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2.
EuroIntervention ; 2020 Oct 27.
Artigo em Inglês | MEDLINE | ID: mdl-33106225

RESUMO

AIMS: Cardiogenic shock (CGS) occurs in 6-10% of patients with acute coronary syndromes (ACS). Mortality has fallen over time from 80% to approximately 50% consequent on acute revascularization but plateaued since the 1990s. Once established, patients with CGS develop adverse compensatory mechanisms that contribute to the downwards spiral towards death, which becomes difficult to reverse. METHODS AND RESULTS: The "EURO SHOCK' trial will test the benefit or otherwise of mechanical cardiac support using veno-arterial extra-corporeal membrane oxygenation (VA-ECMO), initiated early after acute percutaneous coronary intervention (PCI) for CGS. The trial sets out to randomize 428 patients with CGS complicating ACS, following primary PCI (P-PCI), to either very early ECMO plus standard pharmacotherapy, or to standard pharmacotherapy alone. It will be conducted in 39 European centers. The primary endpoint is 30-day all-cause mortality with key secondary endpoints: 1) 12-month all-cause mortality or admission for heart failure, 2) 12-month all-cause mortality, 3) 12-month admission for heart failure. Cost-effectiveness analysis (including quality of life measures) will be embedded. Mechanistic and hypothesis-generating sub-studies will be undertaken. CONCLUSIONS: The EURO SHOCK trial will determine whether early initiation of VA-ECMO in patients presenting with ACS-CGS persisting after PCI, improves mortality and morbidity.

4.
Eur J Heart Fail ; 2020 Jul 04.
Artigo em Inglês | MEDLINE | ID: mdl-32621557

RESUMO

AIMS: Whether glycaemic control is associated with cardiovascular outcomes in patients with type 2 diabetes (T2D) is unclear. Consequently, we assessed the relationship between glycated haemoglobin (HbA1c ) and cardiovascular outcomes in a placebo-controlled randomized trial which demonstrated no cardiovascular effect of sitagliptin in patients with T2D and atherosclerotic vascular disease. METHODS AND RESULTS: Secondary analysis of 14 656 TECOS participants with time to event analyses using multivariable Cox proportional hazard models. During a median 3.0 (interquartile range 2.3-3.8) year follow-up, 456 (3.1% of 14 656) patients had first hospitalization for heart failure (HF), 1084 (11.5%) died, 1406 (9.6%) died or were hospitalized for HF, and 1689 (11.5%) had a non-HF cardiovascular event (cardiovascular death, non-fatal stroke, non-fatal myocardial infarction, or hospitalization for unstable angina). Associations between baseline or time-varying HbA1c and cardiovascular outcomes were U-shaped, with the lowest risk when HbA1c was around 7%. Each one-unit increase in the time-varying HbA1c above 7% was associated with an adjusted hazard ratio (HR) of 1.21 [95% confidence interval (CI) 1.11-1.33] for first HF hospitalization, 1.11 (1.03-1.21) for all-cause death, 1.18 (1.09-1.26) for death or HF hospitalization, and 1.10 (1.02-1.17) for non-HF cardiovascular events. Each one-unit decrease in the time-varying HbA1c below 7% was associated with an adjusted HR of 1.35 (95% CI 1.12-1.64) for first HF hospitalization, 1.37 (1.16-1.61) for death, 1.42 (1.23-1.64) for death or HF hospitalization, and 1.22 (1.06-1.41) for non-HF cardiovascular events. CONCLUSION: Glycated haemogobin exhibits a U-shaped association with cardiovascular outcomes in patients with T2D and atherosclerotic vascular disease, with nadir around 7%. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00790205.

