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Introduction and objectives: Drug-eluting balloon (DEB) angioplasty is an effective technique to treat in-stent restenosis (ISR). Neointimal modification with cutting balloon (CB) or scoring balloon (SB) enhances the angiographic results of DEB, but with no benefits have been reported in the clinical endpoints at the mid-term. There is lack of information on the clinical long-term results of this strategy. We aim to compare very long-term results of CB before DEB vs standard DEB to treat real-world patients with ISR. Methods: Retrospective cohort registry of DEB PCIs to treat ISR defined by the use of CB. The primary endpoint was clinically driven target lesion revascularization (TLR) at 5 years. The secondary endpoints were based on the ARC-2 criteria. Results: From January 2010 to December 2015, 107 ISRs were treated with DEB in 91 patients. CBs were used in 51 lesions (46 patients). Both cohorts were well balanced regarding clinical, lesion, and procedural characteristics. Compared to standard DEBs, CBs showed lower, although statistically non-significant rates, of TLR at 5 years (9.8% vs 23.6%, OR, 0.36; 95% confidence interval 0.19 to 1.09 P = .05). The Kaplan-Meier cumulative incidence of time until TLR showed similar results (log-rank test P value = .05) with similar rates of TLR at 1 year (3.9% vs 7.1%, P = .68) as curve separation in the long-term. There were no differences in the secondary endpoints. No stent thrombosis was reported. Conclusions: In a real-world setting, neointimal modification with CB before DEB vs standard DEB to treat ISR shows lower, although statistically non-significant rates of TLR at 5 years. This benefit has been confirmed in the long-term and is consistent with bare-metal and drug-eluting stents.

Resumen Introduccion y objetivos Los pacientes mayores de 75 anos con infarto agudo de miocardio con elevacion del segmento ST sometidos a angioplastia primaria en situacion de shock cardiogenico sufren una gran mortalidad. La identificacion previa al procedimento de variables predictoras de la posterior mortalidad seria muy util para guiar la toma de decisiones. Metodos Analisis del registro multicentrico de angioplastia primaria en pacientes mayores de 75 anos (ESTROFA MI + 75), que incluye a 3.576 pacientes. Se analizaron las caracteristicas y la evolucion clinica del subgrupo con shock cardiogenico para identificar predictores de supervivencia a 1 ano tras la angioplastia y elaborar un indice pronostico. Se valido el indice en una cohorte independiente. Resultados Se incluyo a 332 pacientes. Los predictores basales independientes fueron: la localizacion anterior (HR = 2,8; IC95%, 1,4-6,0; p = 0,005), una fraccion de eyeccion 6 h (HR = 3,2; IC95%, 1,6-7,5; p = 0,001). Se diseno un indice basado en estas variables (indice «6-ANT-40»). La supervivencia a 1 ano fue del 54,5% de aquellos con indice 0, el 32,3% con indice 1, el 27,4% con indice 2 y el 17% con indice 3 (p = 0,004, estadistico C = 0,70). En una cohorte independiente de 124 pacientes, las supervivencias a 1 ano fueron del 64,5, el 40,0, el 28,9 y el 22,2% respectivamente (p = 0,008; estadistico C = 0,68). Conclusiones Un indice basado en simples variables clinicas previas al procedimiento (localizacion anterior, fraccion de eyeccion 6 h) permite estimar la supervivencia tras una angioplastia primaria de los pacientes mayores con shock cardiogenico, y asi ayudar en la toma de decisiones.

Introduction and objectives: Coronary in-stent restenosis (ISR) is associated with a high target lesion revascularization rate, while the drug-eluting balloon (DEB) presents IA class level of evidence for its treatment. Nevertheless, very long-term outcomes of DEB for ISR in non-selected populations of patients are unknown. Our goal is to evaluate the very long-term (5 year) effectiveness of DEBs in a real-world registry. Methods: Retrospective registry from an ISR cohort treated with DEB. The primary outcome was the rate of target lesion revascularization (TLR) at 5 years. Secondary outcomes were evaluated according to the ARC-2 criteria. Results: From January 2010 through December 2013, 53 ISRs were treated using DEBs in 48 patients. Patients were old (69.3 ± 11.8 years-old) and 55.8% had diabetes. The rate of TLR at 1 year was 9.4%, and 20.8% at 3 and 5 years, respectively. The rate of late TLR (after the first year) was 11.4%, only after DEB for bare metal ISR. The 5-year TLR was not associated with diabetes (22.7% vs 19.2%; P = .76) and was not significantly lower after cutting-balloon (12.5% vs 24.3%; P = .47) or in bare-metal stent ISR (20.6% vs 21.1%; P = .96). There was no definite/probable stent thrombosis of the lesions treated with DEB at follow-up. Conclusions: In a real-world cohort, the 5-year TLR rate after DEB for ISR was 20.8%. Late TLR accounted for half of the TLR at follow-up (after DEB for bare metal ISR), while the rate of TLR seemed to stabilize at 3 years. There was no stent thrombosis of the lesions treated with DEB.

