RESUMO
BACKGROUND: Everolimus-eluting and paclitaxel-eluting stents, compared with bare metal stents, reduced the risk of restenosis in clinical trials with strict inclusion and exclusion criteria. We compared the safety and efficacy of the second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice. METHODS: We randomly assigned 1800 consecutive patients (aged 18-85 years) undergoing percutaneous coronary intervention at one centre to treatment with everolimus-eluting or paclitaxel-eluting stents. The primary endpoint was a composite of safety and efficacy (all-cause mortality, myocardial infarction, and target vessel revascularisation) within 12 months. Patients were not told which stent they had been allocated. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT01016041. FINDINGS: Follow-up was completed in 1797 patients. The primary endpoint occurred in 56 (6%) of 897 patients in the everolimus-eluting stent group versus 82 (9%) of 903 in the paclitaxel-eluting stent group (relative risk 0.69 [95% CI 0.50-0.95], p value for superiority=0.02). The difference was attributable to a lower rate of stent thrombosis (6 [<1%] vs 23 [3%], 0.26 [0.11-0-64], p=0.002), myocardial infarction (25 [3%] vs 48 [5%], 0.52 [0.33-0.84], p=0.007), and target vessel revascularisation (21 [2%] vs 54 [6%], 0.39 [0.24-0.64], p=0.0001). Cardiac death, non-fatal myocardial infarction, or target lesion revascularisation occurred in 44 [5%] patients in the everolimus-eluting stent group versus 74 [8%] patients in the paclitaxel-eluting stent group, p value for superiority was 0.005. INTERPRETATION: The everolimus-eluting stent is better than the second generation paclitaxel-eluting stent in unselected patients in terms of safety and efficacy. On the basis of our results, we suggest that paclitaxel-eluting stents should no longer be used in everyday clinical practice. FUNDING: Unrestricted grants from Abbott Vascular and Boston Scientific.
Assuntos
Angioplastia Coronária com Balão , Vasos Coronários , Stents Farmacológicos , Imunossupressores , Paclitaxel , Sirolimo/análogos & derivados , Idoso , Idoso de 80 Anos ou mais , Stents Farmacológicos/efeitos adversos , Everolimo , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Paclitaxel/efeitos adversos , Método Simples-Cego , Sirolimo/efeitos adversos , Resultado do TratamentoRESUMO
OBJECTIVES: To reassess the reproducibility of the SYNTAX score. BACKGROUND: The SYNTAX score appears to have an important role to play in the evaluation of patients with complex coronary artery disease undergoing revascularisation. However, the calculation of the SYNTAX score relies on the subjective assessment of lesions using coronary angiography, and therefore is subject to intra-and inter-observer variability. METHODS: The SYNTAX score was calculated in 100 patients randomly selected from the SYNTAX trial, on two occasions 8 weeks apart, by a team made up of three interventional cardiologists. The weighted kappa values were compared with values obtained 1 year previously, when core lab analysts assessed the intra-observer reproducibility amongst the same patient cohort. RESULTS: The mean +/- standard deviation difference in SYNTAX score was 2.1 +/- 7.6. The respective weighted kappa values for the number of lesions, bifurcation lesions, ostial lesions, and total occlusions were 0.62, 0.36, 0.66, and 0.91 compared with 0.59, 0.41, 0.63, and 0.82 in the previous core lab assessment. The weighted kappa for the intra-observer reproducibility of the SYNTAX score grouped into deciles was 0.54, and according to the terciles < or = 22, >22-< or = 32, >32 was 0.51 both indicating a moderate level of agreement beyond the level of chance. In the previous assessment, the comparative kappa values were 0.45 and 0.53. CONCLUSIONS: The SYNTAX score has moderate intra-observer reproducibility when assessed by a team of three interventional cardiologists, which is consistent with a prior evaluation performed by core lab analysts. The scoring of bifurcation lesions remains the main source of inconsistency.