5.
Eur Heart J ; 41(27): 2589-2596, 2020 Jul 14.
Artigo em Inglês | MEDLINE | ID: mdl-32484542

RESUMO

The new European Union (EU) law governing the regulatory approval of medical devices that entered into force in May 2017 will now take effect from 26 May 2021. Here, we consider how it will change daily practice for cardiologists, cardiac surgeons, and healthcare professionals. Clinical evidence for any high-risk device must be reported by the manufacturer in a Summary of Safety and Clinical Performance (SSCP) that will be publicly available in the European Union Database on Medical Devices (Eudamed) maintained by the European Commission; this will facilitate evidence-based choices of which devices to recommend. Hospitals must record all device implantations, and each high-risk device will be trackable by Unique Device Identification (UDI). Important new roles are envisaged for clinicians, scientists, and engineers in EU Expert Panels-in particular to scrutinize clinical data submitted by manufacturers for certain high-risk devices and the evaluations of that data made by notified bodies. They will advise manufacturers on the design of their clinical studies and recommend to regulators when new technical specifications or guidance are needed. Physicians should support post-market surveillance by reporting adverse events and by contributing to comprehensive medical device registries. A second law on In Vitro Diagnostic Medical Devices will take effect from 2022. We encourage all healthcare professionals to contribute proactively to these new systems, in order to enhance the efficacy and safety of high-risk devices and to promote equitable access to effective innovations. The European Society of Cardiology will continue to advise EU regulators on appropriate clinical evaluation of high-risk devices.

6.
Am Heart J ; 226: 140-146, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32553932

RESUMO

BACKGROUND: The STREAM study demonstrated that a pharmaco-invasive strategy was at least as effective as primary PCI (pPCI) in patients presenting early with ST-elevation myocardial infarction (STEMI). The current trial is a response to the finding that reduced intracranial hemorrhage (ICH) in patients ≥75 years occurred after halving the dose of tenecteplase. Additionally, a subsequent analysis of full dose tenecteplase or alteplase in the Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT) trials demonstrated a steep increase in bleeding events beginning around the age of 60 years. METHODS: STREAM-2 will compare the efficacy and safety of a novel pharmaco-invasive strategy as compared to routine pPCI in STEMI patients ≥60 years presenting within 3 hours from symptom onset. In the pharmaco-invasive arm patients will receive half-dose tenecteplase, as soon as possible before transport to a PCI center. In the pPCI arm, patients will be treated according to optimal standard of care defined by local practice. The key criteria for efficacy will be the number of patients achieving ≥50% ST-segment resolution before and after PCI in lead with maximal ST elevation at baseline and the clinical endpoints of death, congestive heart failure, shock or re-infarction, rescue PCI and aborted myocardial infarction, both singularly and as a composite at 30 days. Key safety criteria are total stroke, ICH and major non-intracranial bleeds. Approximately 600 patients will be randomized (400 to pharmaco-invasive treatment and 200 to pPCI). An interim analysis is planned after 300 patients are enrolled to consider adapting the trial to include a larger sample size aimed at undertaking a formal confirmatory trial. DISCUSSION: The study will provide new insights aimed at establishing an effective and safer pharmaco-invasive treatment for the growing population of older STEMI patients who cannot undergo timely pPCI.


Assuntos
Fibrinolíticos/administração & dosagem , Intervenção Coronária Percutânea , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Infarto do Miocárdio com Supradesnível do Segmento ST/tratamento farmacológico , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Tenecteplase/administração & dosagem , Fatores Etários , Idoso , Humanos , Estudos Prospectivos , Fatores de Tempo
7.
Eur Heart J Acute Cardiovasc Care ; : 2048872620911853, 2020 Mar 11.
Artigo em Inglês | MEDLINE | ID: mdl-32159359

RESUMO

BACKGROUND: The European Society of Cardiology established a set of quality indicators for the management of acute myocardial infarction. Our aim was to evaluate their degree of attainment, prognostic value and potential use for centre benchmarking in a large international cohort. METHODS: Quality indicators were extracted from the long-tErm follow-uP of antithrombotic management patterns In acute CORonary syndrome patients (EPICOR) (555 hospitals, 20 countries in Europe and Latin America, 2010-2011) and EPICOR Asia (218 hospitals, eight countries, 2011-2012) registries, including non-ST-segment elevation acute myocardial infarction (n=6558) and ST-segment elevation acute myocardial infarction (n=11,559) hospital survivors. The association between implementation rates for each quality indicator and two-year adjusted mortality was evaluated using adjusted Cox models. Composite quality indicators were categorized for benchmarking assessment at different levels. RESULTS: The degree of attainment of the 17 evaluated quality indicators ranged from 13% to 100%. Attainment of most individual quality indicators was associated with two-year survival. A higher compliance with composite quality indicators was associated with lower mortality at centre-, country- and region-level. Moreover, the higher the risk for two-year mortality, the lower the compliance with composite quality indicators. CONCLUSIONS: When EPICOR and EPICOR Asia were conducted, the European Society of Cardiology quality indicators would have been attained to a limited extent, suggesting wide room for improvement in the management of acute myocardial infarction patients. After adjustment for confounding, most quality indicators were associated with reduced two-year mortality and their prognostic value should receive further attention. The two composite quality indicators can be used as a tool for benchmarking either at centre-, country- or world region-level.

