[Primary angioplasty in Argentina. Results from ARGEN-IAM-ST registry]. / Angioplastia primaria en Argentina. Registro ARGEN-IAM-ST (Relevamiento Nacional del infarto agudo de miocardio con elevación del segmento ST).

Our objective was to evaluate clinical characteristics, results and morbi-mortality in primary angioplasty (PA), of patients treated with PA within 36 hours of a myocardial infarction (MI), included in a prospective, transversal, multicenter and national survey (ARGEN-IAM-ST). A total of 1142 patients treated with PA were registered, 61.2 ± 12 years old, 88% male, 20% diabetics and 58% with hypertension; 77.6% in Killip Kimball I and 6.2% in cardiogenic shock. The time from the onset of pain until admission was 153 (75-316) minutes, and door-balloon of 91 (60-150) minutes. The transferred patients (17%) showed longer delay to admission, 200 minutes (195-420; p = 0.0001) and door-to-balloon 113.5 minutes (55-207); p = 0.099. In 47.6% of the cases, the PA was made in the anterior descending artery, in 36.4% in the right coronary artery, in 14.8% in the circumflex artery and in 1.2% in the left coronary artery; in 95% with stent (29% pharmacological); 95% was successful, 1.3% presented post-infarct angina (APIAM), 1.3% re-infarct, 8.8% shock and 3.2% bleeding. Age > 64 years (OR 6.2 (95% CI: 3.2-12), p <0.001), diabetes (OR 2.5, 95% CI 1.6-3.9, p < 0.001), re-infarction or APIAM (OR 3.3, 95% CI 1.3-8.3, p = 0.011) and shock (OR 29.2 (15.6-54.8), p < 0.001) were independently associated with higher mortality. In-hospital mortality of acute myocardial infarction with ST-segment elevation treated with PA was 7.6%. Transference from other center was associated with delay in the admission and treatment. Cardiogenic shock and post-infarct ischemia were associated with high mortality. There were no procedural variables associated with mortality.

Se evaluaron las características clínicas, demoras, resultados y morbimortalidad de 1142 pacientes tratados con angioplastia primaria (AP) dentro de las 36 horas del infarto, incluidos en el registro ARGEN-IAM-ST, de carácter prospectivo, transversal, multicéntrico y de alcance nacional. Edades: 61.2 ± 12 años, 88% varones, 20% diabéticos y 58% hipertensos; 77.6% en Killip y Kimball I y 6.2% en shock cardiogénico. El tiempo desde el inicio del dolor hasta el ingreso fue de 153 (75-316) minutos, y puerta-balón de 91 (60-150) minutos. Los casos derivados (17%) tuvieron mayor demora de ingreso, 200 minutos (195-420; p = 0.0001) y mayor tiempo puerta-balón, 113 minutos (55-207); p = 0.099. En 47.6% de los casos la AP se hizo en arteria descendente anterior, en 36.4% a coronaria derecha, en 14.8% a circunfleja y en 1.2% al tronco de coronaria izquierda; en 95% con stent (29% farmacológico). El 95% fue exitoso. El 1.3% presentó angina post-infarto (APIAM), 1.3% re-infarto, 8.8% shock y 3.2% sangrado. Se asociaron a mayor mortalidad edad > 64 años (OR 6.2 (IC 95%: 3.2-12), p < 0.001), diabetes (OR 2.5, IC 95% 1.6-3.9, p < 0.001), re-infarto o APIAM (OR 3.3, IC 95% 1.3-8.3, p = 0.011) y shock (OR 29.2 (15.6-54.8), p < 0.001). La mortalidad hospitalaria del infarto agudo de miocardio con elevación del segmento ST tratado con AP fue de 7.6%. La derivación se asoció a demora de tratamiento. El shock cardiogénico y la isquemia post-infarto se asociaron a alta mortalidad. No hubo variables del procedimiento asociadas a mortalidad.

Angioplastia primaria en Argentina. Registro ARGEN-IAM-ST (relevamiento nacional del infarto agudo de miocardio con elevación del segmento ST) / Primary angioplasty in Argentina. Results from ARGEN-IAM-ST registr

Se evaluaron las características clínicas, demoras, resultados y morbimortalidad de 1142 pacientes tratados con angioplastia primaria (AP) dentro de las 36 horas del infarto, incluidos en el registro ARGEN-IAM-ST, de carácter prospectivo, transversal, multicéntrico y de alcance nacional. Edades: 61.2 ± 12 años, 88% varones, 20% diabéticos y 58% hipertensos; 77.6% en Killip y Kimball I y 6.2% en shock cardiogénico. El tiempo desde el inicio del dolor hasta el ingreso fue de 153 (75-316) minutos, y puerta-balón de 91 (60-150) minutos. Los casos derivados (17%) tuvieron mayor demora de ingreso, 200 minutos (195-420; p = 0.0001) y mayor tiempo puerta-balón, 113 minutos (55-207); p = 0.099. En 47.6% de los casos la AP se hizo en arteria descendente anterior, en 36.4% a coronaria derecha, en 14.8% a circunfleja y en 1.2% al tronco de coronaria izquierda; en 95% con stent (29% farmacológico). El 95% fue exitoso. El 1.3% presentó angina post-infarto (APIAM), 1.3% re-infarto, 8.8% shock y 3.2% sangrado. Se asociaron a mayor mortalidad edad > 64 años (OR 6.2 (IC 95%: 3.2-12), p < 0.001), diabetes (OR 2.5, IC 95% 1.6-3.9, p < 0.001), re-infarto o APIAM (OR 3.3, IC 95% 1.3-8.3, p = 0.011) y shock (OR 29.2 (15.6-54.8), p < 0.001). La mortalidad hospitalaria del infarto agudo de miocardio con elevación del segmento ST tratado con AP fue de 7.6%. La derivación se asoció a demora de tratamiento. El shock cardiogénico y la isquemia post-infarto se asociaron a alta mortalidad. No hubo variables del procedimiento asociadas a mortalidad.

