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BACKGROUND: The rate of intracranial haemorrhage after an acute coronary syndrome has been studied in detail in the era of thrombolysis; however, in the contemporary era of percutaneous coronary intervention, most of the data have been derived from clinical trials. With this background, we aim to analyse the incidence, timing, predictors and prognostic impact of post-discharge intracranial haemorrhage in patients with acute coronary syndrome undergoing percutaneous coronary intervention. METHODS: We analysed data from the BleeMACS registry (patients discharged for acute coronary syndrome and undergoing percutaneous coronary intervention from Europe, Asia and America, 2003-2014). Analyses were conducted using a competing risk framework. Uni and multivariate predictors of intracranial haemorrhage were assessed using the Fine-Gray proportional hazards regression analysis. The endpoint was 1-year post-discharge intracranial haemorrhage. RESULTS: Of 11,136 patients, 30 presented with intracranial haemorrhage during the first year (0.27%). The median time to intracranial haemorrhage was 150 days (interquartile range 55.7-319.5). The fatality rate of intracranial haemorrhage was very high (30%). After multivariate analysis, only age (subhazard ratio 1.05, 95% confidence interval 1.01-1.07) and prior stroke/transient ischaemic attack (hazard ratio 3.29, 95% confidence interval 1.36-8.00) were independently associated with a higher risk of intracranial haemorrhage. Hypertension showed a trend to associate with higher intracranial haemorrhage rate. The combination of older age (⩾75 years), prior stroke/transient ischaemic attack, and/or hypertension allowed us to identify most of the patients with intracranial haemorrhage (86.7%). The annual rate of intracranial haemorrhage was 0.1% in patients with no risk factors, 0.2% in those with one factor, 0.6% in those with two factors and 1.3% in those with three factors. CONCLUSION: The incidence of intracranial haemorrhage in the first year after an acute coronary syndrome treated with percutaneous coronary intervention is low. Advanced age, previous stroke/transient ischaemic attack, and hypertension are the main predictors of increased intracranial haemorrhage risk.
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Síndrome Coronariana Aguda/cirurgia , Hemorragias Intracranianas/epidemiologia , Intervenção Coronária Percutânea/efeitos adversos , Sistema de Registros , Medição de Risco/métodos , Idoso , Feminino , Saúde Global , Humanos , Incidência , Hemorragias Intracranianas/etiologia , Masculino , Prognóstico , Fatores de RiscoRESUMO
INTRODUCTION AND OBJECTIVES: For patients with acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI), it is unclear whether angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) are associated with reduced mortality, particularly with preserved left ventricular ejection fraction (LVEF). The goal of this study was to determine the association between ACEI/ARB and mortality in ACS patients undergoing PCI, with and without reduced LVEF. METHODS: Data from the BleeMACS registry were used. The endpoint was 1-year all-cause mortality. The prognostic value of ACEI/ARB was tested after weighting by survival-time inverse probability and after adjustment by Cox regression, propensity score, and instrumental variable analysis. RESULTS: Among 15 401 ACS patients who underwent PCI, ACEI/ARB were prescribed in 75.2%. There were 569 deaths (3.7%) during the first year after hospital discharge. After multivariable adjustment, ACEI/ARB were associated with lower 1-year mortality, ≤ 40% (HR, 0.62; 95%CI, 0.43-0.90; P=.012). The relative risk reduction of ACEI/ARB in mortality was 46.1% in patients with LVEF ≤ 40%, and 15.7% in patients with LVEF> 40% (P value for treatment-by-LVEF interaction=.008). For patients with LVEF> 40%, ACEI/ARB was associated with lower mortality only in ST-segment elevation myocardial infarction (HR, 0.44; 95%CI, 0.21-0.93; P=.031). CONCLUSION: The benefit of ACEI/ARB in decreasing mortality after an ACS in patients undergoing PCI is concentrated in patients with LVEF ≤ 40%, and in those with LVEF> 40% and ST-segment elevation myocardial infarction. In non-ST-segment elevation-ACS patients with LVEF> 40%, further studies are needed to assess the prognostic impact of ACEI/ARB.
