Assuntos
Doença da Artéria Coronariana , Estenose Coronária , Reserva Fracionada de Fluxo Miocárdico , Humanos , Resultado do Tratamento , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Angiografia Coronária , Vasos Coronários , Valor Preditivo dos TestesAssuntos
Tomada de Decisão Clínica , Definição da Elegibilidade/legislação & jurisprudência , Política de Saúde/legislação & jurisprudência , Medicare/legislação & jurisprudência , Seleção de Pacientes , Substituição da Valva Aórtica Transcateter/legislação & jurisprudência , Consenso , Planos de Pagamento por Serviço Prestado/legislação & jurisprudência , Acessibilidade aos Serviços de Saúde/legislação & jurisprudência , Necessidades e Demandas de Serviços de Saúde/legislação & jurisprudência , Humanos , Formulação de Políticas , Estados UnidosRESUMO
BACKGROUND: Both the prevalence and complexity of coronary artery disease are on the rise in the United States, leading to a resurgence in novel techniques and equipment utilized to treat complex coronary disease. However, declining percutaneous coronary intervention (PCI) volumes and lack of formal post-graduate education opportunities have created a gap in treatment delivery for this patient population. Several complex, high-risk, and indicated PCI (CHIP) fellowships have been developed in an attempt to bridge this disparity. We present data from the first year of practice from a former CHIP fellow during development of a formal complex coronary therapeutics program. METHODS: Data was prospectively collected for PCIs performed during the first 12 months of practice for the lead author and compared to procedures performed in the 12 months prior to the study period. RESULTS: Out of 371 PCIs performed during the study period, 53.4% (198/371) were considered complex, including 126 chronic total occlusion (CTO) procedures. Compared to the previous 12 months, there was a significant increase in the number and complexity (median J-CTO score 2.1 vs. 1.3, p .04) of CTOs performed during the study period. CTO procedural characteristics and complication rates were similar to those previously published in large U.S. registries, with technical success in 93.4% (118/126) and procedural success in 85.7% (108/126). CONCLUSION: Following dedicated CHIP fellowship training and establishment of a formal CHIP program, procedural success and complication rates were achieved similar to those published in prior studies evaluating CTO PCI at high volume centers.
Assuntos
Cardiologistas/educação , Competência Clínica , Doença da Artéria Coronariana/terapia , Oclusão Coronária/terapia , Educação de Pós-Graduação em Medicina , Bolsas de Estudo , Intervenção Coronária Percutânea/educação , Idoso , Doença Crônica , Currículo , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Sistema de Registros , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Women may derive differential benefit from prolonged DAPT (dual antiplatelet therapy) after coronary stenting than men. We assessed whether the risks/benefits of prolonged DAPT differ between women and men. METHODS AND RESULTS: The DAPT study was a randomized double-blind, placebo-controlled trial comparing continued thienopyridine versus placebo beyond 12 months after coronary stenting. We compared rates of myocardial infarction, stent thrombosis, major adverse cardiovascular and cerebrovascular events, and bleeding by sex and randomized treatment. Of 11 648 patients, women (N=2925) were older, with higher prevalence of diabetes mellitus and lower rates of acute coronary syndrome than men. At 12 to 30 months, women had similar adjusted ischemic and bleeding events as men. The effects of continued thienopyridine therapy did not differ significantly by sex for stent thrombosis (women: hazard ratio [HR], 0.54; 95% confidence interval [CI], 0.22-1.36; men: HR, 0.26; 95% CI, 0.15-0.44; interaction P=0.17), myocardial infarction (women: HR, 0.75; 95% CI, 0.50-1.14; men: HR, 0.46; 95% CI, 0.36-0.60; interaction P=0.052), major adverse cardiovascular and cerebrovascular events (women: HR, 0.87; 95% CI, 0.62-1.22; men: HR, 0.70; 95% CI, 0.58-0.85; interaction P=0.26), and bleeding (women: HR, 1.45; 95% CI, 0.88-2.40; men: HR, 1.78; 95% CI, 1.28-2.49; interaction P=0.50). CONCLUSIONS: Women had similar late risks of ischemia and bleeding as men after coronary stent procedures. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00977938.