Introduction and objectives: The proportion of elderly patients undergoing primary angioplasty is growing. The present study describes the clinical profile, procedural characteristics, outcomes, and predictors of outcome. Methods: A 31-center registry of consecutive patients older than 75 years treated with primary angioplasty. Clinical and procedural data were collected, and the patients underwent clinical follow-up. Results: The study included 3576 patients (39.3% women, 48.5% with renal failure, 11.5% in Killip III or IV, and 29.8% with > 6 hours of chest pain). Multivessel disease was present in 55.4% and nonculprit lesions were additionally treated in 24.8%. Radial access was used in 56.4%, bivalirudin in 11.8%, thromboaspiration in 55.9%, and drug-eluting stents in 26.6%. The 1-month and 2-year incidences cardiovascular death were 10.1% and 14.7%, respectively. The 2-year rates of definite or probable thrombosis, repeat revascularization, and BARC bleeding > 2 were 3.1%, 2.3%, and 4.2%, respectively. Predictive factors were diabetes mellitus, renal failure, atrial fibrillation, delay to reperfusion > 6 hours, ejection fraction < 45%, Killip class III-IV, radial access, bivalirudin, drug-eluting stents, final TIMI flow of III, and incomplete revascularization at discharge. Conclusions: Notable registry findings include frequently delayed presentation and a high prevalence of adverse factors such as renal failure and multivessel disease. Positive procedure-related predictors include shorter delay, use of radial access, bivalirudin, drug-eluting stents, and complete revascularization before discharge. (C) 2016 Sociedad Espanola de Cardiologia. Published by Elsevier Espana, S.L.U. All rights reserved.

Resumen Introduccion y objetivos La proporcion de pacientes de edad avanzada que se someten a angioplastia primaria esta creciendo. Este estudio describe el perfil clinico, las caracteristicas de los procedimientos, la evolucion y los predictores pronosticos. Metodos Registro en 31 centros de pacientes consecutivos mayores de 75 anos tratados con angioplastia primaria. Se recogieron variables clinicas y del procedimiento y se efectuo seguimiento clinico. Resultados Se incluyo a 3.576 pacientes (el 39,3% mujeres, el 48,5% con insuficiencia renal, el 11,5% en Killip III o IV y el 29,8% con mas de 6 h de dolor). El 55,4% presentaba enfermedad multivaso y al 24,8% se les trato ademas lesiones no culpables. Se utilizo via radial en el 56,4%, bivalirudina en el 11,8%, aspiracion de trombo en el 55,9% y stents farmacoactivos en el 26,6%. La incidencia de muerte cardiaca al mes era del 10,1% y a los 2 anos, del 14,7%. A los 2 anos la trombosis definitiva o probable era del 3,1%; la revascularizacion de lesion tratada, del 2,3% y las hemorragias BARC > 2, del 4,2%. Los predictores pronosticos fueron: diabetes mellitus, insuficiencia renal, fibrilacion auricular, retraso > 6 h, fraccion de eyeccion III - IV , via radial, bivalirudina, stents farmacoactivos, flujo final TIMI III y revascularizacion incompleta al alta. Conclusiones En este registro destaca el frecuente retraso en la presentacion y la alta prevalencia de factores adversos como la insuficiencia renal o la enfermedad multivaso. Se identificaron como factores protectores relacionados con el procedimiento el menor retraso, el uso de via radial, la bivalirudina, los stents farmacoactivos y la revascularizacion completa antes del alta.