Assuntos
Angioplastia Coronária com Balão , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Angiografia Coronária/estatística & dados numéricos , Doença da Artéria Coronariana/cirurgia , Humanos , Variações Dependentes do Observador , Seleção de Pacientes , Valor Preditivo dos Testes , Reprodutibilidade dos Testes , Medição de Risco , Índice de Gravidade de Doença , Resultado do TratamentoRESUMO
Antiplatelet therapy with clopidogrel has been shown to reduce major adverse cardiac events in acute coronary syndromes and after percutaneous interventions. This effect is not only due to its anti-platelet effect but also possibly due to an anti-inflammatory effect. The effect of clopidogrel cessation after one year of therapy on markers of inflammation has been investigated in diabetics and showed an increase in platelet aggregation as well as hsCRP and surface P-selectin levels. This was an exploratory multicenter prospective open-label single arm study of 98 non-diabetic patients who had received one or more drug eluting stents and were coming to the end of their 12 months course of clopidogrel therapy. The effect of clopidogrel cessation on expression of biomarkers: sCD40L, soluble P-selectin and hsCRP was measured right before clopidogrel cessation (day 0), and subsequently at 1, 2, 3 and 4 weeks after drug withdrawal. A median increase in sCD40L expression from 224 to 324.5 pg/ml was observed between baseline and 4 weeks after clopidogrel cessation, which corresponded to a 39% mean percent change based on an ANCOVA model (P < 0.001). Over the 4 weeks observation period the change in sCD40L expression correlated weakly with soluble P-selectin levels (at 4 weeks Spearman's correlation coefficient = 0.32; P = 0.0024). Increase in P-selectin expression from baseline was statistically significant at week 1 and 2. Conversely, hsCRP level decreased by 21% at 1 week (P = 0.008) and was still reduced by 18% by 4 weeks (P = 0.062). The change in sCD40L expression appeared to vary with the type of drug eluting stent. Patients treated with drug eluting stents at 1 year after implantation display significant increase in sCD40L and decrease in hsCRP after clopidogrel cessation. Further studies should elucidate if this increase in sCD40L levels reflects solely the removal of the inhibitory effects of clopidogrel on platelet activity or rather an increase in pro-inflammatory state. The latter hypothesis may be less likely given decrease in hsCRP levels. Randomized studies are urgently needed to establish potential link of clopidogrel discontinuation and vascular outcomes.
Assuntos
Proteína C-Reativa/biossíntese , Ligante de CD40/sangue , Stents Farmacológicos , Selectina-P/sangue , Ticlopidina/análogos & derivados , Adulto , Idoso , Idoso de 80 Anos ou mais , Biomarcadores/sangue , Ligante de CD40/biossíntese , Clopidogrel , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Selectina-P/biossíntese , Ticlopidina/administração & dosagem , Fatores de TempoRESUMO
BACKGROUND: Morphology discrimination (MD) in implantable cardioverter-defibrillators (ICDs) is based on the comparison of the ventricular electrogram during tachycardia with a stored reference template obtained during baseline rhythm. However, the effect of heart rate on the template match percentage during supraventricular tachyarrhythmias (SVT) is not known. The purpose of this study was to evaluate the performance of the template match percentage during SVT at different heart rates. METHODS AND RESULTS: Stored electrograms of 868 tachyarrhythmias from 88 patients with a dual-chamber ICD (St Jude Medical, USA) were analysed by the investigators. The effect of heart rate on template match percentage was estimated by regression analysis. For performance measures, data were corrected for multiple episodes in a patient by using the generalized estimating equation method. The mean template match percentage was 86.6 +/- 22.2% (median 100%) for SVT episodes. No significant differences in template match percentage between fast [ventricular cycle length (CL) 300-350 ms] and slow (ventricular CL >400 ms) SVTs were observed (85.4 +/- 27.0 vs. 87.1 +/- 19.7%). Using nominal settings, MD alone provided sensitivity and specificity of 70.2% and 89.4% overall, respectively. Morphology discrimination in conjunction with rate branch analysis, sudden onset, and stability yielded sensitivity and specificity of 98.5% and 91.2%, respectively. CONCLUSION: Morphology discrimination has a consistently high template match percentage during SVTs, which is independent of ventricular CL. The consistent high match percentage results in high specificity for arrhythmia discrimination.
Assuntos
Algoritmos , Inteligência Artificial , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/terapia , Desfibriladores Implantáveis , Eletrocardiografia/métodos , Frequência Cardíaca , Reconhecimento Automatizado de Padrão/métodos , Terapia Assistida por Computador/métodos , Análise Discriminante , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Sensibilidade e EspecificidadeRESUMO
According to pathologic studies, the content of a necrotic core increases in a "linear fashion" as plaque enlarges. In addition, these 2 plaque characteristics have been associated with plaque vulnerability. This study assessed the relation between plaque cross-sectional area (CSA) and content of necrotic core (NC). Twenty-five patients (75 arteries) with acute coronary syndrome were studied. In total, 7,834 CSAs were analyzed. An analysis of plaque CSA in percentiles was performed (median 5.5 mm(2), interquartile range 3.7 to 7.8); subsequently, plaque CSA values were categorized as small (< or = 3.7 mm(2)), medium (>3.7 to < or = 7.8 mm(2)), and large (>7.8 mm(2)). There was a difference in content of the NC between arteries within each plaque CSA category. This observation was confirmed in a multivariate analysis in which only 2 variables remained statistically significant, plaque CSA (estimate 1.34, SE 0.05, p <0.0001) and studied artery (left anterior descending coronary artery, estimate 0.29, SE 0.08, p = 0.0003; left circumflex coronary artery, estimate 0.23, SE 0.07, p = 0.0014; and these vs the right coronary artery). In conclusion, the NC and plaque increase in patients with acute coronary syndromes.
