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1.
Eur. heart j ; 40(25)Jul. 1, 2019. ilus
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1009597

RESUMO

Non-adherence has been well recognized for years to be a common issue that significantly impacts clinical outcomes and health care costs. Medication adherence is remarkably low even in the controlled environment of clinical trials where it has potentially complex major implications. Collection of non-adherence data diverge markedly among cardiovascular randomized trials and, even where collected, is rarely incorporated in the statistical analysis to test the consistency of the primary endpoint(s). The imprecision introduced by the inconsistent assessment of non-adherence in clinical trials might confound the estimate of the calculated efficacy of the study drug. Hence, clinical trials may not accurately answer the scientific question posed by regulators, who seek an accurate estimate of the true efficacy and safety of treatment, or the question posed by payers, who want a reliable estimate of the effectiveness of treatment in the marketplace after approval. The Non-adherence Academic Research Consortium is a collaboration among leading academic research organizations, representatives from the U.S. Food and Drug Administration and physician-scientists from the USA and Europe. One in-person meeting was held in Madrid, Spain, culminating in a document describing consensus recommendations for reporting, collecting, and analysing adherence endpoints across clinical trials. The adoption of these recommendations will afford robustness and consistency in the comparative safety and effectiveness evaluation of investigational drugs from early development to post-marketing approval studies. These principles may be useful for regulatory assessment, as well as for monitoring local and regional outcomes to guide quality improvement initiatives.(AU)


Assuntos
Adesão à Medicação
2.
BMJ Open ; 9(3): e026053, 2019 Mar 09.
Artigo em Inglês | MEDLINE | ID: mdl-30852547

RESUMO

INTRODUCTION: The GLOBAL LEADERS is an open-label, pragmatic and superiority randomised controlled trial designed to challenge the current treatment paradigm of dual antiplatelet therapy (DAPT) for 12 months followed by aspirin monotherapy among patients undergoing percutaneous coronary intervention. By design, all study endpoints are investigator reported (IR) and not subject to formal adjudication by an independent Clinical Event Committee (CEC), which may introduce detection, reporting or ascertainment bias. METHODS AND ANALYSIS: We designed the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY) to prospectively implement, in a large sample of patients enrolled within the GLOBAL LEADERS trial (7585 of 15 991, 47.5%), an independent adjudication process of reported and unreported potential endpoints, using standardised CEC procedures, in order to assess whether 23-month ticagrelor monotherapy (90 mg twice daily) after 1-month DAPT is non-inferior to a standard regimen of DAPT for 12 months followed by aspirin monotherapy for the primary efficacy endpoint of death, non-fatal myocardial infarction, non-fatal stroke or urgent target vessel revascularisation and superior for the primary safety endpoint of type 3 or 5 bleeding according to the Bleeding Academic Research Consortium criteria.This study will comprehensively assess the comparative safety and efficacy of the two tested antithrombotic strategies on CEC-adjudicated ischaemic and bleeding endpoints and will provide insights into the role of a standardised CEC adjudication process on the interpretation of study findings by quantifying the level of concordance between IR-reported and CEC-adjudicated events. ETHICS AND DISSEMINATION: GLASSY has been approved by local ethics committee of all study sites and/or by the central ethics committee for the country depending on country-specific regulations. In all cases, they deemed that it was not necessary to obtain further informed consent from individual subjects. TRIAL REGISTRATION NUMBER: NCT01813435.

