RESUMO
BACKGROUND: In patients with distal bifurcation left main stem lesions requiring intervention, the European Bifurcation Club Left Main Coronary Stent Study trial found a non-significant difference in major adverse cardiac events (MACEs, composite of all-cause death, non-fatal myocardial infarction and target lesion revascularisation) favouring the stepwise provisional strategy, compared with the systematic dual stenting. AIMS: To estimate the 1-year cost-effectiveness of stepwise provisional versus systematic dual stenting strategies. METHODS: Costs in France and the UK, and MACE were calculated in both groups to estimate the incremental cost-effectiveness ratio (ICER). Uncertainty was explored by probabilistic bootstrapping. The analysis was conducted from the perspective of the healthcare provider with a time horizon of 1 year. RESULTS: The cost difference between the two groups was -755 (5700 in the stepwise provisional group and 6455 in the systematic dual stenting group, p value<0.01) in France and -647 (6728 and 7375, respectively, p value=0.08) in the UK. The point estimates for the ICERs found that stepwise provisional strategy was cost saving and improved outcomes with a probabilistic sensitivity analysis confirming dominance with an 80% probability. CONCLUSION: The stepwise provisional strategy at 1 year is dominant compared with the systematic dual stenting strategy on both economic and clinical outcomes.
Assuntos
Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Humanos , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/terapia , Doença da Artéria Coronariana/etiologia , Análise Custo-Benefício , Intervenção Coronária Percutânea/efeitos adversos , Resultado do Tratamento , Fatores de Tempo , StentsRESUMO
BACKGROUND: Elderly patients receive bare metal stents instead of drug-eluting stents (DES) to shorten the duration of dual antiplatelet therapy (DAPT). The SENIOR trial compared outcomes between these 2 types of stents combined with a short duration of DAPT. A significant decrease in the number of patients with at least 1 major adverse cardiac and cerebrovascular event (MACCE) was noted in the DES group. OBJECTIVES: The objective of this article was to perform an economic evaluation of the SENIOR trial. METHODS: This evaluation was performed separately in 5 participating countries using pooled patient-level data from all study patients and country-specific unit costs and utility values. Costs, MACCEs, and quality-adjusted life-years (QALYs) were calculated in both arms at 1 year, and an incremental cost-effectiveness ratio was estimated. Uncertainty was explored by probabilistic bootstrapping. RESULTS: A total of 1200 patients underwent randomization. The average total cost per patient was higher in the DES group. The number of MACCEs and average QALYs were not statistically different between the 2 groups. The 1-year incremental cost-effectiveness ratio for each country of reference ranged from 13 752 to 20 511/MACCE avoided and from 42 835 to 68 231/QALY gained. The scatter plots found a wide dispersion, reflecting a large uncertainty surrounding the results. But in each country studied, 90% of the bootstrap replications indicated a higher cost for greater effectiveness for the DES group. Assuming a willingness to pay of 50 000/QALY, there was between a 40% and 50% chance that the use of DES was cost-effective in 4 countries. CONCLUSION: The use of DES instead of bare metal stents combined with a short duration of DAPT in elderly patients induced higher cost for greater effectiveness in each of the 5 countries studied.