Our objective was to evaluate clinical characteristics, results and morbi-mortality in primary angioplasty (PA), of patients treated with PA within 36 hours of a myocardial infarction (MI), included in a prospective, transversal, multicenter and national survey (ARGEN-IAM-ST). A total of 1142 patients treated with PA were registered, 61.2 ± 12 years old, 88% male, 20% diabetics and 58% with hypertension; 77.6% in Killip Kimball I and 6.2% in cardiogenic shock. The time from the onset of pain until admission was 153 (75-316) minutes, and door-balloon of 91 (60-150) minutes. The transferred patients (17%) showed longer delay to admission, 200 minutes (195-420; p = 0.0001) and door-to-balloon 113.5 minutes (55-207); p = 0.099. In 47.6% of the cases, the PA was made in the anterior descending artery, in 36.4% in the right coronary artery, in 14.8% in the circumflex artery and in 1.2% in the left coronary artery; in 95% with stent (29% pharmacological); 95% was successful, 1.3% presented post-infarct angina (APIAM), 1.3% re-infarct, 8.8% shock and 3.2% bleeding. Age > 64 years (OR 6.2 (95% CI: 3.2-12), p <0.001), diabetes (OR 2.5, 95% CI 1.6-3.9, p < 0.001), re-infarction or APIAM (OR 3.3, 95% CI 1.3-8.3, p = 0.011) and shock (OR 29.2 (15.6-54.8), p < 0.001) were independently associated with higher mortality. In-hospital mortality of acute myocardial infarction with ST-segment elevation treated with PA was 7.6%. Transference from other center was associated with delay in the admission and treatment. Cardiogenic shock and post-infarct ischemia were associated with high mortality. There were no procedural variables associated with mortality.

Exceso de mortalidad no cardíaca en pacientes sometidos a angioplastía de puentes coronarios / Excess non cardiac mortality in patients undergoing PCI of venous coronary bypass grafts

Resumen: Introducción Las fallas de los puentes venosos pueden llegar casi al 50% a 10 años y la angioplastía percutánea es el tratamiento de elección. Estos pacientes constituyen un grupo de muy alto riesgo cardiovascular con tasas de mortalidad cercanas al 30% en el mediano plazo. Objetivo Caracterizar a la población sometida a angioplastia de puentes coronarios (APC) y comparar su mortalidad con un grupo pareado de pacientes intervenidos con Infarto agudo al miocardio con elevación del segmento ST (IAMCEST). Métodos Estudio retrospectivo de tipo Caso-Control que incluyó a pacientes con APC entre los años 2010-2016 comparados con igual número de controles con IAMCEST pareados por edad y sexo. Se analizaron características clínicas del procedimiento y mortalidad, tanto global como de causa cardiaca usando T Student, Chi2 y curvas de Kaplan Meier. Resultados Se identificaron 63 pacientes sometidos a APC (total 76 procedimientos). Los puentes más comúnmente intervenidos fueron a la arteria circunfleja 48,7%. Hubo 18 (28,5%) pacientes fallecidos en el grupo APC y 6 (9,5%) pacientes en el grupo con IAM-CEST, lo que resultó en un exceso de mortalidad global en pacientes con APC (HR 3,02; IC 95% 1,11 - 8,22, p=0,02). Esta diferencia se debió a una mayor mortalidad de causa no cardiaca en el grupo APC (12,7% (n=8) vs 3,2% (n= 2) [p=0,04]). Conclusión Los pacientes sometidos a APC presentan una mortalidad 3 veces mayor que aquellos pacientes con IAMCEST, principalmente derivada de una mayor mortalidad no cardíaca.

Abstract: Background Failure rates of saphenous vein grafts can reach almost 50% at 10 years and percutaneous angioplasty is the treatment of choice. This is a group with a very high cardiovascular risk, with mid-term mortality rates close to 30%. Aim To describe the population undergoing coronary bypass angioplasty (CBA) and compare their mortality with an age and gender matched group of patients with acute myocardial infarction with ST segment elevation (STEMI) Methods This was a retrospective case-control study including patients with CBA between 2010-2016. This group was compared with the same number of controls with STEMI matched by age and sex. Clinical characteristics, procedure variables and overall mortality as well as cardiac mortality were analyzed using Student's T test, Chi squared test and Kaplan Meier curves (significance set at p <0.05). Results: We identified 63 patients undergoing CBA (76 procedures). The most commonly intervened bypasses were to the circumflex artery (48.7%). There were 18 (28.5%) patients who died in the CBA group and 6 (9.5%) patients in the STEMI group, which resulted in an excess of global mortality risk in patients with CBA (HR 3.02, 95% CI 1.11 - 8.22, p = 0.02). This difference was driven by a higher non-cardiac mortality in the CBA group (12.7% (n = 8) vs 3.2% (n = 2) [p = 0.04]) Conclusion Patients undergoing CBA have a mortality rate more than three times that of the STEMI patients, mainly due to a higher non-cardiac mortality.

