Predictors of Hospital Mortality Based on Primary Angioplasty Treatment: A Multicenter Case-Control Study. / Preditores de Mortalidade Hospitalar nos Pacientes Tratados por Angioplastia Primária: Um Estudo de Caso-Controle Multicêntrico.

BACKGROUND: Identification of high-risk patients undergoing primary angioplasty (PCI) is essential. OBJECTIVE: Identify factors related to the causes of death in PCI patients. METHODS: This work consisted of a multicenter case-control study using a Brazilian registry of cardiovascular interventions as the data source. The association between each variable and death was assessed using a binary logistic regression model, p <0.05 was considered significant. RESULTS: A total of 26,990 records were analyzed, of which 18,834 (69.8%) were male patients, with a median age of 61 (±17) years. In the multivariate analysis, the main variables related to the causes of death with their respective odds ratios and 95%confidence intervals (CI) were advanced age, 70-79 years (2.46; 1.64-3.79) and ≥ 80 years (3.69; 2.38-5.81), p<0.001; the classification of Killip II (2.71; 1.92-3.83), Killip III (8.14; 5.67-11.64), and Killip IV (19.83; 14.85-26.69), p<0.001; accentuated global dysfunction (3.63; 2,39-5.68), p<0.001; and the occurrence of infarction after intervention (5.01; 2.57-9.46), p<0.001. The main protective factor was the post-intervention thrombolysis in myocardial infarction (TIMI) III flow (0.18; 0.13-0.24), p<0.001, followed by TIMI II (0.59; 0.41 -0.86), p=0.005, and male (0.79; 0.64-0.98), p = 0.032; dyslipidemia (0.69; 0.59-0.85), p<0.001; and number of lesions treated (0.86; 0.9-0.94), p<0.001. CONCLUSION: The predictors of mortality in patients undergoing PCI were Killip's classification, reinfarction, advanced age, severe left ventricular dysfunction, female gender, and post-intervention TIMI 0 / I flow.

FUNDAMENTO: A estratificação do risco de morte dos pacientes no contexto da angioplastia primária (ATC) é fundamental. OBJETIVO: Identificar os fatores relacionados ao desfecho morte em pacientes submetidos a ATC. MÉTODOS: Estudo de caso-controle, utilizando como fonte de dados um registro brasileiro. A associação entre cada variável e o desfecho óbito foi avaliada via modelo de regressão logística binária. Consideramos significativo p<0,05. RESULTADOS: Foram analisados 26.990 registros, sendo 18.834 (69,8%) do sexo masculino, com idade mediana de 61 (17) anos. Na análise multivariada, as principais variáveis relacionadas ao desfecho óbito com seus respectivos odds ratio e intervalos de confiança (IC) com nível de significância de 95% foram a idade avançada 70 - 79 anos (2,46; 1,64 - 3,79) e ≥ 80 anos (3,68; 2,38 - 5,81), p<0,001, classificação de Killip II (2,71; 1,92 - 3,83), Killip III (8,14; 5,67 - 11,64), Killip IV (19,83; 14,85 - 26,69), p<0,001, disfunção global acentuada do ventrículo esquerdo (VE) (3,63; 2,39 - 5,68), p<0,001 e ocorrência de infarto após a intervenção (5,01; 2,57- 9,46), p<0,001. O principal fator protetor foi o fluxo TIMI III pós-intervenção (0,18; 0,13 - 0,24), p<0,001, seguido do TIMI II (0,59; 0,41 - 0,86), p=0,005, sexo masculino (0,79; 0,64 - 0,98), p= 0,032, dislipidemia (0,69; 0,59 - 0,85), p<0,001 e número de lesões tratadas (0,86; 0,9 - 0,94), p<0,001. CONCLUSÃO: Os preditores de mortalidade nos pacientes submetidos a ATC foram: classificação de Killip, reinfarto, idade, disfunção global acentuada do VE, sexo feminino e fluxo TIMI 0/I pós-intervenção.

Retrospective Analysis of Risk Factors for Related Complications of Chemical Ablation on Hypertrophic Obstructive Cardiomyopathy.