Assuntos
Doença da Artéria Coronariana/terapia , Stents Farmacológicos/economia , Idoso , Análise de Variância , Benchmarking , Doença da Artéria Coronariana/economia , Análise Custo-Benefício , Europa (Continente) , Humanos , Anos de Vida Ajustados por Qualidade de Vida , Método Simples-Cego , Resultado do TratamentoRESUMO
OBJECTIVES: The aim of the present study was to assess outcomes after coronary artery bypass grafting surgery (CABG) and percutaneous coronary intervention (PCI) according to sex in a large randomized trial of patients with unprotected left main disease. BACKGROUND: In the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial, sex had a significant interaction effect with revascularization strategy, and women had an overall higher mortality when treated with PCI than CABG. METHODS: The EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial was a multinational randomized trial that compared PCI with everolimus-eluting stents and CABG in patients with unprotected left main disease. The primary endpoint was the composite of all-cause death, myocardial infarction, or stroke at 3 years. RESULTS: Of 1,905 patients randomized, 1,464 (76.9%) were men and 441 (23.1%) were women. Compared with men, women were older; had higher prevalence rates of hypertension, hyperlipidemia, and diabetes; and were less commonly smokers but had lower coronary anatomic burden and complexity (mean SYNTAX score 24.2 vs. 27.2, p < 0.001). By multivariate analysis, sex was not independently associated with either the primary endpoint (hazard ratio [HR]: 1.10; 95% confidence interval [CI]: 0.82 to 1.48; p = 0.53) or all-cause death (HR: 1.39; 95% CI: 0.92 to 2.10; p = 0.12) at 3 years. At 30 days, all-cause death, myocardial infarction, or stroke had occurred in 8.9% of woman treated with PCI, 6.2% of women treated with CABG, 3.6% of men treated with PCI, and 8.4% of men treated with CABG (p for interaction = 0.003). The 3-year rate of the composite primary endpoint was 19.7% in women treated with PCI, 14.6% in women treated with CABG, 13.8% in men treated with PCI, and 14.7% in men treated with CABG (p for interaction = 0.06). These differences were driven by higher periprocedural rates of myocardial infarction in women after PCI and in men after CABG. CONCLUSIONS: In patients with unprotected left main disease in the EXCEL trial, sex was not an independent predictor of adverse outcomes after revascularization. However, women undergoing PCI had a trend toward worse outcomes, a finding related to associated comorbidities and increased periprocedural complications. Further studies are required to determine the optimal revascularization modality in women with complex coronary artery disease.
Assuntos
Ponte de Artéria Coronária , Doença da Artéria Coronariana/terapia , Estenose Coronária/terapia , Intervenção Coronária Percutânea , Idoso , Comorbidade , Ponte de Artéria Coronária/efeitos adversos , Ponte de Artéria Coronária/mortalidade , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/mortalidade , Feminino , Disparidades nos Níveis de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/mortalidade , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Fatores Sexuais , Stents , Acidente Vascular Cerebral/epidemiologia , Fatores de Tempo , Resultado do TratamentoRESUMO
AIMS: In patients at high risk of bleeding who undergo PCI the biolimus A9 polymer-free drug coated stent (DCS) has superior efficacy and safety compared to a bare metal stent (BMS). We estimated the cost effectiveness of DCS vs. BMS. METHODS AND RESULTS: The Leaders FREE-based economic evaluation estimated service use and quality of life data collected prospectively. The entire trial population was analysed using cost-weights from England, France, Germany, Italy, Scotland and Spain. Country-specific QALYs were derived from EQ-5D scores. We estimated cost per event averted and per QALY gained. DCS use resulted in -0.095 cardiac deaths, target vessel MI, stent thrombosis and revascularization per patient (0.152 vs. 0.237;p<0.001). One-year QALYs were non-significantly higher in the DCS group. Total costs for the index admission were similar between groups. One-year costs using cost-weights from each of the 6 countries, including the additional 300 per DCS stent, ranged from 4,664-8,593 for DCS and 4,845-9,742 for BMS and were lower in the DCS group (England:-428, France:-137, Germany:-33, Italy:-522, Scotland:-298, Spain:-854). CONCLUSIONS: The probability that DCS dominated BMS was >50% in all countries. At a threshold of 10,000 per event averted DCS had a 98% probability of being cost-effective in all 6 countries.