Risk and timing of clinical events according to diabetic status of patients treated with everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting stent: 2-year results from a propensity score matched comparison of ABSORB EXTEND and SPIRIT trials.

OBJECTIVES: to compare the occurrence of clinical events in diabetics treated with the Absorb bioresorbable vascular scaffold (Absorb BVS; Abbott Vascular, Santa Clara, CA) versus everolimus-eluting metal stents (EES; XIENCE V; Abbott Vascular, Santa Clara, CA) BACKGROUND: There are limited data dedicated to clinical outcomes of diabetic patients treated with bioresorbable scaffolds (BRS) at 2-year horizon. METHODS: The present study included 812 patients in the ABSORB EXTEND study in which a total of 215 diabetic patients were treated with Absorb BVS. In addition, 882 diabetic patients treated with EES in pooled data from the SPIRIT clinical program (SPIRIT II, SPIRIT III and SPIRIT IV trials) were used for comparison by applying propensity score matching using 29 different variables. The primary endpoint was ischemia driven major adverse cardiac events (ID-MACE), including cardiac death, myocardial infarction (MI), and ischemia driven target lesion revascularization (ID-TLR). RESULTS: After 2 years, the ID-MACE rate was 6.5% in the Absorb BVS vs. 8.9% in the Xience group (P = 0.40). There was no difference for MACE components or definite/probable device thrombosis (HR: 1.43 [0.24,8.58]; P = 0.69). The occurrence of MACE was not different for both diabetic status (insulin- and non-insulin-requiring diabetes) in all time points up to the 2-year follow-up for the Absorb and Xience groups. CONCLUSION: In this largest ever patient-level pooled comparison on the treatment of diabetic patients with BRS out to two years, individuals with diabetes treated with the Absorb BVS had a similar rate of MACE as compared with diabetics treated with the Xience EES. © 2017 Wiley Periodicals, Inc.

Increased Hazard of Myocardial Infarction With Insulin-Provision Therapy in Actively Smoking Patients With Diabetes Mellitus and Stable Ischemic Heart Disease: The BARI 2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) Trial.

BACKGROUND: In the BARI 2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) trial, randomization of diabetic patients with stable ischemic heart disease to insulin provision (IP) therapy, as opposed to insulin sensitization (IS) therapy, resulted in biochemical evidence of impaired fibrinolysis but no increase in adverse clinical outcomes. We hypothesized that the prothrombotic effect of IP therapy in combination with the hypercoagulable state induced by active smoking would result in an increased risk of myocardial infarction (MI). METHODS AND RESULTS: We analyzed BARI 2D patients who were active smokers randomized to IP or IS therapy. The primary end point was fatal or nonfatal MI. PAI-1 (plasminogen activator inhibitor 1) activity was analyzed at 1, 3, and 5 years. Of 295 active smokers, MI occurred in 15.4% randomized to IP and in 6.8% randomized to IS over the 5.3 years (P=0.023). IP therapy was associated with a 3.2-fold increase in the hazard of MI compared with IS therapy (hazard ratio: 3.23; 95% confidence interval, 1.43-7.28; P=0.005). Baseline PAI-1 activity (19.0 versus 17.5 Au/mL, P=0.70) was similar in actively smoking patients randomized to IP or IS therapy. However, IP therapy resulted in significantly increased PAI-1 activity at 1 year (23.0 versus 16.0 Au/mL, P=0.001), 3 years (24.0 versus 18.0 Au/mL, P=0.049), and 5 years (29.0 versus 15.0 Au/mL, P=0.004) compared with IS therapy. CONCLUSIONS: Among diabetic patients with stable ischemic heart disease who were actively smoking, IP therapy was independently associated with a significantly increased hazard of MI. This finding may be explained by higher PAI-1 activity in active smokers treated with IP therapy. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00006305.

Potential Utility of the SYNTAX Score 2 in Patients Undergoing Left Main Angioplasty / Utilidade Potencial do SYNTAX Score 2 em Pacientes Submetidos a Angioplastia do Tronco Comum

Abstract Background: The revascularization strategy of the left main disease is determinant for clinical outcomes. Objective: We sought to 1) validate and compare the performance of the SYNTAX Score 1 and 2 for predicting major cardiovascular events at 4 years in patients who underwent unprotected left main angioplasty and 2) evaluate the long-term outcome according to the SYNTAX score 2-recommended revascularization strategy. Methods: We retrospectively studied 132 patients from a single-centre registry who underwent unprotected left main angioplasty between March 1999 and December 2010. Discrimination and calibration of both models were assessed by ROC curve analysis, calibration curves and the Hosmer-Lemeshow test. Results: Total event rate was 26.5% at 4 years.The AUC for the SYNTAX Score 1 and SYNTAX Score 2 for percutaneous coronary intervention, was 0.61 (95% CI: 0.49-0.73) and 0.67 (95% CI: 0.57-0.78), respectively. Despite a good overall adjustment for both models, the SYNTAX Score 2 tended to underpredict risk. In the 47 patients (36%) who should have undergone surgery according to the SYNTAX Score 2, event rate was numerically higher (30% vs. 25%; p=0.54), and for those with a higher difference between the two SYNTAX Score 2 scores (Percutaneous coronary intervention vs. Coronary artery by-pass graft risk estimation greater than 5.7%), event rate was almost double (40% vs. 22%; p=0.2). Conclusion: The SYNTAX Score 2 may allow a better and individualized risk stratification of patients who need revascularization of an unprotected left main coronary artery. Prospective studies are needed for further validation.