BACKGROUND: The analysis of risk factors for predicting related complications has not been reported to date. OBJECTIVE: This study aims to investigate the risk factors of related complications of percutaneous transluminal septal myocardial ablation (PTSMA) for hypertrophic obstructive cardiomyopathy (HOCM) retrospectively. METHOD: Clinical data, and one-year follow-up results of patients with HOCM, who underwent PTSMA between January 2000 and July 2013 in the Department of Cardiology, Liaoning Province People's Hospital, Liaoning Province, China, were retrospectively analyzed to determine risk factors for operative complications with multiple logistic regression analysis. All p values are two-sided, with values of p < 0.05 being considered statistically significant. RESULTS: Among 319 patients with HOCM, PTSMA was performed in 224 patients (120 males and 104 females, mean age was 48.20 ± 14.34 years old). The incidence of PTSMA procedure-related complications was 36.23% (66/224), which included three cardiac deaths, two cardiac shocks, one ST-segment elevated myocardial infarction, two ventricular fibrillations, 20 third-degree atrioventricular (AV) blocks (four patients were implanted with a permanent pacemaker (PPM)), 32 complete right bundle branch blocks, two complete left bundle branch blocks, and four puncture-related complications. After multivariate logistic regression analysis, it was found that age, gender, coronary artery diseases, diabetes, heart rate, cardiac function on admission, the number of septal ablations, and the volume of alcohol were not independent risk factors correlated to the whole complications, except for hypertension (OR: 4.856; 95% CI: 1.732-13.609). Early experience appears to be associated with the occurrence of complications. CONCLUSION: Hypertension was an independent risk factor for PTSMA procedure-related complications. It might be much safer and more efficient if PTSMA procedures are restricted to experienced centers, according to the analysis results for the learning curve.

Retrospective Analysis of Risk Factors for Related Complications of Chemical Ablation on Hypertrophic Obstructive Cardiomyopathy / Análise Retrospectiva de Fatores de Risco para Complicações Relacionadas com Ablação Química na Cardiomiopatia Hipertrófica Obstrutiva

Abstract Background: The analysis of risk factors for predicting related complications has not been reported to date. Objective: This study aims to investigate the risk factors of related complications of percutaneous transluminal septal myocardial ablation (PTSMA) for hypertrophic obstructive cardiomyopathy (HOCM) retrospectively. Method: Clinical data, and one-year follow-up results of patients with HOCM, who underwent PTSMA between January 2000 and July 2013 in the Department of Cardiology, Liaoning Province People's Hospital, Liaoning Province, China, were retrospectively analyzed to determine risk factors for operative complications with multiple logistic regression analysis. All p values are two-sided, with values of p < 0.05 being considered statistically significant. Results: Among 319 patients with HOCM, PTSMA was performed in 224 patients (120 males and 104 females, mean age was 48.20 ± 14.34 years old). The incidence of PTSMA procedure-related complications was 36.23% (66/224), which included three cardiac deaths, two cardiac shocks, one ST-segment elevated myocardial infarction, two ventricular fibrillations, 20 third-degree atrioventricular (AV) blocks (four patients were implanted with a permanent pacemaker (PPM)), 32 complete right bundle branch blocks, two complete left bundle branch blocks, and four puncture-related complications. After multivariate logistic regression analysis, it was found that age, gender, coronary artery diseases, diabetes, heart rate, cardiac function on admission, the number of septal ablations, and the volume of alcohol were not independent risk factors correlated to the whole complications, except for hypertension (OR: 4.856; 95% CI: 1.732-13.609). Early experience appears to be associated with the occurrence of complications. Conclusion: Hypertension was an independent risk factor for PTSMA procedure-related complications. It might be much safer and more efficient if PTSMA procedures are restricted to experienced centers, according to the analysis results for the learning curve.

