RESUMO
RATIONALE: The management of acute infarction often necessitates a network of organisation between different centres, thus making it the object of an evaluation of professional practices (EPP). We report the experience in the Franche Comté province of an EPP at a regional level in the management of infarction. METHODS: All of the patients admitted to 10 of the 11 centres in the region were included in a prospective survey. Quality indicators for acute and chronic care were defined, as well as scores, on the basis of use of treatments specified in guidelines. RESULTS: Between May 2005 and May 2006, 1,170 patients were admitted. The patients' risk levels and quality scores were calculated. The rate of use of the quality indicators was higher in our survey than that observed in all of the published studies, except for the use of betablockers. The quality of care could therefore be considered as highly satisfactory. Comparison between the centres revealed some differences. Even after adjustment for the risk score on admission, the quality score for acute care was related to mortality at 1 month. CONCLUSIONS: An EPP is possible for the management of infarction, on a regional scale such as in the province of Franche Comté. The acute quality score turned out to be an independent factor for mortality. The indicators showed that the quality of care was highly satisfactory, even though more progress could be made in the prescription of betablockers.
Assuntos
Infarto do Miocárdio/terapia , Padrões de Prática Médica/estatística & dados numéricos , Antagonistas Adrenérgicos beta/uso terapêutico , Idoso de 80 Anos ou mais , Angioplastia Coronária com Balão/estatística & dados numéricos , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Uso de Medicamentos , Feminino , França/epidemiologia , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Masculino , Infarto do Miocárdio/epidemiologia , Educação de Pacientes como Assunto , Inibidores da Agregação Plaquetária/uso terapêutico , Estudos Prospectivos , Garantia da Qualidade dos Cuidados de Saúde , Sistema de Registros , Abandono do Hábito de Fumar , Terapia Trombolítica/estatística & dados numéricosRESUMO
gamma-Glutamyltransferase ((5-glutamyl)-peptide: amino-acid 5-glutamyltransferase, EC 2.3.2.2) of rabbit liver (detergent form) was purified 1100-fold in order to study its kinetic properties. Kinetic studies were conducted from pH 6.0 to 12.0 in the absence and presence of the acceptor substrate glycylglycine using gamma-glutamyl-3-carboxy-4-nitroanilide as the donor. The existence of more than one binding site for both donor and acceptor is postulated on kinetic evidence such as donor substrate activation, donor substrate inhibition and acceptor substrate activation. Homotropic interaction is also observed, in the form of negative cooperativity, in donor substrate binding, in the absence of acceptor at pH less than 9.0 and positive cooperativity (n = 2), in the absence or presence of acceptor at pH greater than 9.0. Hydrolase reaction reaches a maximum of activity at pH 10 (pK 8.6). Transferase activity under conditions of maximal velocity is maximal at pH 9.0 (pK 7.1). The ratio of transferase activity/hydrolase activity is maximal at pH 7.0-7.5. At low donor substrate concentrations, maximal activity is attained at pH 7.5.
Assuntos
Fígado/enzimologia , gama-Glutamiltransferase/metabolismo , Ácido 1-Carboxiglutâmico/análogos & derivados , Anilidas , Animais , Sítios de Ligação , Ativação Enzimática , Glicilglicina , Concentração de Íons de Hidrogênio , Cinética , CoelhosRESUMO
OBJECTIVES AND BACKGROUND: To assess the long-term results of percutaneous aortic valvuloplasty and aortic valve replacement in elderly persons, two similar nonrandomized series of patients greater than or equal to 75 years old treated by one or the other method between January 1986 and March 1989 in the same institution were compared. METHODS: Forty-six patients, 23 men and 23 women, with a mean age of 79.7 +/- 3.6 years (range 75 to 90) underwent percutaneous aortic valvuloplasty with use of the Cribier method (group 1). Twenty-three additional patients, 14 men and 9 women with a mean age of 78.4 +/- 2.4 years (range 75 to 86) underwent aortic valve replacement with a bioprosthesis (group 2). All of them suffered from severe calcified aortic stenosis. Clinical and hemodynamic status were similar in both groups. The mean follow-up period was 21.5 months (5 days to 60 months) in group 1 and 27.5 months (7 days to 61 months) in group 2. RESULTS: Three patients (6.5%) in group 1 died within 5 days after percutaneous aortic valvuloplasty; 24 patients (52%) died during the follow-up period, 16 of whom died of recurrent cardiac failure. Of 16 patients (35%) subsequently operated on at an average of 15.8 months after percutaneous aortic valvuloplasty, 2 died at operation. Only three group 1 patients (6.5%) are still alive without subsequent aortic valve replacement. In group 2, two patients (8.7%) died postoperatively and three (13%) died during the follow-up period. All other patients (78%) are still alive and in New York Heart Association functional class I or II. The overall survival rate in group 1 was 75% at 1 year, 47% at 2 years and 33% at 5 years. In group 2, the survival rate was 83% at 1 and 2 years and 75% at 3 and 4 years. CONCLUSIONS: The results of percutaneous aortic valvuloplasty do not compare favorably with those of surgery in elderly people, and this treatment should not be recommended.
