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BACKGROUND: COVID-19 has disrupted the care of all patients, and little is known about its impact on the utilization and short-term mortality of percutaneous coronary intervention (PCI) patients, particularly nonemergency patients. METHODS: New York State's PCI registry was used to study the utilization of PCI and the presence of COVID-19 in four patient subgroups ranging in severity from ST-elevation myocardial infarction (STEMI) to elective patients before (December 01, 2018-February 29, 2020) and during the COVID-19 era (March 01, 2020-May 31, 2021), as well as to examine the impact of different COVID severity levels on the mortality of different types of PCI patients. RESULTS: Decreases in the mean quarterly PCI volume from the prepandemic period to the first quarter of the pandemic ranged from 20% for STEMI patients to 61% for elective patients, with the other two subgroups having decreases in between these values. PCI quarterly volume rebounds from the prepandemic period to the second quarter of 2021 were in excess of 90% for all patient subgroups, and 99.7% for elective patients. Existing COVID-19 was rare among PCI patients, ranging from 1.74% for STEMI patients to 3.66% for elective patients. PCI patients with COVID-19 and acute respiratory distress syndrome (ARDS) who were not intubated, and PCI patients with COVID-19 and ARDS who were either intubated or were not intubated because of Do Not Resuscitate//Do Not Intubate status had higher risk-adjusted mortality ([adjusted ORs = 10.81 [4.39, 26.63] and 24.53 [12.06, 49.88], respectively]) than patients who never had COVID-19. CONCLUSIONS: There were large decreases in the utilization of PCI during COVID-19, with the percentage of decrease being highly sensitive to patient acuity. By the second quarter of 2021, prepandemic volumes were nearly restored for all patient subgroups. Very few PCI patients had current COVID-19 throughout the pandemic period, but the number of PCI patients with a COVID-19 history increased steadily during the pandemic. PCI patients with COVID-19 accompanied by ARDS were at much higher risk of short-term mortality than patients who never had COVID-19. COVID-19 without ARDS and history of COVID-19 were not associated with higher mortality for PCI patients as of the second quarter of 2021.
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COVID-19 , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Humanos , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Infarto do Miocárdio com Supradesnível do Segmento ST/etiologia , New York/epidemiologia , Intervenção Coronária Percutânea/efeitos adversos , Resultado do TratamentoRESUMO
Pendrin is an intercalated cell Cl-/[Formula: see text] exchanger thought to participate in K+-sparing NaCl absorption. However, its role in K+ homeostasis has not been clearly defined. We hypothesized that pendrin-null mice will develop hypokalemia with dietary K+ restriction. We further hypothesized that pendrin knockout (KO) mice mitigate urinary K+ loss by downregulating the epithelial Na+ channel (ENaC). Thus, we examined the role of ENaC in Na+ and K+ balance in pendrin KO and wild-type mice following dietary K+ restriction. To do so, we examined the relationship between Na+ and K+ balance and ENaC subunit abundance in K+-restricted pendrin-null and wild-type mice that were NaCl restricted or replete. Following a NaCl-replete, K+-restricted diet, K+ balance and serum K+ were similar in both groups. However, following a Na+, K+, and Cl--deficient diet, pendrin KO mice developed hypokalemia from increased K+ excretion. The fall in serum K+ observed in K+-restricted pendrin KO mice was enhanced with ENaC stimulation but eliminated with ENaC inhibition. The fall in serum K+ observed in K+-restricted pendrin KO mice was enhanced with ENaC stimulation but eliminated with ENaC inhibition. However, reducing ENaC activity also reduced blood pressure and increased apparent intravascular volume contraction, since KO mice had lower serum Na+, higher blood urea nitrogen and hemoglobin, greater weight loss, greater metabolic alkalosis, and greater NaCl excretion. We conclude that dietary Na+ and K+ restriction induces hypokalemia in pendrin KO mice. Pendrin-null mice limit renal K+ loss by downregulating ENaC. However, this ENaC downregulation occurs at the expense of intravascular volume.NEW & NOTEWORTHY Pendrin is an apical Cl-/[Formula: see text] exchanger that provides renal K+-sparing NaCl absorption. The pendrin-null kidney has an inability to fully conserve K+ and limits renal K+ loss by downregulating the epithelial Na+ channel (ENaC). However, with Na+ restriction, the need to reduce ENaC for K+ balance conflicts with the need to stimulate ENaC for intravascular volume. Therefore, NaCl restriction stimulates ENaC less in pendrin-null mice than in wild-type mice, which mitigates their kaliuresis and hypokalemia but exacerbates volume contraction.