Resumo Fundamento: A análise dos fatores de risco para previsão de complicações relacionadas não foi relatada até o momento. Objetivo: Este estudo tem como objetivo investigar retrospectivamente os fatores de risco de complicações relacionadas da ablação miocárdica septal transluminal percutânea (PTSMA) para cardiomiopatia hipertrófica obstrutiva (CMHO). Método: Dados clínicos e resultados de acompanhamento de um ano de pacientes com CMHO submetidos a PTSMA entre janeiro de 2000 e julho de 2013 no Departamento de Cardiologia do Hospital Popular da Província de Liaoning, província de Liaoning, China, foram analisados retrospectivamente para determinar fatores de risco para complicações operatórias com análise de regressão logística múltipla. Todos os valores de p são bilaterais, com valores de p < 0,05 sendo considerados estatisticamente significativos. Resultados: Entre os 319 pacientes com CMHO, a PTSMA foi realizada em 224 pacientes (120 homens e 104 mulheres, com idade média de 48,20 ± 14,34 anos). A incidência de complicações relacionadas ao procedimento PTSMA foi de 36,23% (66/224), incluindo três mortes cardíacas, dois choques cardíacos, um infarto do miocárdio com supradesnivelamento de ST, duas fibrilações ventriculares e 20 bloqueios atrioventriculares (AV) de terceiro grau (quatro pacientes receberam implantes de marca-passo permanente), 32 bloqueios completos de ramo direito, dois bloqueios completos de ramo esquerdo e quatro complicações relacionadas com a punção. Após análise de regressão logística multivariada, verificou-se que idade, sexo, doenças coronarianas, diabetes, frequência cardíaca, função cardíaca à admissão, número de ablações septais e volume de álcool não foram fatores de risco independentes correlacionados com as complicações totais, exceto para hipertensão (OR: 4,856; IC 95%: 1,732-13,609). A experiência principiante parece estar associada à ocorrência de complicações. Conclusão: A hipertensão arterial foi um fator de risco independente para complicações relacionadas com o procedimento de PTSMA. Pode ser muito mais seguro e eficiente se os procedimentos de PTSMA forem restritos a centros experientes, de acordo com os resultados da análise para a curva de aprendizado.

Effects of Rosuvastatin on Apolipoprotein J in Balloon-Injured Carotid Artery in Rats.

BACKGROUND: Restenosis after percutaneous coronary intervention in coronary heart disease remains an unsolved problem. Clusterin (CLU) (or Apolipoprotein [Apo] J) levels have been reported to be elevated during the progression of postangioplasty restenosis and atherosclerosis. However, its role in neointimal hyperplasia is still controversial. OBJECTIVE: To elucidate the role Apo J in neointimal hyperplasia in a rat carotid artery model in vivo with or without rosuvastatin administration. METHODS: Male Wistar rats were randomly divided into three groups: the control group (n = 20), the model group (n = 20) and the statin intervention group (n = 32). The rats in the intervention group were given 10mg /kg dose of rosuvastatin. A 2F Fogarty catheter was introduced to induce vascular injury. Neointima formation was analyzed 1, 2, 3 and 4 weeks after balloon injury. The level of Apo J was measured by real-time PCR, immunohistochemistry and western blotting. RESULTS: Intimal/medial area ratio (intimal/medial, I/M) was increased after balloon-injury and reached the maximum value at 4weeks in the model group; I/M was slightly increased at 2 weeks and stopped increasing after rosuvastatin administration. The mRNA and protein levels of Apo J in carotid arteries were significantly upregulated after rosuvastatin administration as compared with the model group, and reached maximum values at 2 weeks, which was earlier than in the model group (3 weeks). CONCLUSION: Apo J served as an acute phase reactant after balloon injury in rat carotid arteries. Rosuvastatin may reduce the neointima formation through up-regulation of Apo J. Our results suggest that Apo J exerts a protective role in the restenosis after balloon-injury in rats.

Effects of Rosuvastatin on Apolipoprotein J in Balloon-Injured Carotid Artery in Rats / Efeitos da Rosuvastatina sobre Apolipoproteína J em Artérias de Ratos Lesionadas com Balão