Assuntos
Doença da Artéria Coronariana/diagnóstico por imagem , Infarto do Miocárdio/diagnóstico por imagem , Doença da Artéria Coronariana/patologia , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/patologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/patologia , Necrose , Estudos Prospectivos , Índice de Gravidade de Doença , Ultrassonografia de IntervençãoRESUMO
BACKGROUND: To reduce inappropriate therapy from implantable cardioverter-defibrillators (ICDs), electrogram morphology discrimination has been developed to improve arrhythmia discrimination without compromising device safety. OBJECTIVES: The purpose of this study was to determine the accuracy of the morphology discrimination algorithm for detecting ventricular tachycardia (VT). METHODS: Stored electrograms of 795 tachyarrhythmias from 106 patients with a St. Jude Medical ICD (51 single-chamber and 55 dual-chamber) were analyzed by the investigators. The data were analyzed for morphology discrimination alone, sudden onset and stability, and morphology discrimination in combination with sudden onset and stability. Data were corrected for multiple episodes within a patient with the generalized estimating equation method. RESULTS: Using the nominal template match of 60%, morphology discrimination alone provided sensitivity and specificity of 78% and 95% for single-chamber ICDs and 63% and 92% for dual-chamber ICDs, respectively. Based on the receiver operator characteristic curve, the optimal-match percent threshold was 80% to 85% but at the expense of specificity. Morphology discrimination combined with sudden onset and stability increased sensitivity to 98% with specificity of 86% in single-chamber devices. In dual-chamber devices, the loss in sensitivity is compensated by rate branch analysis, yielding a sensitivity of 98%. CONCLUSION: Arrhythmia discrimination based on electrogram morphology has the potential to reject atrial tachyarrhythmias. However, there is a risk for underdetection of ventricular tachyarrhythmias if arrhythmia discrimination is primarily based on morphology. To guarantee patient safety in single-chamber devices, the morphology discrimination algorithm must be programmed in combination with established detection algorithms. In dual-chamber devices, loss of sensitivity is compensated by the V > A rate branch.
Assuntos
Algoritmos , Desfibriladores Implantáveis , Cardioversão Elétrica/instrumentação , Eletrocardiografia/métodos , Frequência Cardíaca/fisiologia , Taquicardia Ventricular/diagnóstico , Taquicardia Ventricular/terapia , Análise Discriminante , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Taquicardia Ventricular/fisiopatologia , Resultado do TratamentoRESUMO
BACKGROUND: The impact of vascular closure devices (VCDs) via the femoral arterial access site on short-term mortality in patients undergoing percutaneous coronary intervention is currently unknown. METHODS AND RESULTS: The association between femoral arterial vascular access site management (manual pressure [including external clamp] versus VCD) and 30-day mortality was examined in a national real-world registry of 271 845 patients undergoing percutaneous coronary intervention for elective, non-ST-segment-elevation myocardial infarction and ST-segment-elevation myocardial infarction indications in the United Kingdom between 2006 and 2011. Crude and propensity score-corrected analyses were performed using Cox regression, with additional analyses undertaken in clinically relevant subgroups; 40.1% (n=109 001) of subjects were treated with manual pressure and 59.9% (n=162 844) with VCD. Subjects treated with VCD had fewer comorbidities and were less likely to present with ST-segment-elevation myocardial infarction and cardiogenic shock (P<0.001). Crude 30-day mortality was lower in the group treated with VCD compared with manual pressure (hazard ratio [HR], 0.58; 95% confidence interval [CI], 0.54-0.61; 1.4% versus 2.4%, log rank P<0.0001), findings that were substantially reduced but persisted after propensity score correction (HR, 0.91; 95% CI, 0.86-0.97; 1.8% versus 2.0% versus P<0.001). A more pronounced association of VCD with a reduction in 30-day mortality was evident in females (HR, 0.85; 95% CI, 0.77-0.94; Pinteraction=0.037), presentation with acute coronary syndrome (HR, 0.88; 95% CI, 0.83-0.94; Pinteraction=0.0027), or recent lysis (HR, 0.63; 95% CI, 0.40-1.01; Pinteraction=0.0001). CONCLUSIONS: When compared with manual pressure, VCD was associated with a minor short-term (30-day) prognostic benefit after propensity score correction in the global population and clinically relevant subgroups. The potential for residual confounding factors impacting on short-term mortality cannot be excluded, despite the study having measured and balanced all recorded confounder factors.
