencia , Factores de Riesgo , Índice de Severidad de la Enfermedad , Stents/efectos adversos , Accidente Cerebrovascular/etiología , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: The recent recognition that coronary-artery stenting has improved the short- and long-term outcomes of patients treated with angioplasty has made it necessary to reevaluate the relative benefits of bypass surgery and percutaneous interventions in patients with multivessel disease. METHODS: A total of 1205 patients were randomly assigned to undergo stent implantation or bypass surgery when a cardiac surgeon and an interventional cardiologist agreed that the same extent of revascularization could be achieved by either technique. The primary clinical end point was freedom from major adverse cardiac and cerebrovascular events at one year. The costs of hospital resources used were also determined. RESULTS: At one year, there was no significant difference between the two groups in terms of the rates of death, stroke, or myocardial infarction. Among patients who survived without a stroke or a myocardial infarction, 16.8 percent of those in the stenting group underwent a second revascularization, as compared with 3.5 percent of those in the surgery group. The rate of event-free survival at one year was 73.8 percent among the patients who received stents and 87.8 percent among those who underwent bypass surgery (P<0.001 by the log-rank test). The costs for the initial procedure were $4,212 less for patients assigned to stenting than for those assigned to bypass surgery, but this difference was reduced during follow-up because of the increased need for repeated revascularization; after one year, the net difference in favor of stenting was estimated to be $2,973 per patient. CONCLUSION: As measured one year after the procedure, coronary stenting for multivessel disease is less expensive than bypass surgery and offers the same degree of protection against death, stroke, and myocardial infarction. However, stenting is associated with a greater need for repeated revascularization.
Asunto(s)
Angioplastia Coronaria con Balón , Puente de Arteria Coronaria , Enfermedad Coronaria/cirugía , Enfermedad Coronaria/terapia , Stents , Adulto , Anciano , Anciano de 80 o más Años , Angioplastia Coronaria con Balón/economía , Trastornos Cerebrovasculares/epidemiología , Trastornos Cerebrovasculares/prevención & control , Puente de Arteria Coronaria/economía , Enfermedad Coronaria/mortalidad , Análisis Costo-Beneficio , Creatina Quinasa/sangre , Forma MB de la Creatina-Quinasa , Complicaciones de la Diabetes , Supervivencia sin Enfermedad , Femenino , Costos de Hospital , Humanos , Isoenzimas/sangre , Masculino , Persona de Mediana Edad , Infarto del Miocardio/epidemiología , Infarto del Miocardio/prevención & control , Calidad de Vida , Recurrencia , Stents/economía , Resultado del TratamientoRESUMEN
The aim of the study was to assess the safety and feasibility of implantation of the Scimed Radius stent. Secondary objectives were to assess the result of stent placement by quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS). The ESSEX study was a prospective, multicenter, observational study in which candidates for a single elective stent implantation, in a de novo or restenotic lesion, reference diameter 2.75-4.00 mm and target lesion < 14 mm in length, were enrolled. QCA at baseline, postprocedure, and 6-month follow-up was performed. IVUS was used to assess optimal stent implantation. One hundred and three patients were enrolled. Forty-four percent of the patients had unstable angina. Stent implantation was technically successful in all patients. Additional stents were implanted in 17 patients for procedural dissection (16) and spasm (1). Ninety-seven percent of patients were event-free at 1 month and 76% at 6-month follow-up. Angiographic restenosis rates for de novo lesions and for all patients were 19% and 21%, respectively. Clinical events occurred at 1- and 6-month follow-up in 2.9% and 24.3% of patients, respectively. No patients suffered subacute thrombosis. Retrospective analysis of peak balloon inflation pressure (< or = 12 and > 12 atm) as a determinant of clinical, QCA, and IVUS outcomes suggested no benefit or detrimental effect from optimization with high-pressure balloon inflation. Implantation of the self-expanding Radius stent is safe and efficacious. Based on registry data, clinical, angiographic, and IVUS, data comparable with modern balloon-expandable stents were obtained.