9.
Eur Heart J ; 41(7): 867-869, 2020 Feb 14.
Artigo em Inglês | MEDLINE | ID: mdl-31638646
10.
Circ Genom Precis Med ; 12(12): e002656, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31756302

RESUMO

BACKGROUND: The identification of patients with acute myocardial infarction (MI) at risk of subsequent left ventricular (LV) dysfunction remains challenging, but it is important to optimize therapies. The aim of this study was to determine the unbiased RNA profile in peripheral blood of patients with acute MI and to identify and validate new prognostic markers of LV dysfunction. METHODS: We prospectively enrolled a discovery cohort with acute MI (n=143) and performed whole-blood RNA profiling at different time points. We then selected transcripts on admission that related to LV dysfunction at follow-up and validated them by quantitative polymerase chain reaction in the discovery cohort, in an external validation cohort (n=449), and in a representative porcine MI model with cardiac magnetic resonance-based measurements of infarct size and postmortem myocardial pathology (n=33). RESULTS: RNA profiling in the discovery cohort showed upregulation of genes involved in chemotaxis, IL (interleukin)-6, and NF-κB (nuclear factor-κB) signaling in the acute phase of MI. Expression levels of the majority of these transcripts paralleled the rise in cardiac troponin T and decayed at 30 days. RNA levels of QSOX1, PLBD1, and S100A8 on admission with MI correlated with LV dysfunction at follow-up. Using quantitative polymerase chain reaction, we confirmed that QSOX1 and PLBD1 predicted LV dysfunction (odds ratio, 2.6 [95% CI, 1.1-6.1] and 3.2 [95% CI, 1.4-7.4]), whereas S100A8 did not. In the external validation cohort, we confirmed QSOX1 and PLBD1 as new independent markers of LV dysfunction (odds ratio, 1.41 [95% CI, 1.06-1.88] and 1.43 [95% CI, 1.08-1.89]). QSOX1 had an incremental predictive value in a model consisting of clinical variables and cardiac biomarkers (including NT-proBNP [N-terminal pro-B-type natriuretic peptide]). In the porcine MI model, whole-blood levels of QSOX1 and PLBD1 related to neutrophil infiltration in the ischemic myocardium in an infarct size-independent manner. CONCLUSIONS: Peripheral blood QSOX1 and PLBD1 in acute MI are new independent markers of LV dysfunction post-MI.

11.
J Am Coll Cardiol ; 74(11): 1454-1461, 2019 09 17.
Artigo em Inglês | MEDLINE | ID: mdl-31514947

RESUMO

BACKGROUND: The relationship between in-hospital coronary revascularization rate (CRR) and post-discharge mortality rates in survivors of non-ST-segment elevation acute coronary syndrome (NSTE-ACS) at a system level is unclear. OBJECTIVES: The purpose of this study was to evaluate CRR and 2-year post-discharge mortality rate (2YMR) in NSTE-ACS. METHODS: CRR and 2YMR were analyzed by hospital rate of CRR (in deciles), by country, and by world region in 11,931 patients with NSTE-ACS who survived to discharge and were enrolled in the EPICOR (long-tErm follow uP of antithrombotic management patterns In acute CORonary syndrome patients) and EPICOR Asia: twin multinational, observational, prospective cohort studies. RESULTS: Significant differences in patient baseline characteristics, medical therapies, CRR, and 2YMR were found. Mean CRR ranged from 0.0% to 96.8% in the first and tenth decile, respectively (p < 0.001); from 12.3% in Romania to 92.4% in Slovenia (p < 0.001); and from 53.9% in South East Asia (SEAsia) to 90.4% in South Korea-Singapore-Hong Kong. 2YMR varied significantly between hospital deciles of CRR (3.6% in tenth decile vs. 9.2% in first decile; p < 0.001), countries (lowest 1.5% in Slovenia, highest 19.4% in Malaysia; p < 0.001), and regions (lowest 3.8% in South Korea-Singapore-Hong Kong, highest 11.7% in SEAsia; p < 0.001). Poisson regression models, adjusted for 15 mortality predictors, showed a significant inverse association between CRR and 2YMR for hospitals (r = -0.90; p < 0.001), countries (r = -0.65; p < 0.001), and regions (r = -0.87; p = 0.005). CONCLUSIONS: Higher CRRs at the hospital, country, and world region levels are strongly associated with higher post-discharge survival, suggesting CRR as a marker of higher system quality.