Assuntos
Stents Farmacológicos/economia , Hemorragia/etiologia , Intervenção Coronária Percutânea/economia , Análise Custo-Benefício , Custos de Cuidados de Saúde , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Polímeros , Probabilidade , Estudos Prospectivos , Anos de Vida Ajustados por Qualidade de VidaRESUMO
OBJECTIVES: The study sought to investigate the impact of different computing methods for composite endpoints other than time-to-event (TTE) statistics in a large, multicenter registry of unprotected left main coronary artery (ULMCA) disease. BACKGROUND: TTE statistics for composite outcome measures used in ULMCA studies consider only the first event, and all the contributory outcomes are handled as if of equal importance. METHODS: The TTE, Andersen-Gill, win ratio (WR), competing risk, and weighted composite endpoint (WCE) computing methods were applied to ULMCA patients revascularized by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) at 14 international centers. RESULTS: At a median follow-up of 1,295 days (interquartile range: 928 to 1,713 days), all analyses showed no difference in combinations of death, myocardial infarction, and cerebrovascular accident between PCI and CABG. When target vessel revascularization was incorporated in the composite endpoint, the TTE (p = 0.03), Andersen-Gill (p = 0.04), WR (p = 0.025), and competing risk (p < 0.001) computing methods showed CABG to be significantly superior to PCI in the analysis of 1,204 propensity-matched patients, whereas incorporating the clinical relevance of the component endpoints using WCE resulted in marked attenuation of the treatment effect of CABG, with loss of significance for the difference between revascularization strategies (p = 0.10). CONCLUSIONS: In a large study of ULMCA revascularization, incorporating the clinical relevance of the individual outcomes resulted in sensibly different findings as compared with the conventional TTE approach. In particular, using the WCE computing method, PCI and CABG were no longer significantly different with respect to the composite of death, myocardial infarction, cerebrovascular accident, or target vessel revascularization at a median of 3 years.
Assuntos
Ponte de Artéria Coronária/estatística & dados numéricos , Doença da Artéria Coronariana/terapia , Modelos Estatísticos , Intervenção Coronária Percutânea/estatística & dados numéricos , Sistema de Registros/estatística & dados numéricos , Projetos de Pesquisa/estatística & dados numéricos , Idoso , Transtornos Cerebrovasculares/etiologia , Ponte de Artéria Coronária/efeitos adversos , Ponte de Artéria Coronária/mortalidade , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/mortalidade , Interpretação Estatística de Dados , Stents Farmacológicos , Determinação de Ponto Final/estatística & dados numéricos , Feminino , Humanos , Estimativa de Kaplan-Meier , Modelos Logísticos , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Análise Multivariada , Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/mortalidade , Pontuação de Propensão , Modelos de Riscos Proporcionais , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
AIMS: Recent cost-effectiveness analyses of percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) have been limited by a short time horizon or were restricted to the US healthcare perspective. We, therefore, used individual patient-level data from the SYNTAX trial to evaluate the cost-effectiveness of PCI versus CABG from a European (Dutch) perspective. METHODS AND RESULTS: Between 2005 and 2007, 1800 patients with three-vessel or left main coronary artery disease were randomised to either CABG (n=897) or PCI with drug-eluting stents (DES; n=903). Costs were estimated for all patients based on observed healthcare resource usage over 5â years of follow-up. Health state utilities were evaluated with the EuroQOL questionnaire. A patient-level microsimulation model based on Dutch life-tables was used to extrapolate the 5-year in-trial data to a lifetime horizon. Although initial procedural costs were lower for CABG, total initial hospitalisation costs per patient were higher (17â 506 vs 14â 037, p<0.001). PCI was more costly during the next 5â years of follow-up, due to more frequent hospitalisations, repeat revascularisation procedures and higher medication costs. Nevertheless, total 5-year costs remained 2465/patient higher with CABG. When the in-trial results were extrapolated to a lifetime horizon, CABG was projected to be economically attractive relative to DES-PCI, with gains in both life expectancy and quality-adjusted life expectancy. The incremental cost-effectiveness ratio (ICER) (5390/quality-adjusted life year (QALY) gained) was favourable and remained <80â 000/QALY in >90% of the bootstrap replicates. Outcomes were similar when incorporating the prognostic impact of non-fatal myocardial infarction and stroke, as well as across a broad range of assumptions regarding the effect of CABG on post-trial survival and costs. However, DES-PCI was economically dominant compared with CABG in patients with a SYNTAX Score ≤22 or in those with left main disease. In patients for whom the SYNTAX Score II favoured PCI based on lower predicted 4-year mortality, PCI was also economically dominant, whereas in those patients for whom the SYNTAX Score II favoured surgery, CABG was highly economically attractive (ICER range, 2967 to 3737/QALY gained). CONCLUSIONS: For the broad population with three-vessel or left main disease who are candidates for either CABG or PCI, we found that CABG is a clinically and economically attractive revascularisation strategy compared with DES-PCI from a Dutch healthcare perspective. The cost-effectiveness of CABG versus PCI differed according to several anatomic factors, however. The newly developed SYNTAX Score II provides enhanced prognostic discrimination in this population, and may be a useful tool to guide resource allocation as well. TRIAL REGISTRATION NUMBER: Clinical trial unique identifier: NCT00114972 (http://www.clinical-trials.gov).