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Síndrome Coronariana Aguda/terapia , Antagonistas de Receptores de Angiotensina/uso terapêutico , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Intervenção Coronária Percutânea/métodos , Sistema Renina-Angiotensina/efeitos dos fármacos , Volume Sistólico/fisiologia , Função Ventricular Esquerda/fisiologia , Síndrome Coronariana Aguda/mortalidade , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Pontuação de Propensão , Sistema de Registros , Estudos Retrospectivos , Resultado do TratamentoRESUMO
The relationship between obstructive sleep apnea (OSA) and adverse cardiovascular outcomes in patients undergoing percutaneous coronary intervention (PCI) remains unclear. We performed a systematic review and meta-analysis to assess the impact of OSA on subsequent cardiovascular events after PCI.We searched the PubMed, EMBASE, and Cochrane library from their inceptions to August 5, 2017. We included cohort studies that described the association between OSA (based on apnea-hypopnea index) and cardiovascular outcomes after PCI with stenting. The primary endpoint was major adverse cardiovascular event (MACE), including all-cause or cardiovascular death, myocardial infarction, stroke, repeat revascularization, or heart failure. Outcomes data were pooled using random effects models and heterogeneity was assessed with the I statistic.We identified 9 studies with 2755 participants. The prevalence of OSA in patients treated with PCI ranged from 35.3% to 61.8%. OSA was associated with increased risk of MACE after PCI (pooled risk ratio [RR] 1.96, 95% confidence interval [CI]: 1.36-2.81, Pâ<â.001, Iâ=â54%). Between-study heterogeneity was partially explained by sample size (2 studies with ≤100 participants; RR 9.12, 95% CI: 2.69-31.00, Iâ=â0% vs 7 studies with >100 participants; RR 1.64, 95% CI: 1.23-2.18, Iâ=â35%). Moreover, the presence of OSA significantly increased the incidence of all-cause death (4 studies), cardiovascular death (4 studies), and repeat revascularization (7 studies) in patients undergoing PCI.Patients with OSA are at greater risk of subsequent cardiovascular events after PCI. Whether treatment of OSA prevents such events warrants further investigation.
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Doenças Cardiovasculares/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Complicações Pós-Operatórias/etiologia , Apneia Obstrutiva do Sono/complicações , Idoso , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/instrumentação , Fatores de Risco , Stents/efeitos adversosRESUMO
INTRODUCTION: Bleeding is an independent risk factor of mortality in patients with acute coronary syndromes (ACS). BleeMACS project focuses on long-term bleeding events after hospital discharge, thus we evaluated gender-related differences in post-discharge bleeding among patients with ACS. MATERIALS AND METHODS: We investigated 13,727 ACS patients treated with percutaneous coronary intervention and discharged on dual antiplatelet therapy (either with clopidogrel or prasugrel/ticagrelor). Endpoint was defined as intracranial bleeding or any other bleeding leading to hospitalization and/or red blood transfusion. RESULTS: Post-discharge bleeding was reported more frequently in females as compared with males (3.7% vs. 2.7%, log-rank Pâ¯=â¯0.001). Females (nâ¯=â¯3165, 23%) were older compared to men (69.0 vs. 61.5â¯years, Pâ¯<â¯0.001) and with more comorbidities. Hence, in multivariate analysis female sex was not identified as an independent risk factor of bleeding (HR 1.012, CI 0.805 to 1.274, Pâ¯=â¯0.816). Administration of newer antiplatelet agents compared to clopidogrel was associated with over twofold greater bleeding rate in females (7.3% vs. 3.5%, log-rank Pâ¯=â¯0.004), but not in males (2.6% vs. 2.7%, log-rank Pâ¯=â¯0.887). Differences among females remained significant after propensity score matching (7.2% vs 2.4%, log-rank Pâ¯=â¯0.020) and multivariate analysis confirmed that newer antiplatelet agents are independent risk factor for bleeding only in women (HR 2.775, CI 1.613 to 4.774, Pâ¯<â¯0.001). CONCLUSIONS: Bleeding events occurred more frequently in women, but female sex itself was not independent risk factor. Administration of newer antiplatelet agents was identified as independent risk factor of bleeding after hospital discharge in female gender, but not in male patients.
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Síndrome Coronariana Aguda/tratamento farmacológico , Hemorragia/induzido quimicamente , Inibidores da Agregação Plaquetária/uso terapêutico , Idoso , Feminino , Identidade de Gênero , Humanos , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação Plaquetária/farmacologia , Fatores de RiscoRESUMO
PURPOSE: The aim was to evaluate prognostic value of beta-blocker (BB) administration in acute coronary syndromes (ACS) patients in the percutaneous coronary intervention (PCI) era. METHODS AND RESULTS: The BleeMACS project is a multicenter, observational, retrospective registry enrolling patients with ACS worldwide in 15 hospitals. Patients discharged with BB therapy were compared to those discharged without a BB before and after propensity score with matching. The primary endpoint was all-cause mortality at 1 year. Secondary endpoints included in-hospital reinfarction, in-hospital heart failure, 1-year myocardial infarction, 1-year bleeding and 1-year composite of death and recurrent myocardial infarction. After matching, 2935 patients for each group were enrolled. The primary endpoint of 1-year death was significantly lower in the group on BB therapy (4.5 vs 7%, p < 0.05), while only a trend was noted for recurrent acute myocardial infarction (4.5 vs 4.9%, p = 0.54). These results were consistent for patients older than 80 years of age, for ST-elevation myocardial infarction (STEMI) patients, and for those discharged with complete versus incomplete revascularization, but not for non-STEMI/unstable angina patients. CONCLUSIONS: BB therapy was related to 1-year lower risk of all-cause mortality, independently from completeness of revascularization, admission diagnosis, age and ejection fraction. Randomized controlled trials for patients treated with PCI for ACS should be performed.
