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AIM: Patients with diabetes mellitus are at high risk of adverse events after percutaneous revascularization, with no differences in outcomes between most contemporary drug-eluting stents. The Cre8 EVO stent releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells, and has shown clinical benefits in diabetes. We aimed to compare Cre8 EVO stents to Resolute Onyx stents (a contemporary polymer-based zotarolimus-eluting stent) in patients with diabetes. METHODS AND RESULTS: We did an investigator-initiated, randomized, controlled, assessor-blinded trial at 23 sites in Spain. Eligible patients had diabetes and required percutaneous coronary intervention. A total of 1175 patients were randomly assigned (1:1) to receive Cre8 EVO or Resolute Onyx stents. The primary endpoint was target-lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization at 1-year follow-up. The trial had a non-inferiority design with a 4% margin for the primary endpoint. A superiority analysis was planned if non-inferiority was confirmed. There were 106 primary events, 42 (7.2%) in the Cre8 EVO group and 64 (10.9%) in the Resolute Onyx group [hazard ratio (HR): 0.65, 95% confidence interval (CI): 0.44-0.96; Pnon-inferiority < 0.001; Psuperiority = 0.030]. Among the secondary endpoints, Cre8 EVO stents had significantly lower rate than Resolute Onyx stents of target-vessel failure (7.5% vs. 11.1%, HR: 0.67, 95% CI: 0.46-0.99; P = 0.042). Probable or definite stent thrombosis and all-cause death were not significantly different between groups. CONCLUSION: In patients with diabetes, Cre8 EVO stents were non-inferior to Resolute Onyx stents with regard to target-lesion failure composite outcome. An exploratory analysis for superiority at 1 year suggests that the Cre8 EVO stents might be superior to Resolute Onyx stents with regard to the same outcome. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT03321032.

BACKGROUND: Obesity has been described as a protective factor in cardiovascular and other diseases being expressed as 'obesity paradox'. However, the impact of obesity on clinical outcomes including mortality in COVID-19 has been poorly systematically investigated until now. We aimed to compare clinical outcomes among COVID-19 patients divided into three groups according to the body mass index (BMI). METHODS: We retrospectively collected data up to May 31st, 2020. 3635 patients were divided into three groups of BMI (30 kg/m2; n = 1061). Demographic, in-hospital complications, and predictors for mortality, respiratory insufficiency, and sepsis were analyzed. RESULTS: The rate of respiratory insufficiency was more recorded in BMI 25-30 kg/m2 as compared to BMI < 25 kg/m2 (22.8% vs. 41.8%; p < 0.001), and in BMI > 30 kg/m2 than BMI < 25 kg/m2, respectively (22.8% vs. 35.4%; p < 0.001). Sepsis was more observed in BMI 25-30 kg/m2 and BMI > 30 kg/m2 as compared to BMI < 25 kg/m2, respectively (25.1% vs. 42.5%; p = 0.02) and (25.1% vs. 32.5%; p = 0.006). The mortality rate was higher in BMI 25-30 kg/m2 and BMI > 30 kg/m2 as compared to BMI < 25 kg/m2, respectively (27.2% vs. 39.2%; p = 0.31) (27.2% vs. 33.5%; p = 0.004). In the Cox multivariate analysis for mortality, BMI < 25 kg/m2 and BMI > 30 kg/m2 did not impact the mortality rate (HR 1.15, 95% CI: 0.889-1.508; p = 0.27) (HR 1.15, 95% CI: 0.893-1.479; p = 0.27). In multivariate logistic regression analyses for respiratory insufficiency and sepsis, BMI < 25 kg/m2 is determined as an independent predictor for reduction of respiratory insufficiency (OR 0.73, 95% CI: 0.538-1.004; p = 0.05). CONCLUSIONS: HOPE COVID-19-Registry revealed no evidence of obesity paradox in patients with COVID-19. However, Obesity was associated with a higher rate of respiratory insufficiency and sepsis but was not determined as an independent predictor for a high mortality.