Asunto(s)
Angina de Pecho/terapia , Angioplastia Coronaria con Balón , Stents , Adulto , Anciano , Anciano de 80 o más Años , Angina de Pecho/diagnóstico por imagen , Angiografía Coronaria , Europa (Continente) , Femenino , Humanos , Masculino , Persona de Mediana Edad , Observación , Estudios Prospectivos , Diseño de Prótesis , Recurrencia , Seguridad , Ultrasonografía IntervencionalRESUMEN
BACKGROUND: Coronary stenting improves outcomes compared with balloon angioplasty, but it is costly and may have other disadvantages. Limiting stent use to patients with a suboptimal result after angioplasty (provisional angioplasty) may be as effective and less expensive. METHODS AND RESULTS: To analyze the cost-effectiveness of provisional angioplasty, patients scheduled for single-vessel angioplasty were first randomized to receive primary stenting (97 patients) or balloon angioplasty guided by Doppler flow velocity and angiography (523 patients). Patients in the latter group were further randomized after optimization to either additional stenting or termination of the procedure to further investigate what is "optimal." An optimal result was defined as a flow reserve >2.5 and a diameter stenosis <36%. Bailout stenting was needed in 129 patients (25%) who were randomized to balloon angioplasty, and an optimal result was obtained in 184 of the 523 patients (35%). There was no significant difference in event-free survival at 1 year between primary stenting (86.6%) and provisional angioplasty (85.6%). Costs after 1 year were significantly higher for provisional angioplasty (EUR 6573 versus EUR 5885; P:=0.014). Results after the second randomization showed that stenting was also more effective after optimal balloon angioplasty (1-year event free survival, 93.5% versus 84.1%; P:=0. 066). CONCLUSIONS: After 1 year of follow-up, provisional angioplasty was more expensive and without clinical benefit. The beneficial value of stenting is not limited to patients with a suboptimal result after balloon angioplasty.
Asunto(s)
Angina de Pecho/terapia , Angioplastia de Balón/economía , Stents/economía , Análisis de Varianza , Velocidad del Flujo Sanguíneo , Análisis Costo-Beneficio , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana EdadRESUMEN
OBJECTIVES: This study was performed to assess whether angiography six months after coronary balloon angioplasty or stent implantation has an influence on clinical management and one-year outcome. BACKGROUND: The Benestent II study randomized 827 patients to balloon angioplasty or stent implantation. A subrandomization was undertaken allocating patients to six-month clinical follow-up (CF) or clinical and angiographic follow-up (AF). METHODS: Seven hundred and six patients (349 CF and 357 AF) had no intercurrent angiography, so that restenosis and disease progression elsewhere remained unknown until the time of six-month follow-up. These two groups, which were well matched at enrolment, were compared with respect to symptoms, medication and major cardiac events defined as death, myocardial infarction and need for revascularization at six and 12 months. RESULTS: At six-month follow-up, 53 (15%) of the CF and 76 (21%) of the AF patients had stable angina (p = 0.041), while 5 (1%) and 4 (1%) had symptoms of unstable angina. At 12-month follow-up, 44 (13%) patients in both groups had stable angina, and only 1 patient in the CF group had unstable angina. Seventy-seven patients (27 CF and 50 AF; p < 0.01) had major cardiac events between 6 and 12 months. Of the 349 patients in the CF group, 21 underwent repeat percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery between 6 and 12 months, compared with 44 of the 357 patients in the AF group (relative risk 2.05 [1.24 to 3.37], p = 0.003). CONCLUSIONS: Patients who had AF six months after balloon angioplasty or stent implantation experienced more repeat revascularization procedures than those who had CF. They also had significantly more angina at six-month follow-up but this may be due to bias.