Assuntos
Estenose da Valva Aórtica/terapia , Bioprótese , Cateterismo , Próteses Valvulares Cardíacas , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica , Estenose da Valva Aórtica/mortalidade , Feminino , Seguimentos , Mortalidade Hospitalar , Humanos , Masculino , Morbidade , Estudos Retrospectivos , Taxa de Sobrevida , Fatores de TempoRESUMO
OBJECTIVES: The aim of the study was to prospectively estimate the safety of thrombolytic therapy in elderly patients with massive pulmonary embolism in comparison with that in nonelderly patients. BACKGROUND: In massive pulmonary embolism, lysis of thrombi can be achieved faster with thrombolytic therapy than with conventional heparin therapy, but it is administered with great caution in elderly patients because the risk of bleeding is thought to be higher than in nonelderly patients. Yet, thrombolytic therapy might be of value in elderly patients also, in allowing potentially more rapid improvement than is achieved with conventional heparin therapy. METHODS: Eighty-nine patients with massive pulmonary embolism defined as Miller score > or = 17/34 underwent thrombolytic therapy without consideration of age if they had no contraindication for such treatment. Fifty-three patients were < or = 70 years old (mean age +/- SD 54 +/- 15 years; range 18 to 70), and 36 patients were > or = 71 years old (78 +/- 5 years; range 71 to 88). Except for mean age, there were no significant differences between the two treatment groups, particularly in terms of clinical presentation, average Miller score and pulmonary artery pressure regimen. Thrombolytic therapy was administered in the form of streptokinase at a dose of 100,000 IU/h over 12 h, with an initial injection of 250,000 IU over 15 min. Heparin was introduced 12 h after initiation of thrombolytic therapy. Urokinase or tissue-type plasminogen activator was used only in case of contraindication to streptokinase. RESULTS: The frequency of uncomplicated clinical course was the same in both treatment groups. Surgical embolectomy was necessary in three nonelderly patients (5.6%) and one elderly patient (2.7%). Changes in pulmonary pressure regimen and Miller score were identical in both groups. Three patients died during the in-hospital course: two nonelderly patients (3.7%) and one elderly patient (2.7%). Minor bleeding occurred in five nonelderly (9.4%) and five elderly (13.8%) patients (p = 0.74). Major bleeding was observed in three nonelderly (5.6%) and five elderly (13.8%) patients (p = 0.29). Bleeding subsequent to early invasive procedure accounted for six (75%) of eight patients with major bleeding: two nonelderly patients (one of whom died) and four elderly patients. No intracranial hemorrhage was observed. No predisposing factor for bleeding was identified, except the need for early vascular access for pulmonary angiography through the femoral approach or for percutaneous insertion of an intracaval device for partial interruption of the inferior vena cava. CONCLUSIONS: Thrombolytic therapy administered for massive pulmonary embolism in patients free of contraindication yields similar results and carries a similar risk for bleeding complications in elderly compared with nonelderly patients. Limiting early invasive procedures may result in less frequent major bleeding complications.