Assuntos
Ponte de Artéria Coronária/economia , Doença da Artéria Coronariana/economia , Doença da Artéria Coronariana/terapia , Custos Hospitalares , Intervenção Coronária Percutânea/economia , Simulação por Computador , Ponte de Artéria Coronária/efeitos adversos , Ponte de Artéria Coronária/mortalidade , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/mortalidade , Análise Custo-Benefício , Técnicas de Apoio para a Decisão , Stents Farmacológicos/economia , Nível de Saúde , Humanos , Tempo de Internação/economia , Modelos Econômicos , Países Baixos , Readmissão do Paciente/economia , Seleção de Pacientes , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/mortalidade , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Retratamento/economia , Inquéritos e Questionários , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: The Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) trial demonstrated that in patients with 3-vessel or left main coronary artery disease, coronary artery bypass graft surgery (CABG) was associated with a lower rate of cardiovascular death, myocardial infarction, stroke, or repeat revascularization compared with percutaneous coronary revascularization with drug-eluting stents (DES-PCI)). The long-term cost-effectiveness of these strategies is unknown. METHODS AND RESULTS: Between 2005 and 2007, 1800 patients with left main or 3-vessel coronary artery disease were randomized to CABG (n=897) or DES-PCI (n=903). Costs were assessed from a US perspective, and health state utilities were evaluated with the EuroQOL questionnaire. A patient-level microsimulation model based on the 5-year in-trial data was used to extrapolate costs, life expectancy, and quality-adjusted life expectancy over a lifetime horizon. Although initial procedural costs were $3415 per patient lower with CABG, total hospitalization costs were $10 036 per patient higher. Over the next 5 years, follow-up costs were higher with DES-PCI as a result of more frequent hospitalizations, revascularization procedures, and higher medication costs. Over a lifetime horizon, CABG remained more costly than DES-PCI, but the incremental cost-effectiveness ratio was favorable ($16 537 per quality-adjusted life-year gained) and remained <$20 000 per quality-adjusted life-year in most bootstrap replicates. Results were consistent across a wide range of assumptions about the long-term effect of CABG versus DES-PCI on events and costs. In patients with left main disease or a SYNTAX score ≤22, however, DES-PCI was economically dominant compared with CABG, although these findings were less certain. CONCLUSIONS: For most patients with 3-vessel or left main coronary artery disease, CABG is a clinically and economically attractive revascularization strategy compared with DES-PCI. However, among patients with less complex disease, DES-PCI may be preferred on both clinical and economic grounds. CLINICAL TRIAL REGISTRATION URL: www.clinicaltrials.gov. Unique identifier: NCT00114972.
Assuntos
Ponte de Artéria Coronária/economia , Ponte de Artéria Coronária/métodos , Doença da Artéria Coronariana , Stents Farmacológicos/economia , Intervenção Coronária Percutânea/economia , Intervenção Coronária Percutânea/métodos , Idoso , Assistência Ambulatorial/economia , Ponte de Artéria Coronária/mortalidade , Doença da Artéria Coronariana/economia , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/cirurgia , Vasos Coronários/cirurgia , Análise Custo-Benefício , Stents Farmacológicos/estatística & dados numéricos , Feminino , Custos Hospitalares , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/mortalidade , Médicos/economia , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Resultado do TratamentoRESUMO
Every year, the EAPCI Board invites presidents and representatives of the interventional working groups affiliated to EAPCI to discuss issues and strategies surrounding the goals of education and advanced healthcare practices in interventional cardiology. In 2013, the 2nd EAPCI Summit, organised by the EAPCI Board in collaboration with the NIFYI committee, was entirely dedicated to discussing the unmet needs of the young generation of interventional cardiologists. In this article, we highlight a selection of the key points and proposed actions highlighted during the summit.