Asunto(s)
Angina de Pecho/diagnóstico por imagen , Angina de Pecho/terapia , Angina Inestable/diagnóstico por imagen , Angina Inestable/terapia , Angioplastia Coronaria con Balón , Angiografía Coronaria , Stents , Femenino , Humanos , Masculino , Persona de Mediana Edad , Resultado del TratamientoRESUMEN
The rising costs of health care have forced policy makers to make choices, and new treatments are increasingly assessed in terms of the balance between additional costs and additional effects. The recent recognition that stenting has a major and long-lasting effect enhancing balloon PTCA procedure has made it imperative to compare in patients with multivessel disease the standard surgical procedure with multiple stenting in a large scale multinational and multicentre approach (19 countries, 68 sites). Selection and inclusion of patients is based on a consensus of the cardiac surgeon and interventional cardiologist on equal 'treatability' of patients by both techniques with analysis of clinical follow-up (event-free survival) on the short (30 day), medium (1 year), and long-term (3 and 5 year) with analysis of cost-effectiveness and quality of life (EuroQol and SF-36). Of the entire trial, the primary null hypothesis which needs to be rejected is that there will be no difference in event-free survival or effectiveness (E), at 1 year and also that the direct and indirect costs (C) per event-free year are not different between surgery or stenting. For this to become significant with a power of 90% one needs 1200 patients. Between April 97 and June 98, 1205 patients have been randomized with a monthly recruitment of 83 patients. Expected costs, effects and cost-effectiveness ratio (CE ratio) are: Stent high costs 2 VDStent high costs 3 VDStent low costs 2 VDStent low costs 3 VDCABG costs (C)$19.297$24.566$16.638$20.456$21.350 effects (E)81%81%81%81%88% CE ratio$23.876$30.397$20.586$25.322$24.348 Clinically, stenting is not expected to be more effective than CABG, but should be cost effective in both the 2- and 3-VD group when using the lower cost estimate and in the 2 VD group when using the higher cost assumptions.
Asunto(s)
Angioplastia Coronaria con Balón , Puente de Arteria Coronaria , Enfermedad Coronaria/terapia , Stents , Angioplastia Coronaria con Balón/economía , Angiografía Coronaria , Enfermedad Coronaria/diagnóstico por imagen , Enfermedad Coronaria/economía , Enfermedad Coronaria/cirugía , Análisis Costo-Beneficio , Humanos , Estudios Multicéntricos como Asunto , Selección de Paciente , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , Stents/economíaRESUMEN
BACKGROUND: The multicentre, randomised Benestent-II study investigated a strategy of implantation of a heparin-coated Palmar-Schatz stent plus antiplatelet drugs compared with the use of balloon angioplasty in selected patients with stable or stabilised unstable angina, with one or more de-novo lesions, less than 18 mm long, in vessels of diameter 3 mm or more. METHODS: 827 patients were randomly assigned stent implantation (414 patients) or standard balloon angioplasty (413 patients). The primary clinical endpoint was event-free survival at 6 months, including death, myocardial infarction, and the need for revascularisation. The secondary endpoints were the restenosis rate at 6 months and the cost-effectiveness at 12 months. There was also one-to-one subrandomisation to either clinical and angiographic follow-up or clinical follow-up alone. Analyses were by intention to treat. FINDINGS: Four patients (one stent group, three angioplasty group) were excluded from analysis since no lesion was found. At 6 months, a primary clinical endpoint had occurred in 53 (12.8%) of 413 patients in the stent group and 79 (19.3%) of 410 in the angioplasty group (p=0.013). This significant difference in clinical outcome was maintained at 12 months. In the subgroup assigned angiographic follow-up, the mean minimum lumen diameter was greater in the stent group than in the balloon-angioplasty group, (1.89 [SD 0.65] vs 1.66 [0.57] mm, p=0.0002), which corresponds to restenosis rates (diameter stenosis > or =50%) of 16% and 31% (p=0.0008). In the group assigned clinical follow-up alone, event-free survival rate at 12 months was higher in the stent group than the balloon-angioplasty group (0.89 vs 0.79, p=0.004) at a cost of an additional 2085 Dutch guilders (US$1020) per patient. INTERPRETATION: Over 12-month follow-up, a strategy of elective stenting with heparin-coated stents is more effective but also more costly than balloon angioplasty.