Assuntos
Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Embolia Pulmonar/terapia , Estreptoquinase/efeitos adversos , Terapia Trombolítica/efeitos adversos , Ativador de Plasminogênio Tecidual/efeitos adversos , Ativador de Plasminogênio Tipo Uroquinase/efeitos adversos , Adolescente , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Angiografia , Causalidade , Terapia Combinada , Contraindicações , Embolectomia/estatística & dados numéricos , Feminino , Heparina/farmacologia , Heparina/uso terapêutico , Mortalidade Hospitalar , Humanos , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Embolia Pulmonar/classificação , Embolia Pulmonar/diagnóstico por imagem , Embolia Pulmonar/mortalidade , Recidiva , Índice de Gravidade de Doença , Terapia Trombolítica/métodos , Resultado do TratamentoRESUMO
Immediate hemodynamic results of percutaneous mitral valvuloplasty were compared in two consecutive series of unselected patients from the same institution undergoing valvuloplasty with the double-balloon (161 patients) or the Inoue balloon (71 patients) technique. Before valvuloplasty, the patient series were comparable with regard to average age, gender repartition and most clinical, electrocardiographic, X-ray and hemodynamic variables. Poor anatomic forms of mitral stenosis were equally distributed in both series (41% vs. 45%, p = NS). The magnitude of mitral valve area increase and of mean mitral gradient decrease during percutaneous mitral valvuloplasty did not differ significantly in the Inoue balloon and double-balloon series (mean +/- SEM 1.1 +/- 0.2 to 1.95 +/- 0.5 and 1.0 +/- 0.2 to 1.97 +/- 0.5 cm2, respectively, for mitral valve area and 12 +/- 3 to 5 +/- 2 and 13 +/- 4 to 5 +/- 2 mm Hg, respectively, for mean mitral gradient). Four cases of 3+ mitral regurgitation occurred in the Inoue balloon series and 7 in the double-balloon series (p = NS). A good immediate result--defined as mitral valve area greater than or equal to 1.5 cm2 with greater than or equal to 25% in mitral valve area gain and mitral regurgitation less than 2+ at the end of the procedure--was observed in 78% of patients in both series. Three cases of tamponade due to chamber perforation and 14 cases of transient air embolism in the right coronary system due to balloon rupture were observed in the double-balloon series.(ABSTRACT TRUNCATED AT 250 WORDS)
Assuntos
Oclusão com Balão , Cateterismo/métodos , Estenose da Valva Mitral/terapia , Tamponamento Cardíaco/epidemiologia , Cateterismo/efeitos adversos , Embolia Aérea/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Insuficiência da Valva Mitral/epidemiologia , Insuficiência da Valva Mitral/etiologia , Estenose da Valva Mitral/diagnóstico , Fatores de Risco , Fatores de TempoRESUMO
OBJECTIVES: We aimed to investigate the impact of intravascular ultrasound (IVUS)-guided stent implantation on the 6-month restenosis rate, which has not yet been fully established in randomized trials. BACKGROUND: The 6-month angiographic restenosis rate was compared in patients with symptomatic ischemic heart disease who were randomly allocated to angioplasty and stent deployment, with versus without IVUS guidance. METHODS: After successful stent implantation, patients were randomized into two groups: Group A had no further dilation, and Group B had additional balloon dilation until achievement of IVUS criterion for stent expansion. The study group consisted of 164 patients, assuming a 50% reduction of the restenosis rate in Group B (15% vs. 30%) (alpha = 10%, beta = 20%). RESULTS: We enrolled 155 patients. Overdilation was carried out in 31 (39%) of 79 Group B patients, with the IVUS criterion being achieved in 63 (80%) of 79. No significant difference was observed in the minimal luminal diameter (MLD), but the stent lumen cross-sectional area (CSA) was significantly larger in Group B (mean +/- SD) (7.16 +/- 2.48 vs. 7.95 +/- 2.21 mm2, p = 0.04). At 6 months, there was no significant difference in the restenosis rate, (28.8% [21 of 73] in Group A vs. 22.5% [16 of 71] in Group B, p = 0.25), but according to the observed difference in the restenosis rate, the power of the study was only 40%. The difference in MLD was also nonsignificant (1.60 +/- 0.65 mm in Group A vs. 1.70 +/- 0.64 mm in Group B, p = 0.20), whereas the lumen CSA was 20% larger in the IVUS-guided group (4.47 +/- 2.59 vs. 5.36 +/- 2.81 mm2, p = 0.03). Lumen CSA was the only predictor of restenosis by multivariate logistic regression analysis. CONCLUSIONS: A nonsignificant 6.3% absolute reduction in the restenosis rate and a nonsignificant difference in MLD were observed in this study. Nonetheless, we still cannot rule out a beneficial effect of IVUS guidance, although this may have gone undetected owing to a lack of statistical power. A significant increase was observed in immediate and 6-month lumen size, as detected by IVUS, indicating that ultrasound guidance in stent deployment may be beneficial.