OBJECTIVES: To identify predictors of poor prognosis in previously healthy young individuals admitted with COVID-19. METHODS: We studied a cohort of patients hospitalized with COVID-19 disease. All patients without comorbidities, no usual treatments and =65years old were selected from an international registry (HOPE-COVID-19, NCT04334291). We focused on baseline variables-symptoms and signs at admission-to analyze risk factors for poor prognosis. The primary endpoint was a composite of major adverse clinical events during hospitalization including mortality, mechanical ventilation, high flow nasal oxygen therapy, prone, sepsis, SIRS, and embolic events. RESULTS: Overall, 773 healthy young patients were included. The primary composite endpoint was observed in 29% (225/773) and the overall mortality rate was 3.6% (28/773). In the combined event group, 75% (168/225) of patients were men and the mean age was 49 (±11) years, whereas in the non-combined event group, the prevalence of male gender was 43% (238/548) and the mean age was 42 (±13) years; p

Background The coronavirus disease 2019 (COVID‐19) shown high morbidity and mortality, particularly in patients with concomitant cardiovascular diseases. Some of these patients are under oral anticoagulation (OAC) at admission but to date, there are no data on the clinical profile, prognosis, and risk factors of such patients during hospitalization for COVID‐19. Design Sub‐analysis of the international ‘real‐world’ HOPE COVID‐19 registry. All patients with prior OAC at hospital admission for COVID‐19 were suitable for the study. All‐cause mortality was the primary endpoint. Results From 1002 patients included, 110 were on OAC (60.9% male, median age of 81.5 [IQR 75‐87] years, median Short‐Form Charlson Comorbidity Index [CCI] of 1 [IQR 1‐3]) at admission, mainly for atrial fibrillation and venous thromboembolism. After propensity score matching, 67.9% of these patients died during hospitalization, which translated into a significantly higher mortality risk compared to patients without prior OAC (HR 1.53, 95% CI 1.08‐2.16). After multivariate Cox regression analysis, respiratory insufficiency during hospitalization (HR 6.02, 95% CI 2.18‐16.62), systemic inflammatory response syndrome (SIRS) during hospitalization (HR 2.29, 95% CI 1.34‐3.91), and the short‐form CCI (HR 1.24, 95% CI 1.03‐1.49) were the main risk factors for mortality in patients on prior OAC. Conclusion Compared to patients without prior OAC, COVID‐19 patients on OAC therapy at hospital admission showed lower survival and higher mortality risk. In these patients on OAC therapy, the prevalence of several comorbidities is high. Respiratory insufficiency and SIRS during hospitalization, as well as higher comorbidity, pointed‐out those anticoagulated patients with increased mortality risk.

Resumen Introduccion y objetivos La enfermedad por coronavirus de 2019 (COVID-19) esta causada por el segundo coronavirus del sindrome respiratorio agudo y grave. La fibrilacion auricular (FA) es comun en situaciones agudas, en las que conlleva mas complicaciones y mortalidad. Metodos Analisis del Registro internacional HOPE (NCT04334291); el objetivo es evaluar la informacion pronostica de FA en pacientes con COVID-19. Se realizo un analisis multivariable y un emparejamiento por puntuacion de propension para evaluar la relacion entre FA y mortalidad. Ademas, se evaluo en estos pacientes el impacto en la mortalidad y los eventos embolicos de la puntuacion CHA2DS2-VASc. Resultados Entre los 6.217 pacientes inscritos en el registro HOPE, 250 tenian FA (4,5%). Los pacientes con FA tenian una mayor prevalencia de factores de riesgo cardiovascular y comorbilidades. Despues del emparejamiento por puntuacion de propension, estas diferencias se atenuaron. A pesar de ello, los pacientes con FA tuvieron una mayor incidencia de complicaciones hospitalarias como insuficiencia cardiaca (el 19,3 frente al 11,6%; p = 0,021) e insuficiencia respiratoria (el 75,9 frente al 62,3%; p = 0,002), asi como una mayor tasa de mortalidad a los 60 dias (el 43,4 frente al 30,9%; p = 0,005). En el analisis multivariado, la FA se asocio de manera independiente con una mayor mortalidad a los 60 dias (hazard ratio = 1,234; IC95%, 1,003-1,519). La puntuacion CHA2DS2-VASC predice de manera aceptable la mortalidad a los 60 dias de los pacientes con COVID-19 (area ROC = 0,748; IC95%, 0,733-0,764), pero no su riesgo embolico (area ROC = 0,411; IC95%, 0,147-0,675). Conclusiones La FA en pacientes con COVID-19 se asocia con mas complicaciones y mayor mortalidad a los 60 dias. La puntuacion CHA2DS2-VASc puede ser un buen marcador de riesgo en pacientes con COVID-19, pero no predice su riesgo embolico.