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Síndrome Coronariana Aguda/tratamento farmacológico , Síndrome Coronariana Aguda/terapia , Antagonistas Adrenérgicos beta/uso terapêutico , Idoso , Feminino , Mortalidade Hospitalar , Humanos , Masculino , Intervenção Coronária Percutânea/métodos , Pontuação de Propensão , Sistema de Registros , Estudos Retrospectivos , Infarto do Miocárdio com Supradesnível do Segmento ST/tratamento farmacológico , Resultado do TratamentoRESUMO
BACKGROUND: The prevalence and outcome of patients with cancer that experience acute coronary syndrome (ACS) have to be determined. METHODS AND RESULTS: The BleeMACS project is a multicentre observational registry enrolling patients with acute coronary syndrome undergoing percutaneous coronary intervention worldwide in 15 hospitals. The primary endpoint was a composite event of death and re-infarction after one year of follow-up. Bleedings were the secondary endpoint. 15,401 patients were enrolled, 926 (6.4%) in the cancer group and 14,475 (93.6%) in the group of patients without cancer. Patients with cancer were older (70.8±10.3 vs. 62.8±12.1 years, P<0.001) with more severe comorbidities and presented more frequently with non-ST-segment elevation myocardial infarction compared with patients without cancer. After one year, patients with cancer more often experienced the composite endpoint (15.2% vs. 5.3%, P<0.001) and bleedings (6.5% vs. 3%, P<0.001). At multiple regression analysis the presence of cancer was the strongest independent predictor for the primary endpoint (hazard ratio (HR) 2.1, 1.8-2.5, P<0.001) and bleedings (HR 1.5, 1.1-2.1, P=0.015). Despite patients with cancer generally being undertreated, beta-blockers (relative risk (RR) 0.6, 0.4-0.9, P=0.05), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (RR 0.5, 0.3-0.8, P=0.02), statins (RR 0.3, 0.2-0.5, P<0.001) and dual antiplatelet therapy (RR 0.5, 0.3-0.9, P=0.05) were shown to be protective factors, while proton pump inhibitors (RR 1, 0.6-1.5, P=0.9) were neutral. CONCLUSION: Cancer has a non-negligible prevalence in patients with acute coronary syndrome undergoing percutaneous coronary intervention, with a major risk of cardiovascular events and bleedings. Moreover, these patients are often undertreated from clinical despite medical therapy seems to be protective. Registration:The BleeMACS project (NCT02466854).
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Síndrome Coronariana Aguda/epidemiologia , Neoplasias/epidemiologia , Intervenção Coronária Percutânea , Complicações Pós-Operatórias/epidemiologia , Sistema de Registros , Medição de Risco , Síndrome Coronariana Aguda/complicações , Síndrome Coronariana Aguda/cirurgia , Idoso , Ásia/epidemiologia , Europa (Continente)/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/complicações , América do Norte/epidemiologia , Prevalência , América do Sul/epidemiologia , Taxa de Sobrevida/tendências , Resultado do TratamentoRESUMO
BACKGROUND: A poor ability of recommended risk scores for predicting in-hospital bleeding has been reported in elderly patients with acute coronary syndromes (ACS). No study assessed the prediction of post-discharge bleeding in the elderly. The new BleeMACS score (Bleeding complications in a Multicenter registry of patients discharged with diagnosis of Acute Coronary Syndrome), was designed to predict post-discharge bleeding in ACS patients. We aimed to assess the predictive ability of the BleeMACS score in elderly patients. METHODS: We assessed the incidence and characteristics of severe bleeding after discharge in ACS patients aged ≥ 75 years. Bleeding was defined as any intracranial bleeding or bleeding leading to hospitalization and/or red blood transfusion, occurring within the first year after discharge. We assessed the predictive ability of the BleeMACS score according to age by Fine-Gray proportional hazards regression analysis, calculating receiver-operating characteristic (ROC) curves and the area under the ROC curves (AUC). RESULTS: The BleeMACS registry included 15,401 patients of whom 3,376/15,401 (21.9%) were aged ≥ 75 years. Elderly patients were more commonly treated with clopidogrel and less often treated with ticagrelor or prasugrel. Of 3,376 elderly patients, 190 (5.6%) experienced post-discharge bleeding. The incidence of bleeding was moderately higher in elderly patients (hazard ratio [HR], 2.31, 95% confidence interval [CI], 1.92-2.77). The predictive ability of the BleeMACS score was moderately lower in elderly patients (AUC, 0.652 vs. 0.691, p = 0.001). CONCLUSION: Elderly patients with ACS had a significantly higher incidence of post-discharge bleeding. Despite a lower predictive ability in older patients, the BleeMACS score exhibited an acceptable performance in these patients.