Resumo Fundamento: A estratégia de revascularização na doença do tronco comum é determinante para os resultados clínicos. Objetivo: Procurou-se: 1) validar e comparar o desempenho do SYNTAX Score 1 e 2 na predição de eventos cardiovasculares aos 4 anos, em pacientes submetidos a angioplastia do tronco comum não protegido e 2) avaliar os resultados a longo prazo de acordo com a estratégia de revascularização recomendada pelo SYNTAX Score. Métodos: Estudo retrospectivo de centro único de 132 pacientes consecutivos submetidos a angioplastia do tronco comum não protegido entre março de 1999 e dezembro de 2010. A discriminação e calibração de ambos os modelos foram avaliadas por análise de curva ROC, curvas de calibração e teste de Hosmer-Lemeshow. Resultados: A taxa de eventos aos 4 anos foi de 26,5%. A AUC para o SYNTAX Score 1 e 2 foi de 0,61 (IC 95% 0,49-0,73) e 0,67 (IC 95% 0,57-0,78), respectivamente. Apesar de uma calibração global boa, o SYNTAX Score 2 tende a subestimar o risco. Nos 47 pacientes (36%) que deveriam ter sido submetidos a cirurgia de revascularização de acordo com o SYNTAX Score 2, a taxa de eventos foi numericamente superior (30% vs. 25%; p=0,54) e para os que tinham uma diferença superior entre as estimativas do SYNTAX Score 2 (>5,7%), a taxa de eventos foi quase o dobro (40% vs. 22%; p=0,2). Conclusão: O SYNTAX Score 2 permite uma estratificação de risco individualizada e melhor em pacientes que requerem revascularização do tronco comum não protegido. São necessários estudos prospectivos para validação adicional.

Potential Utility of the SYNTAX Score 2 in Patients Undergoing Left Main Angioplasty.

BACKGROUND: The revascularization strategy of the left main disease is determinant for clinical outcomes. OBJECTIVE: We sought to 1) validate and compare the performance of the SYNTAX Score 1 and 2 for predicting major cardiovascular events at 4 years in patients who underwent unprotected left main angioplasty and 2) evaluate the long-term outcome according to the SYNTAX score 2-recommended revascularization strategy. METHODS: We retrospectively studied 132 patients from a single-centre registry who underwent unprotected left main angioplasty between March 1999 and December 2010. Discrimination and calibration of both models were assessed by ROC curve analysis, calibration curves and the Hosmer-Lemeshow test. RESULTS: Total event rate was 26.5% at 4 years.The AUC for the SYNTAX Score 1 and SYNTAX Score 2 for percutaneous coronary intervention, was 0.61 (95% CI: 0.49-0.73) and 0.67 (95% CI: 0.57-0.78), respectively. Despite a good overall adjustment for both models, the SYNTAX Score 2 tended to underpredict risk. In the 47 patients (36%) who should have undergone surgery according to the SYNTAX Score 2, event rate was numerically higher (30% vs. 25%; p=0.54), and for those with a higher difference between the two SYNTAX Score 2 scores (Percutaneous coronary intervention vs. Coronary artery by-pass graft risk estimation greater than 5.7%), event rate was almost double (40% vs. 22%; p=0.2). CONCLUSION: The SYNTAX Score 2 may allow a better and individualized risk stratification of patients who need revascularization of an unprotected left main coronary artery. Prospective studies are needed for further validation.

In-hospital mortality risk prediction after percutaneous coronary interventions: Validating and updating the Toronto score in Brazil.

OBJECTIVES: We aimed to assess the accuracy of the simple, contemporary and well-designed Toronto PCI mortality risk score in ICP-BR registry, the first Brazilian PCI multicenter registry with follow-up information. BACKGROUND: Estimating percutaneous coronary intervention (PCI) mortality risk by a clinical prediction model is imperative to help physicians, patients and family members make informed clinical decisions and optimize participation in the consent process, reducing anxiety and improving quality of care. At a healthcare system level, risk prediction scores are essential to measure and benchmark performance. METHODS: Between 2009 and 2013, a cohort of 4,806 patients from the ICP-BR registry, treated with PCI in eight tertiary referral medical centers, was included in the analysis. This population was compared to 10,694 patients of the derivation dataset from the Toronto study. To assess predictive performance, an update of the model was performed by three different methods, which were compared by discrimination, calculating the area under the receiver operating characteristic curve (AUC), and by calibration, assessed through Hosmer-Lemeshow (H-L) test and graphical analysis. RESULTS: Death occurred in 2.6% of patients in the ICP-BR registry and in 1.3% in the Toronto cohort. The median age was 64 and 63 years, 23.8 and 32.8% were female, 28.6 and 32.3% were diabetics, respectively. Through recalibration of intercept and slope (AUC = 0.8790; H-L P value = 0.3132), we achieved a well-calibrated and well-discriminative model. CONCLUSIONS: After updating to our dataset, we demonstrated that the Toronto PCI in-hospital mortality risk score performed well in Brazilian hospitals.

First-in-man randomised comparison of a novel sirolimus-eluting stent with abluminal biodegradable polymer and thin-strut cobalt-chromium alloy: INSPIRON-I trial.