Background—Chronic liver disease is a known risk factor for perioperative morbidity and mortality in patients undergoing cardiac surgery. Very little data exist about such patients treated with transcatheter aortic valve replacement (TAVR). Our objective was to evaluate early and late clinical outcomes in a large cohort of patients with liver disease undergoing TAVR and to determine predictive factors of mortality among these patients. Methods and Results—This multicenter study collected data from 114 patients with chronic liver disease who underwent TAVR in 12 institutions. Perioperative and long-term outcomes were compared with a cohort of 1118 patients without liver disease after a propensity score–matching analysis (114 matched pairs). In-hospital mortality and vascular and bleeding complications were similar between matched groups. Acute kidney injury was more common in liver disease group (30.8% versus 13.5%; P=0.010). Although cardiovascular mortality was similar between groups (9.4% versus 6.5%; P=0.433) at 2-year follow-up, noncardiac mortality was higher in the liver group (26.4% versus 14.8%; P=0.034). Lower glomerular filtration rate (hazard ratio, 1.10, for each decrease of 5 mL/min in estimated glomerular filtration rate; 95% confidence interval, 1.03–1.17; P=0.005) and Child-Pugh class B or C (hazard ratio, 3.11; 95% confidence interval, 1.47–6.56; P=0.003) were the predictors of mortality in patients with chronic liver disease, with a mortality rate of 83.2% at 2-year follow-up in patients with both factors (estimated glomerular filtration rate

Additional file 1: Appendix. Definitions and outcomes.

Aims To compare primary percutaneous coronary intervention (pPCI) and fibrinolysis in very old patients with ST-segment elevation myocardial infarction (STEMI), in whom head-to-head comparisons between both strategies are scarce. Methods and results Patients ≥75 years old with STEMI

BackgroundTreatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) remains a major challenge.ObjectivesThis study evaluated the comparative efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients presenting with DES-ISR.MethodsThe study design of this multicenter randomized clinical trial assumed superiority of EES for the primary endpoint, in-segment minimal lumen diameter at the 6- to 9-month angiographic follow-up.ResultsA total of 309 patients with DES-ISR from 23 Spanish university hospitals were randomly allocated to DEB (n = 154) or EES (n = 155). At late angiography (median 247 days; 90% of eligible patients), patients in the EES arm had a significantly larger minimal lumen diameter (2.03 ± 0.7 mm vs. 1.80 ± 0.6 mm; p < 0.01) (absolute mean difference: 0.23 mm; 95% CI: 0.07 to 0.38), net lumen gain (1.28 ± 0.7 mm vs. 1.01 ± 0.7 mm; p < 0.01), and lower percent diameter stenosis (23 ± 22% vs. 30 ± 22%; p < 0.01) and binary restenosis rate (11% vs. 19%; p = 0.06), compared with patients in the DEB arm. Consistent results were observed in the in-lesion analysis. At the 1-year clinical follow-up (100% of patients), the main clinical outcome measure (composite of cardiac death, myocardial infarction, and target vessel revascularization) was significantly reduced in the EES arm (10% vs. 18%; p = 0.04; hazard ratio: 0.58; 95% CI: 0.35 to 0.98), mainly driven by a lower need for target vessel revascularization (8% vs. 16%; p = 0.035).ConclusionsIn patients with DES-ISR, EES provided superior long-term clinical and angiographic results compared with DEB. (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent [RIBS IV]; NCT01239940)