Assuntos
Síndrome Coronariana Aguda/mortalidade , Síndrome Coronariana Aguda/cirurgia , Hospitalização , Intervenção Coronária Percutânea/estatística & dados numéricos , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Alta do Paciente , Estudos Prospectivos , Medição de Risco , Taxa de Sobrevida , Fatores de Tempo
12.
Eur Heart J Cardiovasc Pharmacother ; 5(4): 200-206, 2019 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-31218354

RESUMO

AIMS: In PEGASUS-TIMI 54, ticagrelor significantly reduced the risk of the composite of major adverse cardiovascular (CV) events by 15-16% in stable patients with a prior myocardial infarction (MI) 1-3 years earlier. We report the efficacy and safety in the subpopulation recommended for treatment in the European (EU) label, i.e. treatment with 60 mg b.i.d. initiated up to 2 years from the MI, or within 1 year after stopping previous adenosine diphosphate receptor inhibitor treatment. METHODS AND RESULTS: Of the 21 162 patients enrolled in PEGASUS-TIMI 54, 10 779 patients were included in the primary analysis for this study, randomized to ticagrelor 60 mg (n = 5388) or matching placebo (n = 5391). The cumulative proportions of patients with events at 36 months were calculated by the Kaplan-Meier (KM) method. The composite of CV death, MI, or stroke occurred less frequently in the ticagrelor group (7.9% KM rate vs. 9.6%), hazard ratio (HR) 0.80 [95% confidence interval (CI) 0.70-0.91; P = 0.001]. Ticagrelor also reduced the risk of all-cause mortality, HR 0.80 (0.67-0.96; P = 0.018). Thrombolysis in myocardial infarction major bleeding was more frequent in the ticagrelor group 2.5% vs. 1.1%; HR 2.36 (1.65-3.39; P < 0.001). The corresponding HR for fatal or intracranial bleeding was 1.17 (0.68-2.01; P = 0.58). CONCLUSION: In PEGASUS-TIMI 54, treatment with ticagrelor 60 mg as recommended in the EU label, was associated with a relative risk reduction of 20% in CV death, MI, or stroke. Thrombolysis in myocardial infarction major bleeding was increased, but fatal or intracranial bleeding was similar to placebo. There appears to be a favourable benefit-risk ratio for long-term ticagrelor 60 mg in this population. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov NCT01225562.

13.
Clin Cardiol ; 42(1): 111-119, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30443916

RESUMO

BACKGROUND: Patients discharged after an acute coronary syndrome (ACS) have substantial risk of recurrent ischemic events or dying. HYPOTHESIS: A difference may exist in risk predictors for all-cause mortality and ischemic events between year 1 and 2 of follow-up post-ACS. METHODS: EPICOR (NCT01171404) was a prospective, international, real-world cohort study of consecutive patients hospitalized for ACS within 24 hours of symptom onset and surviving to discharge. Total of 10 568 patients were enrolled (555 hospitals; 20 countries) and followed-up for 2 years. From these, 4943 were admitted with ST-elevation myocardial infarction (STEMI) and 5625 with non-ST-elevation ACS (NSTE-ACS). Potential baseline predictors of major adverse cardiac and cerebrovascular events (MACCE; death, non-fatal myocardial infarction [MI], non-fatal stroke) were evaluated in year 1 and 2 post-discharge. RESULTS: MACCE incidence per 100 person-years at risk within and after 1 year was 5.3 vs 3.6, primarily death (4.1 vs 2.3), with no significant differences for MI or stroke. Older age, lack of coronary revascularization, raised creatinine, low hemoglobin, previous cardiac disease, previous chronic obstructive pulmonary disease, raised glucose, male sex, and geographic region were risk factors for MACCE in both year 1 and 2. By contrast, low ejection fraction, poorer quality of life, low body mass index (BMI) <20 kg/m2 , in-hospital cardiac complications, and Killip class lost predictive power after 1 year. CONCLUSION: We observed continuous MACCE risk during 2 years of follow-up after discharge for ACS, with greater mortality within the first year. Specific predictors at discharge for events after 1 year could not be identified.


