ABSTRACT
AIMS: To evaluate whether a strategy of double-dose influenza vaccination during hospitalization for an acute coronary syndrome (ACS) compared with standard-dose outpatient vaccination (as recommended by current guidelines) would further reduce the risk of major cardiopulmonary events. METHODS AND RESULTS: Vaccination against Influenza to Prevent cardiovascular events after Acute Coronary Syndromes (VIP-ACS) was a pragmatic, randomized, multicentre, active-comparator, open-label trial with blinded outcome adjudication comparing two strategies of influenza vaccination following an ACS: double-dose quadrivalent inactivated vaccine before hospital discharge vs. standard-dose quadrivalent inactivated vaccine administered in the outpatient setting 30 days after randomization. The primary outcome was a hierarchical composite of all-cause death, myocardial infarction, stroke, unstable angina, hospitalization for heart failure, urgent coronary revascularization, and hospitalization for respiratory causes, analysed by the win ratio method. Patients were followed for 12 months. During two influenza seasons, 1801 participants were included at 25 centres in Brazil. The primary outcome was not different between groups, with 12.7% wins in-hospital double-dose vaccine group and 12.3% wins in the standard-dose vaccine group {win ratio: 1.02 [95% confidence interval (CI): 0.79-1.32], P = 0.84}. Results were consistent for the key secondary outcome, a hierarchical composite of cardiovascular death, myocardial infarction and stroke [win ratio: 0.94 (95% CI: 0.66-1.33), P = 0.72]. Time-to-first event analysis for the primary outcome showed results similar to those of the main analysis [hazard ratio 0.97 (95% CI: 0.75-1.24), P = 0.79]. Adverse events were infrequent and did not differ between groups. CONCLUSION: Among patients hospitalized with an ACS, double-dose influenza vaccination before discharge did not reduce cardiopulmonary outcomes compared with standard-dose vaccination in the outpatient setting. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number: NCT04001504.
Subject(s)
Acute Coronary Syndrome , Influenza, Human , Myocardial Infarction , Stroke , Humans , Acute Coronary Syndrome/therapy , Influenza, Human/prevention & control , Myocardial Infarction/prevention & control , Vaccination , Stroke/prevention & control , Vaccines, Inactivated , Treatment OutcomeABSTRACT
Introdução: Estudos demonstram que a intervenção coronária percutânea primária realizada fora do horário de rotina está relacionada a pior prognóstico. Nosso objetivo foi avaliar os desfechos da intervenção coronária percutânea primária realizada nos períodos diurno e noturno em um centro cardiológico de referência. Métodos: Estudo de coorte prospectivo, que incluiu 1.108 pacientes consecutivamente atendidos por infarto agudo do miocárdio com supradesnivelamento do segmento ST, divididos nos grupos intervenção coronária percutânea primária diurna (se realizada entre 8 e 20 horas) e intervenção coronária percutânea primária noturna (se realizada entre 20 e 8 horas). Resultados: Incluímos 680 pacientes no grupo diurno e 428 no grupo noturno. As características basais referentes ao perfil demográfico, fatores de risco e classificação Killip foram semelhantes em ambos os grupos, porém o tempo porta-balão foi significativamente maior no grupo noturno (84 ± 66 minutos vs. 102 ± 98 minutos; p < 0,01). Vasos culpados, e fluxos TIMI pré e pós-procedimento não foram diferentes entre os grupos. Não encontramos diferenças significantes em relação à mortalidade hospitalar (7,6% vs. 10,2%; p = 0,16), trombose de stent (2,8% vs. 2,4%; p = 0,69) ou presença de sangramento maior (1,9% vs. 2,1%; p = 0,50). Em 1 ano, a mortalidade também foi semelhante (9,5% vs. 12,6%; p = 0,12). O principal preditor de mortalidade em 1 ano foi a classe III/IV de Killip (OR = 10,02; IC 95% 5,8-17,1; p < 0,01). Conclusões: Pacientes com infarto agudo do miocárdio apresentam taxas de desfechos clínicos semelhantes, independentemente do horário de realização da intervenção coronária percutânea primária. No entanto, o tempo porta-balão é significativamente maior nos pacientes tratados entre 20 e 8 horas.