Assuntos
Cardiologia , Avaliação das Necessidades , Educação Médica Continuada , Europa (Continente) , Bolsas de Estudo , Humanos , Mentores , Pesquisa , Sociedades MédicasRESUMO
OBJECTIVES: This study sought to evaluate the accuracy, reproducibility, and predictive value for post-procedural aortic regurgitation (AR) of an automated multidetector computed tomography (MDCT) post-processing imaging software, 3mensio Valves (version 5.1.sp1, 3mensio Medical Imaging BV, the Netherlands), in the assessment of patients undergoing transcatheter aortic valve implantation (TAVI). BACKGROUND: Accurate pre-operative aortic annulus measurements are crucial for patients undergoing TAVI. METHODS: One hundred five patients undergoing MDCT screening before TAVI were evaluated. Aortic annular measurement was compared between automated 3mensio Valves software and manual data post-processing software on a dedicated workstation; we analyzed the discrimination value of annulus measurement for post-procedural AR in 44 recipients of a self-expanding valve. RESULTS: The automated 3mensio Valves software showed good concordance with manual MDCT measurements as demonstrated by Bland-Altman analysis. The automated software provided equally good reproducibility as manual measurement, especially for measurement of aortic annulus area (intraobserver intraclass correlation coefficients 0.98 vs. 0.97, interobserver 0.98 vs. 0.95). In 44 patients after implantation of a self-expanding valve, the valve diameter/CT-measured geometric mean annulus diameter ratio by automated 3mensio Valves software showed moderate and better discrimination ability in predicting post-procedural AR compared with manual measurement (p = 0.12, area under the curve 0.77, 95% confidence interval: 0.63 to 0.91, area under the curve 0.68, 95% confidence interval: 0.50 to 0.86, respectively). CONCLUSIONS: The automated 3mensio Valves software demonstrated reliable, reproducible aortic annulus measurement and better predictive value for post-procedural AR, suggesting important clinical implications for pre-operative assessment of patients undergoing TAVI.
Assuntos
Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/terapia , Valva Aórtica/diagnóstico por imagem , Cateterismo Cardíaco , Implante de Prótese de Valva Cardíaca/métodos , Imageamento Tridimensional , Tomografia Computadorizada Multidetectores , Interpretação de Imagem Radiográfica Assistida por Computador , Idoso , Idoso de 80 Anos ou mais , Área Sob a Curva , Automação Laboratorial , Cateterismo Cardíaco/instrumentação , Feminino , Próteses Valvulares Cardíacas , Implante de Prótese de Valva Cardíaca/instrumentação , Humanos , Masculino , Variações Dependentes do Observador , Seleção de Pacientes , Valor Preditivo dos Testes , Estudos Prospectivos , Desenho de Prótese , Curva ROC , Reprodutibilidade dos Testes , Índice de Gravidade de Doença , SoftwareRESUMO
OBJECTIVES: The purpose of this study was to examine the performance of the European system for cardiac operative risk evaluation II (ESII) in patients undergoing transcatheter aortic valve implantation (TAVI). BACKGROUND: The ESII was developed recently to improve the predictive value of the original logistic EuroSCORE (LES). METHODS: Between October 2006 and November 2011, 453 consecutive patients with severe aortic stenosis undergoing TAVI with either the Edwards valve or the Corevalve were included in the current analysis. The performance of the ESII, LES, and society of thoracic surgeons predicted risk of mortality score (STS) was evaluated. RESULTS: Mean age was 83.1 ± 6.4 years. The Edwards valve was used in 382 patients (84.3%) of the cohort, transfemoral approach (TF) in 55.0%, transapical approach (TA) in 25.2%, transaortic approach (TAo) 17.8%, transsubclabian approach (SC) 2.0%. The observed 30-day mortality was 12.6% (11.2, 18.4, 7.4, and 22.2% for TF, TA, TAo, SC, respectively). The mean LES, STS, and ESII were 22.4 ± 12.1, 8.1 ± 6.0, and 8.1 ± 5.2, respectively. The Hosmer-Lemeshow test showed ESII was inadequately calibrated for 30-day mortality compared with other risk scores (ESII P = 0.09, LES P = 0.84, STS P = 0.34). By using the area under the receiver operating characteristic curve (AUC), ESII better predicted 30-day mortality, albeit poorly, compared to LES and STS (AUC = 0.68, 0.65, and 0.60, respectively). In the TF cohort, ESII was better in predicting 30-day mortality compared to LES and STS (AUC = 0.74, 0.61, 0.60, respectively). CONCLUSIONS: Although the ESII demonstrated better predictive performance especially in the TF cohort, ESII is still inadequate in predicting mortality after TAVI as are LES and STS.