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Síndrome Coronariana Aguda/cirurgia , Clopidogrel/efeitos adversos , Técnicas de Apoio para a Decisão , Hemorragias Intracranianas/induzido quimicamente , Alta do Paciente , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária/efeitos adversos , Síndrome Coronariana Aguda/diagnóstico , Fatores Etários , Idoso , Ásia/epidemiologia , Brasil/epidemiologia , Canadá/epidemiologia , Transfusão de Eritrócitos , Europa (Continente)/epidemiologia , Feminino , Humanos , Incidência , Hemorragias Intracranianas/diagnóstico , Hemorragias Intracranianas/epidemiologia , Hemorragias Intracranianas/terapia , Masculino , Pessoa de Meia-Idade , Readmissão do Paciente , Intervenção Coronária Percutânea/efeitos adversos , Cloridrato de Prasugrel/efeitos adversos , Valor Preditivo dos Testes , Sistema de Registros , Medição de Risco , Fatores de Risco , Ticagrelor/efeitos adversos , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Accurate 1-year bleeding risk estimation after hospital discharge for acute coronary syndrome (ACS) may help clinicians guide the type and duration of antithrombotic therapy. Currently there are no predictive models for this purpose. The aim of this study was to derive and validate a simple clinical tool for bedside risk estimation of 1-year post-discharge serious bleeding in ACS patients. METHODS: The risk score was derived and internally validated in the BleeMACS (Bleeding complications in a Multicenter registry of patients discharged with diagnosis of Acute Coronary Syndrome) registry, an observational international registry involving 15,401 patients surviving admission for ACS and undergoing percutaneous coronary intervention (PCI) from 2003 to 2014, engaging 15 hospitals from 10 countries located in America, Europe and Asia. External validation was conducted in the SWEDEHEART population, with 96,239 ACS patients underwent PCI and 93,150 without PCI. RESULTS: Seven independent predictors of bleeding were identified and included in the BleeMACS score: age, hypertension, vascular disease, history of bleeding, malignancy, creatinine and hemoglobin. The BleeMACS risk score exhibited a C-statistic value of 0.71 (95% CI 0.68-0.74) in the derivation cohort and 0.72 (95% CI 0.67-0.76) in the internal validation sample. In the SWEDEHEART external validation cohort, the C-statistic was 0.65 (95% CI 0.64-0.66) for PCI patients and 0.63 (95% CI 0.62-0.64) for non-PCI patients. The calibration was excellent in the derivation and validation cohorts. CONCLUSIONS: The BleeMACS bleeding risk score is a simple tool useful for identifying those ACS patients at higher risk of serious 1-year post-discharge bleeding. ClinicalTrials.govIdentifier: NCT02466854.
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Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/epidemiologia , Hemorragia/diagnóstico , Hemorragia/epidemiologia , Alta do Paciente/tendências , Índice de Gravidade de Doença , Idoso , Estudos de Coortes , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Suécia/epidemiologiaRESUMO
OBJECTIVE: The optimal antithrombotic regimen for patients on oral anticoagulation (OAC) after acute coronary syndrome (ACS) and percutaneous coronary intervention (PCI) remains debated. This study sought to evaluate the efficacy and safety of OAC plus clopidogrel with or without aspirin in a real-world setting. METHODS: We retrospectively analyzed data from an international, multi-center registry between 2003 and 2014 (n = 15,401). Patients with ACS and receiving OAC after PCI were screened. The composite primary endpoint was 1-year all-cause death, re-infarction, or severe bleeding. RESULTS: The final analysis enrolled 642 patients including 62 patients (9.7%) with OAC and clopidogrel (dual therapy), and 580 patients (90.3%) with the combination of aspirin, OAC and clopidogrel (triple therapy). Patients on triple therapy were more often female and were more likely to have comorbidities. There was no significant difference regarding the primary end point between dual therapy with triple therapy patients [17.74% vs. 17.24%; unadjusted hazard ratio (HR): 1.035; 95% confidence interval (CI): 0.556-1.929; adjusted HR: 1.026; 95% CI: 0.544-1.937]. However, the re-infarction rate was significantly higher in dual therapy than triple therapy patients (14.52% vs. 5.34%; unadjusted HR: 2.807; 95% CI: 1.329-5.928; adjusted HR: 2.333; 95% CI: 1.078-5.047). In addition, there was no difference between two regimes in all-cause death and severe bleeding. CONCLUSIONS: In real-life patients with ACS following PCI and with an indication of OAC, triple therapy was not associated with an increased rate of adverse outcomes compared to dual therapy. Moreover, it decreased risk of re-infarction and did not increase risk of severe bleeding.