Abstract Background: Restenosis after percutaneous coronary intervention in coronary heart disease remains an unsolved problem. Clusterin (CLU) (or Apolipoprotein [Apo] J) levels have been reported to be elevated during the progression of postangioplasty restenosis and atherosclerosis. However, its role in neointimal hyperplasia is still controversial. Objective: To elucidate the role Apo J in neointimal hyperplasia in a rat carotid artery model in vivo with or without rosuvastatin administration. Methods: Male Wistar rats were randomly divided into three groups: the control group (n = 20), the model group (n = 20) and the statin intervention group (n = 32). The rats in the intervention group were given 10mg /kg dose of rosuvastatin. A 2F Fogarty catheter was introduced to induce vascular injury. Neointima formation was analyzed 1, 2, 3 and 4 weeks after balloon injury. The level of Apo J was measured by real-time PCR, immunohistochemistry and western blotting. Results: Intimal/medial area ratio (intimal/medial, I/M) was increased after balloon-injury and reached the maximum value at 4weeks in the model group; I/M was slightly increased at 2 weeks and stopped increasing after rosuvastatin administration. The mRNA and protein levels of Apo J in carotid arteries were significantly upregulated after rosuvastatin administration as compared with the model group, and reached maximum values at 2 weeks, which was earlier than in the model group (3 weeks). Conclusion: Apo J served as an acute phase reactant after balloon injury in rat carotid arteries. Rosuvastatin may reduce the neointima formation through up-regulation of Apo J. Our results suggest that Apo J exerts a protective role in the restenosis after balloon-injury in rats.

Resumo Fundamento: A reestenose após intervenção coronária percutânea (ICP) após doença coronariana continua um problema não solucionado. Estudos relataram que os níveis de clusterina (CLU), também chamada de apolipoproteína (Apo) J, encontram-se elevados na progressão da reestenose pós-angioplastia e na aterosclerose. Contudo, seu papel na hihperplasia neointimal ainda é controverso. Objetivo: Elucidar o papel da Apo J na hiperplasia neointimal na artéria carótida utilizando um modelo experimental com ratos in vivo, com e sem intervenção com rosuvastatina. Métodos: ratos Wistar machos foram divididos aleatoriamente em três grupos - grupo controle (n = 20), grupo modelo (n = 20), e grupo intervenção com estatina (n = 32). Os ratos no grupo intervenção receberam 10 mg/kg de rosuvastatina. Um cateter Fogarty 2 F foi introduzido para induzir lesão vascular. A formação de neoíntima foi analisada 1, 2, 3 e 4 semanas após lesão com balão. Concentrações de Apo J foram medidas por PCR em tempo real, imuno-histoquímica e western blotting. Resultados: A razão área íntima/média (I/M) aumentou após a lesão com balão e atingiu o valor máximo 4 semanas pós-lesão no grupo modelo; observou-se um pequeno aumento na I/M na semana 2, que cessou após a administração de rosuvastatina. Os níveis de mRNA e proteína da Apo J nas artérias carótidas aumentaram significativamente após administração de rosuvastatina em comparação ao grupo modelo, atingindo o máximo na semana 2, mais cedo em comparação ao grupo modelo (semana 3). Conclusão: A Apo J atuou como reagente de fase aguda após lesão com balão nas artérias carótidas de ratos. A rosuvastatina pode reduzir a formação de neoíntoma por aumento de Apo J. Nossos resultados sugerem que a Apo J exerce um papel protetor na reestenose após lesão com balão em ratos.

Two HEmostasis Methods After TransradIal Catheterization: THEMATIC - protocol for a randomized clinical trial.

OBJECTIVE: Randomized clinical trial protocol to evaluate the incidence of radial artery occlusion with two different arterial compression devices after transradial procedures. METHODS: Barbeau's test will be performed in adults scheduled to undergo transradial interventional procedures. Those with A, B, or C plethysmographic patterns will be selected. At the end of the procedure, patients will be randomly assigned (1:1) to receive patent haemostasis with TR Band™ device or conventional haemostasis with an elastic adhesive bandage. The primary outcome is the incidence of radial artery occlusion. Secondary outcomes are Barbeau's test curve change, additional time to achieve haemostasis, incidence of bleeding at the puncture site, pain severity, development of arteriovenous fistula, radial pseudo aneurysm, any access-site complication requiring vascular surgery intervention and costs between the two devices. DISCUSSION: The results of this trial should provide valuable additional information on the best approach for haemostasis after transradial percutaneous cardiovascular interventions.

Lesión cutánea por radiación en angioplastía coronaria compleja / Cutaneous radiation injury after failed percutaneous coronary angioplasty

Resumen: Las lesiones cutáneas por radiación (LCR) son una complicación infrecuente, con un estimado de 3.600 casos de lesiones mayores reportados en la actualidad. Presentamos un caso de lesión eritematosa mayor por radiación posterior a angioplastía coronaria fallida y en segundo tiempo angioplastía coronaria con rotablación.