Assuntos
Estenose da Valva Aórtica/terapia , Cateterismo Cardíaco/mortalidade , Indicadores Básicos de Saúde , Implante de Prótese de Valva Cardíaca/mortalidade , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/mortalidade , Área Sob a Curva , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/instrumentação , Feminino , Próteses Valvulares Cardíacas , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/instrumentação , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Estimativa de Kaplan-Meier , Modelos Logísticos , Masculino , Análise Multivariada , Razão de Chances , Desenho de Prótese , Curva ROC , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Resultado do TratamentoRESUMO
Cardiovascular disease is the leading cause of death amongst women, with acute coronary syndromes (ACS) representing a significant proportion. It has been reported that in women presenting with ACS there is underdiagnosis and consequent undertreatment leading to an increase in hospital and long-term mortality. Several factors have to be taken into account, including lack of awareness both at patient and at physician level. Women are generally not aware of the cardiovascular risk and symptoms, often atypical, and therefore wait longer to seek medical attention. In addition, physicians often underestimate the risk of ACS in women leading to a further delay in accurate diagnosis and timely appropriate treatment, including cardiac catheterisation and primary percutaneous coronary intervention, with consequent delayed revascularisation times. It has been acknowledged by the European Society of Cardiology that gender disparities do exist, with a Class I, Level of Evidence B recommendation that both genders should be treated in the same way when presenting with ACS. However, there is still a lack of awareness and the mission of Women in Innovation, in association with Stent for Life, is to change the perception of women with ACS and to achieve prompt diagnosis and treatment.
Assuntos
Síndrome Coronariana Aguda/terapia , Disparidades nos Níveis de Saúde , Disparidades em Assistência à Saúde , Infarto do Miocárdio/terapia , Revascularização Miocárdica , Saúde da Mulher , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/mortalidade , Conscientização , Feminino , Comportamentos Relacionados com a Saúde , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Masculino , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/mortalidade , Revascularização Miocárdica/efeitos adversos , Revascularização Miocárdica/mortalidade , Educação de Pacientes como Assunto , Medição de Risco , Fatores de Risco , Fatores Sexuais , Fatores de Tempo , Tempo para o Tratamento , Resultado do TratamentoRESUMO
BACKGROUND: As assessment of SYNTAX score is made by visual estimate of coronary angiography, discrepancies between evaluations by different observers and the impact of observer experience have not yet been evaluated. METHODS: Using the data of 166 patients with unprotected left main lesions treated with the second generation everolimus-eluting stent, we sought to analyze SYNTAX score assessment provided by one junior and two independent senior observers and to assess the impact of the quality of angiographies on the reproducibility of SYNTAX score determination. Intra-observer variability was assessed by a senior observer by analyzing 50 sets of angiograms after an interval of at least 6 weeks. RESULTS: The weighted kappa value for the inter-observer reproducibility of SYNTAX score classified as tertiles, according to SYNTAX trial, was 0.71 and the intra-observer weighted kappa value was 0.79. When compared with junior's measurements, SYNTAX score assessed by senior investigators was 0.46 and 0.50. Changes in SYNTAX score classification were arbitrarily responsible for changes in weighted kappa values. Angiograms showing the higher rates of discrepancies between observers were of lower quality, when compared with random angiograms. SYNTAX score was closely correlated to 1-year incidence of major adverse cerebro- and cardiovascular events for both junior and senior readers. CONCLUSIONS: SYNTAX score was slightly underestimated by junior reader, when compared with experienced operators. Inter- and intra-observer reproducibility of experienced operators was very acceptable. SYNTAX score evaluation was clearly related to the quality of angiograms. SYNTAX score was correlated to 1-year incidence of major cardiac and cerebrovascular events (MACCE) in all readers.