AIMS: The INSPIRON-I trial is a first-in-man evaluation of the safety and efficacy of the Inspiron drug-eluting stent, a sirolimus-eluting stent with abluminal biodegradable polymer coating and thin cobalt-chromium alloy. METHODS AND RESULTS: This is a randomised, multicentre comparison between Inspiron and a stent with the same metallic structure but without polymer coating or drug elution (Cronus). The primary objective was to evaluate the in-segment late loss (LLL) at six months. Secondary endpoints included percent in-stent obstruction as measured by intravascular ultrasound (IVUS) at six months and major adverse cardiac events (MACE). Fifty-eight patients were enrolled (60 lesions), 39 for Inspiron and 19 for Cronus. Baseline clinical and angiographic characteristics of both groups were similar. At six months, the in-segment LLL was reduced in the Inspiron group compared to the control group (0.19±0.16 mm vs. 0.58±0.4 mm, respectively; p<0.001), as well as the percent neointimal obstruction (7.8±7.1% vs. 26.5±11.4%; p<0.001). At two-year follow-up, incidence of MACE was similar between groups (7.9 vs. 21.1%, respectively; p=0.20), with lower target lesion revascularisation for Inspiron (0 vs. 21.1%, respectively; p=0.01) and no stent thrombosis. CONCLUSIONS: Sirolimus eluted from an abluminal biodegradable polymer on a cobalt-chromium alloy proved effective in reducing restenosis at six months.

Características clínicas, predictores de mortalidad y resultados inmediatos y a largo plazo en el tratamiento con angioplastía primaria del infarto agudo al miocardio con supradesnivel del ST complicado con shock cardiogénico / Clinical characteristics and predictors of early and global mortality in patients with ST segment elevation myocardial infarction and cardiogenic shock undergoing primary angioplasty

Introducción: El shock cardiogénico (SC) es la complicación más grave del infarto agudo al miocardio (IAM). La mortalidad del SC varía entre un 40-60%. Con el acceso a la angioplastía primaria, el pronóstico del SC ha mejorado en los últimos años, aunque la mortalidad permanece elevada. Nuestro objetivo fue analizar las características clínicas, predictores de mortalidad intrahospitalaria y a largo plazo de los pacientes con IAM complicados con SC en 3 centros hospitalarios con disponibilidad de hemodinamia de urgencia las 24 horas del día.Métodos y Resultados. Estudio analítico observacional. Se incluyeron pacientes entre Enero 2009 y Agosto 2013. La mortalidad se confirmó por certificado de defunción emitido por el registro civil. En el período estudiado se encontraron 101 pacientes con IAM con SC, con una mortalidad intrahospitalaria de 40.8% y global de 53.5% con un seguimiento medio de 1.6 años. No hubo deiferencias significativas entre vivos y fallecidos, respecto de la edad de presentación, antecedentes CV, enfermedad renal, PCR al momento de presentación, tiempo transcurrido desde la presentación del SC, trombo-aspiración, uso de balón de contrapulsación intraórtico (BCIAo), ni resultado angiográfico final. El grupo de mortalidad presentaba mayor número de vasos enfermos (83.3% vs 63.2%; p:0.012), peor fracción de eyección (Fe<30% 66.7% vs 22.5%; p<0,001). Los predictores ajustados de mortalidad intrahospitalaria fueron la presencia de 2 o más vasos enfermos OR 2.9 (IC 95% 1.19-7,1; p= 0.012), y la FE < 30% (OR 6.8, IC 95% 2.23 - 21.27; p=0.001)...

Background. Cardiogenic shock in acute myocardial infarction (AMI) is associated with a high mortality rate (40-60%). An improvement in this prognosis has followed the introduction of primary angioplasty. The aim of this study was to analyze the clinical and angiographic characteristics as well as to determine the early and late mortality in patients with St elevation AMI and cardiogenic shock undergoing primary angioplasty in 3 hospital centers where this procedure was available on a 24hr basis.Methods and Results. We analyzed the clinical an angiographic data of patients treated with primary PTCA for AMI and cardiogenic shock from January 2009 to August 2013. Mortality was confirmed by the data from a National Statistics Office. 101 patients were included and followed for an average of 1.6 years after primary PTCA. Early and total mortality rates were 40.8% and 53.5%, respectively. No differences were found between survivors and non survivors regarding age, risk factors, previous cardiovascular disease, renal failure, CRP and time to PTCA. Intracoronary thrombus aspiration, use of intra-aortic balloon pumping or final angiographic findings were also similar between groups. Compared to survivors, deceased patients had more vessels involved (>= 2 vessels in 83.3% vs 63.2%, respectively, p=0.012) and lower EF (under 30% in 66.7% vs 22.5%, respectively, p<0.001). Predictors of hospital mortality were the presence of >= 2 vessel disease (OR 2.9, 95% C.I. 1.19 - 7.1, p=0.012) and EF under 30% (OR 6.8, C.I. 2.23 - 21.27, p= 0.001)...

Predictors of suboptimal TIMI flow after primary angioplasty for acute myocardial infarction: results from the HORIZONS-AMI trial.