Abstract: Cutaneous radiation injuries are an infrequent complication, with an estimated 3.600 cases of major injuries reported up to now. We present a case of a major erythematous lesion induced by radiation after failed coronary angioplasty and consecutive coronary rotablation.

Persistent Inflammatory Activity in Blood Cells and Artery Tissue from Patients with Previous Bare Metal Stent.

BACKGROUND: Studies have pointed out a higher mortality after coronary artery bypass surgery (CABG) in patients with stent. OBJECTIVE: To evaluate inflammatory markers in peripheral blood cells and in coronary artery tissue samples obtained during CABG in patients with stent compared to controls. METHODS: The case series consisted of two groups, one with previous stent implantation (n = 41) and one control (n = 26). The expression of the LIGHT, IL-6, ICAM, VCAM, CD40, NFKB, TNF, IFNG genes was analyzed in peripheral blood cells collected preoperatively. The coronary artery was evaluated for: interleukin-6, ICAM, VCAM, CD40, NFKB, TNF-alpha and IFN-gamma by immunohistochemistry. A total of 176 tissue samples were grouped for analysis in: A1- arteries with stent (n = 38); A2- native arteries from patients with stent in another artery (n = 68); and A3- arteries without stent from controls undergoing routinely CABG surgery (n = 70). A significance level of 0.05 was adopted. RESULTS: Patients with stent showed higher TNF (p = 0.03) and lower CD40 gene expression (p = 0.01) in peripheral blood cells than controls without stent. In coronary artery samples, the TNF-alpha protein staining was higher in the group A1, not only in the intima-media layer (5.16 ± 5.05 vs 1.90 ± 2.27; p = 0.02), but also in the adipose tissue (6.69 ± 3.87 vs 2.27 ± 4.00; p < 0.001). Furthermore, group A1 had a higher interleukin-6 protein staining in adipose tissue than group A3 (p = 0.04). CONCLUSION: We observed a persistently higher systemic TNF expression associated with exacerbated TNF-alpha and interleukin-6 local production in patients with stents. This finding may contribute to a worse clinical outcome.

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.

Two HEmostasis Methods After TransradIal Catheterization: THEMATIC - protocol for a randomized clinical trial / Dos métodos de hemostasia luego de un cateterismo transradial: THEMATIC - protocolo de ensayo clínico aleatorizado / Dois métodos de hemostasia após cateterismo transradial: THEMATIC - protocolo de ensaio clínico randomizado

Abstract OBJECTIVE Randomized clinical trial protocol to evaluate the incidence of radial artery occlusion with two different arterial compression devices after transradial procedures. METHODS Barbeau's test will be performed in adults scheduled to undergo transradial interventional procedures. Those with A, B, or C plethysmographic patterns will be selected. At the end of the procedure, patients will be randomly assigned (1:1) to receive patent haemostasis with TR Band™ device or conventional haemostasis with an elastic adhesive bandage. The primary outcome is the incidence of radial artery occlusion. Secondary outcomes are Barbeau's test curve change, additional time to achieve haemostasis, incidence of bleeding at the puncture site, pain severity, development of arteriovenous fistula, radial pseudo aneurysm, any access-site complication requiring vascular surgery intervention and costs between the two devices. DISCUSSION The results of this trial should provide valuable additional information on the best approach for haemostasis after transradial percutaneous cardiovascular interventions.

Resumen OBJETIVO Protocolo de ensayo clínico randomizado para evaluar la incidencia de oclusión de la arteria radial con dos dispositivos de compresión arterial después de pasar por procedimientos transradiales. MÉTODO Se realizará el test de Barbeau en adultos que están esperando una intervención transradial. Se seleccionarán aquellos con padrones pletismográficos A, B o C. Al final del procedimiento, se dividirán a los pacientes de forma aleatoria (1:1) para recibir la hemostasia patente con dispositivo TR Band™ o hemostasia convencional con vendaje elástico adhesivo. El resultado primario es la incidencia de oclusión de la arteria radial. Los resultados secundarios son la alteración de la curva del test de Barbeau, tiempo adicional para alcanzar la hemostasia, incidencia de sangrado en el local de la punción, intensidad del dolor, desarrollo de una fístula arteriovenosa, pseudoaneurisma, cualquier complicación en el lugar de acceso que necesite intervención quirúrgica vascular y costos entre ambos dispositivos. DISCUSIÓN Los resultados de este estudio deben proporcionar informaciones adicionales valiosas sobre un mejor enfoque para la hemostasia luego de intervenciones cardiovasculares percutáneas transradiales.