ObjectivesThis study sought to compare the efficacy of drug-eluting balloons (DEB) with that of everolimus-eluting stents (EES) in patients with bare-metal stents (BMS) in-stent restenosis (ISR).BackgroundTreatment of patients with ISR remains a challenge.MethodsThis was a prospective, multicenter, randomized trial comparing DEB with EES in patients with bare-metal stents (BMS) in-stent restenosis (ISR). The primary endpoint was the minimal lumen diameter at 9 months' follow-up.ResultsA total of 189 patients with BMS-ISR from 25 Spanish sites were included (95 were allocated to DEB and 94 to EES). Procedural success was achieved in all patients. At late angiography (median 249 days; 92% of eligible patients), patients in the EES arm had a significantly larger minimal lumen diameter (2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm, p

The purpose of this study was to compare the effect of dual antiplatelet therapy [clopidogrel + aspirin (ASA)] with respect to ASA on the protein expression of platelets from controlled type-2 diabetic patients with stable coronary ischemia. Patients had been taking ASA (100 mg day) and they were randomized to receive (n = 29) or not (n = 28) 75 mg day clopidogrel for 12 ± 2 weeks in a blind form. Protein expression was analyzed by two-dimensional electrophoresis and mass spectrometry. The protein expression of a limited number of proteins such as actin-binding protein isotypes 2 and 5, lactate dehydrogenase, serotransferrin isotype 4, protein disulfide isomerase-A3 isotype 1, fibrinogen beta chain isotype 5, Ras-related protein Rab-7b isotypes 1 and 6, and immunoglobulin heavy chain was changed after dual antiplatelet therapy. Plasma level of platelet factor 4 (PF4), an in vivo marker of platelet activity, was not different between both groups. These changes suggest lower platelet reactivity after dual antiplatelet therapy in the studied patients. However, the variation in platelet proteome was lower than it would be initially expected, taking into account the apparent clinical beneficial effects of dual antiplatelet therapy. PF4 plasma level was not further decreased in the platelets treated for a longer time than 9-12 months with ASA + clopidogrel, as compared with ASA alone.

Nieves Gonzalo, Carlos MacayaInterventional Cardiology, Cardiovascular Institute. Hospital Clinico San Carlos, Instituto de Investigación Sanitaria del Hospital Clinico San Carlos, Madrid, SpainAbstract: Coronary stents have improved very significantly the immediate and long-term results of percutaneous coronary interventions. However, once the vessel has healed, the scaffolding function of the stent is no longer needed, and the presence of a permanent metallic prosthesis poses important disadvantages. This has led to the idea of creating new devices that are able to provide mechanical support for a determined period and then disappear from the vessel, allowing its natural healing and avoiding the risks associated with having a permanent metallic cage, such as stent thrombosis. Absorbable stents currently appear as one of the most promising fields in interventional cardiology. The present article will review the available clinical evidence regarding these devices at present and their future perspectives.Keywords: absorbable stent, bioresorbable stent, absorb, percutaneous coronary intervention

Hypertension is a widely prevalent and important risk factor for cardiovascular diseases that increase with aging. The hallmark of hypertension in the elderly is increased vascular dysfunction. However, the molecular mechanisms by which increased blood pressure leads to vascular injury and impaired endothelial function are not well defined. In the present paper, we will analyze several mechanisms described in the scientific literature involved in hypertension in the elderly as endothelial dysfunction, increased oxygen delivery to tissues, inflammation, cellular apoptosis, and increased concentration of active metabolites. Also, we will focus on new molecular mechanisms involved in hypertension such as telomeres shortening, progenitor cells, circulating microparticles, and epigenetic factors that have appeared as possible causes of hypertension in the elderly. These molecular mechanisms may elucidate different origin for hypertension in the elderly and provide us with new targets for hypertension treatment.