espanolIntroduccion y objetivos: La reestenosis de stents coronarios (RS) presentan altas tasas de necesidad de revascularizacion, y el balon farmacoactivo (BFA) presenta clase I (nivel de evidencia A) en su tratamiento. La eficacia de esta estrategia a muy largo plazo en pacientes no seleccionados es desconocida. Se pretende evaluar la eficacia del BFA en un registro de pacientes de la practica clinica a muy largo plazo de seguimiento (5 anos). Metodos: Registro retrospectivo de una cohorte formada por pacientes con RS tratados con BFA. El evento primario fue la tasa de revascularizacion de la lesion tratada (RLT) con BFA a 5 anos. Se valoraron eventos secundarios segun los criterios Academic Research Consortium-2. Resultados: Entre enero de 2010 y diciembre de 2013 se uso BFA de forma eficaz en 53 RS de 48 pacientes. Los pacientes presentaban edad avanzada (69,3 ± 11,8 anos) y alta prevalencia de diabetes (55,8%). La tasa de RLT a 1 ano fue del 9,4%, y del 20,8% a los 3 y 5 anos. La tasa de RLT tardia (mas alla del ano de seguimiento) fue del 11,4%, tan solo en reestenosis de stent convencional. La RLT a 5 anos no se asocio a diabetes (22,7 frente a 19,2%; p = 0,76) ni fue significativamente menor con el uso de balon de corte (12,5 frente a 24,3%; p = 0,47) o en reestenosis de stent convencional (20,6 frente a 21,1%; p = 0,96). No hubo casos de trombosis de stent definitiva/probable de la lesion tratada con BFA. Conclusiones: En una cohorte de la practica clinica, el BFA para RS presenta una RLT a 5 anos del 20,8%. La RLT tardia supone la mitad de los casos a lo largo del seguimiento, y se produce en RS convencional. La tasa de RLT parece estabilizarse a partir del tercer ano de seguimiento. No se evidencio trombosis de stent de la lesion tratada con BFA. EnglishIntroduction and objectives: Coronary in-stent restenosis (ISR) is associated with a high target lesion revascularization rate, while the drug-eluting balloon (DEB) presents IA class level of evidence for its treatment. Nevertheless, very long-term outcomes of DEB for ISR in non-selected populations of patients are unknown. Our goal is to evaluate the very long-term (5 year) effectiveness of DEBs in a real-world registry. Methods: Retrospective registry from an ISR cohort treated with DEB. The primary outcome was the rate of target lesion revascularization (TLR) at 5 years. Secondary outcomes were evaluated according to the ARC-2 criteria. Results: From January 2010 through December 2013, 53 ISRs were treated using DEBs in 48 patients. Patients were old (69.3 ± 11.8 years-old) and 55.8% had diabetes. The rate of TLR at 1 year was 9.4%, and 20.8% at 3 and 5 years, respectively. The rate of late TLR (after the first year) was 11.4%, only after DEB for bare metal ISR. The 5-year TLR was not associated with diabetes (22.7% vs 19.2%; P = .76), and was not significantly lower after cutting-balloon (12.5% vs 24.3%; P = .47) or in bare-metal stent ISR (20.6% vs 21.1%; P = .96). There was no definite/probable stent thrombosis of the lesions treated with DEB at follow-up. Conclusions: In a real-world cohort, the 5-year TLR rate after DEB for ISR was 20.8%. Late TLR accounted for half of the TLR at follow-up (after DEB for bare metal ISR), while the rate of TLR seemed to stabilize at 3 years. There was no stent thrombosis of the lesions treated with DEB.

BACKGROUND AND OBJECTIVES: Patients older than 75 years with ST-segment elevation myocardial infarction undergoing primary angioplasty in cardiogenic shock have high mortality. Identification of preprocedural predictors of short- and long-term mortality could be useful to guide decision-making and further interventions. METHODS: We analyzed a nationwide registry of primary angioplasty in the elderly (ESTROFA MI+75) comprising 3576 patients. The characteristics and outcomes of the subgroup of patients in cardiogenic shock were analyzed to identify associated factors and prognostic predictors in order to derive a baseline risk prediction score for 1-year mortality. The score was validated in an independent cohort. RESULTS: A total of 332 patients were included. Baseline independent predictors of mortality were anterior myocardial infarction (HR 2.8, 95%CI, 1.4-6.0 P=.005), ejection fraction6hours (HR 3.2, 95%CI, 1.6-7.5; P=.001). A score was designed that included these predictive factors (score "6-ANT-40"). Survival at 1 year was 54.5% for patients with score 0, 32.3% for score 1, 27.4% for score 2 and 17% for score 3 (P=.004, c-statistic 0.70). The score was validated in an independent cohort of 124 patients, showing 1-year survival rates of 64.5%, 40.0%, 28.9%, and 22.2%, respectively (P=.008, c-statistic 0.68). CONCLUSIONS: A preprocedural score based on 3 simple clinical variables (anterior location, ejection fraction6 hours) may be used to estimate survival after primary angioplasty in elderly patients with cardiogenic shock and to guide preinterventional decision-making.