Resumo OBJETIVO Protocolo de ensaio clínico randomizado para avaliar a incidência de oclusão da artéria radial com dois dispositivos diferentes de compressão arterial após procedimentos transradiais. MÉTODOS O teste de Barbeau será realizado em adultos que serão submetidos a procedimentos de intervenção transradial previamente agendados. Aqueles com padrões pletismográficos A, B ou C serão selecionados. No final do procedimento, os pacientes serão distribuídos aleatoriamente (1:1) para receber hemostasia patente com dispositivo TR Band™ ou hemostasia convencional com bandagem elástica adesiva. O desfecho primário é a incidência da oclusão da artéria radial. Os desfechos secundários são alteração da curva do teste de Barbeau, tempo adicional para atingir a hemostasia, incidência de sangramento no local da punção, intensidade da dor, desenvolvimento de fístula arteriovenosa, pseudoaneurisma, qualquer complicação no local de acesso que necessite intervenção cirúrgica vascular e custos entre os dois dispositivos. DISCUSSÃO: Os resultados deste estudo devem fornecer informações adicionais valiosas sobre a melhor abordagem para a hemostasia após intervenções cardiovasculares percutâneas transradiais.

Impact of Paclitaxel-Eluting Balloons Compared to Second-Generation Drug-Eluting Stents for of In-Stent Restenosis in a Primarily Acute Coronary Syndrome Population.

BACKGROUND: The place of drug-eluting balloons (DEB) in the treatment of in-stent restenosis (ISR) is not well-defined, particularly in a population of all-comers with acute coronary syndromes (ACS). OBJECTIVE: Compare the clinical outcomes of DEB with second-generation drug-eluting stents (DES) for the treatment of ISR in a real-world population with a high proportion of ACS. METHODS: A retrospective analysis of consecutive patients with ISR treated with a DEB compared to patients treated with a second-generation DES was performed. The primary endpoint was a composite of major adverse cardiovascular events (MACE: all-cause death, non-fatal myocardial infarction, and target lesion revascularization). Comparisons were performed using Cox proportional hazards multivariate adjustment and Kaplan-Meier analysis with log-rank. RESULTS: The cohort included 91 patients treated with a DEB and 89 patients treated with a DES (74% ACS). Median follow-up was 26 months. MACE occurred in 33 patients (36%) in the DEB group, compared to 17 patients (19%) in the DES group (p log-rank = 0.02). After multivariate adjustment, there was no significant difference between the groups (HR for DEB = 1.45 [95%CI: 0.75-2.83]; p = 0.27). Mortality rates at 1 year were 11% with DEB, and 3% with DES (p = 0.04; adjusted HR = 2.85 [95%CI: 0.98-8.32]; p = 0.06). CONCLUSION: In a population with a high proportion of ACS, a non-significant numerical signal towards increased rates of MACE with DEB compared to second-generation DES for the treatment of ISR was observed, mainly driven by a higher mortality rate. An adequately-powered randomized controlled trial is necessary to confirm these findings.

Impact of Paclitaxel-Eluting Balloons Compared to Second-Generation Drug-Eluting Stents for of In-Stent Restenosis in a Primarily Acute Coronary Syndrome Population / Impacto dos Balões de Eluição de Paclitaxel Comparados a Stents Farmacológicos de Segunda Geração para Reestenose Intra-Stent em uma População com Síndrome Coronária Aguda Primária