AIMS: The predictors of TIMI flow <3 after PCI in patients with acute myocardial infarction have not been examined in a contemporary, large-scale multicentre prospective study. METHODS AND RESULTS: The HORIZONS-AMI trial randomised 3,602 patients with STEMI undergoing primary PCI to bivalirudin (n=1,800) vs. unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor (n=1,802). A total of 3,845 treated lesions (3,362 vessels) were analysed by the core lab; 2,942 vessels (87.5%) and 2,758 patients (87.1%) had final TIMI 3 flow, while 407 (12.9%) had TIMI flow <3. The independent predictors of TIMI flow <3 were age (OR 1.23 per 10-year increase; 95% CI: 1.12 to 1.35; p<0.0001), anterior MI (OR 1.65; 95% CI: 1.33 to 2.05; p<0.0001), baseline TIMI flow grade 0/1 (OR 2.79; 95% CI: 2.14 to 3.62; p<0.0001), and lesion length (OR 1.05 per 10 mm increase; 95% CI: 1.02 to 1.09; p=0.005). The three-year mortality of patients in whom final TIMI 3 flow was achieved was significantly lower than that of patients in whom TIMI 3 flow was not achieved (5.5% vs. 10.5%; p<0.0001). CONCLUSIONS: In this large-scale, randomised trial, failure to restore normal TIMI flow after primary PCI in STEMI occurred in 12.9% of patients, and was associated with patient-related factors (age), anatomical factors (anterior MI location), and angiographic factors (baseline TIMI 0/1 flow and lesion length). Failure to achieve TIMI 3 flow continues to be a powerful predictor of mortality after primary PCI in the contemporary era. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique identifier: NCT00433966.

Meta-analysis of 5,674 patients treated with percutaneous coronary intervention and drug-eluting stents or coronary artery bypass graft surgery for unprotected left main coronary artery stenosis.

OBJECTIVES: To compare the safety and efficacy of coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI) using drug-eluting stents (DES) in patients with unprotected left main coronary artery (ULMCA) disease. METHODS: MEDLINE, EMBASE, CENTRAL/CCTR, SciELO, LILACS, Google Scholar and reference lists of relevant articles were searched for clinical studies that reported outcomes at the 1-year follow-up after PCI with DES and CABG for the treatment of ULMCA stenosis. Sixteen studies (three randomized controlled trials and 13 observational studies) were identified and included a total of 5674 patients (2331 for PCI with DES and 3343 for CABG). RESULTS: At the 1-year follow-up, there was no significant difference between the CABG and DES groups in the risk for death (odds ratio [OR] 0.691, P = 0.051) or the composite endpoint of death, myocardial infarction or stroke (OR 0.832, P = 0.258). The risk for target vessel revascularization (TVR) was significantly higher in the PCI group compared with the CABG group (OR 3.597, P < 0.001). The risk of major adverse cardiac and cerebrovascular events (MACCE) was significantly higher in the PCI group compared with the CABG group (OR 1.607, P < 0.001). A publication bias was observed regarding the outcome of death and also a considerable heterogeneity effect on the composite endpoint of death, myocardial infarction or stroke and MACCE. CONCLUSIONS: CABG surgery remains the best option of treatment for patients with ULMCA disease, with less need of TVR and lower MACCE rates.

Ten-year outcomes of patients randomized to surgery, angioplasty, or medical treatment for stable multivessel coronary disease: effect of age in the Medicine, Angioplasty, or Surgery Study II trial.

OBJECTIVE: With progressive aging, coronary artery disease has been diagnosed at more advanced ages. Although patients aged 65 years or more have been referred to surgical or percutaneous coronary interventions, the best option for coronary artery disease treatment remains uncertain. The current study compared the 3 treatment options for coronary artery disease in patients aged 65 years or more and analyzed the impact of age in treatment options. METHODS: Patients were separated according to age: 65 years or more (n = 200) and less than 65 years (n = 411). All patients were followed for 10 years. The rates of overall mortality, acute myocardial infarction, and new revascularizations were analyzed. RESULTS: Of 200 patients aged 65 years or more, 68 were randomized to medical therapy, 68 were randomized to percutaneous coronary intervention, and 64 were randomized to coronary artery bypass grafting. At 10 years, overall survival was 63% (medical therapy), 69% (percutaneous coronary intervention), and 66% (coronary artery bypass grafting) (P = .93). The survival free of combined events was 43% (medical therapy), 38% (percutaneous coronary intervention ), and 66% (coronary artery bypass grafting) (P = .007). The survival free of myocardial infarction was 82% (medical therapy), 77% (percutaneous coronary intervention), and 90% (coronary artery bypass grafting) (P = .17), and survival free of new revascularizations was 59% (medical therapy), 58% (percutaneous coronary intervention ), and 91% (coronary artery bypass grafting) (P = .0003). When the 2 age groups were compared, survival free of myocardial infarction for patients treated by percutaneous coronary intervention was 77% (older patients) and 92% (younger patients) (P = .004). CONCLUSIONS: In this analysis, treatment options for patients aged 65 years or more who have coronary artery disease yield similar overall survival. However, coronary artery bypass grafting was associated with fewer coronary events, and percutaneous coronary intervention was associated with a higher incidence of myocardial infarction.

One-year outcome of patients with diabetes mellitus after percutaneous coronary intervention with three different revascularization strategies: results from the Diabetic Argentina Registry (DEAR).