3.
Heart ; 105(14): 1087-1095, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30792241

RESUMO

OBJECTIVE: To evaluate cardiovascular (CV) outcomes in outpatients with coronary artery disease (CAD) living alone compared with those living with others. METHODS: The prospeCtive observational LongitudinAl RegIstry oF patients with stable coronarY artery disease (CLARIFY) included outpatients with stable CAD. CLARIFY enrolled participants in 45 countries from November 2009 to July 2010, with 5 years of follow-up. Living arrangement was documented at baseline. The primary outcome was a composite of major adverse cardiovascular events (MACEs) defined as CV death, myocardial infarction (MI) and stroke. RESULTS: Among 32 367 patients, 3648 patients were living alone (11.3%). After multivariate adjustment, there were no residual differences in MACE among patients living alone compared with those living with others (HR 1.04, 95% CI 0.92 to 1.18, p=0.52); however, there was significant heterogeneity in the exposure effect by sex (Pinteraction<0.01). Specifically, men living alone were at higher risk for MACE (HR 1.17, 95% CI 1.002 to 1.36, p=0.047) as opposed to women living alone (HR 0.82, 95% CI 0.65 to 1.04, p=0.1), predominantly driven by a heterogeneous effect by sex on MI (Pinteraction=0.006). There was no effect modification for MACE by age group (Pinteraction=0.3), although potential varying effects by age for MI (Pinteraction=0.046) and stroke (Pinteraction=0.05). CONCLUSIONS: Living alone was not associated with an independent increase in MACE, although significant sex-based differences were apparent. Men living alone may have a worse prognosis from CV disease than women; further analyses are needed to elucidate the mechanisms underlying this difference. TRIAL REGISTRATION NUMBER: ISRCTN43070564.

4.
J Nucl Cardiol ; 2018 Dec 20.
Artigo em Inglês | MEDLINE | ID: mdl-30574676

RESUMO

BACKGROUND: The aim of this study was to compare the diagnostic performances for the detection of myocardial ischemia of 82-Rb-PET-MPS and 99m-Tc-SPECT-MPS in overweight individuals and women. METHODS AND RESULTS: Men with BMI ≥ 25 and women referred for MPS were considered for inclusion. All individuals underwent 99m-Tc-SPECT-MPS with CZT cameras and 82-Rb-PET-MPS in 3D-mode. Individuals with at least one positive MPS were referred for coronary angiography (CA) with FFR measurements. A criterion for positivity was a composite endpoint including significant stenosis on CA or, in the absence of CA, the occurrence of acute coronary event during the following year. 313 patients (46% women) with mean BMI of 31.8 ± 6.5 were included. Sensitivity for the detection of myocardial ischemia was higher with 82-Rb-PET-MPS compared with 99m-Tc-SPECT-MPS (85% vs. 57%, P < .05); specificity was equally high with both imaging techniques (93% vs. 94%, P > .05). 82-Rb-PET allowed for a more accurate detection of patients with a high-risk coronary artery disease (HR-CAD) than 99m-Tc-SPECT-MPS (AUC = 0.86 vs. 0.75, respectively; P = .04). CONCLUSIONS: In women and overweight individuals, 82-Rb-PET-MPS provides higher sensitivity for the detection of myocardial ischemia than 99m-Tc-SPECT-MPS thanks to a better image quality and an improved detection of HR-CAD.

5.
Eur Heart J ; 2018 Jul 09.
Artigo em Inglês | MEDLINE | ID: mdl-29992264

RESUMO

Non-adherence has been well recognized for years to be a common issue that significantly impacts clinical outcomes and health care costs. Medication adherence is remarkably low even in the controlled environment of clinical trials where it has potentially complex major implications. Collection of non-adherence data diverge markedly among cardiovascular randomized trials and, even where collected, is rarely incorporated in the statistical analysis to test the consistency of the primary endpoint(s). The imprecision introduced by the inconsistent assessment of non-adherence in clinical trials might confound the estimate of the calculated efficacy of the study drug. Hence, clinical trials may not accurately answer the scientific question posed by regulators, who seek an accurate estimate of the true efficacy and safety of treatment, or the question posed by payers, who want a reliable estimate of the effectiveness of treatment in the marketplace after approval. The Non-adherence Academic Research Consortium is a collaboration among leading academic research organizations, representatives from the U.S. Food and Drug Administration and physician-scientists from the USA and Europe. One in-person meeting was held in Madrid, Spain, culminating in a document describing consensus recommendations for reporting, collecting, and analysing adherence endpoints across clinical trials. The adoption of these recommendations will afford robustness and consistency in the comparative safety and effectiveness evaluation of investigational drugs from early development to post-marketing approval studies. These principles may be useful for regulatory assessment, as well as for monitoring local and regional outcomes to guide quality improvement initiatives.