Assuntos
Doença da Artéria Coronariana/cirurgia , Intervenção Coronária Percutânea/instrumentação , Inibidores da Agregação Plaquetária/administração & dosagem , Stents , Tienopiridinas/administração & dosagem , Comorbidade , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/fisiopatologia , Trombose Coronária/epidemiologia , Método Duplo-Cego , Esquema de Medicação , Quimioterapia Combinada , Feminino , Disparidades nos Níveis de Saúde , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Estudos Prospectivos , Recidiva , Medição de Risco , Fatores de Risco , Fatores Sexuais , Tienopiridinas/efeitos adversos , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Previous studies showed more adverse events with coronary bioresorbable vascular scaffolds (BVS) than with metallic drug-eluting stents (DES), although in one randomised trial angina was reduced with BVS. However, these early studies were unmasked, lesions smaller than intended for the scaffold were frequently enrolled, implantation technique was suboptimal, and patients with myocardial infarction, in whom BVS might be well suited, were excluded. METHODS: In the active-controlled, blinded, multicentre, randomised ABSORB IV trial, patients with stable coronary artery disease or acute coronary syndromes aged 18 years or older were recruited from 147 hospitals in five countries (the USA, Germany, Australia, Singapore, and Canada). Enrolled patients were randomly assigned (1:1) to receive polymeric everolimus-eluting BVS (Absorb; Abbott Vascular, Santa Clara, CA, USA) with optimised implantation technique or cobalt-chromium everolimus-eluting stents (EES; Xience; Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetic status, whether patients would have been eligible for enrolment in the previous ABSORB III trial, and site. Patients and clinical assessors were masked to randomisation. The primary endpoint was target lesion failure (cardiac death, target vessel myocardial infarction, or ischaemia-driven target lesion revascularisation) at 30 days, tested for non-inferiority with a 2·9% margin for the risk difference. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02173379, and is closed to accrual. FINDINGS: Between Aug 15, 2014, and March 31, 2017, we screened 18â722 patients for eligibility, 2604 of whom were enrolled. 1296 patients were assigned to BVS, and 1308 patients were assigned to EES. Follow-up data at 30 days and 1 year, respectively, were available for 1288 and 1254 patients with BVS and for 1303 and 1272 patients with EES. Biomarker-positive acute coronary syndromes were present in 622 (24%) of 2602 patients, and, by angiographic core laboratory analysis, 78 (3%) of 2893 of lesions were in very small vessels. Target lesion failure at 30 days occurred in 64 (5·0%) patients assigned to BVS and 48 (3·7%) patients assigned to EES (difference 1·3%, upper 97·5% confidence limit 2·89; one-sided pnon-inferiority=0·0244). Target lesion failure at 1 year occurred in 98 (7·8%) patients assigned to BVS and 82 (6·4%) patients assigned to EES (difference 1·4%, upper 97·5% confidence limit 3·4; one-sided pnon-inferiority=0·0006). Angina, adjudicated by a central events committee at 1 year, occurred in 270 (20·3%) patients assigned to BVS and 274 (20·5%) patients assigned to EES (difference -0·3%, 95% CI -3·4% to 2·9%; one-sided pnon-inferiority=0·0008; two-sided psuperiority=0·8603). Device thrombosis within 1 year occurred in nine (0·7%) patients assigned to BVS and four (0·3%) patients assigned to EES (p=0·1586). INTERPRETATION: Polymeric BVS implanted with optimised technique in an expanded patient population resulted in non-inferior 30-day and 1-year rates of target lesion failure and angina compared with metallic DES. FUNDING: Abbott Vascular.