AIMS: Percutaneous coronary interventions (PCI) in patients with diabetes mellitus (DM) are associated with a high incidence of coronary restenosis, myocardial infarction (MI) and death. This study was to assess the potential role of a paclitaxel-eluting balloon (PEB) treatment in patients with DM with coronary lesions compared to those treated either with bare-metal stents (BMS) or drug-eluting stents (DES). METHODS AND RESULTS: The Diabetic Argentina Registry (DEAR) was an observational, prospective, non-randomised, open-label study that enrolled 92 patients with diabetes mellitus in three centers from Buenos Aires, Argentina, between April 2009 and March 2011, to be treated with PEB. Results were compared with previous outcome data in all patients with DM treated with DES (n=129 pts) or BMS (n=96 pts) in clinical studies conducted at our institutions. At one-year follow-up, patients with DM who received PEB followed by BMS implantation (96%) had a significantly lower incidence of major adverse cardiac events (MACE) compared to the BMS group (BMS 32.3%, PEB 13.2%; P=.003). The incidence of target-vessel failure (TVF) was 30.2% (BMS) and 11% (PEB) (P=.003), that of target-vessel revascularization (TVR) was 22.9% (BMS) and 8.3% (PEB) (P=.005) and the composite of death/MI occurred in 13.5% (BMS) and in 2.2% for PEB (P=.05). These positive results are persistent even after subgroups analysis. When comparing with previous DES patients, TVF was 18.6% in DES vs. 11.0% in PEB (P=.13), MACE was 18.6% in DES vs. 13.2% in PEB (P=.29), TVR rate was 14.0% in DES vs. 8.3% in PEB (P=.14) and the composite death/MI was 9.3% in DES vs. 4.4% in PEB (0.18) CONCLUSIONS: Diabetic patients treated with PEB followed by BMS resulted in a significantly better outcome than BMS alone and appeared to be comparable to DES treatment.

Does the site of bleeding matter? A stratified analysis on location of TIMI-graded bleedings and their impact on 12-month outcome in patients with ST-segment elevation myocardial infarction.

AIMS: While bleeding in patients with STEMI undergoing primary percutaneous coronary intervention (pPCI) is known to be associated with poor outcomes, the differential prognostic impact of access-site related versus non access-site related bleedings is unknown. We aimed to assess the relative impact of access-site related bleeding, as compared to non access-site related, on 12-month clinical outcome in patients undergoing intervention for STEMI. METHODS AND RESULTS: Thirty-day bleeding endpoints, stratified into access-site versus non access-site, were examined according to the TIMI scale in 744 patients with STEMI enrolled in the MULTISTRATEGY trial. TIMI major or minor bleeding complications occurred in 56 (7.5%) patients within 30 days, 46% had an access-site related bleed and 34% required blood transfusion. Bleeding severity and the need for transfusion were equally distributed between site access- versus non-site access-related bleeds. After adjustment, patients with any TIMI rated bleed were more likely to die or develop recurrent MI within 12 months (HR 2.1 [95% CI: 1.13-3.8]; p=0.02). This ratio was entirely driven by non-site access-related bleeds (adjusted HR: 2.66 [95% CI: 1.21-5.8]; p=0.007), whereas site-access bleeds were not associated with worse outcomes (HR: 0.74 [95% CI: 0.16-3.4]; p=0.70). CONCLUSIONS: While bleeds of any TIMI severity within 30 days were independently associated with worse cardiovascular outcomes at 12 months, thus confirming previous analyses, this relationship was entirely driven in our study by non access-site related haemorrhagic events. Investigation on whether the site of bleeding complications may preferentially impact cardiovascular outcomes is warranted.

Coronary artery bypass graft surgery performance and costs by the Brazilian Public Health System (SUS) in the State of Rio de Janeiro, from 1999 to 2008.

BACKGROUND: Expenses with coronary artery bypass grafting (CABG) surgery and coronary angioplasty (CA) represented a significant cost to SUS. OBJECTIVE: To analyze SUS expenses with CABG and CA and their performance in hospitals in the state of Rio de Janeiro (SRJ), from 1999 to 2008. METHODS: The information came from paid HAA in hospitals with more than 100 revascularization procedures. Mortality rates were adjusted by Poisson (with covariates age, length of hospital stay and ICU expenses). Mean relative cost indices were calculated by dividing the mean value of the cost fraction spent in each hospital by the mean expense in the SRJ in U.S. dollars. Stata software was used for statistical analysis. RESULTS: A total of 10,983 CABG and 19,661 CA were paid by SUS in 20 hospitals during the 10 years, with mean values of US$ 3,088.12 and 2,183.93, respectively. The mortality rate in CABG varied from 9.2%-1999 to 7.7%-2008, with ranges of 5.0%-9.2% and in CA, from 1.6%-1999 to 1.5%-2008, with ranges of 0.9%-2.3%. The hospitals decreased the number of CABG procedures and doubled CA procedures. Age, time of hospital stay and ICU costs significantly correlated with lethality in CABG and CA paid by SUS in the SRJ. On average, hospital service costs represented 41% of the total cost of CABG and 18% of CA, and with ortheses and prostheses, 55% in CA and 28% in CABG. CONCLUSION: It is clear the need to improve the quality of healthcare service in institutions that perform CABG and CA paid by SUS.

Coronary angioplasty versus CABG: review of randomized trials.

We carried out a review that included results of randomized trials that made a comparison between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). The 25 selected trials involved 12,305 patients, 11,103 of whom were from studies in patients with multi-vessel disease and 1,212 were from studies in patients with single lesion of the left anterior descending (LAD). In the studies of multi-vessel disease patients, the PCI showed a trend towards lower early mortality (1.2% versus 2%) and lower incidence of stroke: 0.7% versus 1.65%. There was no difference in the intermediate mortality (3.8% versus 3.8%). There was a trend towards the superiority of CABG in late mortality (10.5% versus 9.6%). The difference was exclusively due to "balloon era" studies, with a trend towards an inversion in the "stent era" (9.6% versus 9.9%). In studies of single lesion of LAD, there was no significant difference in any endpoint. The aggregation of results from nine studies that assessed late mortality in diabetic patients showed a difference in favor of surgery (21.3% versus 15.9%). Two studies that evaluated main coronary artery disease did not show a significant difference in mortality at one year (3.9% versus 4.7%). The incidence of repeat revascularization was consistently higher in PCI, despite the progressive improvement in results in the stent era.