Assuntos
Síndrome Coronariana Aguda/complicações , Infarto do Miocárdio/epidemiologia , Sistema de Registros , Medição de Risco/métodos , Síndrome Coronariana Aguda/mortalidade , Idoso , Causas de Morte/tendências , Europa (Continente)/epidemiologia , Feminino , Seguimentos , Humanos , Incidência , América Latina/epidemiologia , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Vigilância da População , Prognóstico , Estudos Prospectivos , Taxa de Sobrevida/tendências , Fatores de Tempo
14.
Eur Heart J Acute Cardiovasc Care ; 8(8): 745-754, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-27357206

RESUMO

Regulatory authorities interpret the results of randomized controlled trials according to published principles. The European Medicines Agency (EMA) is planning a revision of the 2000 and 2003 guidance documents on clinical investigation of new medicinal products for the treatment of acute coronary syndrome (ACS) to achieve consistency with current knowledge in the field. This manuscript summarizes the key output from a collaborative workshop, organized by the Cardiovascular Round Table and the European Affairs Committee of the European Society of Cardiology, involving clinicians, academic researchers, trialists, European and US regulators, and pharmaceutical industry researchers. Specific questions in four key areas were selected as priorities for changes in regulatory guidance: patient selection, endpoints, methodologic issues and issues related to the research for novel agents. Patients with ST-segment elevation myocardial infarction (STEMI) and non-STEMI (NSTEMI) should be studied separately for therapies aimed at the specific pathophysiology of either condition, particularly for treatment of the acute phase, but can be studied together for other treatments, especially long-term therapy. Unstable angina patients should be excluded from acute phase ACS trials. In general, cardiovascular death and reinfarction are recommended for primary efficacy endpoints; other endpoints may be considered if specifically relevant for the therapy under study. New agents or interventions should be tested against a background of evidence-based therapy with expanded follow-up for safety assessment. In conclusion, new guidance documents for randomized controlled trials in ACS should consider changes regarding patient and endpoint selection and definitions, and trial designs. Specific requirements for the evaluation of novel pharmacological therapies need further clarification.


Assuntos
Síndrome Coronariana Aguda/terapia , Cardiologia/organização & administração , Educação/métodos , Infarto do Miocárdio/terapia , Infarto do Miocárdio sem Supradesnível do Segmento ST/terapia , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Síndrome Coronariana Aguda/fisiopatologia , Angina Instável/terapia , Morte , Determinação de Ponto Final/métodos , Europa (Continente)/epidemiologia , Feminino , Humanos , Masculino , Infarto do Miocárdio/mortalidade , Intervenção Coronária Percutânea/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto , Reperfusão/métodos , Medição de Risco , Terapia Trombolítica/métodos
17.
Eur Heart J Acute Cardiovasc Care ; 8(2): 121-129, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-29611427

RESUMO

BACKGROUND:: Atrial fibrillation (AF) is associated with increased morbidity in acute coronary syndrome patients, but impact on outcomes beyond 1 year is unclear. METHODS:: This was a post-hoc analysis from the long-tErm follow-uP of antithrombotic management patterns In acute CORonary syndrome patients (EPICOR) registry (NCT01171404), a prospective, observational study conducted in Europe and Latin America, which enrolled acute coronary syndrome survivors at discharge. Antithrombotic management patterns, mortality, a composite endpoint of death/new non-fatal myocardial infarction/stroke and bleeding events were assessed after 2 years of follow-up in patients with or without AF. RESULTS:: Of 10,568 patients enrolled, 397 (4.7%) had prior AF and 382 (3.6%) new-onset AF during index hospitalisation. Fewer patients with AF underwent percutaneous coronary intervention (52.1% vs. 66.6%; P<0.0001). At discharge, fewer AF patients received dual antiplatelet therapy (71.6% vs. 89.5%; P<0.0001); oral anticoagulant use was higher in AF patients but was still infrequent (35.0% vs. 2.5%; P<0.0001). Use of dual antiplatelet therapy and oral anticoagulants declined over follow-up with over 50% of all AF/no AF patients remaining on dual antiplatelet therapy (55.6% vs. 60.6%), and 23.3% (new-onset AF) to 42.1% (prior AF) on oral anticoagulants at 2 years. At 2 years, mortality, composite endpoint and bleeding rates were higher in AF patients (all P<0.0001) compared to patients without AF. On multivariable analysis, the risk of mortality or the composite endpoint was significant for prior AF ( P=0.003, P=0.001) but not new-onset AF ( P=0.88, P=0.92). CONCLUSIONS:: Acute coronary syndrome patients with AF represent a high-risk group with increased event rates during long-term follow-up. Prior AF is an independent predictor of mortality and/or ischaemic events at 2 years. Use of anticoagulants in AF after acute coronary syndrome is still suboptimal.