6.
Heart Lung Circ ; 2018 May 08.
Artigo em Inglês | MEDLINE | ID: mdl-29843973

RESUMO

BACKGROUND: Compared with other manifestations of cardiovascular disease, peripheral arterial disease (PAD) is under-diagnosed. This study aims to investigate the prevalence, risk profile and cardiovascular outcomes of undiagnosed PAD in Australian general practices. METHOD: A sub-study of the Australian Reduction of Atherothrombosis for Continued Health (REACH) Registry, a prospective cohort study of patients at high risk of atherothrombosis recruited from Australian general practices. Eligible patients for this study had no previous clinical diagnosis of PAD and had an ankle-brachial index (ABI) ≤1.4 at recruitment. RESULTS: Peripheral arterial disease was undiagnosed in 34% Australian REACH participants, 28% patients had low ABI (ABI<0.9) and 11% had intermittent claudication (IC) based on responses to the Edinburgh Claudication Questionnaire (ECQ). We found no significant differences in risk factor control between patient with or without PAD. Intermittent claudication patients had higher risks of non-fatal cardiovascular events and PAD interventions at one year, whereas all-cause mortality rate was higher among patients with ABI<0.9, especially in those who also reported IC. Finally, an ABI<0.9, together with poorly controlled risk factors were independent predictors of incident IC at one year. CONCLUSIONS: This study suggests a high rate of undiagnosed PAD among high risk patients in Australian primary health care. These patients are at high risk of events and therefore would potentially benefit from better secondary prevention measures.

7.
EuroIntervention ; 13(15): e1841-e1849, 2018 Feb 02.
Artigo em Inglês | MEDLINE | ID: mdl-28988157

RESUMO

AIMS: The aim of this study was to determine the prognostic significance of periprocedural bleeding based on various definitions on 30-day and one-year all-cause mortality in patients undergoing routine or urgent percutaneous coronary intervention (PCI). METHODS AND RESULTS: In this exploratory analysis of 25,107 patients enrolled in the three phase-3 CHAMPION trials, we assessed the prognostic impact of four bleeding scales (GUSTO, TIMI, ACUITY, and BARC) at 48 hrs. Follow-up all-cause mortality data were available at 30 days in all three trials, and at one year in CHAMPION PCI and CHAMPION PLATFORM. Bleeding rates within 48 hrs of PCI were variably identified by each clinical definition (range: <0.5% to >3.5%). Severe/major bleeding, measured by all bleeding scales, and blood transfusion requirement were independently associated with increased mortality at 30 days and one year after PCI (p<0.001 for all associations). Mild/minor bleeding was not independently predictive of one-year mortality (p>0.07 for all associations). Each bleeding definition demonstrated only modest ability to discriminate 30-day and one-year mortality (adjusted C-statistics range: 0.49 to 0.67). CONCLUSIONS: Commonly employed clinical definitions variably identify rates of bleeding after PCI. Severe or major, but not mild or minor, bleeding is independently associated with increased 30-day and one-year mortality. These data may aid in selection of appropriate bleeding metrics in future clinical trials.