Assuntos
Cateterismo Periférico , Artéria Femoral , Hemorragia/prevenção & controle , Técnicas Hemostáticas/instrumentação , Infarto do Miocárdio sem Supradesnível do Segmento ST/terapia , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Dispositivos de Oclusão Vascular , Idoso , Cateterismo Periférico/efeitos adversos , Cateterismo Periférico/mortalidade , Distribuição de Qui-Quadrado , Comorbidade , Feminino , Hemorragia/etiologia , Hemorragia/mortalidade , Técnicas Hemostáticas/efeitos adversos , Técnicas Hemostáticas/mortalidade , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio sem Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio sem Supradesnível do Segmento ST/mortalidade , Razão de Chances , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Pontuação de Propensão , Modelos de Riscos Proporcionais , Fatores de Proteção , Punções , Sistema de Registros , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Fatores de Tempo , Resultado do Tratamento , Reino UnidoRESUMO
BACKGROUND: The factors associated with the occurrence of restenosis after sirolimus-eluting stent (SES) implantation in complex cases are currently unknown. METHODS AND RESULTS: A cohort of consecutive complex patients treated with SES implantation was selected according to the following criteria: (1) treatment of acute myocardial infarction, (2) treatment of in-stent restenosis, (3) 2.25-mm diameter SES, (4) left main coronary stenting, (5) chronic total occlusion, (6) stented segment >36 mm, and (7) bifurcation stenting. The present study population was composed of 238 patients (441 lesions) for whom 6-month angiographic follow-up data were obtained (70% of eligible patients). Significant clinical, angiographic, and procedural predictors of post-SES restenosis were evaluated. Binary in-segment restenosis was diagnosed in 7.9% of lesions (6.3% in-stent, 0.9% at the proximal edge, 0.7% at the distal edge). The following characteristics were identified as independent multivariate predictors: treatment of in-stent restenosis (OR 4.16, 95% CI 1.63 to 11.01; P<0.01), ostial location (OR 4.84, 95% CI 1.81 to 12.07; P<0.01), diabetes (OR 2.63, 95% CI 1.14 to 6.31; P=0.02), total stented length (per 10-mm increase; OR 1.42, 95% CI 1.21 to 1.68; P<0.01), reference diameter (per 1.0-mm increase; OR 0.46, 95% CI 0.24 to 0.87; P=0.03), and left anterior descending artery (OR 0.30, 95% CI 0.10 to 0.69; P<0.01). CONCLUSIONS: Angiographic restenosis after SES implantation in complex patients is an infrequent event, occurring mainly in association with lesion-based characteristics and diabetes mellitus.
Assuntos
Reestenose Coronária/epidemiologia , Sirolimo/uso terapêutico , Stents , Idoso , Estudos de Coortes , Comorbidade , Angiografia Coronária , Reestenose Coronária/diagnóstico por imagem , Estenose Coronária/tratamento farmacológico , Estenose Coronária/cirurgia , Diabetes Mellitus/epidemiologia , Implantes de Medicamento , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Fatores de Risco , Sirolimo/administração & dosagem , Stents/estatística & dados numéricosRESUMO
OBJECTIVES: The purpose of this randomized study was to investigate the performance of single- and dual-chamber tachyarrhythmia detection algorithms. BACKGROUND: A proposed benefit of dual-chamber implantable cardioverter-defibrillators (ICDs) is improved specificity of tachyarrhythmia detection. METHODS: All ICD candidates received a dual-chamber ICD and were randomized to programmed single- or dual-chamber detection. Of 60 patients (47 male, age 58 +/- 14 years, left ventricular ejection fraction 30%), 29 had single-chamber and 31 had dual-chamber settings. The detection results were corrected for multiple episodes within a patient with the generalized estimating equations method. RESULTS: A total of 653 spontaneous arrhythmia episodes (39 patients) were classified by the investigators; 391 episodes were ventricular tachyarrhythmia (32 patients). All episodes of ventricular tachyarrhythmias were appropriately detected in both settings. In 25 patients, 262 episodes of atrial tachyarrhythmias were recorded. Detection was inappropriate for 109 atrial tachyarrhythmia episodes (42%, 18 patients). Rejection of atrial tachyarrhythmias was not significantly different between both groups (p = 0.55). Episodes of atrial flutter/tachycardia were significantly more misclassified (p = 0.001). Overall, no significant difference in tachyarrhythmia detection (atrial and ventricular) between both settings was demonstrated (p = 0.77). CONCLUSIONS: The applied detection criteria in dual-chamber devices do not offer benefits in the rejection of atrial tachyarrhythmias. Discrimination of atrial tachyarrhythmias with a stable atrioventricular relationship remains a challenge.