Assuntos
Implantes Absorvíveis , Doença da Artéria Coronariana/terapia , Alicerces Teciduais , Síndrome Coronariana Aguda/terapia , Idoso , Materiais Biocompatíveis , Doença da Artéria Coronariana/patologia , Método Duplo-Cego , Stents Farmacológicos , Everolimo/administração & dosagem , Feminino , Seguimentos , Humanos , Imunossupressores/administração & dosagem , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Resultado do TratamentoRESUMO
OBJECTIVES: The purpose of this study was to evaluate the economic impact of the Absorb bioresorbable vascular scaffold compared with the Xience everolimus-eluting stent in patients undergoing percutaneous coronary intervention. BACKGROUND: The ABSORB III trial (Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease) demonstrated that the Absorb scaffold was noninferior to the Xience stent with respect to target lesion failure at 1 year. Whether health care costs differ between the Absorb scaffold and the Xience stent is unknown. METHODS: We performed a prospective health economic study alongside the ABSORB III trial, in which patients undergoing percutaneous coronary intervention for stable or unstable angina were randomized to receive the Absorb scaffold (n = 1,322) or Xience stent (n = 686). Resource use data were collected through 1 year of follow-up. Costs were assessed using resource-based accounting (for procedures), MedPAR data (for other index hospitalization costs), and Medicare reimbursements (for follow-up costs and physician fees). RESULTS: Initial procedural costs were higher with the Absorb scaffold than the Xience stent ($6,316 ± 1,892 vs. $6,103 ± 1,895; p = 0.02), driven mainly by greater balloon catheter use and the higher cost of the scaffold in the Absorb group. Nonetheless, index hospitalization costs ($15,035 ± 2,992 for Absorb vs. $14,903 ± 3,449 for Xience; p = 0.37) and total 1-year costs ($17,848 ± 6,110 for Absorb vs. $17,498 ± 7,411 for Xience; p = 0.29) were similar between the 2 groups. CONCLUSIONS: Although initial procedural costs were higher with the Absorb scaffold, there were no differences in total 1-year health care costs between the 2 cohorts. Longer term follow-up is needed to determine whether meaningful cost savings emerge after scaffold resorption. (A Clinical Evaluation of Absorb™ BVS, the Everolimus-Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT01751906).
Assuntos
Implantes Absorvíveis/economia , Fármacos Cardiovasculares/administração & dosagem , Fármacos Cardiovasculares/economia , Doença da Artéria Coronariana/economia , Doença da Artéria Coronariana/terapia , Stents Farmacológicos/economia , Everolimo/administração & dosagem , Everolimo/economia , Custos de Cuidados de Saúde , Intervenção Coronária Percutânea/economia , Intervenção Coronária Percutânea/instrumentação , Idoso , Austrália , Fármacos Cardiovasculares/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Custos de Medicamentos , Everolimo/efeitos adversos , Feminino , Custos Hospitalares , Humanos , Reembolso de Seguro de Saúde/economia , Masculino , Medicare/economia , Pessoa de Meia-Idade , Modelos Econômicos , Intervenção Coronária Percutânea/efeitos adversos , Estudos Prospectivos , Desenho de Prótese , Fatores de Tempo , Resultado do Tratamento , Estados UnidosAssuntos
Implantes Absorvíveis , Angiografia Coronária , Doença da Artéria Coronariana/terapia , Vasos Coronários/diagnóstico por imagem , Imageamento Tridimensional , Imagem Multimodal/métodos , Intervenção Coronária Percutânea/instrumentação , Tomografia de Coerência Óptica , Idoso , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/fisiopatologia , Circulação Coronária , Vasos Coronários/fisiopatologia , Feminino , Humanos , Valor Preditivo dos Testes , Desenho de Prótese , Interpretação de Imagem Radiográfica Assistida por Computador , Ensaios Clínicos Controlados Aleatórios como Assunto , Estresse Mecânico , Resultado do TratamentoRESUMO
BACKGROUND: The access to and growth of percutaneous coronary intervention (PCI) has not been fully explored with regard to geographic equity and need. Economic factors and timely access to primary PCI provide the impetus for growth in PCI centers, and this is balanced by volume standards and the benefits of regionalized care. METHODS AND RESULTS: Geospatial and statistical analyses were used to model capacity, growth, and access of PCI hospitals relative to population density and myocardial infarction (MI) prevalence at the state level. Longitudinal data were obtained for 2003-2011 from the American Hospital Association, the U.S. Census, and the Centers for Disease Control and Prevention (CDC) with geographical modeling to map PCI locations. The number of PCI centers has grown 21.2% over the last 8 years, with 39% of all hospitals having interventional cardiology capabilities. During the same time, the US population has grown 8.3%, from 217 million to 235 million, and MI prevalence rates have decreased from 4.0% to 3.7%. The most densely concentrated states have a ratio of 8.1 to 12.1 PCI facilities per million of population with significant variability in both MI prevalence and average distance between PCI facilities. CONCLUSIONS: Over the last decade, the growth rate for PCI centers is 1.5× that of the population growth, while MI prevalence is decreasing. This has created geographic imbalances and access barriers with excess PCI centers relative to need in some regions and inadequate access in others.