9.
BMJ ; 354: i4801, 2016 09 20.
Artigo em Inglês | MEDLINE | ID: mdl-27650822

RESUMO

OBJECTIVE: To assess the association between early and prolonged ß blocker treatment and mortality after acute myocardial infarction. DESIGN: Multicentre prospective cohort study. SETTING: Nationwide French registry of Acute ST- and non-ST-elevation Myocardial Infarction (FAST-MI) (at 223 centres) at the end of 2005. PARTICIPANTS: 2679 consecutive patients with acute myocardial infarction and without heart failure or left ventricular dysfunction. MAIN OUTCOME MEASURES: Mortality was assessed at 30 days in relation to early use of ß blockers (≤48 hours of admission), at one year in relation to discharge prescription, and at five years in relation to one year use. RESULTS: ß blockers were used early in 77% (2050/2679) of patients, were prescribed at discharge in 80% (1783/2217), and were still being used in 89% (1230/1383) of those alive at one year. Thirty day mortality was lower in patients taking early ß blockers (adjusted hazard ratio 0.46, 95% confidence interval 0.26 to 0.82), whereas the hazard ratio for one year mortality associated with ß blockers at discharge was 0.77 (0.46 to 1.30). Persistence of ß blockers at one year was not associated with lower five year mortality (hazard ratio 1.19, 0.65 to 2.18). In contrast, five year mortality was lower in patients continuing statins at one year (hazard ratio 0.42, 0.25 to 0.72) compared with those discontinuing statins. Propensity score and sensitivity analyses showed consistent results. CONCLUSIONS: Early ß blocker use was associated with reduced 30 day mortality in patients with acute myocardial infarction, and discontinuation of ß blockers at one year was not associated with higher five year mortality. These findings question the utility of prolonged ß blocker treatment after acute myocardial infarction in patients without heart failure or left ventricular dysfunction.Trial registration Clinical trials NCT00673036.


Assuntos
Antagonistas Adrenérgicos beta/uso terapêutico , Infarto do Miocárdio/tratamento farmacológico , Infarto do Miocárdio/mortalidade , Doença Aguda , Idoso , Unidades de Cuidados Coronarianos , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Alta do Paciente/estatística & dados numéricos , Modelos de Riscos Proporcionais , Estudos Prospectivos , Análise de Sobrevida , Fatores de Tempo
10.
Am J Cardiol ; 118(8): 1178-1186, 2016 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-27569387

RESUMO

The prevalence of factors that are associated with an increased risk of stent thrombosis (ST), including smoking, diabetes mellitus, and small stent size, is different in women and men who underwent percutaneous coronary intervention. Thus, gender may potentially modify the relation between stent type and the incidence of ST during long-term follow-up. We explored the data of Patient Related Outcomes With Endeavor Versus Cypher stenting Trial (PROTECT) to evaluate this hypothesis. PROTECT randomized 2,061 women and 6,648 men who underwent percutaneous coronary intervention for various indications to Endeavor zotarolimus-eluting stenting (E-ZES) or Cypher sirolimus-eluting stenting (C-SES). Dual antiplatelet therapy was prescribed for at least 3 months. Data on study end points were collected until 5 years after randomization, including ST, death, and cardiovascular events. We analyzed end points and treatment effect (E-ZES vs C-SES) in relation to gender. Women were on average 4.7 years older (65.8 vs 61.1), had a higher prevalence of insulin-dependent diabetes mellitus, were less often smokers, and had a shorter total stent length than men. At discharge and throughout follow-up, a slightly lower fraction of women were using dual antiplatelet therapy. During 5-year follow-up, definite or probable ST was observed in 36 women (1.8%) and 152 men (2.4%; log-rank p = 0.15). E-ZES reduced the incidence of ST compared with C-SES in women (hazard ratio 0.58) and men (hazard ratio 0.61), with no evidence of heterogeneity (p = 0.89). In conclusion, in PROTECT, women and men had similar cumulative incidence of ST at 5 years after stent placement. The favorable effect of the study stent E-ZES over C-SES was not modified by gender.


Assuntos
Antibióticos Antineoplásicos/uso terapêutico , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Oclusão de Enxerto Vascular/epidemiologia , Inibidores da Agregação de Plaquetas/uso terapêutico , Sirolimo/análogos & derivados , Sirolimo/uso terapêutico , Trombose/epidemiologia , Idoso , Diabetes Mellitus/tratamento farmacológico , Diabetes Mellitus/epidemiologia , Feminino , Humanos , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea , Modelos de Riscos Proporcionais , Fatores Sexuais , Resultado do Tratamento
13.
Eur Heart J ; 37(4): 400-8, 2016 Jan 21.
Artigo em Inglês | MEDLINE | ID: mdl-26443023