Assuntos
Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Intervenção Coronária Percutânea , Fármacos Cardiovasculares/administração & dosagem , Doenças Cardiovasculares/etiologia , Doenças Cardiovasculares/mortalidade , Distribuição de Qui-Quadrado , Competência Clínica , Doença da Artéria Coronariana/mortalidade , Stents Farmacológicos , Everolimo , França/epidemiologia , Humanos , Incidência , Variações Dependentes do Observador , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/mortalidade , Valor Preditivo dos Testes , Desenho de Prótese , Reprodutibilidade dos Testes , Medição de Risco , Fatores de Risco , Sirolimo/administração & dosagem , Sirolimo/análogos & derivados , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Left ventricular ejection fraction (LVEF) is an important indicator of left ventricular function and of the severity and prognosis of ischaemic heart disease. Assessment of regional function using the wall motion score index (WMSI) is an alternative means of evaluating left ventricular function. AIM: We attempted to evaluate LVEF by a method using the WMSI with cardiac magnetic resonance imaging (MRI). METHODS: One hundred and twenty-two patients referred for evaluation of heart disease had rest WMSI evaluation by cardiac MRI. The WMSI was evaluated using the 16-segment model and score proposed by the American Society of Echocardiography. In our first group of 80 patients, a correlation between WMSI and cardiac MRI LVEF was established and a regression equation was derived. This regression equation was then used in 42 consecutive patients to compare WMSI LVEF with the gold standard MRI LVEF. RESULTS: In the first 80 patients, MRI LVEF and WMSI correlated very well (r=0.93). Similarly, in the second group of 42 patients, WMSI LVEF derived from the regression equation correlated very well with MRI LVEF (r=0.94). CONCLUSION: An objective evaluation of LVEF can be easily made using the WMSI with cardiac MRI, which correlates very well with standard MRI planimetric methods.
Assuntos
Imagem Cinética por Ressonância Magnética , Volume Sistólico , Disfunção Ventricular Esquerda/diagnóstico , Função Ventricular Esquerda , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , França , Humanos , Processamento de Imagem Assistida por Computador , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Variações Dependentes do Observador , Valor Preditivo dos Testes , Reprodutibilidade dos Testes , Índice de Gravidade de Doença , Ultrassonografia , Disfunção Ventricular Esquerda/diagnóstico por imagem , Disfunção Ventricular Esquerda/fisiopatologiaRESUMO
OBJECTIVES: We aimed to assess the predictive value of the SYNTAX score (SXscore) for major adverse cardiac events in the all-comers population of the LEADERS (Limus Eluted from A Durable versus ERodable Stent coating) trial. BACKGROUND: The SXscore has been shown to be an effective predictor of clinical outcomes in patients with multivessel disease undergoing percutaneous coronary intervention. METHODS: The SXscore was prospectively collected in 1,397 of the 1,707 patients enrolled in the LEADERS trial (patients after surgical revascularization were excluded). Post hoc analysis was performed by stratifying clinical outcomes at 1-year follow-up, according to 1 of 3 SXscore tertiles. RESULTS: The 1,397 patients were divided into tertiles based on the SXscore in the following fashion: SXscore
Assuntos
Stents Farmacológicos , Infarto do Miocárdio/diagnóstico por imagem , Infarto do Miocárdio/tratamento farmacológico , Vigilância da População/métodos , Índice de Gravidade de Doença , Idoso , Stents Farmacológicos/efeitos adversos , Stents Farmacológicos/normas , Feminino , Seguimentos , Humanos , Masculino , Estudos Prospectivos , Radiografia , Valores de Referência , Medição de RiscoRESUMO
