In-Hospital influenza vaccination to prevent cardiorespiratory events in the first 45 days after acute coronary syndrome: A prespecified analysis of the VIP-ACS trial.

BACKGROUND: Influenza vaccination prevents major cardiovascular events in individuals presenting a recent acute coronary syndrome (ACS), however the early effect of an in-hospital double-dose vaccination strategy remains uncertain. METHODS: The VIP-ACS was a randomized, pragmatic, multicenter, open-label trial with a blinded-adjudication endpoint. Patients with ACS ≤ 7 days of hospitalization were randomized to an in-hospital double-dose quadrivalent inactivated influenza vaccine (double-dose) or a standard-dose influenza vaccine at 30 days post-randomization. The primary endpoint was a hierarchical composite of death, myocardial infarction, stroke, hospitalization for unstable angina, hospitalization for heart failure, urgent coronary revascularization, and hospitalization for respiratory infections, analyzed with the win ratio (WR) method in short-term follow-up (45-days after randomization). RESULTS: The trial enrolled 1,801 patients (≥18 years old). Median participant age was 57 years, 70 % were male. There were no significant differences between groups on the primary hierarchical endpoint: there were 5.7 % wins in the double-dose in-hospital group and 5.5 % wins in the standard-dose delayed vaccination group (WR: 1.03; 95 % CI: 0.70---1.53; P = 0.85). In a sensitivity analysis including COVID-19 infection in the hospitalizations for respiratory infections endpoint, overall results were maintained (WR: 1.03; 95 % CI 0.71---1.51; P = 0.87). Results were consistent for major cardiovascular events only (WR: 0.82; 95 % CI: 0.48---1.39; P = 0.46). No serious adverse events were observed. CONCLUSION: In patients with recent ACS, in-hospital double-dose influenza vaccination did not significantly reduce cardiorespiratory events at 45 days compared with standard-dose vaccination at 30 days post-randomization.

Randomized Noninferiority Trial of Radiation Exposure During Coronary Angiography: the Transradial and Transfemoral Approach by EXPERienced Operators in Daily rouTine (EXPERT) Trial.

BACKGROUND: The transradial approach (TRA) to coronary angiography reduces vascular complications but is associated with greater radiation exposure than the transfemoral approach (TFA). It is unknown whether exposure remains higher when TRA is performed by experienced operators. METHODS: Patients were randomly, prospectively assigned to TRA or TFA. The primary end point was patient radiation dose; secondary end points were the physician radiation dose and 30-day major adverse cardiac event rate. Coronary angiography was performed by experienced operators using a standardized protocol. RESULTS: Clinical and procedural characteristics were similar between the TRA (n = 150) and TFA (n = 149) groups, and they had comparable mean (SD) radiation doses for patients (616.51 [252] vs 585.57 [225] mGy; P = .13) and physicians (0.49 [0.3] vs 0.46 [0.29] mSv; P = .32). The mean (SD) fluoroscopy time (3.52 [2.02] vs 3.13 [2.46] min; P = .14) and the mean (SD) dose area product (35,496.5 [15,670] vs 38,313.4 [17,764.9] mGy·cm2; P = .2) did not differ. None of the following factors predicted higher radiation doses: female sex (hazard ratio [HR], 0.69 [95% CI, 0.38-1.3]; P = .34), body mass index >25 (HR, 0.84 [95% CI, 0.43-1.6]; P = .76), age >65 years (HR, 1.67 [95% CI, 0.89-3.1]; P = .11), severe valve disease (HR, 1.37 [95% CI, 0.52-3.5]; P = .68), or previous coronary artery bypass graft (HR, 0.6; 95% CI, 0.2-1.8; P = .38). CONCLUSION: TRA for elective coronary angiography is noninferior to TFA when performed by experienced operators.

Influenza vaccination strategy in acute coronary syndromes: the VIP-ACS trial.

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.

Rationale and design of the Statins Evaluation in Coronary procedUres and REvascularization: The SECURE-PCI Trial.

BACKGROUND: Previous evidence suggests that acute treatment with statins reduce atherosclerotic complications, including periprocedural myocardial infarction, but currently, there are no large, adequately powered studies to define the effects of early, high-dose statins in patients with acute coronary syndrome (ACS) and planned invasive management. OBJECTIVES: The main goal of Statins Evaluation in Coronary procedUres and REvascularization (SECURE-PCI) Trial is to determine whether the early use of a loading dose of 80 mg of atorvastatin before an intended percutaneous coronary intervention followed by an additional dose of 80 mg 24 hours after the procedure will be able to reduce the rates of major cardiovascular events at 30 days in patients with an ACS. DESIGN: The SECURE-PCI study is a pragmatic, multicenter, double-blind, placebo-controlled randomized trial planned to enroll around 4,200 patients in 58 different sites in Brazil. The primary outcome is the rate of major cardiovascular events at 30 days defined as a composite of all-cause mortality, nonfatal acute myocardial infarction, nonfatal stroke, and coronary revascularization. SUMMARY: The SECURE PCI is a large randomized trial testing a strategy of early, high-dose statin in patients with ACS and will provide important information about the acute treatment of this patient population.

Effect of Loading Dose of Atorvastatin Prior to Planned Percutaneous Coronary Intervention on Major Adverse Cardiovascular Events in Acute Coronary Syndrome: The SECURE-PCI Randomized Clinical Trial.