RESUMO

AIMS: We evaluated the relationship of renal function and ischaemic and bleeding risk as well as the efficacy and safety of ticagrelor in stable patients with prior myocardial infarction (MI). METHODS AND RESULTS: Patients with a history of MI 1-3 years prior from PEGASUS-TIMI 54 were stratified based on estimated glomerular filtration rate (eGFR), with <60 mL/min/1.73 m(2) pre-specified for analysis of the effect of ticagrelor on the primary efficacy composite of cardiovascular death, MI, or stroke (major adverse cardiovascular events, MACE) and the primary safety endpoint of TIMI major bleeding. Of 20 898 patients, those with eGFR <60 (N = 4849, 23.2%) had a greater risk of MACE at 3 years relative to those without, which remained significant after multivariable adjustment (hazard ratio, HRadj 1.54, 95% confidence interval, CI 1.27-1.85, P < 0.001). The relative risk reduction in MACE with ticagrelor was similar in those with eGFR <60 (ticagrelor pooled vs. placebo: HR 0.81; 95% CI 0.68-0.96) vs. ≥60 (HR 0.88; 95% CI 0.77-1.00, Pinteraction = 0.44). However, due to the greater absolute risk in the former group, the absolute risk reduction with ticagrelor was higher: 2.7 vs. 0.63%. Bleeding tended to occur more frequently in patients with renal dysfunction. The absolute increase in TIMI major bleeding with ticagrelor was similar in those with and without eGFR <60 (1.19 vs. 1.43%), whereas the excess of minor bleeding tended to be more pronounced (1.93 vs. 0.69%). CONCLUSION: In patients with a history of MI, patients with renal dysfunction are at increased risk of MACE and consequently experience a particularly robust absolute risk reduction with long-term treatment with ticagrelor.


Assuntos
Adenosina/análogos & derivados , Doença da Artéria Coronariana/prevenção & controle , Trombose Coronária/prevenção & controle , Infarto do Miocárdio/tratamento farmacológico , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Insuficiência Renal Crônica/complicações , Adenosina/administração & dosagem , Adenosina/efeitos adversos , Idoso , Doença da Artéria Coronariana/mortalidade , Trombose Coronária/mortalidade , Esquema de Medicação , Feminino , Hemorragia/induzido quimicamente , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Insuficiência Renal Crônica/mortalidade , Fatores de Risco , Ticagrelor , Resultado do Tratamento
14.
Eur Heart J ; 37(13): 1063-71, 2016 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-26578201

RESUMO

AIMS: The use of opioids is recommended for pain relief in patients with myocardial infarction (MI) but may delay antiplatelet agent absorption, potentially leading to decreased treatment efficacy. METHODS AND RESULTS: In-hospital complications (death, non-fatal re-MI, stroke, stent thrombosis, and bleeding) and 1-year survival according to pre-hospital morphine use were assessed in 2438 ST-elevation MI (STEMI) patients from the French Registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction (FAST-MI) 2010. The analyses were replicated in the 1726 STEMI patients of the FAST-MI 2005 cohort, in which polymorphisms of CYP2C19 and ABCB1 had been assessed. Specific subgroup analyses taking into account these genetic polymorphisms were performed in patients pre-treated with thienopyridines. The 453 patients (19%) receiving morphine pre-hospital were younger, more often male, with a lower GRACE score and higher chest pain levels. After adjustment for baseline differences, in-hospital complications and 1-year survival (hazard ratio = 0.69; 95% confidence interval: 0.35-1.37) were not increased according to pre-hospital morphine use. After propensity score matching, 1-year survival according to pre-hospital morphine was also similar. Consistent results were found in the replication cohort, including in those receiving pre-hospital thienopyridines and whatever the genetic polymorphisms of CYP2C19 and ABCB1. CONCLUSION: In two independent everyday-life cohorts, pre-hospital morphine use in STEMI patients was not associated with worse in-hospital complications and 1-year mortality. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT00673036 (FAST-MI 2005); NCT01237418 (FAST-MI 2010).