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OBJECTIVE: Our objective was to define the most appropriate treatment for acute coronary syndrome (ACS) in patients with malignancy. METHODS AND RESULTS: The BleeMACS project is a worldwide multicenter observational prospective registry in 16 hospitals enrolling patients with ACS undergoing percutaneous coronary intervention. Primary endpoints were death, re-infarction, and major adverse cardiac events (MACE; composite of death and re-infarction) after 1 year of follow-up. The secondary endpoint was bleeding events during follow-up. We performed sub-study analyses according to whether ß-blockers (BBs), angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), statins, or proton pump inhibitors (PPIs) were prescribed at discharge. We also calculated the propensity score for optimal medical therapy (OMT; combination of BB, ACEI/ARB, and statins). The study included 926 patients. According to the multivariate analysis, ACEIs/ARBs (hazard ratio [HR] 0.58, 95 % confidence interval [CI] 0.36-1.94; p = 0.03) and statins (HR 0.37, 95 % CI 0.23-0.61; p < 0.01) reduced the risk of MACE, while the effects of BBs (HR 0.85, 95 % CI 0.55-1.32; p = 0.48) and PPIs (HR 1.33, 95 % CI 0.83-2.12; p = 0.23) were not significant. OMT was prescribed at discharge in 300 (32.4 %) patients; after propensity score analysis, OMT showed a significant reduction in death (3 % vs. 12.5 %, HR 0.21, 95 % CI 0.1-0.4; log-rank p < 0.001) and MACE (6.7 vs. 15.2 %, log-rank p = 0.01). CONCLUSION: In patients with ACS and malignancy, OMT reduces the risk of adverse events at 1 year; in particular, ACEIs/ARBs and statins were the most protective drugs. (Clinical trials identifier: NCT02466854).
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Síndrome Coronariana Aguda/tratamento farmacológico , Síndrome Coronariana Aguda/epidemiologia , Neoplasias/tratamento farmacológico , Neoplasias/epidemiologia , Intervenção Coronária Percutânea/tendências , Sistema de Registros , Síndrome Coronariana Aguda/diagnóstico , Antagonistas Adrenérgicos beta/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Antagonistas de Receptores de Angiotensina/uso terapêutico , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Estudos de Coortes , Feminino , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Masculino , Pessoa de Meia-Idade , Neoplasias/diagnóstico , Estudos Prospectivos , Estudos RetrospectivosRESUMO
AIMS: The benefit of complete or incomplete percutaneous coronary intervention (PCI) in patients with myocardial infarction and multivessel disease remains debated. The aim of our study was to compare a complete vs. a "culprit only" revascularisation strategy in patients with myocardial infarction distinguishing the different clinical subsets (STEMI and NSTEMI) and to provide one-year clinical outcome from the "real-life" BleeMACS (Bleeding complications in a Multicenter registry of patients discharged with diagnosis of Acute Coronary Syndrome) registry. METHODS AND RESULTS: We conducted a multicentre study including all patients with myocardial infarction and multivessel coronary disease included in the BleeMACS (Bleeding complications in a Multicenter registry of patients discharged with diagnosis of Acute Coronary Syndrome) registry. They were divided into two groups, complete revascularisation (CR) and incomplete revascularisation (IR). The primary endpoint was the death rate at one-year follow-up. Secondary endpoints were in-hospital repeat myocardial infarction (re-AMI), in-hospital heart failure (HF), major adverse cardiovascular events (MACE) and myocardial infarction at one year. Four thousand five hundred and twenty patients were included in our analysis, with a diagnosis of STEMI in 67.7% and NSTEMI in 32.3%. CR was performed in 27.2% and 42.4%, respectively. At univariate analysis, in-hospital and one-year outcomes were similar between CR and IR in STEMI patients (all p-values >0.05). In NSTEMI patients, CR was associated with a lower one-year death rate (4.5% vs. 8.5%; p=0.002), re-AMI (3.7% vs. 6.6%; p=0.016) and MACE (8.1% vs. 13.9%; p=0.001). After propensity score matching, CR also reduced events in STEMI patients, including one-year mortality (5.3% vs. 13.8%; p<0.001), re-AMI (4.9% vs. 17.4%; p<0.001) and MACE (8.5% vs. 24.6%; p<0.001). CONCLUSIONS: This multicentre retrospective registry showed the benefit of CR in terms of reduction of one-year mortality in patients with myocardial reinfarction and multivessel coronary disease. Randomised controlled trials including functional evaluation of the lesions should be performed to confirm our results.