AIMS: The SYNTAX score has been designed to better anticipate the risks of percutaneous or surgical revascularisation, taking into account the functional impact of the coronary circulation with all its anatomic components including the presence of bifurcations, total occlusions, thrombus, calcification, and small vessels. The purpose of this paper is to describe the baseline assessment of the SYNTAX score in the Syntax randomised trial, the corelab reproducibility, the potential difference in score assessment between the investigator and the corelab, and to ascertain the impact on one-year outcome after either percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) in patients with complex coronary artery disease. METHODS AND RESULTS: To assess the reliability of Syntax scoring, 100 diagnostic angiograms from the Syntax trial were randomly selected and assessed independently by two observers. Intra-observer variability was assessed by analysing 91 sets of angiograms after an interval of at least eight weeks by one of the observers. Clinical outcomes in the randomised cohort of the Syntax trial up to one year are presented with stratification by tertile group of the SYNTAX score. The weighted kappa value for the inter-observer reproducibility on the global score was 0.45, while the intra-observer weighted kappa value was 0.59. The SYNTAX score as calculated by investigators consistently underscored the corelab score by 3.4 points. When the Syntax randomised cohort was stratified by tertiles of the SYNTAX score, there were similar or non-significantly different MACCE rates in those with low or intermediate scores; however in the top tertile the MACCE rate was greater in those receiving PCI compared to CABG. CONCLUSIONS: The SYNTAX score is a visual coronary score with an acceptable corelab reproducibility that has an impact on the one-year outcome of those having PCI, whereas it has no effect on the one-year outcome following surgical revascularisation. The SYNTAX score tool is likely to be useful in a wide range of patients with complex coronary disease.
Assuntos
Angioplastia Coronária com Balão , Angiografia Coronária , Ponte de Artéria Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Angioplastia Coronária com Balão/efeitos adversos , Doenças Cardiovasculares/etiologia , Ponte de Artéria Coronária/efeitos adversos , Doença da Artéria Coronariana/cirurgia , Europa (Continente) , Humanos , Estudos Multicêntricos como Assunto , Variações Dependentes do Observador , Valor Preditivo dos Testes , Ensaios Clínicos Controlados Aleatórios como Assunto , Sistema de Registros , Reprodutibilidade dos Testes , Estudos Retrospectivos , Medição de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento , Estados UnidosRESUMO
AIMS: Cardiovascular magnetic resonance imaging (CMR) perfusion studies performed early after successful angioplasty in AMI nearly always shows incomplete tissue reperfusion despite normal coronary blood flow by TIMI score. In contrast, when performed a few weeks or months after AMI, CMR first-pass perfusion (FP) is usually normal. This study was conducted to determine the kinetics of tissue reperfusion after reperfused AMI in humans. METHODS AND RESULTS: We prospectively analyzed patients who presented with ST-segment elevation myocardial infarction between July 2002 and January 2005. Included patients had TIMI 3 flow after acute PCI and CMR FP imaging within four months post-MI. CMR FP was performed after injection of 20 cc of gadolinium chelate and imaging was performed with a Siemens Symphony 1.5 T. For FP analysis, each slice was divided into 8 segments which were subdivided into subepicardial and subendocardial layers. Normal perfusion was defined as less than 5% of segments involved by hypoperfusion. Patients were divided into groups according to the delay between MI/reperfusion and CMR. The reperfusion curve was established by plotting the percentage of patients with normal perfusion in each subgroup. A total of 184 CMR were analysed out of 146 patients included in the study. Probability of normal perfusion was 24%, 31%, 35%, 33% and 43% at respectively day 1, day 2, day 4, day 6 and day 8. This probability increased to 67% at week 2, and at week 3 reached a 100% probability (Spearman's rho -0.471, p = 0.001). CONCLUSIONS: Despite complete restoration of epicardial flow, early myocardial reperfusion as assessed by CMR is very uncommon. Myocardial perfusion is progressively restored and capillary blood volume recovered normal values between weeks 2 and 4 after MI.