Assuntos
Doença das Coronárias/terapia , Stents , Ultrassonografia de Intervenção , Angioplastia Coronária com Balão , Cateterismo , Angiografia Coronária , Doença das Coronárias/diagnóstico por imagem , Doença das Coronárias/patologia , Vasos Coronários/patologia , Estudos de Viabilidade , Feminino , Seguimentos , Previsões , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Isquemia Miocárdica/terapia , Recidiva , Resultado do TratamentoRESUMO
OBJECTIVES: This study sought to compare the efficacy of 2-h regimens of alteplase and streptokinase in acute massive pulmonary embolism. The primary end point was immediate hemodynamic improvement, and secondary end points included early clinical efficacy and safety, as well as 1-year clinical outcome. BACKGROUND: Several thrombolytic regimens have been compared for the past 10 years in randomized studies, showing that 2-h infusion regimens of alteplase or urokinase lead to faster hemodynamic improvement than former 12- to 24-h administration protocols in acute massive pulmonary embolism. Many trials have focused on immediate hemodynamic and angiographic outcomes, but none has addressed long-term follow-up after thrombolysis. METHODS: Sixty-six patients with acute massive pulmonary embolism (Miller score > 17 and mean pulmonary artery pressure >20 mm Hg) were randomly assigned to receive either a 100-mg 2-h infusion of alteplase (n = 23) or 1.5 million IU of streptokinase over 2 h (n = 43). In both groups, heparin infusion was started at the end of thrombolytic infusion and adapted thereafter. Total pulmonary resistance was monitored over a 12-h period. Pulmonary vascular obstruction was assessed 36 to 48 h after thrombolytic therapy. One-year follow-up information included death, cause of death, recurrent pulmonary embolism, chronic thromboembolic pulmonary hypertension, stroke and bleeding. RESULTS: Both groups had similar baseline angiographic and hemodynamic characteristics of severity, with maintained cardiac output in 64 (97%) of 66 patients. The results (mean +/- SD) demonstrated that despite a faster total pulmonary resistance improvement observed at 1 h in the alteplase group compared with the streptokinase group (33+/-16% vs. 19 16%, p = 0.006), a similar hemodynamic efficacy was obtained at 2 h when both thrombolytic regimens were completed (38+/-18% vs. 31+/-19%). There was no significant difference in either pulmonary vascular obstruction at 36 to 48 h or bleeding complication rates. One-year event-free survival was similar in both groups, as most events were related to concomitant diseases. CONCLUSIONS: These results suggest that a 2-h regimen of streptokinase can be routinely used in patients with massive pulmonary embolism and maintained cardiac output without obviously compromising efficacy or safety.
Assuntos
Ativadores de Plasminogênio/administração & dosagem , Embolia Pulmonar/tratamento farmacológico , Estreptoquinase/administração & dosagem , Terapia Trombolítica/métodos , Ativador de Plasminogênio Tecidual/administração & dosagem , Doença Aguda , Idoso , Feminino , Hemodinâmica , Humanos , Masculino , Pessoa de Meia-Idade , Embolia Pulmonar/fisiopatologia , Método Simples-Cego , Resultado do TratamentoRESUMO
PURPOSE: The prognostic significance of glomerular filtration rate (GFR) was studied in a registry of 754 patients admitted for myocardial infarction in Franche Comté; 333 of them had STEMI. PATIENTS AND METHODS: One-year mortality was 11.5%: 2.3% in the group with normal GFR, 9.4% in the group with moderate renal failure, and 24.2% in the group with severe renal failure. GFR increased the prognostic value of conventional risk scores. CONCLUSION: Chronic renal failure therefore appears as a major independent predictor of mortality after myocardial infarction.
Assuntos
Taxa de Filtração Glomerular , Falência Renal Crônica/mortalidade , Infarto do Miocárdio/mortalidade , Idoso , Creatinina/análise , Feminino , França/epidemiologia , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Prospectivos , Sistema de RegistrosRESUMO
Oral contraceptive (OC) use and common apo E polymorphism are well known to modify serum lipid and lipoprotein concentrations. The combined effect of OC use and apo E genotype on the concentration of apo E or apo C-III in apo B- (apo E-LpB or apo C-III-LpB) or in non-apo B-containing lipoparticles (apo E-Lp-non-B or apo C-III-Lp-non-B) are unknown. Our study comprised 613 women, aged 30-45 years, genotyped for common apo E polymorphism and who differed in their combined low-dose OC consumption. The concentrations of apo C-III, apo C-III-LpB and apo C-III-Lp-non-B were significantly higher in OC users than in non-users by 13, 23 and 8% respectively, without significant interaction with the apo E genotype. The concentrations of apo E and apo E-Lp-non-B were significantly lower (differences being -14% and -31% respectively) in OC users than in controls whereas the apo E-LpB concentration was significantly higher (+19%), resulting in a redistribution of apo E from Lp-non-B towards LpB. Total apo E and apo E-Lp-non-B concentrations were higher in subjects carrying the epsilon2 allele and lower in those with the epsilon4 allele when compared to epsilon3/epsilon3 subjects (P < 0.001). The opposite held for the apo E- LpB concentration (P < 0.05). The main finding is the significant interaction between apo E genotype and OC use (P < 0.01) on apo E-Lp-non-B concentration, the epsilon4 carriers showing the smallest differences between OC users and non-users in comparison with the epsilon2 or epsilon3/epsilon3 carriers. These results suggest that the common apo E polymorphism can modulate the OC use effect.
