Prospective application of a bleeding and ischemic risks-adjusted antithrombotic protocol in elderly patients revascularized with everolimus-eluting stents: EPIC05-Sierra75 study.

OBJECTIVES: Elderly patients show a higher incidence of ischemic and bleeding events after percutaneous transluminal coronary intervention (PCI). We sought to investigate outcomes in elderly patients treated with antithrombotic strategy guided by bleeding and ischemic risks after revascularization with last generation everolimus-eluting stent (EES). METHODS: Prospective multicenter registry including patients over 75 years revascularized with EES and antithrombotic therapy guided by clinical presentation, PCI complexity and PRECISE DAPT score. Co-primary safety endpoints were: (1) composite of cardiac death, myocardial infarction and stent thrombosis and; (2) bleeding (BARC 2-5). Primary efficacy endpoint was target lesion revascularization. A matched group of patients revascularized with current drug-eluting stents and no such tailored antithrombotic therapy was used as control. RESULTS: Finally, 1064 patients were included in SIERRA-75 cohort, 80.8 ± 4.2 years, 36.6% women, 71% acute coronary syndromes (ACS) and 53.6% complex PCI. Co-primary safety endpoint of major adverse cardiovascular events was met in 6.2%, co-primary safety endpoint of bleeding in 7.8% and primary efficacy endpoint of TKLR in 1.5%. The multivariable adjusted model showed no significant association of the prescribed short/long dual antiplatelet therapy (DAPT) durations with any endpoint suggesting a well tailored therapy. No stent thrombosis reported in the subgroup with 1-3 months DAPT duration. As compared to control group, bleeding BARC 2-5 was significantly lower in SIERRA-75 group (7.4% vs. 10.2%, P = 0.04) as well as the net safety-efficacy endpoint (14.3% vs. 18.5%, P = 0.02). CONCLUSIONS: In elderly population, the application of this risks-adjusted antithrombotic protocol after revascularization with last generation EES seems to be associated with an improved prognosis in terms of ischemic and bleeding outcomes.

Baseline Risk Stratification of Patients Older Than 75 Years With Infarction and Cardiogenic Shock Undergoing Primary Angioplasty.

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 fraction<40% (HR 2.3, 95%CI, 1.14-4.50 P=.018), and time from symptom onset to angioplasty >6hours (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 fraction<40%, and delay time >6 hours) may be used to estimate survival after primary angioplasty in elderly patients with cardiogenic shock and to guide preinterventional decision-making.

Safety and Feasibility of Outpatient Percutaneous Coronary Intervention in Selected Patients: A Spanish Multicenter Registry.

INTRODUCTION AND OBJECTIVES: The exponential increase in coronary interventions plus the generalization of the radial approach represent the ideal scenario for starting outpatient angioplasty programs with the aim of reducing the costs while maintaining safety. This article reports data from a multicenter Spanish registry on fully ambulatory transradial angioplasty in selected patients for the first time. METHODS: Prospective registry of elective outpatient transradial-ulnar angioplasty in patients with stable coronary disease. Patients were discharged the same day and were followed up at 24hours and 30 days. Safety and feasibility were analyzed. RESULTS: Of the 723 patients included (76% male; age, 66.6±10.5 years), 533 (73.7%) were finally discharged after 4 to 12hours of surveillance. Among the remaining 190 (26.7%) patients, the most common reason for hospitalization was clinical instability after the procedure (60.5%). Independent predictors of admission were a history of peripheral artery disease, a higher baseline creatinine level, ad hoc performance of the procedure, and multivessel disease. At 24hours, there was 1 major adverse event in 1 patient (0.19%), who required hospitalization for major bleeding not related to vascular access. At 30 days, there were 3 major adverse events (0.56%): 1 subacute stent thrombosis, 1 revascularization of a vessel other than the treated vessel, and 1 minor stroke. Eight patients (1.5%) required admission at 30 days. CONCLUSIONS: The application of an outpatient transradial-ulnar angioplasty program with discharge after 4 to 12 hours' surveillance is safe and feasible in well-selected patients.