Assuntos
Algoritmos , Desfibriladores Implantáveis , Taquicardia/diagnóstico , Adulto , Idoso , Fibrilação Atrial/diagnóstico , Flutter Atrial/diagnóstico , Desenho de Equipamento , Feminino , Átrios do Coração , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Taquicardia Ventricular/diagnósticoRESUMO
BACKGROUND: Diabetes increases the risk of developing cardiovascular disease. Patients with diabetes undergoing percutaneous coronary intervention (PCI) show poorer outcomes compared with nondiabetic patients. The aim of this study was to determine the clinical benefit of long-term fluvastatin in patients with diabetes who had undergone a successful PCI. METHODS: This subanalysis of a prospective, multicenter, randomized, double-blind, placebo-controlled trial of patients who had undergone PCI and were treated with fluvastatin determined the impact of fluvastatin on the survival-free period of major adverse cardiac events (MACE) (defined as cardiac death, nonfatal myocardial infarction, and reintervention procedure [coronary artery bypass grafting, repeat PCI, PCI for a new lesion]). Patients with baseline total cholesterol levels of 135 to 270 mg/dL (3.5-7.0 mmol/L) and triglyceride levels of 400 mg/dL (4.5 mmol/L) were randomized at discharge either to fluvastatin (n = 844) or to placebo (n = 833); follow-up was 3 to 4 years. Among these patients, there were 202 with diabetes (120 on fluvastatin, 82 placebo) and 1475 without diabetes (724 on fluvastatin, 751 on placebo). The primary clinical outcome was survival time free of MACE and MACE excluding restenosis. RESULTS: The presence of diabetes increased the risk of MACE by almost 2-fold in placebo-treated patients (RR 1.78, 95% CI 1.20-2,64, P = .0045). In contrast, in diabetic patients treated with fluvastatin, the risk of MACE was not significantly different from that in patients without diabetes. Fluvastatin reduced the risk of MACE in diabetic patients by 51% (P = .0088). CONCLUSIONS: Diabetes is a consistent clinical predictor of cardiovascular complications and fluvastatin reduces the increased incidence of long-term adverse complications associated with the presence of diabetes.
Assuntos
Doença das Coronárias/prevenção & controle , Complicações do Diabetes/terapia , Ácidos Graxos Monoinsaturados/uso terapêutico , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Indóis/uso terapêutico , Angioplastia Coronária com Balão , Anticolesterolemiantes/uso terapêutico , Doença das Coronárias/complicações , Doença das Coronárias/mortalidade , Doença das Coronárias/terapia , Método Duplo-Cego , Feminino , Fluvastatina , Seguimentos , Humanos , Lipoproteínas/sangue , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/prevenção & controle , Análise de SobrevidaRESUMO
Mild renal impairment is an important risk factor for late cardiovascular complications. This substudy of the Lescol Intervention Prevention Study (LIPS) assessed the effect of fluvastatin on outcome of patients who had renal dysfunction and those who did not. Complete data for creatinine clearance calculation (Cockcroft-Gault formula) were available for 1,558 patients (92.9% of the LIPS population). Patients were randomized to fluvastatin or placebo after successful completion of a first percutaneous coronary intervention. Follow-up time was 3 to 4 years. The effect of baseline creatinine clearance on coronary atherosclerotic events (cardiac death, nonfatal myocardial infarction, and coronary reinterventions not related to restenosis) was evaluated. Baseline creatinine clearance (logarithmic transformation) was inversely associated with an incidence of adverse events among patients who received placebo (hazard ratio 0.99, 95% confidence interval 0.982 to 0.998, p = 0.01). However, no association was noted between creatinine clearance and the incidence of adverse events among patients who received fluvastatin (hazard ratio 1.0, 95% confidence interval 0.99 to 1.0, p = 0.63). No further deterioration in creatinine clearance was observed during follow-up, regardless of baseline renal function or allocated treatment. Occurrence of adverse events was not related to changes in renal function during follow-up. Fluvastatin therapy markedly decreased the risk of coronary atherosclerotic events after percutaneous intervention in patients who had lower values of creatinine clearance at baseline. The benefit of fluvastatin was unrelated to any effect on renal function.
Assuntos
Doença da Artéria Coronariana/mortalidade , Ácidos Graxos Monoinsaturados/uso terapêutico , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Indóis/uso terapêutico , Nefropatias/prevenção & controle , Fatores Etários , Idoso , Angioplastia Coronária com Balão , Doença da Artéria Coronariana/terapia , Creatinina/sangue , Europa (Continente)/epidemiologia , Feminino , Fluvastatina , Humanos , Nefropatias/sangue , Lipoproteínas/sangue , Lipoproteínas/efeitos dos fármacos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Modelos de Riscos Proporcionais , Índice de Gravidade de Doença , Fatores SexuaisRESUMO
The degree of bronchodilation is usually expressed as a percentage of the predicted or baseline value. It has been shown that the relation between pre- and post-dilation lung function values is not adequately described by this approach: the sensitivity/specificity in separating asthmatics from cases of chronic obstructive pulmonary disease (COPD) could be improved. The alternative method we investigate is based on a logistic regression approach incorporating pre- and post-dilation lung function, age, sex and height. The discriminatory power of forced expiratory volume in one second (FEV1) increase as a percentage of the predicted or baseline FEV1 is compared to our approach using two databases containing bronchodilator data and diagnoses (asthma, chronic bronchitis or emphysema, the latter two grouped as (OPD). The increase as a percentage of the predicted or baseline approach and our alternative method show areas under the receiver operator curve (ROC) (males/females) of 0.552/0.629, 0.523/0.550 and 0.867/0.879 in one database. In the other database the same trend is present although less obvious: 0.628/0.730, 0.592/0.737 and 0.709/0.749. This increase in discriminatory power is obtained in the optimal use of all available information, especially age, which is not used in the increase of the predicted/baseline FEV1 rule.