Asunto(s)
Angina de Pecho/terapia , Angina Inestable/terapia , Angioplastia Coronaria con Balón , Stents , Adulto , Anciano , Angina de Pecho/mortalidad , Angina Inestable/mortalidad , Anticoagulantes/uso terapéutico , Aspirina/uso terapéutico , Angiografía Coronaria , Diseño de Equipo , Femenino , Heparina/uso terapéutico , Humanos , Masculino , Persona de Mediana Edad , Inhibidores de Agregación Plaquetaria/uso terapéutico , Análisis de Supervivencia , Ticlopidina/uso terapéutico , Resultado del TratamientoRESUMEN
The development of the end-point attached HC stent should be regarded against the early unfavourable results with uncoated stents in the pre-IVUS- and pre-ticlopidine era. Despite this, results of pilot- and randomized trials show a surprising low incidence of (sub)acute stent thrombosis under challenging circumstances like acute coronary events. Considering the quite low incidence of early complications of non-coated second generation stents it may require very large trials to test the clinical efficacy of the HC coating against non-coated devices. However, even if the 'added value' of the HC coating is never scientifically proven, it has helped to a large degree to enhance the penetration of stent-therapy in interventional cardiology. Unlike the situation in 1992, very few cardiologists will now oppose the statement that stents contribute to the state of the art treatment of patients with angina pectoris or acute myocardial infarction.
Asunto(s)
Materiales Biocompatibles Revestidos , Stents , Anticoagulantes/uso terapéutico , Heparina/uso terapéutico , Humanos , Diseño de Prótesis , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
To determine whether metallic stent implantation within a coronary artery modifies the accuracy of angina or exercise test results in predicting stenosis, we studied 172 patients assigned to stent implantation and 153 patients assigned to balloon angioplasty enrolled in the Benestent trial comparing de novo stenting with conventional balloon angioplasty. Sensitivity and specificity curves were constructed for the prediction of percentage diameter stenosis and minimal lumen diameter. Receiver-operator curves were constructed for comparison of diagnostic accuracy. Identical exercise load and duration were achieved in the two groups, despite a better angiographic result in patients treated with a stent. Similarly, the diagnostic accuracy of clinical symptoms or exercise test results as a function of the angiographic results were similar in patients with and patients without a stent. The intersection points of the sensitivity and specificity curves for recurrent angina or ST-segment depression were 72% to 77%. The corresponding cut-off points for percentage diameter stenosis were, respectively, 52% and 50% for patients with and without a stent (1.35 and 1.50 mm for minimal lumen diameter). We conclude that the presence of an intracoronary stent does not affect the diagnostic accuracy of recurrent angina or exercise-induced ST depression in predicting residual stenosis. We also conclude that exercise tolerance is similar after balloon angioplasty, with or without stenting, despite a better angiographic outcome in the group receiving a stent, suggesting a minimal threshold beyond which the patient is no longer at risk for ischemia during exercise.
Asunto(s)
Angina de Pecho/diagnóstico , Enfermedad Coronaria/diagnóstico , Electrocardiografía , Prueba de Esfuerzo , Stents , Angina de Pecho/terapia , Angioplastia Coronaria con Balón/estadística & datos numéricos , Angiografía Coronaria/estadística & datos numéricos , Enfermedad Coronaria/terapia , Electrocardiografía/estadística & datos numéricos , Europa (Continente) , Prueba de Esfuerzo/estadística & datos numéricos , Estudios de Seguimiento , Humanos , Pronóstico , Curva ROC , Recurrencia , Sensibilidad y Especificidad , Stents/estadística & datos numéricos , Factores de TiempoRESUMEN
We examined the influence of vessel size using an intention-to-treat approach in 259 patients who underwent stent implantation and in 257 patients who underwent balloon angioplasty alone in the BENESTENT trial. In the stented population, smaller vessel size was associated with a higher stent:vessel ratio, a greater relative gain and a greater subsequent loss index, and a higher risk of adverse cardiac events. In the balloon angioplasty population small vessel size conveyed an increased requirement for revascularization but did not increase the risk of procedural failure or myocardial infarction during follow-up. Logistic regression indicated that decreasing vessel size (as a continous variable) was associated with an increasing risk of a cardiac event for both the stent and balloon angioplasty populations.