Abstract Background: The place of drug-eluting balloons (DEB) in the treatment of in-stent restenosis (ISR) is not well-defined, particularly in a population of all-comers with acute coronary syndromes (ACS). Objective: Compare the clinical outcomes of DEB with second-generation drug-eluting stents (DES) for the treatment of ISR in a real-world population with a high proportion of ACS. Methods: A retrospective analysis of consecutive patients with ISR treated with a DEB compared to patients treated with a second-generation DES was performed. The primary endpoint was a composite of major adverse cardiovascular events (MACE: all-cause death, non-fatal myocardial infarction, and target lesion revascularization). Comparisons were performed using Cox proportional hazards multivariate adjustment and Kaplan-Meier analysis with log-rank. Results: The cohort included 91 patients treated with a DEB and 89 patients treated with a DES (74% ACS). Median follow-up was 26 months. MACE occurred in 33 patients (36%) in the DEB group, compared to 17 patients (19%) in the DES group (p log-rank = 0.02). After multivariate adjustment, there was no significant difference between the groups (HR for DEB = 1.45 [95%CI: 0.75-2.83]; p = 0.27). Mortality rates at 1 year were 11% with DEB, and 3% with DES (p = 0.04; adjusted HR = 2.85 [95%CI: 0.98-8.32]; p = 0.06). Conclusion: In a population with a high proportion of ACS, a non-significant numerical signal towards increased rates of MACE with DEB compared to second-generation DES for the treatment of ISR was observed, mainly driven by a higher mortality rate. An adequately-powered randomized controlled trial is necessary to confirm these findings.

Resumo Fundamento: O papel de balões farmacológicos (BFs) no tratamento de reestenose intra-stent (RIS) não está bem definido, particularmente em na síndrome coronária aguda (SCA). Objetivo: Comparar desfechos clínicos do uso de BF com stents farmacológicos (SFs) de segunda geração no tratamento de RIS em uma população real com alta prevalência de SCA. Métodos: Foi realizada uma análise retrospectiva de pacientes consecutivos com RIS tratados com um BF comparados a pacientes tratados com SF de segunda geração. O desfecho primário incluiu eventos cardiovasculares adversos importantes (morte por todas as causas, infarto do miocárdio não fatal, e revascularização da lesão alvo). As comparações foram realizadas pelo modelo proporcional de riscos de Cox ajustado e análise de Kaplan-Meier com log-rank. Resultados: A coorte incluiu 91 pacientes tratados com BF e 89 pacientes tratados com um SF (75% com SCA). O tempo mediano de acompanhamento foi de 26 meses. Eventos cardiovasculares adversos importantes ocorreram em 33 pacientes (36%) no grupo BF, e em 17 (19%) no grupo SF (p log-rank = 0,02). Após ajuste multivariado, não houve diferença significativa entre os grupos (HR para BF = 1,45 [IC95%: 0,75-2,83]; p = 0,27). As taxas de mortalidade de 1 ano foram 11% com BF, e 3% com SF (p = 0,04; HR ajustado = 2,85 [IC95%: 0,98-8,32; p = 0,06). Conclusão: Em uma população com alta prevalência de SCA, observou-se um aumento não significativo nas taxas de eventos cardiovasculares adversos importantes com o uso de BF comparado ao uso de SF de segunda geração para o tratamento de RIS, principalmente pelo aumento na taxa de mortalidade. É necessário um ensaio clínico controlado, randomizado, com poder estatístico adequado para confirmar esses achados.

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.

Successful management of grade III coronary perforation after percutaneous angioplasty in a high-risk patient: a case report.

Coronary perforation is a rare complication in patients undergoing percutaneous coronary angioplasty. The mortality of this complication varies depending on factors related to the patient and the procedure performed, reaching 44% in patients with Ellis type III perforation. We report the case of an 81 year old male with multiple cardiovascular risk factors, who underwent percutaneous angioplasty for unstable angina management. The patient developed grade III coronary perforation in the anterior descending artery, which was successfully managed with balloon inflation to 6 atmospheres for 10 minutes twice in the affected area, with an interval of 5 minutes between each dilatation. The patient improved and was discharged.

La perforación coronaria es una complicación rara en los pacientes sometidos a angioplastia percutánea coronaria. La mortalidad de esta complicación es variable, dependiendo de factores relacionados al paciente y al procedimiento realizado. Alcanza el 44% en pacientes con perforación tipo III, según la escala de Ellis. Presentamos el caso de un varón de 81 años con múltiples factores de riesgo cardiovascular, a quien se le realizó una angioplastia percutánea para manejo de un síndrome isquémico coronario agudo sin elevación del segmento ST (SICA STNE) de alto riesgo. El procedimiento se complicó con una perforación coronaria grado III en la arteria descendente anterior, la cual fue manejada exitosamente con dilatación de balón a 6 atmósferas por 10 minutos en dos oportunidades en la zona afectada, con intervalo de 5 minutos entre insuflaciones. El paciente evolucionó favorablemente y fue dado de alta.