Primary Angioplasty in Patients Older Than 75 Years. Profile of Patients and Procedures, Outcomes, and Predictors of Prognosis in the ESTROFA IM+75 Registry.

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>6hours 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 of 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>6hours, 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.

Seguridad y factibilidad de la intervención coronaria percutánea ambulatoria en pacientes seleccionados: datos de un registro multicéntrico español / Safety and feasibility of outpatient percutaneous coronary intervention in selected patients: a Spanish multicenter registry

Introducción y objetivos: El aumento exponencial de la intervención coronaria y la generalización del acceso radial son el escenario ideal para iniciar programas de angioplastia ambulatoria con el objetivo de disminuir ocupación y reducir el coste manteniendo la seguridad. Se presentan por primera vez datos de un registro multicéntrico español sobre angioplastia transradial ambulatoria en pacientes seleccionados. Métodos: Registro prospectivo de angioplastia ambulatoria electiva con acceso radial-cubital en pacientes con cardiopatía isquémica estable. Los pacientes eran dados de alta el mismo día y se realizó seguimiento a las 24 h y a los 30 días. Se analizan la seguridad y la factibilidad. Resultados: De un total de 723 pacientes incluidos (el 76% varones; edad, 66,6 ± 10,5 años), a 533 (73,7%) se les dio finalmente el alta tras 4-12 h de vigilancia. El motivo más frecuente de ingreso entre los 190 (26,7%) restantes fue inestabilidad clínica tras el procedimiento (60,5%). El antecedente de arteriopatía periférica, un valor de creatinina basal más elevado, la realización del procedimiento ad hoc y sobre enfermedad multivaso fueron predictores independientes de ingreso. A las 24 h se registró un evento adverso mayor (0,19%) en 1 paciente que necesitó ingreso por hemorragia mayor no relacionada con el acceso vascular. A los 30 días se registraron 3 eventos mayores (0,56%), 1 trombosis subaguda de stent, 1 revascularización sobre un vaso diferente del tratado y 1 ictus minor. A los 30 días habían necesitado ingreso 8 pacientes (1,5%). Conclusiones: La aplicación de un programa de angioplastia ambulatoria transradial-cubital con alta tras 4-12 h de vigilancia es factible y segura en pacientes apropiadamente seleccionados (AU)

Introduction and objectives: The exponential increase in coronary interventions plus the generalization of the radial approach represent the ideal scenario for starting outpatient angioplasty programs with the aim of reducing the costs while maintaining safety. This article reports data from a multicenter Spanish registry on fully ambulatory transradial angioplasty in selected patients for the first time. Methods: Prospective registry of elective outpatient transradial-ulnar angioplasty in patients with stable coronary disease. Patients were discharged the same day and were followed up at 24 hours and 30 days. Safety and feasibility were analyzed. Results: Of the 723 patients included (76% male; age, 66.6 ± 10.5 years), 533 (73.7%) were finally discharged after 4 to 12 hours of surveillance. Among the remaining 190 (26.7%) patients, the most common reason for hospitalization was clinical instability after the procedure (60.5%). Independent predictors of admission were a history of peripheral artery disease, a higher baseline creatinine level, ad hoc performance of the procedure, and multivessel disease. At 24 hours, there was 1 major adverse event in 1 patient (0.19%), who required hospitalization for major bleeding not related to vascular access. At 30 days, there were 3 major adverse events (0.56%): 1 subacute stent thrombosis, 1 revascularization of a vessel other than the treated vessel, and 1 minor stroke. Eight patients (1.5%) required admission at 30 days. Conclusions: The application of an outpatient transradial-ulnar angioplasty program with discharge after 4 to 12 hours’ surveillance is safe and feasible in well-selected patients (AU)

Angioplastia primaria en mayores de 75 años. Perfil de pacientes y procedimientos, resultados y predictores pronósticos en el registro ESTROFA IM + 75 / Primary angioplasty in patients older than 75 years. profile of patients and procedures, outcomes, and predictors of prognosis in the ESTROFA IM + 75 registry