Resumen Introduccion y objetivos Este estudio compara los resultados clinicos a largo plazo de pacientes tratados con stents liberadores de paclitaxel o de everolimus en el infarto agudo de miocardio con elevacion del segmento ST, asi como la influencia de la trombectomia. Metodos El ESTROFA-IM es un registro, en 16 centros, retrospectivo de pacientes consecutivos con infarto agudo de miocardio con elevacion del segmento ST tratados con stents de paclitaxel o everolimus. Se realizo analisis de emparejamiento por propension de tratamiento para seleccionar grupos comparables tanto para el modelo de stent como para uso de trombectomia. Resultados Despues del emparejamiento, se incluyo en el analisis a 350 pacientes tratados con stents de paclitaxel y 350 con stents de everolimus. Las caracteristicas clinicas y angiograficas eran comparables. La incidencia a 2 anos de muerte, infarto y revascularizacion de la lesion tratada fue del 14,9% del grupo de paclitaxel y el 11,5% del de everolimus (p = 0,04) y la incidencia de trombosis definitiva/probable, del 4,3 y el 1,4% (p = 0,01). El stent de paclitaxel fue un predictor independiente de eventos (( hazard ratio = 2,44, intervalo de confianza del 95%, 1,28-4,65; p = 0,006). El beneficio de los stents de everolimus respecto a la trombosis de stent fue mas evidente en el grupo sin trombectomia (el 5,4 frente al 1,4%; p = 0,01).). Se detecto una interaccion significativa en los subgrupos segun trombectomia para el objetivo de trombosis de stent (p = 0,039). Conclusiones Estos resultados indican mejor evolucion clinica con los stents de everolimus en el infarto agudo de miocardio con elevacion del segmento ST. El menor riesgo de trombosis con estos stents podria ser mas relevante en ausencia de trombectomia.

Evidence regarding therapy with drug-eluting stents in the left main coronary artery (LM) is based mostly on trials performed with first-generation drug-eluting stents. The aim of this study was to evaluate long-term clinical outcomes after treatment for unprotected LM disease with paclitaxel-eluting stents (PES) and everolimus-eluting stents (EES). The ESTROFA-LM is a multicenter retrospective registry including consecutive patients with unprotected LM disease treated with PES or EES. A total of 770 patients have been included at 21 centers, 415 with treated PES and 355 with EES. Treatment with 2 stents was more frequent with PES (17% vs 10.4%, p = 0.007), whereas intravascular ultrasound was more frequently used with EES (35.2% vs 26%, p = 0.006). The 3-year death and infarction survival rates were 86.1% for PES and 87.3% for EES (p = 0.50) and for death, infarction, and target lesion revascularization were 83.6% versus 82% (p = 0.60), respectively. Definite or probable thrombosis was 1.6% for PES and 1.4% for EES (p = 0.80). The use of 2 stents, age, diabetes, and acute coronary syndromes were independent predictors of mortality. In the subgroup of distal lesions, the use of intravascular ultrasound was an independent predictor of better outcome. Comparison of propensity score-matched groups did not yield differences between the 2 stents. In conclusion, the results of this multicenter registry show comparable safety and efficacy at 3 years for PES and EES in the treatment of LM disease. The use of bifurcation stenting techniques in distal lesions was a relevant independent predictor for events. The use of intravascular ultrasound appears to have a positive impact on patients treated for LM distal disease.

Introduction and objectives We sought to compare the long-term clinical outcome of with ST-segment elevation myocardial infarction treated with paclitaxel-eluting stents or everolimus-eluting stents and the influence of thrombectomy on outcomes. Methods The ESTROFA-IM is a multicenter retrospective registry collecting consecutive patients with infarction treated with these stents in 16 centers. Propensity-score matching was performed to select comparable stent groups and comparable groups with and without thrombectomy. Results After matching patients, 350 treated with everolimus-eluting stents and 350 with paclitaxel-eluting stents were included in the analysis. The clinical and angiographic characteristics were comparable in both groups. The 2-year incidence of death, infarction, and target lesion revascularization was 14.9% for paclitaxel-eluting stents and 11.5% for everolimus-eluting stents (P = .04) and the incidence of definite/probable thrombosis 4.3% and 1.4%, respectively (P = .01). The use of paclitaxel-eluting was an independent predictor for events (hazard ratio = 2.44, 95% confidence interval, 1.28-4.65; P = .006). The benefit of everolimus-eluting stents over paclitaxel-eluting stents regarding stent thrombosis was more evident in the nonthrombectomy subgroup (5.4% vs 1.4%; P = .01). A significant interaction was found in the subgroups with and without thombectomy in the comparison between paclitaxel-eluting stents and everolimus-eluting stents for the end-point of stent thrombosis (P = .039). Conclusions The results of this multicenter registry suggest better clinical outcomes with the everolimus-eluting stents in ST-segment elevation myocardial infarction. The lower risk of thrombosis with these stents could be more relevant in the absence of thrombectomy.