Assuntos
Apolipoproteínas B/sangue , Apolipoproteínas C/sangue , Apolipoproteínas E/sangue , Anticoncepcionais Orais Hormonais/farmacologia , Lipoproteínas/sangue , Isoformas de Proteínas/sangue , Adulto , Apolipoproteína C-III , Apolipoproteína E4 , Apolipoproteínas E/genética , Índice de Massa Corporal , Doenças Cardiovasculares/epidemiologia , Colesterol/sangue , Estudos de Coortes , Anticoncepcionais Orais Hormonais/efeitos adversos , Feminino , França/epidemiologia , Genótipo , Humanos , Hiperlipidemias/epidemiologia , Pessoa de Meia-Idade , Polimorfismo Genético , Isoformas de Proteínas/genética , Fatores de Risco , Triglicerídeos/sangueRESUMO
As part of the ApoEurope Project, the apolipoprotein E (apo E) serum concentration and polymorphism were determined in 6934 healthy subjects aged 25-64 years recruited in six European countries: Finland; France; Greece; Northern Ireland; Portugal and Spain. Age and sex influenced apo E concentration with concentrations being significantly higher in men than in women for those aged between 25 and 44 years. The age effect differed between the sexes after the age of 44 years, displaying a linear increase in women and a plateau in men. As expected, the serum apo E concentration was highest in varepsilon2 carriers and lowest in varepsilon4 carriers in each country with a significantly higher frequency of the varepsilon4 allele in the northern regions. The main finding of this study was a clear increasing North-South gradient in serum apo E concentration independent of age, sex and apo E genotype. In subjects aged <45 years and with the varepsilon3/varepsilon3 genotype, apo E concentration was higher in the South-East (Greece) as compared to the North by 20% for men and 32% for women. In addition to the genetic polymorphism, the geographical area is an important factor to take into account when studying serum apo E concentration in multicentre studies and defining reference values.
Assuntos
Apolipoproteínas E/sangue , Apolipoproteínas E/genética , Polimorfismo Genético , Adulto , Envelhecimento/sangue , Europa (Continente) , Feminino , Frequência do Gene , Genótipo , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
We describe a new double-antibody ELISA system using avidin-biotin amplication for the mass measurement of mitochondrial aspartate aminotransferase (m-AST) in human serum. The assay is very sensitive and as little as 0.5 ng/ml of m-AST may be detected. The method is linear up to 100 micrograms/l. The within-day and day-to-day coefficients of variation were found to be 8.9% and 11.5% respectively for a low m-AST concentration (2.7 micrograms/l), and 5.9% and 8.0% respectively for a high level of m-AST (30 micrograms/l). The assay requires 100 microliters of serum and can be completed within 5 h. The ELISA procedure and a classical immunoprecipitation technique measuring the catalytic activity of the isoenzyme were applied simultaneously to the sera of 189 subjects. The protein levels determined by ELISA correlated poorly (r = 0.66) with the catalytic activity of m-AST.
Assuntos
Aspartato Aminotransferases/sangue , Ensaio de Imunoadsorção Enzimática/métodos , Mitocôndrias/enzimologia , Adolescente , Especificidade de Anticorpos , Aspartato Aminotransferases/imunologia , Aspartato Aminotransferases/metabolismo , Avidina , Biotina , Catálise , Feminino , Humanos , Isoenzimas/sangue , Isoenzimas/metabolismo , Masculino , Testes de Precipitina , Reprodutibilidade dos TestesRESUMO
BACKGROUND: Recombinant hirudin, a pure, specific antithrombin could be more effective than heparin in the treatment of deep vein thrombosis, but its short half-life requires constant intravenous infusion, whereas subcutaneous administration of recombinant hirudin can ensure stable and prolonged plasma levels. The aim of our study was to assess the pharmacokinetics, the results on the coagulation variables, and the safety of a recombinant hirudin (HBW 023) administered subcutaneously in patients suffering from deep vein thrombosis. METHODS: Recombinant hirudin (HBW 023) was administered subcutaneously to 10 patients with recent deep vein thrombosis, at a dose of 0.75 mg/kg of body weight twice daily for 5 days, after which standard heparin and acenocoumarol were introduced. Bilateral lower limb venography, and pulmonary angiography, and/or ventilation-perfusion lung scan were carried out on day 1 prior to recombinant hirudin injection and repeated on day 5. aPTT and recombinant hirudin plasma levels were serially assessed after the 1st and the 10th injections. Prothrombin fragments 1 + 2, thrombin-antithrombin III complexes, fibrin degradation products were collected on days 1 and 5. RESULTS: Clinical evolution was uneventful in all but one patient who had a probable recurrence of pulmonary embolism on day 4. No hemorrhagic complication, no untoward biological event was observed. On days 5, Marder score was unchanged or had decreased. Plasma levels of recombinant hirudin peaked in between 3 and 4 h following the injection. aPTT values paralleled, and were significantly correlated with plasma levels of recombinant hirudin on day 1 as well on day 5 (r = 0.903, r = 0.948 respectively). Fragment 1 + 2, and thrombin antithrombin complexes non-significantly decreased from day 1 to day 5. CONCLUSIONS: Subcutaneous administration of recombinant hirudin ensures prolonged stable plasma levels of recombinant hirudin which results in efficient anticoagulation. A dose-ranging study conducted with subcutaneous recombinant hirudin in comparison to conventional heparin therapy may answer the question as to efficacy.