Assuntos
Síndrome Coronariana Aguda/complicações , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Fibrinolíticos/uso terapêutico , Sistema de Registros , Terapia Trombolítica/métodos , Trombose/epidemiologia , Síndrome Coronariana Aguda/mortalidade , Síndrome Coronariana Aguda/cirurgia , Idoso , Fibrilação Atrial/epidemiologia , Causas de Morte/tendências , Europa (Continente)/epidemiologia , Feminino , Seguimentos , Humanos , Incidência , América Latina/epidemiologia , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea , Prognóstico , Estudos Prospectivos , Fatores de Risco , Taxa de Sobrevida/tendências , Trombose/prevenção & controle , Fatores de Tempo
18.
Eur Heart J Acute Cardiovasc Care ; 8(8): 727-737, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-28777005

RESUMO

BACKGROUND: Long-term risk of post-discharge mortality associated with acute coronary syndrome remains a concern. The development of a model to reliably estimate two-year mortality risk from hospital discharge post-acute coronary syndrome will help guide treatment strategies. METHODS: EPICOR (long-tErm follow uP of antithrombotic management patterns In acute CORonary syndrome patients, NCT01171404) and EPICOR Asia (EPICOR Asia, NCT01361386) are prospective observational studies of 23,489 patients hospitalized for an acute coronary syndrome event, who survived to discharge and were then followed up for two years. Patients were enrolled from 28 countries across Europe, Latin America and Asia. Risk scoring for two-year all-cause mortality risk was developed using identified predictive variables and forward stepwise Cox regression. Goodness-of-fit and discriminatory power was estimated. RESULTS: Within two years of discharge 5.5% of patients died. We identified 17 independent mortality predictors: age, low ejection fraction, no coronary revascularization/thrombolysis, elevated serum creatinine, poor EQ-5D score, low haemoglobin, previous cardiac or chronic obstructive pulmonary disease, elevated blood glucose, on diuretics or an aldosterone inhibitor at discharge, male sex, low educational level, in-hospital cardiac complications, low body mass index, ST-segment elevation myocardial infarction diagnosis, and Killip class. Geographic variation in mortality risk was seen following adjustment for other predictive variables. The developed risk-scoring system provided excellent discrimination (c-statistic=0.80, 95% confidence interval=0.79-0.82) with a steep gradient in two-year mortality risk: >25% (top decile) vs. ~1% (bottom quintile). A simplified risk model with 11 predictors gave only slightly weaker discrimination (c-statistic=0.79, 95% confidence interval =0.78-0.81). CONCLUSIONS: This risk score for two-year post-discharge mortality in acute coronary syndrome patients ( www.acsrisk.org ) can facilitate identification of high-risk patients and help guide tailored secondary prevention measures.


Assuntos
Síndrome Coronariana Aguda/sangue , Síndrome Coronariana Aguda/mortalidade , Alta do Paciente/estatística & dados numéricos , Infarto do Miocárdio com Supradesnível do Segmento ST/complicações , Síndrome Coronariana Aguda/epidemiologia , Síndrome Coronariana Aguda/terapia , Idoso , Ásia/epidemiologia , Europa (Continente)/epidemiologia , Feminino , Fibrinolíticos/uso terapêutico , Seguimentos , Hospitalização , Humanos , América Latina/epidemiologia , Masculino , Pessoa de Meia-Idade , Mortalidade/tendências , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/mortalidade , Valor Preditivo dos Testes , Prognóstico , Estudos Prospectivos , Fatores de Risco , Infarto do Miocárdio com Supradesnível do Segmento ST/epidemiologia
19.
J Am Heart Assoc ; 7(24): e009609, 2018 12 18.
Artigo em Inglês | MEDLINE | ID: mdl-30526198