Background: Previous studies have shown that off-hours primary percutaneous coronary interventions are related to a worse prognosis. The objective of this study was to evaluate the outcomes of patients undergoing on- and off-hours primary percutaneous coronary interventions performed at a reference cardiology center. Methods: Prospective cohort study, including 1,108 consecutive patients with ST elevation myocardial infarction divided into primary percutaneous coronary intervention performed during regular working hours group (on-hours: 8:00 am to 8:00 pm) and primary percutaneous coronary intervention during nonregular working hours group (off-hours: 8:00 pm to 8:00 am). Results: The sample included 680 patients in the on-hours group and 428 in the off-hours group. Baseline demographic data, risk factors and Killip classification were similar in both groups, however door-to-balloon time was significantly longer in the off-hours group (84 ± 66 minutes vs. 102 ± 98 minutes; p < 0.01). Culprit vessels, pre- and post-procedure TIMI flows were not different between groups. There were no significant differences for in-hospital mortality (7.6% vs. 10.2%; p = 0.16), stent thrombosis (2.8% vs. 2.4%; p = 0.69) or major bleeding (1.9% vs. 2.1%; p = 0.50). One-year mortality was also similar (9.5% vs. 12.6%; p = 0.12). The main predictor of mortality at 1 year was Killip III/IV (OR, 10.02; 95% CI, 5.8-17.1; p < 0.01). Conclusions: Patients with myocardial infarction have similar in-hospital clinical outcomes regardless of the time primary percutaneous coronary intervention is performed. However, door-to-balloon time is significantly longer in patients treated during off-hours.
Subject(s)
Humans , Male , Female , Middle Aged , Myocardial Infarction/physiopathology , Myocardial Infarction/drug therapy , Percutaneous Coronary Intervention/adverse effects , Myocardial Reperfusion/methods , Aspirin/administration & dosage , Chi-Square Distribution , Multivariate Analysis , Observational Study , Statistics, Nonparametric , Stents , Treatment Outcome , Thrombosis/complicationsABSTRACT
INTRODUÇÃO: A tromboaspiração é recomendada como método adjunto à intervenção coronária percutânea (ICP) primária, mas o insucesso em recuperar trombos é relativamente frequente. O objetivo deste estudo foi avaliar as taxas de insucesso de tromboaspiração e identificar seus preditores, em uma série contemporânea de pacientes. MÉTODOS: Estudo de coorte prospectivo que incluiu pacientes consecutivos atendidos com infarto agudo do miocárdio com elevação do segmento ST e submetidos à ICP primária com tromboaspiração no período de dezembro de 2009 a dezembro de 2011. Os procedimentos de tromboaspiração foram realizados por decisão do operador, e o sucesso foi definido como aspiração efetiva de trombo pelo cateter dedicado, com recuperação do fluxo coronário (fluxo TIMI > 0). RESULTADOS: Foram realizadas 1.055 ICPs primárias, sendo que a tromboaspiração foi utilizada em 37% dos casos, com taxa de sucesso de 70%. Foram identificados 254 pacientes com sucesso e 107 com insucesso da tromboaspiração. Insucesso de tromboaspiração foi associado a: idade, hipertensão, diabetes mellitus, dislipidemia, ICP prévia, escore de risco TIMI, Killip IV, contagem de leucócitos, fibrinogênio sérico, diâmetro de referência do vaso-alvo e TIMI 3 pré-procedimento. Pacientes com insucesso da tromboaspiração apresentaram tendência a maior mortalidade (11,6% vs. 5,9%; P = 0,09). CONCLUSÕES: Insucesso de tromboaspiração durante ICP primária ocorreu em 30% dos casos e esteve associado a tendência de maior mortalidade. A identificação de preditores clínicos, laboratoriais e angiográficos pode auxiliar no aprimoramento desses dispositivos e em sua técnica, além da escolha de pacientes mais adequados para seu emprego.