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Síndrome Coronariana Aguda/cirurgia , Doença da Artéria Coronariana/cirurgia , Vasos Coronários/cirurgia , Infarto do Miocárdio/cirurgia , Revascularização Miocárdica , Síndrome Coronariana Aguda/diagnóstico , Idoso , Angioplastia Coronária com Balão/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Revascularização Miocárdica/métodos , Recidiva , Sistema de RegistrosRESUMO
BACKGROUND: There is great debate on the possible adverse interaction between proton pump inhibitors (PPIs) and clopidogrel. In addition, whether the use of PPIs affects the clinical efficacy of ticagrelor remains less known. We aimed to determine the impact of concomitant administration of PPIs and clopidogrel or ticagrelor on clinical outcomes in patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI). METHODS: We retrospectively analyzed data from a "real world", international, multi-center registry between 2003 and 2014 (n = 15,401) and assessed the impact of concomitant administration of PPIs and clopidogrel or ticagrelor on 1-year composite primary endpoint (all-cause death, re-infarction, or severe bleeding) in patients with ACS after PCI. RESULTS: Of 9429 patients in the final cohort, 54.8% (n = 5165) was prescribed a PPI at discharge. Patients receiving a PPI were older, more often female, and were more likely to have comorbidities. No association was observed between PPI use and the primary endpoint for patients receiving clopidogrel (adjusted HR: 1.036; 95% CI: 0.903-1.189) or ticagrelor (adjusted HR: 2.320; 95% CI: 0.875-6.151) (P interaction = 0.2004). Similarly, use of a PPI was not associated with increased risk of all-cause death, re-infarction, or a decreased risk of severe bleeding for patients treated with either clopidogrel or ticagrelor. CONCLUSIONS: In patients with ACS following PCI, concomitant use of PPIs was not associated with increased risk of adverse outcomes in patients receiving either clopidogrel or ticagrelor. Our findings indicate it is reasonable to use a PPI in combination with clopidogrel or ticagrelor, especially in patients with a higher risk of gastrointestinal bleeding.
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BACKGROUND: Bleeding events after an acute coronary syndrome have a negative impact on prognosis. Available risk scores are limited by suboptimal accuracy, prediction of only in-hospital events and absence of patients treated with new antiplatelet agents in the current era of widespread use of percutaneous coronary intervention. DESIGN: The BleeMACS (Bleeding complications in a Multicenter registry of patients discharged after an Acute Coronary Syndrome) project is a multicenter investigator-initiated international retrospective registry that enrolled more than 15â000 patients discharged with a definitive diagnosis of acute coronary syndrome and treated with percutaneous revascularization. The primary end point is the incidence of major bleeding events requiring hospitalization and/or red cell transfusion concentrates within 1 year. An integer risk score for bleeding within the first year after hospital discharge will be developed from a multivariate competing-risks regression. CONCLUSION: The BleeMACS registry collaborative will allow development and validation of a risk score for prediction of major bleeding during follow-up for patients receiving contemporary therapies for acute coronary syndrome.
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Síndrome Coronariana Aguda/cirurgia , Hemorragia/epidemiologia , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Projetos de Pesquisa , Hemorragia/etiologia , Hospitalização , Humanos , Incidência , Cooperação Internacional , Análise Multivariada , Alta do Paciente , Sistema de Registros , Análise de Regressão , Estudos Retrospectivos , Fatores de Risco , Índice de Gravidade de Doença , Resultado do TratamentoRESUMO
BACKGROUND: Blood transfusions (BTs) may worsen the prognosis of patients affected by acute coronary syndromes (ACS), although few data detail their impact on short-term events according to clinical presentation (ST Segment Elevation Myocardial Infarction, STEMI vs. Non-ST Segment Elevation ACS, NSTE-ACS). METHODS: Patients undergoing percutaneous coronary intervention (PCI) for ACS, with data on BTs, were selected from the BleeMACS registry. The primary end point was the incidence of myocardial infarction during hospitalization (reAMI), the secondary end-points were 30-day mortality and the combined end-point of 30-day mortality and reAMI. Sensitivity analyses were performed according to clinical presentation (STEMI vs. NSTE-ACS). RESULTS: Overall, 13,975 patients were included: mean age was 64.1years, 10,651 (76.2%) were male and 7711 (55.2%) had STEMI. BTs were administered during hospitalization to 465 (3.3%) patients, who were older and presented a more relevant burden of risk factors. The primary end-point of reAMI occurred in 197 (1.4%) patients, of whom 102 (1.1%) with STEMI. After controlling for confounding variables, BTs independently predicted the primary end-point reAMI in patients admitted for STEMI (OR 4.059, 95% CI 2244-7.344) and not in those admitted for NSTE-ACS. Moreover, BTs independently related to 30-day mortality in STEMI and NSTE-ACS patients and to the composite of 30-day mortality and reAMI in STEMI patients. CONCLUSIONS: In patients undergoing PCI for ACS, BTs increase the risk of reAMI only in those admitted for STEMI, and not in those with NSTE-ACS. These results may help physicians to choose appropriate BT administration according to the admission diagnosis.