Assuntos
Hirudinas/administração & dosagem , Tromboflebite/tratamento farmacológico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Testes de Coagulação Sanguínea , Feminino , Hirudinas/efeitos adversos , Hirudinas/farmacocinética , Humanos , Injeções Subcutâneas , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Proteínas Recombinantes/administração & dosagem , Proteínas Recombinantes/efeitos adversos , Proteínas Recombinantes/farmacocinética , Tromboflebite/metabolismoRESUMO
AIM OF THE STUDY: To assess the antithrombotic properties of SR90107/ORG31540. a sulfated pentasaccharide, which enhances specifically antithrombin III mediated inactivation of factor-Xa, in a clinical setting known to promote arterial thrombosis, i.e. coronary angioplasty. METHODS AND RESULTS: Percutaneous transluminal coronary angioplasty (PTCA) was carried out with conventional balloons with a single 5 min intravenous infusion of 12 mg pentasaccharide, and 500 mg intravenous aspirin. Heparin was not allowed before, during PTCA, and within 24 h after PTCA. The primary end point was the rate of abrupt vessel closure during and within 24 h after the procedure. The sample size was set at 60 evaluable patients, in order to be able to conclude with a good level of confidence (>95%) that the abrupt vessel closure rate was less than 10%, if less than 3 abrupt vessel closures were observed. Seventy-one patients were included in the study, of whom 10 needed elective stenting, and were not considered as evaluable for efficacy. Two out of the 61 remaining evaluable patients experienced acute vessel closure during the study period [3.28%, 95% confidence interval (0.4%; 11.4%)]. No major bleeding occurred. The drug plasma concentrations reached 1.91+/-0.39 mg/], 10 min after pentasaccharide injection, and decreased on average to 1. 18+/-0.27 mg/l at 2 h, and to 0.36+/-0.11 mg/l at 23 h after administration of pentasaccharide. Activated clotting time (ACT) and activated partial thromboplastin (aPTT) time remained within normal range. Thrombin-antithrombin complex levels fell from 22+/-17.1 to 4.5+/-3.4 microg/ml, prothrombin fragment 1+2 levels decreased from 2.15+/-1.01 to 1.73+/-0.87, and activated factor VII levels decreased from 43.4+/-16.8 mU/ml to 18.9+/-7.3 mU/ml respectively from baseline to 2 h following injection of the tested drug. CONCLUSIONS: Administration of pentasaccharide led to the inhibition of thrombin generation without modification of aPTT and ACT. The rate of abrupt vessel closure was within range of rates reported in historical series. Thus we conclude that the anti-thrombotic activity of pentasaccharide, as shown in this pilot trial in the setting of coronary angioplasty, deserves further investigation.
Assuntos
Angioplastia Coronária com Balão/efeitos adversos , Doença das Coronárias/terapia , Trombose Coronária/prevenção & controle , Fibrinolíticos/uso terapêutico , Oligossacarídeos/uso terapêutico , Adolescente , Adulto , Idoso , Aspirina/uso terapêutico , Angiografia Coronária , Doença das Coronárias/diagnóstico por imagem , Quimioterapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Inibidores da Agregação Plaquetária/uso terapêutico , Pré-Medicação , Resultado do TratamentoRESUMO
The aim of this multicentre, prospective, randomised, dose-ranging study was to compare the safety and efficacy of subcutaneous recombinant hirudin (HBW 023) against intravenous sodium heparin in acute lower limb deep venous thrombosis (DVT). Patients were randomized to treatment with either HBW 023 or heparin for 5 +/- 1 days. HBW 023 was given according to body-weight in three dose groups. Thromboembolic disease was assessed by phlebography and ventilation/perfusion (V/Q) scanning on Day 1 and Day 5 +/- 1. One hundred and fifty-five patients were enrolled, of these 121 were evaluable for efficacy analysis. Significantly fewer patients on HBW 023 developed new V/Q abnormalities during the treatment period, (p = 0.006). There was no difference between the groups in thrombus extension or regression, major bleeding complications or serious adverse events. There were significantly fewer findings of new V/Q mismatch after treatment with HBW 023, and anticoagulant control was superior in these patients.