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Hipopotassemia , Animais , Proteínas de Transporte de Ânions/metabolismo , Dieta , Canais Epiteliais de Sódio/metabolismo , Camundongos , Camundongos KnockoutRESUMO
OBJECTIVES: To compare mortality for women and men hospitalized with ST-elevation myocardial infarction (STEMI) by age and revascularization status. BACKGROUND: There is little information on the mortality of men and women not undergoing revascularization, and the impact of age on relative male-female mortality needs to be revisited. METHODS AND RESULTS: An observational database of 23,809 patients with STEMI presenting at nonfederal New York State hospitals between 2013 and 2015 was used to compare risk-adjusted inhospital/30-day mortality for women and men and to explore the impact of age on those differences. Women had significantly higher mortality than men overall (adjusted odds ratio [AOR] = 1.15, 95% CI [1.04, 1.28]), and among patients aged 65 and older. Women had lower revascularization rates in general (AOR = 0.64 [0.59, 0.69]) and for all age groups. Among revascularized STEMI patients, women overall (AOR = 1.30 [1.10, 1.53]) and over 65 had higher mortality than men. Among patients not revascularized, women between the ages of 45 and 64 had lower mortality (AOR = 0.68 [0.48, 0.97]). CONCLUSIONS: Women with STEMI, and especially older women, had higher inhospital/30-day mortality rates than their male counterparts. Women had higher mortality among revascularized patients, but not among patients who were not revascularized.
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Disparidades nos Níveis de Saúde , Disparidades em Assistência à Saúde , Revascularização Miocárdica , Admissão do Paciente , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Bases de Dados Factuais , Feminino , Mortalidade Hospitalar , Humanos , Masculino , Pessoa de Meia-Idade , Revascularização Miocárdica/efeitos adversos , Revascularização Miocárdica/mortalidade , Medição de Risco , Fatores de Risco , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Fatores Sexuais , Fatores de Tempo , Resultado do Tratamento , Adulto JovemRESUMO
BACKGROUND: Target lesion percutaneous coronary intervention (TLPCI) within 1 year of PCI has been proposed by critics of public reporting of short-term mortality as an alternative measure for PCI reporting. METHODS: New York's PCI registry was used to identify 1-year repeat TLPCI and 1-year repeat TLPCI/mortality for patients discharged between December 1, 2013 and November 30, 2014. Significant independent predictors of the outcomes were identified. Hospital and cardiologist risk-adjusted outcomes were calculated, and outlier status and correlations of risk-adjusted rates were examined for the three outcomes. RESULTS: The adverse outcome rates were 1.30, 4.21, and 8.97% for in-hospital/30-day mortality, 1-year repeat TLPCI, and 1-year repeat TLPCI/mortality. There were many commonalities but also many differences in significant predictors of the outcomes. Hospital and cardiologist risk-adjusted 1-year repeat TLPCI rates and repeat TLPCI/mortality rates were poorly correlated with risk-adjusted in-hospital/30-day mortality rates (eg, Spearman R = -.16 [p = .23] and .27 [p = .04], respectively, for hospital 1-year repeat TLPCI vs. in-hospital/30-day mortality). Many more providers were found to have significantly higher and lower rates for repeat TLPCI than for short-term mortality. CONCLUSIONS: Hospital and cardiologist quality assessments are very different for TLPCI and repeat TLPCI/mortality than they are for short-term mortality. Repeat TLPCI/mortality rates are highly correlated with repeat TLPCI rates, but outlier providers differ. More study of repeat TLPCI and all the patient, cardiologist, and hospital factors associated with it may be required before using it as a supplement to, or in lieu of, short-term mortality in public reporting of PCI outcomes.