Asunto(s)
Implantación de Prótesis Vascular , Enfermedad Coronaria/cirugía , Vasos Coronarios/patología , Stents , Angioplastia Coronaria con Balón , Angiografía Coronaria , Enfermedad Coronaria/etiología , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Recurrencia , Resultado del TratamientoRESUMEN
The aim of this paper is to assess the costs and effects of stent implantation versus percutaneous transluminal coronary angioplasty (PTCA). Data have been taken from both the BENESTENT-I and BENESTENT-II pilot study. Effects are expressed in terms of event-free survival and costs include those of the initial hospitalization and those during follow-up. The costs per additional event-free survivor after 7 months are estimated at Dfl 88,315, Dfl 28,127 and Dfl 6747 using respectively the results from the BENSTENT-I study, the BENESTENT-II pilot study and phase IV of the BENESTENT-II pilot study. Significant decreases in complications and ischaemic events have made stent implantation not only the most favourable in terms of event-free survival but also in terms of cost effectiveness.
Asunto(s)
Angioplastia Coronaria con Balón/economía , Implantación de Prótesis Vascular/economía , Enfermedad Coronaria/economía , Stents , Enfermedad Coronaria/cirugía , Análisis Costo-Beneficio , Supervivencia sin Enfermedad , Estudios de Seguimiento , Humanos , Proyectos Piloto , Calidad de Vida , Stents/economíaRESUMEN
OBJECTIVES: This study sought to determine the 1-year clinical follow-up of patients included in the Benestent trial. BACKGROUND: The Benestent trial is a randomized study comparing elective Palmaz-Schatz stent implantation with balloon angioplasty in patients with stable angina and a de novo coronary artery lesion. Seven-month follow-up data have shown a decreased rate of restenosis and fewer clinical events in the stent group. It is not established whether this favorable clinical outcome is maintained for longer periods or whether coronary stenting defers restenosis and its subsequent clinical manifestations. METHODS: To clarify this uncertainty, we updated clinical information on all but 1 of 516 patients enrolled in the Benestent trial (257 in balloon group, 259 in stent group) at least 12 months after the intervention. Major clinical events (primary clinical end point) were tabulated according to the intention to treat principle and included death, the occurrence of a cerebrovascular accident, myocardial infarction, the need for bypass surgery or a further percutaneous intervention in the previously treated lesion. RESULTS: After 1 year, no significant differences in mortality (1.2% vs. 0.8%), stroke (0.0% vs. 0.8%), myocardial infarction (5.0% vs. 4.2%) or coronary bypass graft surgery (6.9% vs. 5.1%) were found between the stent and balloon angioplasty groups, respectively. However, the requirement for a repeat angioplasty procedure was significantly lower in the stent group (10%) than the balloon angioplasty group (21%, relative risk [RR] 0.49, 95% confidence interval [CI] 0.31 to 0.75, p = 0.001), and overall primary end points were less frequently reached by stent group patients (23.2%) than those in the balloon group (31.5%, RR 0.74, 95% CI 0.55 to 0.98, p = 0.04). No differences were found between groups with respect to functional class angina and prescribed medication at the time of follow-up. CONCLUSIONS: These clinical follow-up data show that the benefit of elective native coronary artery stenting in patients with stable angina is maintained to at least 1 year after the procedure and results in a significantly reduced requirement for repeat intervention.