BACKGROUND: Aspiration thrombectomy is recommended as an adjunctive method in patients undergoing primary percutaneous coronary intervention (PCI), however, thrombus aspiration failure is relatively frequent. The objective of this study was to evaluate the rate and identify predictors of failed thrombus aspiration in a contemporaneous series of patients. METHODS: Prospective cohort study including consecutive patients with acute ST-segment elevation myocardial infarction undergoing primary PCI with thrombus aspiration from December 2009 to December 2011. Aspiration thrombectomy was performed at the operator's discretion and success was defined as effective thrombus aspiration by a dedicated catheter with the achievement of a final TIMI flow > 0. RESULTS: 1,055 primary PCIs were performed and aspiration thrombectomy was used in 37% of cases with a success rate of 70%. Aspiration thrombectomy success was observed in 254 patients whereas failure was observed in 107 patients. Aspiration thrombectomy failure was associated with age, hypertension, diabetes mellitus, dyslipidemia, previous PCI, TIMI risk score, Killip IV, leukocyte count, serum fibrinogen, target vessel reference diameter and preprocedural TIMI 3 flow. Patients with failed thrombus aspiration had a trend towards higher mortality (11.6% vs. 5.9%; P = 0.09). CONCLUSIONS: Aspiration thrombectomy failure during primary PCI was observed in 30% of the cases and was associated with a trend towards higher mortality. The identification of clinical, laboratory and angiographic predictors may help improve these devices and the technique and enable better patient selection.
Subject(s)
Humans , Male , Female , Middle Aged , Antifibrinolytic Agents , Myocardial Infarction/complications , Myocardial Infarction/mortality , Percutaneous Coronary Intervention , Thrombosis/therapy , Risk FactorsABSTRACT
Introdução: A via radial é um acesso seguro para procedimentos percutâneos e reduz as complicações vasculares locais. Neste estudo comparou-se a evolução hospitalar de pacientes com infarto agudo do miocárdio com supradesnivelamento do segmento ST (IAMCSST) submetidos a intervenção coronária percutânea primária (ICPp) por via radial vs. via femoral. Métodos: Estudo de coorte prospectivo com pacientes consecutivamente atendidos entre dezembro de 2009 e maio de 2011. Resultados: Foram incluídos 794 pacientes, 82 (10,3%) tratados por via radial e 712 (89,7%), por via femoral. Pacientes do grupo radial eram mais jovens (56,2 ± 10,7 anos vs. 61,2 ± 11,9 anos; P < 0,01), mais frequentemente do sexo masculino (78% vs. 68%; P = 0,06), com menor prevalência de diabetes (9,8% vs. 20%; P = 0,02) e maior fração de ejeção do ventrículo esquerdo (61,2 ± 11,8% vs. 55,5 ± 12,1%; P = 0,05). Não houve diferença em relação à maior parte das características angiográficas. Tromboaspiração (44% vs. 31%; P = 0,01) e administração de glicoproteína IIb/IIIa (41% vs. 26%; P = 0,004) foram mais utilizadas no grupo radial. O fluxo TIMI 3 final (93% vs. 88%; P = 0,47) e o blush miocárdico 3 (70% vs. 66%; P = 0,87) foram semelhantes entre os grupos. Não foram observadas diferenças em relação a óbito (7,5% vs. 8,4%; P = 0,78), reinfarto (4,9% vs. 4,4%; P = 0,77), revascularização de urgência (3,7% vs. 4,1%; P > 0,99), trombose do stent (2,4% vs. 3%; P > 0,99), sangramento maior (0 vs. 1,6%; P = 0,61) ou sangramento menor (5,3% vs. 7,3%; P = 0,81). Conclusões: A abordagem transradial mostrou-se segura e efetiva, com resultados semelhantes aos da abordagem transfemoral em pacientes com IAMCSST.