Desempenho e gastos do SUS com revascularizações do miocárdio no Estado do Rio de Janeiro, de 1999 a 2008 / Coronary artery bypass graft surgery performance and costs by the Brazilian Public Health System (SUS) in the State of Rio de Janeiro, from 1999 to 2008

FUNDAMENTO: Os gastos com cirurgia de revascularização do miocárdio (RVM) e angioplastia coronariana (AC), representaram importante ônus para o SUS. OBJETIVO: Analisar gastos do SUS com RVM e AC e sua performance nos hospitais do Estado do Rio de Janeiro (ERJ), de 1999 a 2008. MÉTODOS: As informações provieram das AIH pagas dos hospitais com mais de 100 revascularizações. As taxas de letalidade foram ajustadas por modelos Poisson (covariáveis idade, dias de permanência no hospital e gasto em UTI). Foram construídos índices de gasto médio relativo, dividindo-se o valor médio da fração de gasto em cada hospital pelo gasto médio no ERJ, em dólares. Para análise estatística empregou-se o Stata. RESULTADOS: Foram pagas 10.983 RVM e 19.661 AC em 20 hospitais nos 10 anos, com valores médios de US$ 3.088,12 e 2.183,93, respectivamente. A taxa de letalidade nas RVM flutuou de 9,2 por cento-1999 para 7,7 por cento-2008, com valores extremos de 5,0 por cento-9,2 por cento e nas AC de 1,6 por cento-1999 para 1,5 por cento-2008, com valores extremos de 0,9 por cento-2,3 por cento. Os hospitais diminuíram a realização de RVM e duplicaram a de AC. Idade, tempo de internação e gastos em UTI correlacionaram-se significativamente com a letalidade nas RVM e AC pagas no ERJ. Em média, os gastos com os serviços hospitalares representaram 41 por cento do total das RVM e 18 por cento das AC, e os com as órteses e próteses, 55 por cento das AC e 28 por cento nas RVM. CONCLUSÃO: Evidencia-se necessidade de melhorar a qualidade do atendimento das instituições que realizam RVM e AC pagas pelo SUS.

BACKGROUND: Expenses with coronary artery bypass grafting (CABG) surgery and coronary angioplasty (CA) represented a significant cost to SUS. OBJECTIVE: To analyze SUS expenses with CABG and CA and their performance in hospitals in the state of Rio de Janeiro (SRJ), from 1999 to 2008. METHODS: The information came from paid HAA in hospitals with more than 100 revascularization procedures. Mortality rates were adjusted by Poisson (with covariates age, length of hospital stay and ICU expenses). Mean relative cost indices were calculated by dividing the mean value of the cost fraction spent in each hospital by the mean expense in the SRJ in U.S. dollars. Stata software was used for statistical analysis. RESULTS: A total of 10,983 CABG and 19,661 CA were paid by SUS in 20 hospitals during the 10 years, with mean values of US$ 3,088.12 and 2,183.93, respectively. The mortality rate in CABG varied from 9.2 percent-1999 to 7.7 percent-2008, with ranges of 5.0 percent-9.2 percent and in CA, from 1.6 percent-1999 to 1.5 percent-2008, with ranges of 0.9 percent-2.3 percent. The hospitals decreased the number of CABG procedures and doubled CA procedures. Age, time of hospital stay and ICU costs significantly correlated with lethality in CABG and CA paid by SUS in the SRJ. On average, hospital service costs represented 41 percent of the total cost of CABG and 18 percent of CA, and with ortheses and prostheses, 55 percent in CA and 28 percent in CABG. CONCLUSION: It is clear the need to improve the quality of healthcare service in institutions that perform CABG and CA paid by SUS.

Outcomes of patients with left main coronary artery disease undergoing medical or surgical treatment: a propensity-matched analysis.

OBJECTIVE: To evaluate the outcomes of patients with significant (≥ 50%) left main coronary artery disease (LMCAD) undergoing medical treatment (MT) or coronary artery bypass grafting surgery (CABG). METHODS: A total of 181 patients with significant LMCAD were followed for 4 ± 2 years. MT was done when patients refused CABG or because of either thin native vessels or high clinical risk. Events were defined as all-cause death, myocardial infarction, percutaneous coronary intervention, or subsequent CABG. Logistic regression analysis was used to identify independent predictors of death. A propensity score was created to compare outcomes of patients from the two treatment groups. RESULTS: CABG was performed in 78.5% of the patients. Overall, there were no significant differences in the incidences of death or other events between treatment groups. In patients with normal left ventricular (LV) function (ejection fraction, ≥ 45%), there were no significant differences in event rates with MT or CABG (death, 7.7 vs. 12.1%; myocardial infarction, 0 vs. 1.9%; percutaneous coronary intervention, 3.8 vs. 5.6%). For patients with LV dysfunction, death was more frequent with MT than with CABG (53.8 vs. 22.9%, P<0.001), whereas the incidence of other events was not statistically different. Age and LV dysfunction, but not treatment type, were independent predictors of death. When comparing propensity-matched patients from both treatment groups, there was also no difference in survival. CONCLUSION: Patients with 50% or more LMCAD and LV dysfunction had increased survival with CABG. However, outcomes of patients with 50% or more LMCAD and normal LV function were not significantly different with either MT or CABG.