Asunto(s)
Angina de Pecho/terapia , Angioplastia Coronaria con Balón , Stents , Angina de Pecho/epidemiología , Puente de Arteria Coronaria/estadística & datos numéricos , Enfermedad Coronaria/epidemiología , Enfermedad Coronaria/terapia , Vasos Coronarios , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Recurrencia , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: The purpose of the Benestent-II Pilot Study was to evaluate the safety of delaying and eliminating anticoagulant therapy in patients receiving a heparin-coated stent in conjunction with antiplatelet drugs. METHODS AND RESULTS: The study consisted of three initial phases (I, II, III) during which resumption of heparin therapy after sheath removal was progressively deferred by 6, 12, and 36 hours. In phase IV, coumadin and heparin were replaced by 250 mg ticlopidine and 100 mg aspirin. Of the 207 patients with stable angina pectoris and a de novo lesion in whom heparin-coated stent implantation was attempted, implantation was successful in 202 patients (98%). Stent thrombosis did not occur during all four phases, and the overall clinical success rate at discharge was 99%. Bleeding complications requiring blood transfusion or surgery fell from 7.9% in phase I to 5.9%, 4%, and 0% in the three following phases. Hospital stay was 7.4, 6.1, 7.2, and 3.1 days for the consecutive phases. The restenosis rate for the combined four phases was 13% (15% in phase I, 20% in phase II, 11% in phase III, and 6% in phase IV). The overall rate of reintervention for the four phases was 8.9%. At 6 months, 84%, 75%, 94%, and 92% of the patients of phases I to IV, respectively, were event free. For the four phases, the event-free rate was 86%, which compares favorably with the rate observed in the Benestent-I study (80%; relative risk, 0.68 [0.45 to 1.04]). CONCLUSIONS: The implantation of stents coated with polyamine and end-point-attached heparin in stable patients with one significant de novo coronary lesion is well tolerated, is associated with no (sub)acute stent thrombosis, and results in a favorable event-free survival after 6 months.
Asunto(s)
Enfermedad Coronaria/terapia , Vasos Coronarios , Heparina/administración & dosificación , Stents , Aspirina/administración & dosificación , Angiografía Coronaria , Enfermedad Coronaria/mortalidad , Supervivencia sin Enfermedad , Diseño de Equipo , Prueba de Esfuerzo , Femenino , Estudios de Seguimiento , Humanos , Tiempo de Internación , Masculino , Persona de Mediana Edad , Proyectos Piloto , Seguridad , Stents/efectos adversos , Ticlopidina/administración & dosificación , Resultado del Tratamiento , Warfarina/administración & dosificaciónRESUMEN
In order to better understand the role of diet in etiology of urolithiasis, 84 oxalo-phospho-calcic-lithiasic patients (52 men, 32 women) have been studied by a nutritional week-interview and by urinary and blood testing. Diet data were compared to an ideal standard. Total caloric intake was 2428 +/- 651 calories/d; this intake is high in 7% women and 40% men. 79% out of patients are fat. Protidic intake is 87 +/- 21 g/d higher than 1 g/kg/d in 84.5% of patients. Lipids are high in 38.9 +/- 7%, glucid are low in 45.3 +/- 7%. Calcium intake is 934 +/- 406 mg/d, sodium intake is 12.9 + 3 g/d. Water intake is 2305 +/- 759 ml/d. Different groups of patients are studied: a) 21 patients with mean age of 43 +/- 12 years have recurrent lithiasis (R). This group is compared to 48 patients with 37 +/- 44 years who have a single lithiasis. Half of (R) patients have hypercalciuria, hyperphosphaturia and hyperoxaluria. Diet study is no different between these two groups. b) Other groups are studied: 21 have hyperophosphaturia (HPU) without hypophosphoremia and they have hypercalciuria, hyperuraturia and high urinary urea; diet shows higher glucicid and potassium intake than group with normal phosphaturia; 23 have hypercalciuria (HCU) and high uraturia and phosphaturia: diet study shows no difference with a group with normal calciuria. 21 have hyperoxaluria (HOU): diet study of a normal oxaluric group shows higher lipid intake, lower glucidic and calcium intake; 22 have hyperuraturia (HAU) and higher urinary urea, sodium and potassium than normouraturia group: in this group potassium intake is higher.(ABSTRACT TRUNCATED AT 250 WORDS)