A novel drug-coated scoring balloon for the treatment of coronary in-stent restenosis: Results from the multi-center randomized controlled PATENT-C first in human trial.

BACKGROUND: Scoring balloons produce excellent acute results in the treatment of in-stent restenosis (ISR), fibro-calcific and bifurcation lesions but have not been shown to affect the restenosis rate. A novel paclitaxel-coated scoring balloon (SB) was developed and tested to overcome this limitation. METHODS AND RESULTS: SB were coated with paclitaxel admixed with a specific excipient. Patients at four clinical sites in Germany and one in Brazil with ISR of coronary bare metal stent (BMS) were randomized 1:1 to treatment with either a drug-coated or uncoated SB. Baseline and 6-month follow-up quantitative coronary angiography was performed by an independent blinded core lab and all patients will be evaluated clinically for up to one year. The primary endpoint was angiographic in-segment late lumen loss (LLL). Secondary endpoints included the rate of clinically driven target lesion revascularization (TLR), composite of major adverse cardiovascular events (MACE), stent thrombosis and other variables. Sixty-one patients were randomized (28 uncoated and 33 drug-coated SB); mean age 65 years, males 72%, and presence of diabetes 39%. At 6-month angiography, in-segment LLL was 0.48 ± 0.51 mm in the uncoated SB group versus 0.17 ± 0.40 mm in the drug-coated SB group (P = 0.01; ITT analysis). The rate of binary restenosis was 41% in the uncoated SB group versus 7% in the drug-coated SB group (P = 0.004). The MACE rate was 32% with the uncoated SB vs. 6% in the drug-coated SB group (P = 0.016). This difference was primarily due to the reduced need for clinically driven TLR in the coated SB group (3% vs. 32% P = 0.004). CONCLUSIONS: A novel paclitaxel-coated coronary SB has been developed and successfully used in a first-in-human randomized controlled trial [ClinicalTrials.gov Identifier: NCT01495533]. © 2015 Wiley Periodicals, Inc.

Upstream clopidogrel, prasugrel, or ticagrelor for patients treated with primary angioplasty: Results of an angiographic randomized pilot study.

OBJETIVES: The main objective of the present randomized pilot study was to explore the effects of upstream prasugrel or ticagrelor or clopidogrel for patients with ST-segment-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). BACKGROUND: Administration of clopidogrel "as soon as possible" has been advocated for STEMI. Pretreatment with prasugrel and ticagrelor may improve reperfusion. Currently, the angiographic effects of upstream administration of these agents are poorly understood. METHODS: A total of 132 patients with STEMI within the first 12 hr of chest pain referred to primary angioplasty were randomized to upstream clopidogrel (600 mg), prasugrel (60 mg), or ticagrelor (180 mg) while still in the emergency room. All patients underwent protocol-mandated thrombus aspiration. RESULTS: Macroscopic thrombus material was retrieved in 79.5% of the clopidogrel group, 65.9% of the prasugrel group, and 54.3% of the ticagrelor group (P = 0.041). At baseline angiography, large thrombus burden was 97.7% vs. 87.8% vs. 80.4% in the clopidogrel, prasugrel, and ticagrelor groups, respectively (P = 0.036). Also, at baseline, 97.7% presented with an occluded target vessel in the clopidogrel group, 87.8% in the prasugrel group and 78.3% in the ticagrelor group (P = 0.019). At the end of the procedure, the percentages of patients with combined TIMI grade III flow and myocardial blush grade III were 52.3% for clopidogrel, 80.5% for prasugrel, and 67.4% for ticagrelor (P = 0.022). CONCLUSIONS: In patients with STEMI undergoing primary PCI within 12 hr, upstream clopidogrel, prasugrel or ticagrelor have varying angiographic findings, with a trend toward better results for the latter two agents. © 2015 Wiley Periodicals, Inc.