Assuntos
Acessibilidade aos Serviços de Saúde/tendências , Necessidades e Demandas de Serviços de Saúde/tendências , Hospitais/tendências , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea/tendências , Censos , Centers for Disease Control and Prevention, U.S. , Humanos , Densidade Demográfica , Prevalência , Características de Residência , Fatores de Tempo , Estados Unidos/epidemiologiaRESUMO
BACKGROUND: Although implantable cardioverter-defibrillators (ICDs) reduce mortality in primary prevention patients with left ventricular systolic dysfunction, recent studies have questioned their overall role in clinical practice, especially in older patients and those with major comorbid conditions. METHODS AND RESULTS: In a prospective cohort of 965 patients with ischemic and nonischemic cardiomyopathies (ejection fraction
Assuntos
Arritmias Cardíacas/prevenção & controle , Desfibriladores Implantáveis , Cardioversão Elétrica/instrumentação , Prevenção Primária/instrumentação , Disfunção Ventricular Esquerda/terapia , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Arritmias Cardíacas/economia , Arritmias Cardíacas/etiologia , Arritmias Cardíacas/mortalidade , Comorbidade , Análise Custo-Benefício , Desfibriladores Implantáveis/economia , Cardioversão Elétrica/economia , Custos de Cuidados de Saúde , Humanos , Estimativa de Kaplan-Meier , Cadeias de Markov , Pessoa de Meia-Idade , Seleção de Pacientes , Prevenção Primária/economia , Pontuação de Propensão , Modelos de Riscos Proporcionais , Estudos Prospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos/epidemiologia , Disfunção Ventricular Esquerda/complicações , Disfunção Ventricular Esquerda/economia , Disfunção Ventricular Esquerda/mortalidadeRESUMO
BACKGROUND: Ticagrelor is the first reversibly binding oral P2Y(12) receptor antagonist. This is the first study to compare the onset and offset of platelet inhibition (IPA) with ticagrelor using the PLATO (PLATelet inhibition and patient Outcomes) trial loading dose (180 mg) with a high loading dose (600 mg) of clopidogrel. METHODS AND RESULTS: In a multicenter, randomized, double-blind study, 123 patients with stable coronary artery disease who were taking aspirin therapy (75 to 100 mg/d) received ticagrelor (180-mg load, 90-mg BID maintenance dose [n=57]), clopidogrel (600-mg load, 75-mg/d maintenance dose [n=54]), or placebo (n=12) for 6 weeks. Greater IPA (20 micromol/L ADP, final extent) occurred with ticagrelor than with clopidogrel at 0.5, 1, 2, 4, 8, and 24 hours after loading and at 6 weeks (P<0.0001 for all); by 2 hours after loading, a greater proportion of patients achieved >50% IPA (98% versus 31%, P<0.0001) and >70% IPA (90% versus 16%, P<0.0001) in the ticagrelor group than in the clopidogrel group, respectively. A faster offset occurred with ticagrelor than with clopidogrel (4-to-72-hour slope [% IPA/h] -1.04 versus -0.48, P<0.0001). At 24 hours after the last dose, mean IPA was 58% for ticagrelor versus 52% for clopidogrel (P=NS). IPA for ticagrelor on day 3 after the last dose was comparable to clopidogrel at day 5; IPA on day 5 for ticagrelor was similar to clopidogrel on day 7 and did not differ from placebo (P=NS). CONCLUSIONS: Ticagrelor achieved more rapid and greater platelet inhibition than high-loading-dose clopidogrel; this was sustained during the maintenance phase and was faster in offset after drug discontinuation.