Assuntos
Fibrinolíticos/uso terapêutico , Heparina/uso terapêutico , Terapia com Hirudina , Tromboflebite/tratamento farmacológico , Adulto , Idoso , Relação Dose-Resposta a Droga , Feminino , Fibrinolíticos/efeitos adversos , Fibrinolíticos/farmacocinética , Heparina/efeitos adversos , Heparina/farmacocinética , Hirudinas/efeitos adversos , Hirudinas/farmacocinética , Humanos , Infusões Intravenosas , Injeções Intravenosas , Injeções Subcutâneas , Masculino , Pessoa de Meia-Idade , Seleção de Pacientes , Estudos Prospectivos , Proteínas Recombinantes/efeitos adversos , Proteínas Recombinantes/farmacocinética , Proteínas Recombinantes/uso terapêuticoRESUMO
In cases of acute myocardial infarction (MI), it has been shown that preserving left ventricular function and limiting infarct size with early reperfusion of the occluded artery by means of a thrombolytic agent could eventually result in a reduced mortality rate. The aim of the APSIM study (anisoylated plasminogen streptokinase activator complex [APSAC] dans l'infarctus du Myocarde) was to demonstrate that early administration of APSAC in patients with recent acute MI could limit the infarct size and preserve left ventricular systolic function. In all, 231 patients with a first acute MI were randomly allocated to either APSAC (30 U over 5 minutes) or to conventional heparin therapy (5,000 IU in bolus injection) within 5 hours of the onset of symptoms. Of these patients, 112 received APSAC and 119 received heparin within a mean period of 188 +/- 62 minutes after the onset of symptoms. The patency rate of the infarct-related artery was 77% in the APSAC group and 36% in the heparin group (p less than 0.001). Left ventricular ejection fraction determined from contrast angiography was significantly higher in the APSAC than in the heparin group. This was true for the entire population (0.53 +/- 0.13 vs 0.47 +/- 0.13, p = 0.002) as well as for the subgroups of anterior and inferior wall infarctions (0.47 +/- 0.13 vs 0.4 +/- 0.16, p = 0.004 and 0.56 +/- 0.11 vs 0.51 +/- 0.09, p = 0.02). At 3 weeks, the difference remained significant for patients with anterior MI.(ABSTRACT TRUNCATED AT 250 WORDS)
Assuntos
Fibrinolíticos/administração & dosagem , Infarto do Miocárdio/tratamento farmacológico , Plasminogênio/administração & dosagem , Estreptoquinase/administração & dosagem , Anistreplase , Método Duplo-Cego , Feminino , Seguimentos , Coração/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Infarto do Miocárdio/fisiopatologia , Infarto do Miocárdio/prevenção & controle , Plasminogênio/efeitos adversos , Distribuição Aleatória , Recidiva , Estreptoquinase/efeitos adversos , Fatores de Tempo , Grau de Desobstrução Vascular/efeitos dos fármacosRESUMO
Aortic dissection (AD) is a disease with a high-risk of mortality. Late deaths are often related to complications in nonoperated aortic segments. Between 1984 and 1996, we retrospectively analyzed the data of 109 patients with acute AD (81 men and 28 women; average age 61 +/- 14 years). All imaging examinations were reviewed, and a magnetic resonance imaging examination was performed at the time of the study. Aortic diameters were measured on each aortic segment. Predictive factors of mortality were determined by Cox's proportional hazard model, in univariate and multivariate analyses, using BMDP statistical software. Follow-up was an average of 44 +/- 46 months (range 24 to 164). Actuarial survival rates were 52%, 46%, and 37% at 1, 5, and 10 years, respectively, for type A AD versus 76%, 72%, and 46% for type B AD. Predictors of late mortality were age >70 years and postoperative false lumen patency of the thoracic descending aorta (RR 3.4, 95% confidence intervals 1.20 to 9.8). Descending aorta diameter was larger when false lumen was patent (31 vs 44 mm; p = 0.02) in type A AD. Furthermore, patency was less frequent in operated type A AD when surgery had been extended to the aortic arch. Thus, patency of descending aorta false lumen is responsible for progressive aortic dilation. In type A AD, open distal repair makes it possible to check the aortic arch and replace it when necessary, decreases the false lumen patency rate, and improves late survival.