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Doença da Artéria Coronariana/terapia , Avaliação de Processos e Resultados em Cuidados de Saúde/normas , Intervenção Coronária Percutânea/normas , Registros Públicos de Dados de Cuidados de Saúde , Garantia da Qualidade dos Cuidados de Saúde/normas , Indicadores de Qualidade em Assistência à Saúde/normas , Idoso , Idoso de 80 Anos ou mais , Cardiologistas/normas , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Bases de Dados Factuais , Feminino , Mortalidade Hospitalar , Hospitais/normas , Humanos , Masculino , Pessoa de Meia-Idade , New York , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Sistema de Registros , Retratamento/normas , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Many studies have compared outcomes for incomplete revascularization (IR) among patients undergoing percutaneous coronary interventions (PCIs), but little is known about the correlates of IR, the extent to which complete revascularization (CR) was attempted unsuccessfully, and the variation across operators in the use of IR. METHODS: New York's PCI registry was used to examine medium-term mortality for IR, the variables associated with the use of IR, and the variation across operators in the utilization of IR after controlling for patient factors. RESULTS: Incomplete revascularization occurred for 63% of all patients and was significantly associated with higher 3-year mortality (adjusted hazard ratio1.35, 95% CI 1.23-1.48) than for CR. A total of 96% of all attempted CRs were successful. Operators with 15 or fewer years in practice (the lowest half) used IR significantly more (65% vs 61%, adjusted odds ratio [AOR] 1.17, 95% CI 1.00-1.37) than other operators, and operators with annual volumes of 171 or lower (the lowest 3 quartiles) used IR more than other operators (68% vs 60%, AOR 1.35, 95% CI 1.14-1.59). Also, hospitals with annual volumes of 645 and lower (the lowest 50% of hospitals) used IR more (67% vs 62%, AOR 1.46, 95% CI 1.07-1.99) than other hospitals. CONCLUSIONS: Percutaneous coronary intervention patients without myocardial infarction who undergo IR continue to have higher medium-term (3-year) risk-adjusted mortality rates. There is a large amount of variability among operators in the frequency with which IR occurs. Operators who have been in practice longer, and higher-volume operators and hospitals have lower rates of IR. Failed attempts at CR occur very infrequently.
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Cardiologistas/normas , Competência Clínica , Estenose Coronária/terapia , Hospitais/estatística & dados numéricos , Intervenção Coronária Percutânea , Idoso , Idoso de 80 Anos ou mais , Estenose Coronária/mortalidade , Humanos , Pessoa de Meia-Idade , New York/epidemiologia , Fatores de Risco , Falha de TratamentoRESUMO
BACKGROUND: In some randomized trials comparing revascularization strategies for patients with diabetes, coronary-artery bypass grafting (CABG) has had a better outcome than percutaneous coronary intervention (PCI). We sought to discover whether aggressive medical therapy and the use of drug-eluting stents could alter the revascularization approach for patients with diabetes and multivessel coronary artery disease. METHODS: In this randomized trial, we assigned patients with diabetes and multivessel coronary artery disease to undergo either PCI with drug-eluting stents or CABG. The patients were followed for a minimum of 2 years (median among survivors, 3.8 years). All patients were prescribed currently recommended medical therapies for the control of low-density lipoprotein cholesterol, systolic blood pressure, and glycated hemoglobin. The primary outcome measure was a composite of death from any cause, nonfatal myocardial infarction, or nonfatal stroke. RESULTS: From 2005 through 2010, we enrolled 1900 patients at 140 international centers. The patients' mean age was 63.1±9.1 years, 29% were women, and 83% had three-vessel disease. The primary outcome occurred more frequently in the PCI group (P=0.005), with 5-year rates of 26.6% in the PCI group and 18.7% in the CABG group. The benefit of CABG was driven by differences in rates of both myocardial infarction (P<0.001) and death from any cause (P=0.049). Stroke was more frequent in the CABG group, with 5-year rates of 2.4% in the PCI group and 5.2% in the CABG group (P=0.03). CONCLUSIONS: For patients with diabetes and advanced coronary artery disease, CABG was superior to PCI in that it significantly reduced rates of death and myocardial infarction, with a higher rate of stroke. (Funded by the National Heart, Lung, and Blood Institute and others; FREEDOM ClinicalTrials.gov number, NCT00086450.).