Assuntos
Analgésicos Opioides/uso terapêutico , Morfina/uso terapêutico , Infarto do Miocárdio sem Supradesnível do Segmento ST/tratamento farmacológico , Infarto do Miocárdio com Supradesnível do Segmento ST/tratamento farmacológico , Subfamília B de Transportador de Cassetes de Ligação de ATP/genética , Idoso , Citocromo P-450 CYP2C19/genética , Interações de Medicamentos/genética , Serviços Médicos de Emergência/métodos , Feminino , França/epidemiologia , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio sem Supradesnível do Segmento ST/genética , Infarto do Miocárdio sem Supradesnível do Segmento ST/mortalidade , Dor/prevenção & controle , Inibidores da Agregação de Plaquetas/uso terapêutico , Polimorfismo Genético/genética , Sistema de Registros , Fatores de Risco , Infarto do Miocárdio com Supradesnível do Segmento ST/genética , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Resultado do Tratamento
16.
Hellenic J Cardiol ; 56(2): 112-7, 2015 Mar-Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25854439

RESUMO

INTRODUCTION: Heart rate (HR) is a strong prognostic indicator in patients with coronary artery disease (CAD). However, there is only limited evidence on HR and the use of b-blockers in patients with CAD in contemporary clinical practice. METHODS: CLARIFY is an international, prospective, observational, longitudinal registry of outpatients with stable CAD, defined as prior myocardial infarction or revascularization procedure, evidence of coronary stenosis >50%, or chest pain associated with proven myocardial ischemia. A total of 33,283 patients from 45 countries were enrolled between November 2009 and July 2010; of these, 559 patients were enrolled in Greece (age 62.3 ± 10.6 years, 84.44% men). RESULTS: HR measured by pulse was 68.3 ± 10.2 bpm and by electrocardiogram 67.6 ± 10.9, with an excellent correlation (r=0.91, p<0.001). Overall, 42.8% had HR70 bpm. B-blockers were prescribed in 74.2% of patients. Resting HR by pulse on b-blocker was 67.8 bpm and without b-blocker 69.6 bpm (p=0.069). HR70 bpm was independently associated with a lack of physical activity, higher systolic blood pressure, and a higher prevalence of asthma or chronic obstructive pulmonary disease and carotid artery disease. CONCLUSION: Despite the use of HR lowering agents, the percentage of patients with HR70 bpm was high. It is likely that we can further improve HR control in Greek patients with stable CAD by both increasing the prescription of b-blockers and up-titrating their dose, as well as by using and up-titrating other available HR lowering agents.


Assuntos
Antagonistas Adrenérgicos beta/farmacologia , Doença da Artéria Coronariana , Frequência Cardíaca/efeitos dos fármacos , Idoso , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/tratamento farmacológico , Doença da Artéria Coronariana/epidemiologia , Doença da Artéria Coronariana/fisiopatologia , Eletrocardiografia , Feminino , Grécia/epidemiologia , Humanos , Hipertensão/epidemiologia , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Atividade Motora/fisiologia , Prevalência , Estudos Prospectivos , Doença Pulmonar Obstrutiva Crônica/epidemiologia , Sistema de Registros , Fatores de Risco
17.
The Amer. Jour. of Medicine ; 128(7): 766-775, 2015. ilus
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: ses-31263