Assuntos
Síndrome Coronariana Aguda , Infarto do Miocárdio sem Supradesnível do Segmento ST , Intervenção Coronária Percutânea/efeitos adversos , Infarto do Miocárdio com Supradesnível do Segmento ST , Reação Transfusional , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/terapia , Transfusão de Sangue/métodos , Feminino , Seguimentos , Humanos , Cooperação Internacional , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio sem Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio sem Supradesnível do Segmento ST/fisiopatologia , Infarto do Miocárdio sem Supradesnível do Segmento ST/cirurgia , Seleção de Pacientes , Intervenção Coronária Percutânea/métodos , Prognóstico , Recidiva , Sistema de Registros , Medição de Risco/métodos , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio com Supradesnível do Segmento ST/fisiopatologia , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgiaRESUMO
OBJECTIVE: New P2Y12 inhibitors can be classified as oral (prasugrel and ticagrelor) and intravenous drugs (cangrelor and elinogrel). These P2Y12 inhibitors might be superior to clopidogrel for reducing ischemic events in patients with coronary artery disease (CAD). We performed a meta-analysis of randomized trials that compared new oral or intravenous P2Y12 inhibitors with clopidogrel to determine their efficacy and safety in patients. METHODS AND RESULTS: Twelve randomized, placebo-controlled studies and two subgroup analyses of included studies on ST-segment elevation myocardial infarction (STEMI) were included. The database consisted of 82,784 patients, with 43,875 (53%) on new oral P2Y12 inhibitors and 38909 (47%) on intravenous P2Y12 inhibitors compared with clopidogrel. The primary efficacy endpoint was major adverse cardiac events (MACEs). The primary safety endpoint was thrombolysis in myocardial infarction (TIMI) major bleeding. New oral P2Y12 inhibitors significantly decreased MACEs (odds ratio: 0.85, p<0.0001 for the whole cohort; OR: 0.77, p=0.04 for STEMI) and all-cause death (OR: 0.88, p=0.04 for the whole cohort; OR: 0.77, p=0.01 for STEMI). Among new intravenous P2Y12 inhibitors, only cangrelor significantly decreased the risk of MACEs. An increase in TIMI major bleeding was observed only by prasugrel among the new P2Y12 inhibitors. CONCLUSIONS: New oral P2Y12 inhibitors reduce ischemic events, but there is no obvious increase in major bleeding in patients with CAD, and the risk/benefit ratio is particularly favorable for STEMI patients. Moreover, only cangrelor is beneficial for ischemic events in patients on new intravenous P2Y12 inhibitors.
Assuntos
Doença da Artéria Coronariana/tratamento farmacológico , Infarto do Miocárdio/prevenção & controle , Antagonistas do Receptor Purinérgico P2Y/uso terapêutico , Ticlopidina/análogos & derivados , Síndrome Coronariana Aguda/epidemiologia , Síndrome Coronariana Aguda/etiologia , Síndrome Coronariana Aguda/prevenção & controle , Adenosina/administração & dosagem , Adenosina/efeitos adversos , Adenosina/análogos & derivados , Adenosina/uso terapêutico , Monofosfato de Adenosina/administração & dosagem , Monofosfato de Adenosina/efeitos adversos , Monofosfato de Adenosina/análogos & derivados , Monofosfato de Adenosina/uso terapêutico , Administração Oral , Clopidogrel , Doença da Artéria Coronariana/complicações , Reestenose Coronária/prevenção & controle , Fibrinolíticos/efeitos adversos , Hemorragia/induzido quimicamente , Hemorragia/prevenção & controle , Humanos , Injeções Intravenosas , Estudos Multicêntricos como Assunto/estatística & dados numéricos , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/etiologia , Infarto do Miocárdio/terapia , Piperazinas/administração & dosagem , Piperazinas/efeitos adversos , Piperazinas/uso terapêutico , Cloridrato de Prasugrel , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Quinazolinonas/administração & dosagem , Quinazolinonas/efeitos adversos , Quinazolinonas/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Stents , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/prevenção & controle , Sulfonamidas/administração & dosagem , Sulfonamidas/efeitos adversos , Sulfonamidas/uso terapêutico , Tiofenos/administração & dosagem , Tiofenos/efeitos adversos , Tiofenos/uso terapêutico , Terapia Trombolítica/efeitos adversos , Ticagrelor , Ticlopidina/efeitos adversos , Ticlopidina/uso terapêuticoAssuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Síndrome Coronariana Aguda/etnologia , Inibidores da Agregação Plaquetária/uso terapêutico , Antagonistas do Receptor Purinérgico P2Y/uso terapêutico , Ticlopidina/análogos & derivados , Idoso , Clopidogrel , Europa (Continente)/etnologia , Ásia Oriental/etnologia , Feminino , Seguimentos , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Humanos , Internacionalidade , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação Plaquetária/efeitos adversos , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Sistema de Registros , Estudos Retrospectivos , Ticlopidina/efeitos adversos , Ticlopidina/uso terapêutico , Resultado do TratamentoRESUMO
INTRODUCCIÓN Y OBJETIVOS: No está clara la asociación entre los inhibidores de la enzima de conversión de la angiotensina (IECA) o los antagonistas del receptor de la angiotensina II (ARA-II) y la mortalidad de los pacientes con síndrome coronario agudo (SCA) sometidos a intervención coronaria percutánea (ICP) con fracción de eyección del ventrículo izquierdo (FEVI) conservada. Nuestro objetivo es determinar dicha asociación en pacientes con FEVI conservada o reducida. MÉTODOS: Se analizaron datos procedentes del registro BleeMACS. El objetivo principal fue la mortalidad a 1 año. Se aplicaron ponderación por la probabilidad inversa del tiempo de supervivencia y ajustes por regresión de Cox, puntuación de propensión y variables instrumentales. RESULTADOS: De los 15.401 pacientes con SCA sometidos a ICP, se prescribieron IECA/ARA-II al 75,2%. Se produjeron 569 muertes (3,7%) durante el primer año tras el alta hospitalaria. Después del ajuste multivariado, los IECA/ARA-II se asociaron con menor mortalidad, pero solo en los pacientes con FEVI ≤ 40% (HR=0,62; IC95%, 0,43-0,90; p = 0,012). Con los IECA/ARA-II, la reducción del riesgo relativo de la mortalidad estimada fue del 46,1% en los pacientes con FEVI ≤ 40% y del 15,7% en aquellos con FEVI> 40% (pinteracción=0,008). En los pacientes con FEVI> 40%, los IECA/ARA-II se asociaron con menor mortalidad solo por infarto agudo de miocardio con elevación del segmento ST (HR=0,44; IC95%, 0,21-0.93; p = 0,031). CONCLUSIONES: El beneficio de los IECA/ARA-II en mortalidad tras ICP por SCA se concentra en pacientes con FEVI ≤ 40% y aquellos con FEVI> 40% e infarto agudo de miocardio con elevación del segmento ST. Se precisan estudios contemporáneos que analicen el impacto de los IECA/ARA-II en pacientes con SCA sin elevación del segmento ST y FEVI> 40%
INTRODUCTION AND OBJECTIVES: For patients with acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI), it is unclear whether angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) are associated with reduced mortality, particularly with preserved left ventricular ejection fraction (LVEF). The goal of this study was to determine the association between ACEI/ARB and mortality in ACS patients undergoing PCI, with and without reduced LVEF. METHODS: Data from the BleeMACS registry were used. The endpoint was 1-year all-cause mortality. The prognostic value of ACEI/ARB was tested after weighting by survival-time inverse probability and after adjustment by Cox regression, propensity score, and instrumental variable analysis. RESULTS: Among 15 401 ACS patients who underwent PCI, ACEI/ARB were prescribed in 75.2%. There were 569 deaths (3.7%) during the first year after hospital discharge. After multivariable adjustment, ACEI/ARB were associated with lower 1-year mortality, ≤ 40% (HR, 0.62; 95%CI, 0.43-0.90; P=.012). The relative risk reduction of ACEI/ARB in mortality was 46.1% in patients with LVEF ≤ 40%, and 15.7% in patients with LVEF> 40% (P value for treatment-by-LVEF interaction=.008). For patients with LVEF> 40%, ACEI/ARB was associated with lower mortality only in ST-segment elevation myocardial infarction (HR, 0.44; 95%CI, 0.21-0.93; P=.031). CONCLUSION: The benefit of ACEI/ARB in decreasing mortality after an ACS in patients undergoing PCI is concentrated in patients with LVEF ≤ 40%, and in those with LVEF> 40% and ST-segment elevation myocardial infarction. In non-ST-segment elevation-ACS patients with LVEF> 40%, further studies are needed to assess the prognostic impact of ACEI/ARB