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Angioplastia Coronária com Balão , Ponte de Artéria Coronária , Doença da Artéria Coronariana/terapia , Complicações do Diabetes/terapia , Stents Farmacológicos , Idoso , Doenças Cardiovasculares/mortalidade , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/cirurgia , Complicações do Diabetes/cirurgia , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Acidente Vascular Cerebral/epidemiologiaRESUMO
Patients with diabetes have a high incidence of coronary artery disease, with particularly high rates of acute coronary syndromes and mortality. Revascularization by coronary artery bypass grafting was found to be effective in reducing angina and mortality in patients with extensive coronary artery disease over 30 years ago. Percutaneous coronary intervention, particularly with drug-eluting stents, has more recently been demonstrated to reduce recurrent angina and improve quality of life in diabetic patients with less extensive coronary artery disease. Most recently, coronary artery bypass grafting has been shown to be superior to percutaneous coronary intervention in improving mortality in patients with diabetes and three-vessel coronary artery disease who are not at high surgical risk. The role of coronary artery bypass grafting vs. percutaneous coronary intervention in patients who have less extensive coronary artery disease and/or higher surgical risk has not been fully elucidated. Newer treatment strategies, such as percutaneous coronary intervention with second-generation drug-eluting stents, use of fractional flow reserve guidance, or hybrid revascularization combining minimally invasive coronary artery bypass grafting with percutaneous coronary intervention, may result in further improvements in outcomes in patients with diabetes and coronary artery disease.
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Angioplastia Coronária com Balão/métodos , Ponte de Artéria Coronária/métodos , Angiopatias Diabéticas/terapia , Síndrome Coronariana Aguda/terapia , Angioplastia Coronária com Balão/instrumentação , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , HumanosRESUMO
BACKGROUND/PURPOSE: There has been increasing emphasis on the development of new technology to mitigate unmet clinical needs in cardiovascular disease. This emphasis results in part from recognition that many devices, although being initially developed in the United States, were studied, and then eventually approved abroad before being returned to the U.S. for clinical application. The FDA (Food and Drug Administration) guidance document on Early Feasibility Studies (EFS) and then the 21st Century Cures Act from 2013 to 2016 focused on these issues. MATERIALS/METHODS: There are multiple components of medical device translational pathways to be considered in continuing to reach the goal of providing early access to safe and effective products to the U.S. POPULATION: This review article documents the various stages from early idea innovation to device design and iteration to clinical testing and then potential approval and application in the wide clinical practice of cardiovascular health care. RESULTS: The CDRH (Centers for Devices and Radiological Health) has focused on key components including EFS, Breakthrough Devices Program, Total Product Life Cycle, the Unique Device Identification Program, the establishment of a Digital Health Center of Excellence, and leveraging Collaborative Communities. Each of these initiatives focuses on improving the Medical Device Development Ecosystem. CONCLUSIONS: Major changes in device translational research have improved the device research climate in the United States. Goals remain including increased training and education for constituencies aspiring to work in the field of device development and regulation as part of a continuous health care learning system.
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Doenças Cardiovasculares , Ecossistema , Estados Unidos , Humanos , Aprovação de Equipamentos , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/terapia , United States Food and Drug Administration , Estudos de ViabilidadeRESUMO
BACKGROUND: Little is known about what treatments patients receive after being diagnosed with stable coronary artery disease or what the comparative outcomes are for routine medical treatment (RMT) versus percutaneous coronary intervention (PCI) with RMT for patients in a setting apart from randomized controlled trials. METHODS AND RESULTS: Patients with stable coronary artery disease undergoing cardiac catheterization in New York State between 2003 and 2008 were followed up to determine the treatment they received. Patients receiving RMT and patients receiving PCI with RMT were propensity matched through the use of 20 factors that could have a bearing on outcomes. The resulting cohort of 933 matched pairs was used to compare mortality/myocardial infarction (MI), mortality, MI, and subsequent revascularization rates. A total of 89% of all patients underwent PCI with RMT. PCI/RMT patients had significantly lower adverse outcome rates at 4 years for mortality/MI (16.5% versus 21.2%; P=0.003), mortality (10.2% versus 14.5%; P=0.02), MI (8.0% versus 11.3%; P=0.007), and subsequent revascularization (24.1% versus 29.1%; P=0.005). Adjusted RMT versus (PCI with RMT) hazard ratios were 1.49 (95% confidence interval, 1.16-1.93) for mortality/MI and 1.46 (95% confidence interval, 1.08-1.97) for mortality. There were no differences for patients ≤ 65 years of age or for patients with single-vessel disease. CONCLUSIONS: Most patients with stable coronary artery disease in New York undergoing catheterization between 2003 and 2008 received PCI. Patients who received PCI experienced lower mortality, mortality/MI, and revascularization rates. The reasons for this finding need to be better understood, including the possible role of low medication adherence rates that have been found in other studies.