RESUMO

PURPOSE: Short-term outcomes have been well characterized in acute coronary syndromes; however,longer-term follow-up for the entire spectrum of these patients, including ST-segment-elevation myocardialinfarction, non-ST-segment-elevation myocardial infarction, and unstable angina, is more limited. Therefore,we describe the longer-term outcomes, procedures, and medication use in Global Registry of AcuteCoronary Events (GRACE) hospital survivors undergoing 6-month and 2-year follow-up, and the performanceof the discharge GRACE risk score in predicting 2-year mortality.METHODS: Between 1999 and 2007, 70,395 patients with a suspected acute coronary syndrome wereenrolled. In 2004, 2-year prospective follow-up was undertaken in those with a discharge acute coronarysyndrome diagnosis in 57 sites.RESULTS: From 2004 to 2007, 19,122 (87.2%) patients underwent follow-up; by 2 years postdischarge,14.3% underwent angiography, 8.7% percutaneous coronary intervention, 2.0% coronary bypass surgery,and 24.2% were re-hospitalized. In patients with 2-year follow-up, acetylsalicylic acid (88.7%), betablocker(80.4%), renin-angiotensin system inhibitor (69.8%), and statin (80.2%) therapy was used. Heartfailure occurred in 6.3%, (re)infarction in 4.4%, and death in 7.1%. Discharge-to-6-month GRACE riskscore was highly predictive of all-cause mortality at 2 years (c-statistic 0.80).CONCLUSION: In this large multinational cohort of acute coronary syndrome patients, there were importantlater adverse consequences, including frequent morbidity and mortality. These findings were seen in thecontext of additional coronary procedures and despite continued use of evidence-based therapies in a highproportion of patients. The discriminative accuracy of the GRACE risk score in hospital survivors forpredicting longer-term mortality was maintained. (AU)


Assuntos
Síndrome Coronariana Aguda , Revascularização Miocárdica , Infarto do Miocárdio
18.
Kardiol Pol ; 72(11): 112017 Apr, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-25001472

RESUMO

BACKGROUND: Heart rate (HR) is an important risk factor in coronary artery disease (CAD). However, there is little contemporary data on HR and the use of HR-lowering medications, particularly beta-blockers, among patients with stable CAD in routine clinical practice. AIM: To describe HR in the Polish population of the CLARIFY registry, overall and in relation to beta-blocker use, and to assess the determinants of HR. METHODS AND RESULTS: CLARIFY is an international, prospective, observational, longitudinal registry of outpatients with stable CAD, defined as either prior myocardial infarction or revascularisation procedure, or evidence of coronary stenosis of at least 50%, or chest pain associated with proven myocardial ischaemia. A total of 33,438 patients from 45 countries in Europe, the Americas, Africa, the Middle East, and Asia/Pacific were enrolled between November 2009 and July 2010. In Poland, 1,004 patients were enrolled between February and June 2010, which was the largest population among countries from Eastern Europe. Most patients were men (72.8%). Mean ± standard deviation age was 62.1 ± 9.1 years. HR determined by pulse was 69.3 ± 9.4 bpm and by electrocardiogram was 68.2 ± 10.6 bpm. Beta-blockers were used in 89.9% of patients. Resting HR ≥ 70 bpm was noted in 49.3% of all patients and in 48.6% of patients on beta-blockers. Resting HR ≥ 70 bpm was significantly more frequent among younger patients, and in those with diabetes, those being treated for arterial hypertension, and who lacked regular physical activity. Patients with HR ≥ 70 bpm at rest had more frequent symptoms of angina and more frequently needed hospitalisation due to heart failure. CONCLUSIONS: Despite a very high rate of beta-blocker use, almost 50% of patients with stable CAD had a resting HR ≥ 70 bpm, which was associated with more frequent angina and ischaemia. Further HR lowering is possible in many patients with CAD. Whether or not this will improve symptoms and outcomes is under investigation.


Assuntos
Antagonistas Adrenérgicos beta/uso terapêutico , Doença da Artéria Coronariana/tratamento farmacológico , Frequência Cardíaca/efeitos dos fármacos , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Polônia , Sistema de Registros
19.
Am Heart J ; 168(1): 68-75.e2, 2014 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-24952862