Assuntos
Algoritmos , Asma/diagnóstico , Broncodilatadores , Diagnóstico por Computador/métodos , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Testes de Função Respiratória/métodos , Adulto , Asma/fisiopatologia , Diagnóstico Diferencial , Análise Discriminante , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Reprodutibilidade dos Testes , Sensibilidade e EspecificidadeRESUMO
We assessed the impact of long-term fluvastatin treatment on adverse atherosclerotic cardiac events (cardiac death, myocardial infarction, and revascularization excluding repeat interventions due to restenosis in the first 6 months) in 847 patients (fluvastatin [n = 417] or placebo [n = 430]) with average cholesterol levels treated with stents in the Lescol Intervention Prevention Study (LIPS). During the 4-year follow-up period, fluvastatin significantly decreased total cholesterol and low-density lipoprotein cholesterol levels and decreased the risk of first adverse atherosclerotic cardiac events by 30% compared with placebo (95% confidence interval -49 to -3.4, p = 0.03).
Assuntos
Anticolesterolemiantes/uso terapêutico , Doença da Artéria Coronariana/terapia , Ácidos Graxos Monoinsaturados/uso terapêutico , Indóis/uso terapêutico , Infarto do Miocárdio/prevenção & controle , Revascularização Miocárdica , Stents , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticolesterolemiantes/administração & dosagem , Brasil , Canadá , Colesterol/sangue , HDL-Colesterol/sangue , LDL-Colesterol/sangue , Doença da Artéria Coronariana/sangue , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/patologia , Esquema de Medicação , Europa (Continente) , Ácidos Graxos Monoinsaturados/administração & dosagem , Feminino , Fluvastatina , Humanos , Indóis/administração & dosagem , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Radiografia , Índice de Gravidade de Doença , Resultado do Tratamento , Triglicerídeos/sangueRESUMO
AIMS: Although large clinical trials have shown that everolimus-eluting stents (EES) significantly reduce target vessel revascularisation (TVR), myocardial infarction (MI) and stent thrombosis (ST) compared to paclitaxel-eluting stents (PES) in diverse populations, there is a paucity of data comparing EES and PES in patients presenting with MI. METHODS AND RESULTS: We performed a post hoc subgroup analysis on COMPARE, an all-comer trial comparing EES to PES. We identified 863 patients (EES=434, PES=429 treated for MI: 452 ST-elevation MI (STEMI) and 411 non ST-elevation MI (NSTEMI). EES was associated with a significant reduction in the primary endpoint, a composite of all-cause mortality, MI, and TVR, at two years (RR=0.57; 95% CI: 0.40-0.83, p=0.002). While the effect was more marked in the STEMI (RR=0.51; 95% CI: 0.30-0.87, p=0.01) than the NSTEMI subgroup (RR=0.65; 95% CI: 0.39-1.08, p=0.09), the interaction p-value (0.5) suggests that a difference in treatment effect between presentations is unlikely. ST rates were significantly lower with EES (RR=0.30; 95% CI: 0.12-0.73, p=0.005). CONCLUSIONS: At two years, EES results are superior to PES in terms of safety and efficacy endpoints in treatment of MI.