Assuntos
Angioplastia Coronária com Balão , Doença da Artéria Coronariana/terapia , Idoso , Idoso de 80 Anos ou mais , Angioplastia Coronária com Balão/efeitos adversos , Doença da Artéria Coronariana/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pontuação de Propensão , Resultado do TratamentoRESUMO
BACKGROUND: The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial assigned patients with type 2 diabetes mellitus to prompt coronary revascularization plus intensive medical therapy versus intensive medical therapy alone and reported no significant difference in mortality. Among patients selected for coronary artery bypass graft surgery, prompt coronary revascularization was associated with a significant reduction in death/myocardial infarction/stroke compared with intensive medical therapy. We hypothesized that clinical and angiographic risk stratification would affect the effectiveness of the treatments overall and within revascularization strata. METHODS AND RESULTS: An angiographic risk score was developed from variables assessed at randomization; independent prognostic factors were myocardial jeopardy index, total number of coronary lesions, prior coronary revascularization, and left ventricular ejection fraction. The Framingham Risk Score for patients with coronary disease was used to summarize clinical risk. Cardiovascular event rates were compared by assigned treatment within high-risk and low-risk subgroups. Overall, no outcome differences between the intensive medical therapy and prompt coronary revascularization groups were seen in any risk stratum. The 5-year risk of death/myocardial infarction/stroke was 36.8% for intensive medical therapy compared with 24.8% for prompt coronary revascularization among the 381 coronary artery bypass graft surgery-selected patients in the highest angiographic risk tertile (P=0.005); this treatment effect was amplified in patients with both high angiographic and high Framingham risk (47.3% intensive medical therapy versus 27.1% prompt coronary revascularization; P=0.010; hazard ratio=2.10; P=0.009). Treatment group differences were not significant in other clinical-angiographic risk groups within the coronary artery bypass graft surgery stratum, or in any subgroups within the percutaneous coronary intervention stratum. CONCLUSION: Among patients with diabetes mellitus and stable ischemic heart disease, a strategy of prompt coronary artery bypass graft surgery significantly reduces the rate of death/myocardial infarction MI/stroke in those with extensive coronary artery disease or impaired left ventricular function. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00006305.
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Angioplastia Coronária com Balão , Angiografia Coronária , Ponte de Artéria Coronária , Diabetes Mellitus Tipo 2/diagnóstico por imagem , Diabetes Mellitus Tipo 2/terapia , Idoso , Angioplastia Coronária com Balão/métodos , Angiografia Coronária/métodos , Ponte de Artéria Coronária/métodos , Diabetes Mellitus Tipo 2/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/métodos , Fatores de Risco , Resultado do TratamentoRESUMO
OBJECTIVES: To compare 2-year outcomes (mortality, mortality/myocardial infarction (MI), target vessel PCI (TVPCI), and target lesion PCI (TLPCI)) for patients receiving EES and ZES. BACKGROUND: The utilization of drug-eluting coronary stents (DES) among patients undergoing percutaneous coronary interventions (PCI) has increased dramatically in the last decade. Everolimus-eluting stents (EES) and ENDEAVOR zotarolimus eluting stents (ZES) constitute the latest generation of approved DES in the United States, but little is known about their relative effectiveness. METHODS: New York patients undergoing EES and ZES revascularization without any other type of stent between 7/08 and 12/08 were propensity matched at the hospital level using multiple patient, operator, and hospital characteristics, and matched patients were followed through the end of 2010 to obtain comparative 2-year outcomes. RESULTS: A total of 3286 patients were propensity-matched. Patients receiving EES had a significantly lower TVPCI rate (9.0% vs. 11.9%, AHR = 1.31, 95% CI (1.04, 1.65)) and a significantly lower TLPCI rate (6.0% vs. 8.3%, AHR = 1.35, 95% CI (1.02, 1.79)). There was no significant difference between EES and ZES for mortality or MI/mortality. CONCLUSIONS: There were no significant differences in the hard endpoints of death or MI between patients who received EES versus those who received ZES (ENDEAVOR). Patients with EES experienced lower repeat revascularization rates than patients with ZES at 24 months.