Importance: The effects of loading doses of statins on clinical outcomes in patients with acute coronary syndrome (ACS) and planned invasive management remain uncertain. Objective: To determine if periprocedural loading doses of atorvastatin decrease 30-day major adverse cardiovascular events (MACE) in patients with ACS and planned invasive management. Design, Setting, and Participants: Multicenter, double-blind, placebo-controlled, randomized clinical trial conducted at 53 sites in Brazil among 4191 patients with ACS evaluated with coronary angiography to proceed with a percutaneous coronary intervention (PCI) if anatomically feasible. Enrollment occurred between April 18, 2012, and October 6, 2017. Final follow-up for 30-day outcomes was on November 6, 2017. Interventions: Patients were randomized to receive 2 loading doses of 80 mg of atorvastatin (n = 2087) or matching placebo (n = 2104) before and 24 hours after a planned PCI. All patients received 40 mg of atorvastatin for 30 days starting 24 hours after the second dose of study medication. Main Outcomes and Measures: The primary outcome was MACE, defined as a composite of all-cause mortality, myocardial infarction, stroke, and unplanned coronary revascularization through 30 days. Results: Among the 4191 patients (mean age, 61.8 [SD, 11.5] years; 1085 women [25.9%]) enrolled, 4163 (99.3%) completed 30-day follow-up. A total of 2710 (64.7%) underwent PCI, 333 (8%) underwent coronary artery bypass graft surgery, and 1144 (27.3%) had exclusively medical management. At 30 days, 130 patients in the atorvastatin group (6.2%) and 149 in the placebo group (7.1%) had a MACE (absolute difference, 0.85% [95% CI, -0.70% to 2.41%]; hazard ratio, 0.88; 95% CI, 0.69-1.11; P = .27). No cases of hepatic failure were reported; 3 cases of rhabdomyolysis were reported in the placebo group (0.1%) and 0 in the atorvastatin group. Conclusions and Relevance: Among patients with ACS and planned invasive management with PCI, periprocedural loading doses of atorvastatin did not reduce the rate of MACE at 30 days. These findings do not support the routine use of loading doses of atorvastatin among unselected patients with ACS and intended invasive management. Trial Registration: clinicaltrials.gov Identifier: NCT01448642.

Resultados das Intervenções Coronárias Percutâneas Primárias Realizadas nos Horários Diurno e Noturno / Results of Primary Percutaneous Coronary Interventions Performed During On- and Off-Hours

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.

Preditores de insucesso de tromboaspiração em pacientes submetidos à intervenção coronária percutânea primária / Predictors of failed thrombus aspiration in patients undergoing primary percutaneous coronary intervention

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.

Intervenção coronária pelas vias radial ou femoral no infarto agudo do miocárdio com supradesnivelamento do segmento ST: um, a visão da prática clínica contemporânea / Coronary intevention by radial or femoral access in acute St-Segment elevation myocardial infarction: the real-world clinical practice

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.

Stent direto na intervenção coronária primária: avaliação de seu uso na prática clínica contemporânea / Direct stenting in primary percutaneous coronary intervention: an evaluation in current clinical practice

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.

Angioplastia primária no infarto agudo do miocárdio: existe diferença de resultados entre as angioplastias realizadas dentro e fora do horário de rotina? / Primary percutaneous coronary intervention in acute myocardial infarction: is there a difference in the outcomes of normal and off-hours procedures?

INTRODUÇÃO: Estudos demonstram que as angioplastias primárias realizadas fora do horário de rotina estão relacionadas a pior prognóstico. É objetivo deste estudo avaliar os desfechos das angioplastias primárias realizadas dentro e fora do horário de rotina de serviço de hemodinâmiva. Método: Estudo de coorte prospectivo, incluindo 112 pacientes consecutivamente atendidos por infarto agudo do miocárdio com supradesnivelamento do segmento ST (IAM) entre dezembro de 2009 e janeiro de 2010. Características clínicas e angiográficas e evolução hospitalar foram registradas em banco de dados específicos. Houve dois grupos para comparação: grupo A, IAM tratado entre as 20 horas e as 8 horas e B, IAM tratado entre as 8 horas e as 20 horas. Resultados: A amostra inclui 44 pacientes no grupo A e 68 no grupo B. As características basais foram semelhantes em ambos os grupos. O tempo porta-balão foi significativamente maior no grupo A (133 minutos vs. 90 minutos; P < 0,001). No entanto, não houve diferença significante entre os grupos A e B...

BACKGROUND: Previous studies have reported that off-hours primary percutaneous coronary intervention is related to worse prognosis. The objective of this study is to evaluate the outcomes of normal and off-hours primary percutaneous coronary interventions. METHODS: A prospective observational study including 112 consecutive patients with ST elevation myocardial infarction (MI) was conducted from December 2009 to January 2010. Clinical and angiographic characteristics and in-hospital follow up were registered in a specific database. There were two groups for comparison: group A, MI treated between 8 pm and 8 am and group B, MI treated between 8 am and 8 pm. RESULTS: The sample included 44 patients in group A and 68 in group B. Baseline characteristics were similar in both groups. Door-to-balloon time was significantly longer in group A (133 minutes vs. 90 minutes; P < 0.001). However, there was no significant difference between groups A and B regarding mortality (13.7% vs. 5.9%; P = 0.28), reinfarction (6.8% vs. 4.4%; P = 0.90), progression to cardiogenic shock (11.4% vs. 4.4%; P = 0.30), stent thrombosis (6.8% vs. 1.5%; P = 0.33), or major bleeding (2.3% vs. 1.5%; P > 0.99). The only predictor of combined in-hospital outcome was heart rate at admission (odds ratio 1.02; P < 0.001). CONCLUSIONS: Patients with MI have similar in-hospital clinical outcomes during normal and off-hours primary percutaneous coronary intervention. However, door-to-balloon time is significantly longer during off-hours procedures.