Assuntos
Aneurisma da Aorta Torácica/diagnóstico , Dissecção Aórtica/diagnóstico , Imageamento por Ressonância Magnética , Complicações Pós-Operatórias/mortalidade , Adulto , Idoso , Idoso de 80 Anos ou mais , Dissecção Aórtica/mortalidade , Dissecção Aórtica/cirurgia , Aorta Torácica/patologia , Aorta Torácica/cirurgia , Aneurisma da Aorta Torácica/mortalidade , Aneurisma da Aorta Torácica/cirurgia , Implante de Prótese Vascular , Causas de Morte , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/diagnóstico , Prognóstico , Fatores de Risco , Stents , Taxa de SobrevidaRESUMO
Percutaneous intervention for the first episode of in-stent restenosis was performed in 177 patients 5.4 +/- 0.3 months after native coronary stent implantation. Medical records were reviewed and patients contacted 13.3 +/- 1.2 months after in-stent intervention to ascertain the subsequent clinical course. The effects of demographic, procedural, and angiographic variables on clinical outcomes were determined. At 2 years, Kaplan-Meier estimated survival was 93 +/- 3% and freedom from death, myocardial infarction, and a third target artery revascularization (TAR) was 67 +/- 4%. The actuarial frequency of a third TAR was 26 +/- 4% at 1 year. Stratification of outcomes according to timing of in-stent intervention revealed an approximate twofold higher frequency of adverse events among patients with early (=3 months) in-stent restenosis. Advanced age (p = 0.019), prior coronary bypass (p = 0. 017), and early in-stent intervention (p = 0.006) independently predicted increased mortality at follow-up. Systemic hypertension (p = 0.004), diabetes mellitus (p = 0.044), and early in-stent intervention (p <0.0001) independently predicted a third TAR. These variables (p = 0.007, p = 0.027, and p <0.0001, respectively) also independently predicted a composite end point consisting of death, myocardial infarction, and a third TAR. No angiographic variable predicted outcome after in-stent intervention. Thus, long-term outcome following in-stent intervention was favorable. Early in-stent intervention, advanced age, hypertension, and diabetes predicted adverse outcomes.
Assuntos
Angioplastia Coronária com Balão , Doença das Coronárias/terapia , Stents , Análise Atuarial , Análise de Variância , Angiografia Coronária , Doença das Coronárias/mortalidade , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Recidiva , Análise de Regressão , Fatores de Risco , Análise de Sobrevida , Resultado do TratamentoRESUMO
The use of bilateral in situ internal thoracic arteries is restricted by the risk of sternal devascularization, the length of the pedicle, and the necessity to avoid crossing the midline. The aim of this study is to evaluate Y grafts achieved by anastomosing the proximal end of the free right internal thoracic artery to the side of the attached left internal thoracic artery. Y grafts were performed in 80 patients, aged 41 to 74 years (mean age 58.6 years) between May 1991 and September 1992. Two different techniques were used. Thirty-four patients were included in group 1 and 46 in group 2. Seventy-nine grafts were performed from the left internal thoracic artery to the left anterior descending artery. The right internal thoracic artery was anastomosed to the diagonal artery (5 times), the marginal branch (67 times), the circumflex artery (7 times) and the right coronary artery (2 times). Seventy-five complementary saphenous vein bypasses were performed in 58 patients. Operative mortality was 2.5%. Two patients had perioperative myocardial infarcts (2.5%) on nonbypassed sites. Three patients had sternal wound infections (3.7%). Sixty-two patients (80%) were reexamined by angiography at month 6-25 in group 1 and 37 in group 2. Sixty left internal thoracic artery bypass grafts (97%) were patent versus 39 right internal thoracic artery bypass grafts (63%). In group 1, 23 of 25 left internal thoracic artery bypass grafts were patient (92%) versus 12 right internal thoracic artery grafts (48%). In group 2, all 37 left internal thoracic artery bypass grafts were patent (100%) versus 27 right internal thoracic artery grafts (73%). With this procedure, particular attention must be paid to the length of the right internal thoracic artery, and extensive training is required.
Assuntos
Revascularização Miocárdica/métodos , Artérias Torácicas/cirurgia , Adulto , Angiografia Coronária , Humanos , Pessoa de Meia-Idade , Revascularização Miocárdica/efeitos adversos , Estudos Prospectivos , Infecção da Ferida Cirúrgica/etiologia , Resultado do Tratamento , Grau de Desobstrução VascularRESUMO
We have produced a batch of lyophilized alkaline phosphatase (AP) for use as an enzyme reference material. The enzyme was partly purified from pig kidney to a specific activity of 400 U/mg of protein and is essentially free from contaminating enzyme activities. The kinetic properties of the preparation are very close to those of the enzyme present in human serum. The partly purified AP was lyophilized in a matrix containing bovine serum albumin (40 g/L), MgCl2, ZnCl2 and NaCl. The vial-to-vial variability with respect to the catalytic concentration of the final product was 0.008. The predicted annual relative loss of activity was less than 0.01% at -20 degrees C and 0.04% at 4 degrees C. This material was certified using the IFCC proposed method. The certification procedure involved 19 laboratories throughout the world. The certified alkaline phosphatase catalytic concentration in the reconstituted material was 254 U/L with a 0.95 confidence interval of +/- 6 U/L.