Assuntos
Stents Farmacológicos , Infarto do Miocárdio/terapia , Paclitaxel/administração & dosagem , Sirolimo/análogos & derivados , Idoso , Eletrocardiografia , Everolimo , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/fisiopatologia , Estudos Prospectivos , Sirolimo/administração & dosagemRESUMO
AIMS: Few data document trends in cardiovascular (CV) risk-factors in patients with or without previous symptomatic CV disease. We assessed the prevalence and trends in (non) modifiable CV risk-factors, and the use of cardioprotective therapies in patients enrolled in coronary stent trials. METHODS AND RESULTS: This analysis included prospective data on 10,253 mainly European adults who were enrolled in 32 coronary stent studies between 1995 and 2006. Data was collected at the time of enrolment using a standardised patient clinical record form, and was analysed by considering three consecutive time periods: 1995-1997 (I), 1998-2002 (II) and 2003-2006 (III) rendering approximately equal numbers per period. Overall the proportion of active smokers remained constant (Period I to III: 28%, 27%, 21%, p=0.45), however the proportion increased in females below 50 years (about 2%/ year, R.RR: 1.20, P: 0.05 period III versus I). Prevalent diabetes increased (16%, 17%, 25%; p=0.029). The prevalence of a body-mass index (BMI) ≥25 kg/m² was high, but no trend was observed (69%, 68%, 70%; p=0.24). The proportion of patients with elevated blood pressure (i.e., ≥140/90 mmHg, in diabetes ≥130/80 mmHg) remained unchanged (55%, 50.%, 53%; p=0.22), despite an increase in the number of patients taking anti-hypertensive agents (84%, 89%, 90%; p=0.30). Conversely, the proportion of patients with elevated total cholesterol (i.e., ≥4.5 mmol/L) decreased (80%, 66%, 52%; p=0.002), which was consistent with the increase in patients taking lipid lowering drugs (32%, 62%, 69%; p=0.083). The portion of patients reaching therapeutic targets for blood lipids improved, but no improvement was seen in blood pressure control (p=0.29). CONCLUSIONS: There is an unmet clinical need in primary and secondary CV prevention in Europe. Patients requiring PCI are an important target population in whom lifestyle changes and aggressive secondary preventative measures should be aimed. Ultimately PCI should open the door towards optimising secondary prevention.
Assuntos
Angioplastia Coronária com Balão/instrumentação , Doença da Artéria Coronariana/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto , Prevenção Secundária , Stents , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Doença da Artéria Coronariana/epidemiologia , Europa (Continente)/epidemiologia , Medicina Baseada em Evidências , Feminino , Humanos , Modelos Logísticos , Masculino , Prevalência , Estudos Prospectivos , Medição de Risco , Fatores de Risco , Comportamento de Redução do Risco , Prevenção Secundária/métodos , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVES: IBIS-1 was a pilot study undertaken to correlate coronary imaging with circulating biomarker expression in patients with stable angina, unstable angina and acute myocardial infarction. We hypothesized that patients at high risk of future events could be identified in the future by a combination of high risk plaque features by plaque echogenicity and palpography and a set of circulating blood biomarkers. RESULTS AND METHODS: We assessed the expression of conventional biomarkers and novel marker protein microarray (170 analytes) over 6 months. There were no strong correlations observed between conventional biomarkers and coronary imaging in non-culprit artery. Proteomic microarray was performed in 66 patients. Seventy eight (45%) analytes showed dynamic changes over time. Using hierarchical clustering and principal component analysis two subsets of biomarkers were identified: initial up-regulation and decrease over time (D-dimer, hepatocyte growth factor, CXCL9/MIG, platelet factor 4/CXCL4, CTACK, C-6 Kine, follistatin, and FGF-7) and the opposite increase (PAI-1- anti-apoptotic protein and I-309--chemokine induced on the human endothelium by Lp(a)). CONCLUSIONS: Proteomic analysis identifies dynamic patterns in circulating biomarkers in a wide range of patients with coronary artery disease. Further large natural history studies are needed to better define multibiomarker sets for identification of patients at risk of future CV events.
Assuntos
Biomarcadores/sangue , Cardiopatias , Proteômica , Síndrome Coronariana Aguda/sangue , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/epidemiologia , Técnicas de Imagem Cardíaca , Doença da Artéria Coronariana/sangue , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/epidemiologia , Diagnóstico Diferencial , Cardiopatias/sangue , Cardiopatias/diagnóstico , Cardiopatias/epidemiologia , Humanos , Infarto do Miocárdio/sangue , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/epidemiologia , Projetos Piloto , Fatores de Risco , Fatores de TempoRESUMO
BACKGROUND: The age, creatinine, and ejection fraction (ACEF) score (age/left ventricular ejection fraction+1 if creatinine >2.0 mg/dL) has been established as an effective predictor of clinical outcomes in patients undergoing elective coronary artery bypass surgery; however, its utility in "all-comer" patients undergoing percutaneous coronary intervention is yet unexplored. METHODS AND RESULTS: The ACEF score was calculated for 1208 of the 1707 patients enrolled in the LEADERS trial. Post hoc analysis was performed by stratifying clinical outcomes at the 1-year follow-up according to ACEF score tertiles: ACEF(low) ≤1.0225, 1.0225< ACEF(mid) ≤1.277, and ACEF(high) >1.277. At 1-year follow-up, there was a significantly lower number of patients with major adverse cardiac event-free survival in the highest tertile of the ACEF score (ACEF(low)=92.1%, ACEF(mid)=89.5%, and ACEF(high)=86.1%; P=0.0218). Cardiac death was less frequent in ACEF(low) than in ACEF(mid) and ACEF(high) (0.7% vs 2.2% vs 4.5%; hazard ratio=2.22, P=0.002) patients. Rates of myocardial infarction were significantly higher in patients with a high ACEF score (6.7% for ACEF(high) vs 5.2% for ACEF(mid) and 2.5% for ACEF(low); hazard ratio=1.6, P=0.006). Clinically driven target-vessel revascularization also tended to be higher in the ACEF(high) group, but the difference among the 3 groups did not reach statistical significance. The rate of composite definite, possible, and probable stent thrombosis was also higher in the ACEF(high) group (ACEF(low)=1.2%, ACEF(mid)=3.5%, and ACEF(high)=6.2%; hazard ratio=2.04, P<0.001). CONCLUSIONS: ACEF score may be a simple way to stratify risk of events in patients treated with percutaneous coronary intervention with respect to mortality and risk of myocardial infarction.