RESUMO

Background Vorapaxar, a protease-activated receptor-1 antagonist, is approved for secondary prevention of cardiovascular events but is associated with increased intracranial hemorrhage. Methods and Results TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) was a trial of vorapaxar versus placebo among patients with acute coronary syndrome. Strokes were adjudicated by a central events committee. Of 12 944 patients, 199 (1.5%) had ≥1 stroke during the study period (median follow-up, 477 days). Four patients had a single stroke of unknown type; 195 patients had ≥1 stroke classified as hemorrhagic or nonhemorrhagic (165 nonhemorrhagic, 28 hemorrhagic, and 2 both). Strokes occurred in 96 of 6473 patients (1.5%) assigned vorapaxar and 103 of 6471 patients (1.6%) assigned placebo. Kaplan-Meier incidence of stroke for vorapaxar versus placebo was higher for hemorrhagic stroke (0.45% versus 0.14% [hazard ratio, 2.74; 95% confidence interval, 1.22-6.15]), lower but not significantly different for nonhemorrhagic stroke (1.53% versus 1.98% at 2 years [hazard ratio, 0.79; 95% confidence interval, 0.58-1.07]), and similar for stroke overall (1.93% versus 2.13% at 2 years [hazard ratio, 0.94; 95% confidence interval, 0.71-1.24]). Conclusions Stroke occurred in <2% of patients. Vorapaxar-assigned patients had increased hemorrhagic stroke but a nonsignificant trend toward lower nonhemorrhagic stroke. Overall stroke frequency was similar with vorapaxar versus placebo.


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Hemorragias Intracranianas/induzido quimicamente , Lactonas/efeitos adversos , Inibidores da Agregação de Plaquetas/efeitos adversos , Piridinas/efeitos adversos , Prevenção Secundária/métodos , Acidente Vascular Cerebral/induzido quimicamente , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/epidemiologia , Idoso , Ensaios Clínicos Fase III como Assunto , Feminino , Humanos , Incidência , Hemorragias Intracranianas/diagnóstico por imagem , Hemorragias Intracranianas/epidemiologia , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Recidiva , Medição de Risco , Fatores de Risco , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/epidemiologia , Resultado do Tratamento
20.
J Am Heart Assoc ; 7(22): e009260, 2018 11 20.
Artigo em Inglês | MEDLINE | ID: mdl-30571502

RESUMO

Background Ticagrelor reduced cardiovascular death, myocardial infarction (MI), or stroke in patients with prior MI in PEGASUS-TIMI 54 (Prevention of Cardiovascular Events [eg, Death From Heart or Vascular Disease, Heart Attack, or Stroke] in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin). MI can occur in diverse settings and with varying severity; therefore, understanding the types and sizes of MI events prevented is of clinical importance. Methods and Results MIs were adjudicated by a blinded clinical events committee and categorized by subtype and fold elevation of peak cardiac troponin over the upper limit of normal. A total of 1042 MIs occurred in 898 of the 21 162 randomized patients over a median follow-up of 33 months. The majority of the MIs (76%) were spontaneous (Type 1), with demand MI (Type 2) and stent thrombosis (Type 4b) accounting for 13% and 9%, respectively; sudden death (Type 3), percutaneous coronary intervention-related (Type 4a) and coronary artery bypass graft-related (Type 5) each accounted for <1%. Half of MIs (520, 50%) had a peak troponin ≥10x upper limit of normal and 21% of MIs (220) had a peak troponin ≥100× upper limit of normal. A total of 21% (224) were ST-segment-elevation MI STEMI. Overall ticagrelor reduced MI (4.47% versus 5.25%, hazard ratio 0.83, 95% confidence interval 0.72-0.95, P=0.0055). The benefit was consistent among the subtypes, including a 31% reduction in MIs with a peak troponin ≥100× upper limit of normal (hazard ratio 0.69, 95% confidence interval 0.53-0.92, P=0.0096) and a 40% reduction in ST-segment elevation MI (hazard ratio 0.60, 95% confidence interval 0.46-0.78, P=0.0002). Conclusions In stable outpatients with prior MI, the majority of recurrent MIs are spontaneous and associated with a high biomarker elevation. Ticagrelor reduces the MI consistently among subtypes and sizes including large MIs and ST-segment elevation MI. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT01225562.


Assuntos
Infarto do Miocárdio/prevenção & controle , Inibidores da Agregação de Plaquetas/uso terapêutico , Ticagrelor/uso terapêutico , Idoso , Morte Súbita Cardíaca/prevenção & controle , Humanos , Pessoa de Meia-Idade , Infarto do Miocárdio/patologia , Infarto do Miocárdio com Supradesnível do Segmento ST/patologia , Infarto do Miocárdio com Supradesnível do Segmento ST/prevenção & controle
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