RESUMO

BACKGROUND: Extensive coronary artery disease (CAD) is associated with higher risk. In this substudy of the PLATO trial, we examined the effects of randomized treatment on outcome events and safety in relation to the extent of CAD. METHODS: Patients were classified according to presence of extensive CAD (defined as 3-vessel disease, left main disease, or prior coronary artery bypass graft surgery). The trial's primary and secondary end points were compared using Cox proportional hazards regression. RESULTS: Among 15,388 study patients for whom the extent of CAD was known, 4,646 (30%) had extensive CAD. Patients with extensive CAD had more high-risk characteristics and experienced more clinical events during follow-up. They were less likely to undergo percutaneous coronary intervention (58% vs 79%, P < .001) but more likely to undergo coronary artery bypass graft surgery (16% vs 2%, P < .001). Ticagrelor, compared with clopidogrel, reduced the composite of cardiovascular death, myocardial infarction, and stroke in patients with extensive CAD (14.9% vs 17.6%, hazard ratio [HR] 0.85 [0.73-0.98]) similar to its reduction in those without extensive CAD (6.8% vs 8.0%, HR 0.85 [0.74-0.98], Pinteraction = .99). Major bleeding was similar with ticagrelor vs clopidogrel among patients with (25.7% vs 25.5%, HR 1.02 [0.90-1.15]) and without (7.3% vs 6.4%, HR 1.14 [0.98-1.33], Pinteraction = .24) extensive CAD. CONCLUSIONS: Patients with extensive CAD have higher rates of recurrent cardiovascular events and bleeding. Ticagrelor reduced ischemic events to a similar extent both in patients with and without extensive CAD, with bleeding rates similar to clopidogrel.


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Adenosina/análogos & derivados , Inibidores da Agregação de Plaquetas/uso terapêutico , Síndrome Coronariana Aguda/epidemiologia , Adenosina/uso terapêutico , Idoso , Eletrocardiografia , Feminino , Seguimentos , Saúde Global , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Antagonistas do Receptor Purinérgico P2Y/uso terapêutico , Estudos Retrospectivos , Fatores de Risco , Taxa de Sobrevida/tendências , Ticagrelor , Resultado do Tratamento
20.
Int J Cardiol ; 175(1): 72-7, 2014 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-24816526

RESUMO

BACKGROUND: Atherothrombotic diseases are the leading health problems in the world, both in terms of morbidity and mortality. This study aimed to identify and quantify the predictors of medication, hospital and outpatient service use among patients with or at high risk of atherothrombotic disease. METHODS: Two-year follow-up data were analyzed for 2873 Australian participants of the Reduction of Atherothrombosis for Continued Health (REACH) registry. The analysis was performed using generalized linear models with Poisson and Gamma distributions and log link function. RESULTS: Participants with hypercholesterolemia, diabetes, hypertension, atrial fibrillation (AF), and history of coronary artery disease (CAD) used more medications (p<0.0001). The presence of diabetes predicted higher number of outpatient visits (RR=1.09, 95% CI: 1.07-1.11), as did AF (RR=1.10, 95% CI: 1.08-1.12). The presence of peripheral artery disease (PAD) regardless of ankle brachial index (ABI) status (abnormal or normal) increased the use of outpatient visits (RR=1.24, 95% CI: 1.20-1.29 and RR=1.12, 95% CI: 1.08-1.15), compared to those without PAD. Similarly, the presence of PAD regardless of ABI status increased the risk of vascular interventions, including coronary angioplasty, carotid surgery, amputation affecting lower-limb and peripheral bypass graft (RR=3.64, 95% CI: 2.01-6.60) (RR=2.8, 95% CI: 1.6-4.92) compared to patients without PAD. CONCLUSIONS: The presence of PAD regardless of ABI status predicts a higher number of outpatient visits, non-fatal cardiovascular endpoints and vascular-interventions, while diabetes predicts higher pharmaceutical use and outpatient visits. AF predicts the higher number of outpatient visits and non-fatal cardiovascular events.


Assuntos
Doença da Artéria Coronariana/epidemiologia , Doença da Artéria Coronariana/terapia , Trombose Coronária/epidemiologia , Trombose Coronária/terapia , Aceitação pelo Paciente de Cuidados de Saúde , Idoso , Idoso de 80 Anos ou mais , Austrália/epidemiologia , Estudos de Coortes , Doença da Artéria Coronariana/diagnóstico , Trombose Coronária/diagnóstico , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Sistema de Registros , Fatores de Risco
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