Clinical Impact of IVUS-guided Left Main PCI: Insights from the Multicenter Study ESTROFA-LM. Fernando Alfonso, Jose Maria De La Torre Hernandez, Angel Sanchez Recalde, Manuel F. Jimenez Navarro, Armando Perez De Prado, Felipe Hernandez, Omar Abdul-Jawad Altisent, Gerard Roura, Tamara Garcia Camarero, Jaime Elizaga, Fernando Rivero, Federico Gimeno, Ramon Calvio, Jose Moreu, Francisco Bosa, Jose Ramon Rumoroso, Juan A. Bullones, Arsenio Gallardo, Jose A. Fernandez Diaz, Jose R. Ruiz Arroyo, Victor Aragon, Monica Masotti. Hospital Universitario Marques de Valdecilla, Santander, Spain; Hospital Clinico San Carlos, Madrid, Spain; Hospital La Paz, Madrid, Spain; Hospital Virgen de la Victoria, Malaga, Spain; Hospital de Leon, Leon, Spain; Hospital 12 de Octubre, Madrid, Spain; Hospital Vall d’Hebron, Barcelona, Spain; Hospital Bellvitge, Barcelona, Spain; Hospital Gregorio Maranon, Madrid, Spain; Hospital La Princesa, Madrid, Spain; Hospital de Valladolid, Valladolid, Spain; Hospital de la Corua. CHUAC, La Corua, Spain; Hospital Virgen de la Salud, Toledo, Spain; Hospital Clinico de Tenerife, Santa Cruz de Tenerife, Spain; Hospital de Galdakano, Bilbao, Spain; Hospital Carlos Haya, Malaga, Spain; Hospital de Albacete, Albacete, Spain; Hospital Puerta de Hierro, Madrid, Spain; Hospital Clinico Lozano Blesa, Zaragoza, Spain; Hospital de Jaen, Jaen, Spain; Hospital Clinic, Barcelona, Spain. Background: Percutaneous revascularization of left main coronary artery (LMCA) lesions with drug eluting stent (DES) is an alternative to surgery in high risk patients and in those cases with non severe coronary disease. Whether the use of intravascular ultrasound (IVUS) during the procedure adds a clinical benefit remains unclear. There is only one single study (MAIN COMPARE) that supports this statement. Therefore we sought to investigate the clinical impact of the use of IVUS in this setting. Methods: From a retrospective multicenter study that compared different DES in the setting of left main we have analyzed the clinical impact of the use of IVUS. Consecutive patients from 21 different hospitals with leftmain lesions treatedwithDESwere included. A systematic follow upwas performed. A propensity scorematchingmethodwas used to obtain matched pairs of patients with and without IVUS guidance during DES implantation in LMCA. Results: A total of 770 pts were included in the registry. IVUS was used in 233 cases (30.2%) and not used in 537 pts. After a three years follow up period the use of two stents, age, diabetes and acute coronary syndrome were found independent predictors of events in the global group after a Cox analysis. In the subgroup of 409 (53.1%) patients with distal left main lesions the independent predictors were the use of two stents, age, diabetes and the use of IVUS, being the latest a protective predictor (HR 0.5, IC 95% 0.23-0.99; p1⁄40.04). After propensity score matching 200 matched pairs of patients treated with DES in LMCA with and without IVUS were included in the analysis. Among these, 80 and 85 pts in each group respectively were treated in distal LM lesions. The data for survival free of events at 3 years are shown in table: No IVUS N1⁄4200 IVUS N1⁄4200 p Cardiac death, MI and TLR 86.7% 90.2% 0.9 Cardiac death and MI 89.2% 94.7% 0.6 TLR 97.3% 94% 0.4 Distal lesions No IVUS n[85 IVUS n[80 Cardiac death, MI and TLR 82% 94.4% 0.08 Cardiac death and MI 84% 95.7% 0.09 TLR 97.5% 95.7% 0.9 The American Journal of Cardiology APRIL 23e26, 2013 AN Conclusion: The results of this multicenter registry suggest a potential clinical benefit derived from IVUS-guided PCI with DES in distal left main lesions.