Assuntos
Angioplastia Coronária com Balão/mortalidade , Doença da Artéria Coronariana/terapia , Creatinina/sangue , Volume Sistólico , Fatores Etários , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Doença da Artéria Coronariana/sangue , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Medição de RiscoRESUMO
AIMS: High-risk plaques are prone to develop at the site of coronary vessel bifurcations. The distribution of necrotic core at bifurcation lesions (BL) is known, however, little has been described on the necrotic core distribution in non-BLs. Therefore we compared the distribution of necrotic core between BL and non-BLs in coronary arteries using IVUS-VH imaging. METHODS AND RESULTS: A total of 129 patients (112 non-BL and 108 BL) were included. The lesions were divided into upstream and downstream segments according the location of the minimum lumen area (MLA) within the plaque. In BLs, compositional analysis showed no differences between the three segments. The necrotic core in contact with the lumen that was located in the downstream segment was significantly larger. While in non-BLs, this was not significantly different between segments. Plaque burden in BLs was 56.60±5.79% vs. 55.50±4.54% in non-BLs, p=0.04. Mean necrotic core area was larger in BLs 0.84±0.55mm2 vs. 0.70±0.49mm2, p=0.048. Mean percentage necrotic core was 15.48±8.02% vs. 14.51±7.64%, p=0.37. There was a trend towards a greater content of necrotic core in contact with the lumen in BLs. The percentage of frames with a major confluent pool of necrotic core in contact with the lumen >10% in BLs was 11.78±17.18 vs. 8.95±17.86 in non-BLs, p=0.065. There was a statistically significant difference in the frequency of IVUS derived thin capped fibroatheromas between bifurcation lesions 20 vs. 13 in non-bifurcation lesions, p=0.03. CONCLUSIONS: Bifurcation lesions appear to have a larger plaque burden with a different plaque composition compared to non-bifurcation lesions. This may partly explain the adverse outcomes seen following treatment of bifurcation lesions in contemporary practice.
Assuntos
Doença da Artéria Coronariana/diagnóstico por imagem , Vasos Coronários/patologia , Ultrassonografia de Intervenção/métodos , Vasos Coronários/diagnóstico por imagem , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Necrose , Placa Aterosclerótica/diagnóstico por imagem , Placa Aterosclerótica/patologia , Estudos Prospectivos , Índice de Gravidade de DoençaRESUMO
The aim of this analysis was to assess the effect of body mass index (BMI) on 1-year outcomes in patients enrolled in a contemporary percutaneous coronary intervention trial comparing a sirolimus-eluting stent with a durable polymer to a biolimus-eluting stent with a biodegradable polymer. A total of 1,707 patients who underwent percutaneous coronary intervention were randomized to treatment with either biolimus-eluting stents (n = 857) or sirolimus-eluting stents (n = 850). Patients were assigned to 1 of 3 groups according to BMI: normal (<25 kg/m(2)), overweight (25 to 30 kg/m(2)), or obese (>30 kg/m(2)). At 1 year, the incidence of the composite of cardiac death, myocardial infarction, and clinically justified target vessel revascularization was assessed. In addition, rates of clinically justified target lesion revascularization and stent thrombosis were assessed. Cox proportional-hazards analysis, adjusted for clinical differences, was used to develop models for 1-year mortality. Forty-five percent of the patients (n = 770) were overweight, 26% (n = 434) were obese, and 29% (n = 497) had normal BMIs. At 1-year follow-up, the cumulative rate of cardiac death, myocardial infarction, and clinically justified target vessel revascularization was significantly higher in the obese group (8.7% in normal-weight, 11.3% in overweight, and 14.5% in obese patients, p = 0.01). BMI (hazard ratio 1.47, 95% confidence interval 1.02 to 2.14, p = 0.04) was an independent predictor of stent thrombosis. Stent type had no impact on the composite of cardiac death, myocardial infarction, and clinically justified target vessel revascularization at 1 year in the 3 BMI groups (hazard ratio 1.08, 95% confidence interval 0.63 to 1.83, p = 0.73). In conclusion, BMI was an independent predictor of major adverse cardiac events at 1-year clinical follow-up. The higher incidence of stent thrombosis in the obese group may suggest the need for a weight-adjusted dose of clopidogrel.