Assuntos
Adenosina/análogos & derivados , Doença da Artéria Coronariana/tratamento farmacológico , Inibidores da Agregação Plaquetária/uso terapêutico , Ticlopidina/análogos & derivados , Adenosina/uso terapêutico , Idoso , Aspirina/uso terapêutico , Clopidogrel , Doença da Artéria Coronariana/metabolismo , Relação Dose-Resposta a Droga , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fosfoproteínas/metabolismo , Fosforilação , Ticagrelor , Ticlopidina/uso terapêutico , Resultado do TratamentoAssuntos
Angioplastia Coronária com Balão , Doença das Coronárias/terapia , Readmissão do Paciente , Idoso , Doença das Coronárias/complicações , Planos de Pagamento por Serviço Prestado , Hospitais/classificação , Humanos , Medicare , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/terapia , Retratamento , Estados UnidosAssuntos
Atenção à Saúde , Imperícia , Atitude do Pessoal de Saúde , Compensação e Reparação/legislação & jurisprudência , Atenção à Saúde/legislação & jurisprudência , Humanos , Seguro de Responsabilidade Civil/economia , Seguro de Responsabilidade Civil/legislação & jurisprudência , Advogados/psicologia , Responsabilidade Legal/economia , Médicos/psicologia , Justiça Social , Estados UnidosAssuntos
Atenção à Saúde , Direitos Humanos , Reembolso de Seguro de Saúde/tendências , Cobertura Universal do Seguro de Saúde/ética , Consenso , Atenção à Saúde/economia , Prova Pericial , Previsões , Setor de Assistência à Saúde , Acessibilidade aos Serviços de Saúde , Humanos , Seguro Saúde/economia , Pessoas sem Cobertura de Seguro de Saúde , Justiça Social , Estados UnidosAssuntos
Pesquisa Biomédica/legislação & jurisprudência , Confidencialidade/legislação & jurisprudência , Health Insurance Portability and Accountability Act/legislação & jurisprudência , Assistência ao Paciente/tendências , Pesquisa Biomédica/economia , Prova Pericial , Humanos , Prontuários Médicos/economia , Prontuários Médicos/legislação & jurisprudência , Prontuários Médicos/normas , Estados UnidosAssuntos
Angina Instável/terapia , Angioplastia Coronária com Balão/métodos , Cateterismo Cardíaco/métodos , Fármacos Hematológicos/uso terapêutico , Infarto do Miocárdio/terapia , Angina Instável/tratamento farmacológico , Ensaios Clínicos como Assunto , Farmacoeconomia , Inibidores do Fator Xa , Fármacos Hematológicos/economia , Humanos , Infarto do Miocárdio/tratamento farmacológico , Complexo Glicoproteico GPIIb-IIIa de Plaquetas/antagonistas & inibidores , Guias de Prática Clínica como Assunto , Medição de Risco , StentsAssuntos
Ensaios Clínicos como Assunto , Inibidores da Agregação Plaquetária/economia , Complexo Glicoproteico GPIIb-IIIa de Plaquetas/antagonistas & inibidores , Tirosina/análogos & derivados , Abciximab , Angioplastia Coronária com Balão/métodos , Anticorpos Monoclonais/economia , Anticorpos Monoclonais/uso terapêutico , Doenças Cardiovasculares/tratamento farmacológico , Ensaios Clínicos como Assunto/economia , Trombose Coronária/tratamento farmacológico , Trombose Coronária/prevenção & controle , Análise Custo-Benefício , Eptifibatida , Humanos , Fragmentos Fab das Imunoglobulinas/economia , Fragmentos Fab das Imunoglobulinas/uso terapêutico , Peptídeos/economia , Peptídeos/uso terapêutico , Inibidores da Agregação Plaquetária/uso terapêutico , Padrões de Prática Médica/economia , Tirofibana , Tirosina/economia , Tirosina/uso terapêuticoRESUMO
BACKGROUND: Angiographic features of vessels in which stents have been deployed can be used to predict the risk of postprocedural ischemic events. The purpose of this study was to compare the effects of abciximab in patients with and without high-risk postprocedure features. METHODS AND RESULTS: Protocol-mandated stent implantation was performed in 1586 patients in the Evaluation of Platelet IIb/IIIa Inhibitor for Stenting trial, 783 of whom received abciximab, and was successful in 97% of the patients. High-risk features were defined as the presence of Thrombolysis In Myocardial Infarction (TIMI) flow <3, presence of thrombus or major dissection, or residual stenosis >10%. The primary endpoint was a composite of death, myocardial infarction, and urgent target vessel revascularization at 30 days. High-risk features were present in 21% of the patients. In patients without high-risk features after stent placement, abciximab reduced the primary endpoint from 9.0% to 3.9% (P <.001) compared with 16.2% to 8.6% (P =.046) in patients in whom high-risk features were present. There was no statistical evidence of interaction between abciximab treatment and the presence or absence of high-risk features. CONCLUSION: Glycoprotein IIb-IIIa antagonism with abciximab is equally effective in prevention of a composite of ischemic events in patients with and without high-risk features after stent placement. However, patients in whom high-risk features are present after stent placement are at increased risk of ischemic cardiac events even with abciximab treatment.