Introducción y objetivos: La proporción de pacientes de edad avanzada que se someten a angioplastia primaria está creciendo. Este estudio describe el perfil clínico, las características de los procedimientos, la evolución y los predictores pronósticos. Métodos: Registro en 31 centros de pacientes consecutivos mayores de 75 años tratados con angioplastia primaria. Se recogieron variables clínicas y del procedimiento y se efectuó seguimiento clínico. Resultados: Se incluyó 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 más de 6 h de dolor). El 55,4% presentaba enfermedad multivaso y al 24,8% se les trató además lesiones no culpables. Se utilizó vía radial en el 56,4%, bivalirudina en el 11,8%, aspiración 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 años, del 14,7%. A los 2 años la trombosis definitiva o probable era del 3,1%; la revascularización de lesión tratada, del 2,3% y las hemorragias BARC > 2, del 4,2%. Los predictores pronósticos fueron: diabetes mellitus, insuficiencia renal, fibrilación auricular, retraso > 6 h, fracción de eyección < 45%, clase Killip III-IV, vía radial, bivalirudina, stents farmacoactivos, flujo final TIMI III y revascularización incompleta al alta. Conclusiones: En este registro destaca el frecuente retraso en la presentación 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 vía radial, la bivalirudina, los stents farmacoactivos y la revascularización completa antes del alta (AU)

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 of 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 (AU)

Estratificación basal de riesgo en pacientes mayores de 75 años con infarto y shock cardiogénico referidos para angioplastia primaria / Baseline risk stratification of patients older than 75 years with infarction and cardiogenic shock undergoing primary angioplasty

Introducción y objetivos: Los pacientes mayores de 75 años con infarto agudo de miocardio con elevación del segmento ST sometidos a angioplastia primaria en situación de shock cardiogénico sufren una gran mortalidad. La identificación previa al procedimento de variables predictoras de la posterior mortalidad sería muy útil para guiar la toma de decisiones. Métodos: Análisis del registro multicéntrico de angioplastia primaria en pacientes mayores de 75 años (ESTROFA MI+75), que incluye a 3.576 pacientes. Se analizaron las características y la evolución clínica del subgrupo con shock cardiogénico para identificar predictores de supervivencia a 1 año tras la angioplastia y elaborar un índice pronóstico. Se validó el índice en una cohorte independiente. Resultados: Se incluyó a 332 pacientes. Los predictores basales independientes fueron: la localización anterior (HR=2,8; IC95%, 1,4-6,0; p=0,005), una fracción de eyección<40% (HR=2,3; IC95%, 1,14-4,50; p=0,018) y un tiempo entre el inicio de los síntomas y la angioplastia >6 h (HR=3,2; IC95%, 1,6-7,5; p=0,001). Se diseñó un índice basado en estas variables (índice «6-ANT-40»). La supervivencia a 1 año fue del 54,5% de aquellos con índice 0, el 32,3% con índice 1, el 27,4% con índice 2 y el 17% con índice 3 (p=0,004, estadístico C=0,70). En una cohorte independiente de 124 pacientes, las supervivencias a 1 año fueron del 64,5, el 40,0, el 28,9 y el 22,2% respectivamente (p=0,008; estadístico C=0,68). Conclusiones: Un índice basado en simples variables clínicas previas al procedimiento (localización anterior, fracción de eyección<40%, demora >6 h) permite estimar la supervivencia tras una angioplastia primaria de los pacientes mayores con shock cardiogénico, y así ayudar en la toma de decisiones

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 fraction<40% (HR 2.3, 95%CI, 1.14-4.50; P=.018), and time from symptom onset to angioplasty >6hours (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 fraction<40%, and delay time >6 hours) may be used to estimate survival after primary angioplasty in elderly patients with cardiogenic shock and to guide preinterventional decision-making

Síndrome metabólico, diabetes y enfermedad coronaria: una relación muy frecuente / Metabolic syndrome, diabetes, and coronary artery disease: a very common association

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Falsa determinación de troponina T en el contexto de enfermedades inmunológicas / Erroneus troponin T determination in immune diseases

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