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Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea/instrumentação , Sirolimo/análogos & derivados , Idoso , Idoso de 80 Anos ou mais , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/mortalidade , Everolimo , Feminino , Humanos , Estimativa de Kaplan-Meier , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Infarto do Miocárdio/mortalidade , New York , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Pontuação de Propensão , Modelos de Riscos Proporcionais , Desenho de Prótese , Sistema de Registros , Medição de Risco , Fatores de Risco , Sirolimo/administração & dosagem , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVE: To determine whether disparities in access to invasive cardiac procedures still exist for Medicaid patients, given how old earlier studies are and given changes in the interim in appropriateness guidelines. PATIENTS AND METHODS: A total of 5,022 Medicaid and private insurance patients in New York from January 1, 2008 through December 31, 2009 under age 65 with ST-elevation myocardial infarction (STEMI) were compared with regard to their access to percutaneous coronary interventions (PCI) before and after controlling for numerous patient characteristics and other important factors. RESULTS: Medicaid patients were significantly less likely to be admitted initially to a hospital certified to perform PCI (90.4% vs. 94.3%, P < 0.001). Also, Medicaid patients were found to be significantly less likely to undergo PCI than other patients (adjusted odds ratio [AOR] = 0.81, 95% CI 0.66, 0.98, P = 0.03). When the probability of each hospital performing PCI for STEMI patients was controlled for, Medicaid patients were still less likely to undergo PCI after controlling for other risk factors (AOR = 0.80, 95% CI 0.65, 0.99, P = 0.04). CONCLUSIONS: Medicaid STEMI patients are significantly less likely to undergo PCI within the same day of admission as private pay patients even after adjusting for patient characteristics related to receiving PCI, and the strength of this relationship is not diminished when controlling for whether the admitting hospital has approval to perform PCI or controlling for the tendency of the admitting hospital to treat STEMI with PCI.
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Acessibilidade aos Serviços de Saúde/tendências , Seguro Saúde , Medicaid , Infarto do Miocárdio/cirurgia , Intervenção Coronária Percutânea , Idoso , Feminino , Guias como Assunto , Humanos , Masculino , Pessoa de Meia-Idade , New York , Estados UnidosAssuntos
Angioplastia Coronária com Balão/história , Doença das Coronárias/tratamento farmacológico , Doença das Coronárias/terapia , Angioplastia Coronária com Balão/instrumentação , Anticoagulantes/uso terapêutico , Alemanha , História do Século XX , Humanos , Masculino , Suíça , Estados Unidos , Varfarina/uso terapêuticoRESUMO
IMPORTANCE: The current recommendation is for at least 12 months of dual antiplatelet therapy after implantation of a drug-eluting stent. However, the optimal duration of dual antiplatelet therapy with specific types of drug-eluting stents remains unknown. OBJECTIVE: To assess the clinical noninferiority of 3 months (short-term) vs 12 months (long-term) of dual antiplatelet therapy in patients undergoing percutaneous coronary intervention (PCI) with zotarolimus-eluting stents. DESIGN, SETTING, AND PATIENTS: The OPTIMIZE trial was an open-label, active-controlled, 1:1 randomized noninferiority study including 3119 patients in 33 sites in Brazil between April 2010 and March 2012. Clinical follow-up was performed at 1, 3, 6, and 12 months. Eligible patients were those with stable coronary artery disease or history of low-risk acute coronary syndrome (ACS) undergoing PCI with zotarolimus-eluting stents. INTERVENTIONS: After PCI with zotarolimus-eluting stents, patients were prescribed aspirin (100-200 mg daily) and clopidogrel (75 mg daily) for 3 months (n = 1563) or 12 months (n = 1556), unless contraindicated because of occurrence of an end point. MAIN OUTCOMES AND MEASURES: The primary end point was net adverse clinical and cerebral events (NACCE; a composite of all-cause death, myocardial infarction [MI], stroke, or major bleeding); the expected event rate at 1 year was 9%, with a noninferiority margin of 2.7%. Secondary end points were major adverse cardiac events (MACE; a composite of all-cause death, MI, emergent coronary artery bypass graft surgery, or target lesion revascularization) and Academic Research Consortium definite or probable stent thrombosis. RESULTS: NACCE occurred in 93 patients receiving short-term and 90 patients receiving long-term therapy (6.0% vs 5.8%, respectively; risk difference, 0.17 [95% CI, -1.52 to 1.86]; P = .002 for noninferiority). Kaplan-Meier estimates demonstrated MACE rates at 1 year of 8.3% (128) in the short-term group and 7.4% (114) in the long-term group (HR, 1.12 [95% CI, 0.87-1.45]). Between 91 and 360 days, no statistically significant association was observed for NACCE (39 [2.6%] vs 38 [2.6%] for the short- and long-term groups, respectively; HR, 1.03 [95% CI, 0.66-1.60]), MACE (78 [5.3%] vs 64 [4.3%]; HR, 1.22 [95% CI, 0.88-1.70]), or stent thrombosis (4 [0.3%] vs 1 [0.1%]; HR, 3.97 [95% CI, 0.44-35.49]). CONCLUSIONS AND RELEVANCE: In patients with stable coronary artery disease or low-risk ACS treated with zotarolimus-eluting stents, 3 months of dual antiplatelet therapy was noninferior to 12 months for NACCE, without significantly increasing the risk of stent thrombosis. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01113372.