BACKGROUND: Radial access is a safe approach for percutaneous procedures and reduces local vascular complications. This study compared the hospital outcomes of patients with ST-elevation acute myocardial infarction (STEMI) submitted to primary percutaneous coronary intervention (pPCI) using the radial vs. femoral approaches. METHODS: Prospective cohort study with consecutive patients treated between December 2009 and May 2011. RESULTS: Seven hundred and ninety-four patients were included, 82 (10.3%) treated by radial access and 712 (89.7%) treated by femoral access. Radial access patients were younger (56.2 ± 10,7 years vs. 61,2 ± 11,9 years; P < 0.01), more often male (78% vs. 68%; P = 0.06), had a lower prevalence of diabetes (9.8% vs. 20%; P = 0.02) and higher left ventricle ejection fraction (61.2 ± 11.8% vs. 55.5 ± 12.1%; P = 0.05). There was no difference for most angiographic characteristics. Thromboaspiration (44% vs. 31%; P = 0.01) and glycoprotein IIb/IIIa administration (41% vs. 26%; P = 0.004) were used more often in the radial group. The final TIMI 3 flow (93% vs. 88%; P = 0.47) and myocardial blush grade 3 (70% vs. 66%; P = 0.87) were similar between groups. There were no differences for death (7.5% vs. 8.4%; P = 0.78), reinfarction (4.9% vs. 4.4%; P = 0.77), emergency revascularization (3.7% vs. 4.1%; P > 0.99), stent thrombosis (2.4% vs. 3%; P > 0.99), major bleeding (0 vs. 1.6%; P = 0.61) or minor bleeding (5.3% vs. 7.3%; P = 0.81) rates. CONCLUSIONS: The transradial approach has proven to be safe and effective with similar results to transfemoral approach in patients with STEMI.
Subject(s)
Humans , Male , Female , Middle Aged , Angioplasty/methods , Angioplasty , Femoral Artery/surgery , Radial Artery/surgery , Myocardial Infarction/complications , Myocardial Infarction/diagnosis , Aspirin/administration & dosage , Electrocardiography/methods , Electrocardiography , Prospective Studies , Cohort StudiesABSTRACT
INTRODUÇÃO: Existem poucos estudos contemporâneos avaliando o implante de stent direto em pacientes com infarto agudo do miocárdio com supradesnivelamento do segmento ST (IAM). Método: Estudo de coorte prospectivo com pacientes consecutivamente atendidos com IAM em um centro de referêncioa em cardiologia entre dezembro de 2009 e janeiro de 2010. Dados clínicos e laboratoriais, características angiográficas e evolução hospitalar foram avaliados. Foram excluídos pacientes com mais de 12 horas de evolução, com menos de 18 anos de idade ou por recusa em participar do estudo. Os pacientes submetidos a implante de stent direto foram comparados àqueles tratados com pré-dilatação. Os dados foram armazenados em banco de dados dedicado e analisados com SPSS 17.0. Resultados: No período de estudo, 98 pacientes foram submetidos a angioplastia primária, dos quais em 33 (34,7 por cento) foi implantado stent direto e em 65 (65,3 por cento) foi realizada pré-dilatação. A média de idade dos 98 pacientes foi de 58,6 +- 10,6 anos e 63 por cento eram do sexo masculino. Os procedimentos com stent direto foram menos frequentes em lesões calcificadas (9 por cento vs. 30 por cento; P + 0,02) e mais frequentes naqueles com TIMI 3 pré-procedimento (41 por cento vs. 18 por cento; P=0,06), sendo a tromboaspiração...
BACKGROUND: There are few contemporary studies assessing direct stenting in patients with acute ST-segment elevation myocardial infarction (AMI). METHOD: Prospective cohort study in consecutive patients with AMI seen at a reference cardiology center from December 2009 to January 2010. Clinical and laboratory data, angiographic characteristics and hospital outcomes were evaluated. Patients with over 12 hours of symptom onset, with less than 18 years of age and those who denied participating in the study were excluded. Patients undergoing direct stenting were compared to those treated with stent with balloon pre-dilatation. Data were entered in a dedicated database and analyzed by SPSS 17.0. RESULTS: During the study period, 98 patients were submitted to primary angioplasty, of which 33 (34.7%) received direct stenting and 65 (65.3%) underwent stent with balloon pre-dilatation. Mean age was 58.6 ± 10.6 years and 63% were men. Direct stenting was less frequent in calcified lesions (9% vs. 30%; P = 0.02) and more frequent in those with TIMI 3 before the procedure (41% vs. 18%; P = 0.06) and thrombus aspiration was more frequently used in these cases (41% vs. 14%; P = 0.003). There was no statistically significant difference for the clinical outcome in both groups of patients. CONCLUSION: Direct stenting was more frequently used in patients with normal flow prior the procedure and in combination with thrombus aspiration and less used in calcified lesions. It was not associated to significant differences in clinical outcome rates.