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Síndrome Coronariana Aguda/terapia , Aspirina/administração & dosagem , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Inibidores da Agregação Plaquetária/administração & dosagem , Ticlopidina/análogos & derivados , Idoso , Aspirina/efeitos adversos , Clopidogrel , Esquema de Medicação , Quimioterapia Combinada , Feminino , Hemorragia , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio , Inibidores da Agregação Plaquetária/efeitos adversos , Risco , Sirolimo/administração & dosagem , Sirolimo/análogos & derivados , Acidente Vascular Cerebral , Trombose , Ticlopidina/administração & dosagem , Ticlopidina/efeitos adversosRESUMO
Risk models and risk scores derived from those models require periodic updating to account for changes in procedural performance, patient mix, and new risk factors added to existing systems. No risk model or risk score exists for predicting in-hospital/30-day mortality for percutaneous coronary interventions (PCIs) using contemporary data. This study develops an updated risk model and simplified risk score for in-hospital/30-day mortality following PCI. To accomplish this, New York's Percutaneous Coronary Intervention Reporting System was used to develop a logistic regression model and a simplified risk score model for predicting in-hospital/30-day mortality and to validate both models based on New York data from the previous year. A total of 54,770 PCI patients from 2019 were used to develop the models. Twelve different risk factors and 27 risk factor categories were used in the models. Both models displayed excellent discrimination for the development and validation samples (range from 0.894 to 0.896) and acceptable calibration, but the full logistic model had superior calibration, particularly among higher-risk patients. In conclusion, both the PCI risk model and its simplified risk score model provide excellent discrimination and although the full risk model requires the use of a hand-held device for estimating individual patient risk, it provides somewhat better calibration, especially among higher-risk patients.
Assuntos
Intervenção Coronária Percutânea , Humanos , Intervenção Coronária Percutânea/efeitos adversos , New York/epidemiologia , Medição de Risco , Fatores de Risco , Mortalidade Hospitalar , HospitaisRESUMO
BACKGROUND: There is very little information about the use of ad hoc percutaneous coronary intervention (PCI) in stable patients with multivessel (MV) disease or unprotected left main (LM) disease patients for whom a heart team approach is recommended. OBJECTIVE: To identify the extent of ad hoc PCI utilization for patients with multivessel disease or left main disease, and to explore the inter-hospital variation in ad hoc PCI utilization for those patients. METHODS: New York State's cardiac registries were used to examine the use and variation in use of ad hoc PCI for MV/LM disease as a percentage of all MV/LM PCIs and revascularizations (PCIs plus coronary artery bypass graft procedures) during 2018 to 2019 in New York. RESULTS: After exclusions, 6,425 of the 8,196 stable PCI patients with MV/LM disease (78.4%) underwent ad hoc PCI, ranging from 58.7% for patients with unprotected LM disease to 85.4% for patients with 2-vessel proximal left anterior descending (PLAD) disease. Ad hoc PCIs comprised 35.1% of all revascularizations, ranging from 11.5% for patients with unprotected LM disease to 63.9% for patients with 2-vessel PLAD disease. The risk-adjusted utilization of ad hoc PCI as a percentage of all revascularizations varied widely among hospitals (eg, from 15% in the first quartile to 46% in the last quartile for 3-vessel disease). CONCLUSIONS: Ad hoc PCIs occur frequently even among patients with MV/LM disease. This is particularly true among patients with 2-vessel PLAD disease. The frequency of ad hoc PCIs is lower but still high among patients with diabetes and low ejection fraction and higher in hospitals without surgery on-site (SOS). Given the magnitude of hospital- and physician-level variation in the use of ad hoc PCIs for such patients, consideration should be given to a systems approach to achieving heart team consultation and shared decision making that is consistent for SOS and non-SOS hospitals.