Objectives The aim of this study was to investigate the impact of patient and lesion complexity on outcomes with newer-generation zotarolimus-eluting stents (ZES) and everolimus-eluting stents (EES). Background Clinical and angiographic outcomes of newer-generation stents have not been described among complex patients. Methods Patients enrolled in the RESOLUTE All Comers trial (A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention) were stratified into "complex" and "simple." Results Of 2,292 patients, 1,520 (66.3%) were complex and treated with ZES (n = 764) or EES (n = 756). Event rates were higher among complex patients, and results did not differ between ZES and EES, regardless of complexity. At 1 year, target lesion failure was 8.9% in ZES- and 9.7% in EES-treated complex patients (p = 0.66) and 6.8% in ZES- and 5.7% in EES-treated simple patients (p = 0.55). Rates of cardiac death (1.3% vs. 2.2%, p = 0.24), target-vessel myocardial infarction (4.3% vs. 4.4%, p = 0.90), and clinically indicated target lesion revascularization (4.4% vs. 4.0%, p = 0.80) were similar for both stent types among complex patients. Definite or probable stent thrombosis occurred in 20 (1.3%) complex patients with no difference between ZES (1.7%) and EES (0.9%, p = 0.26). Angiographic follow-up showed similar results for ZES and EES in terms of in-stent percentage diameter stenosis (22.2 +/- 15.4% vs. 21.4 +/- 15.8%, p = 0.67) and in-segment binary restenosis (6.6% vs. 8.0%, p = 0.82) in the complex group. Conclusions In this all-comers randomized trial, major adverse cardiovascular events were more frequent among complex than simple patients. The newer-generation ZES and EES proved to be safe and effective, regardless of complexity, with similar clinical and angiographic outcomes for both stent types through 1 year. (RESOLUTE-III All Comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention; NCT00617084) (J Am Coll Cardiol 2011; 57: 2221-32) (C) 2011 by the American College of Cardiology Foundation

Aims: The aim of the current study was to compare the short and mid-term outcome between males and females treated with percutaneous coronary intervention (PCI) with bare metal stent implantation or coronary artery bypass graft (CABG) surgery and drug-eluting stent implantation in the Arterial Revascularisation Therapies Study I and II (ARTS I and II). Methods and Results: The patients included in ARTS I were randomised to PCI with bare metal stents or to CABG. The patients enrolled in ARTS II were treated with Cypher (TM) stent implantation. All patients were scheduled for clinical follow-up at one, six and twelve months, and after three and five years. Major adverse cardiac and cerebrovascular events (MACCE) included death, cerebrovascular accident (CVA), myocardial infarction (MI), repeat target vessel PCI (RPCI) and CABG. At one and three-year follow-up in ARTS II, both the female and male patients had an incidence of MACCE similar to ARTS I-CABG. When comparing the female and male population of ARTS II, there were no differences between the two genders in terms of in-hospital outcome. At one year and three years there were no gender specific differences in the incidence of MACCE. Conclusions: Female and male patients in ARTS II had significantly lower MACCE rates compared with ARTS I-PCI, but similar to that of ARTS I-CABG. In ARTS II, MACCE free survival was similar for the two genders at three years follow-up.

Objectives The purpose of this study was to assess the 3-year outcome of coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI) using sirolimus-eluting stents (SES) in patients who had multivessel coronary artery disease with and without diabetes mellitus. Background The optimal method of revascularization in diabetic patients remains in dispute. Methods The ARTS-II (Arterial Revascularization Therapies Study-Part II) trial is a single-arm study (n = 607) that included 159 diabetic patients treated with SES whose 3-year clinical outcome was compared with that of the historical diabetic and nondiabetic arms of the randomized ARTS-I trial (n = 1,205, including 96 diabetic patients in the CABG arm and 112 in the PCI arm). Results At 3 years, among nondiabetic patients, the incidence of the primary composite of death, CVA, myocardial infarction (MI), and repeat revascularization (major adverse cardiac and cerebrovascular events [MACCE]), was significantly lower in ARTS-II than in ARTS-I PCI (adjusted odds ratio [OR]: 0.41; 95% confidence interval [CI]: 0.26 to 0.64) and similar to ARTS-I CABG. The ARTS-II patients were at significantly lower risk for death, CVA, and MI as compared with both the ARTS-I PCI (adjusted OR: 0.55; 95% CI: 0.34 to 0.91) and ARTS-I CABG patients (adjusted OR: 0.56; 95% CI: 0.35 to 0.92). Among diabetic patients, the incidence of MACCE in ARTS-II was similar to that of both PCI and CABG in ARTS-I. Conversely, the incidence of death, CVA, and MI was significantly lower in ARTS-II than in ARTS-I PCI (adjusted OR: 0.67; 95% CI: 0.27 to 1.65) and was similar to that of ARTS-I CABG. Conclusions At 3 years, PCI using SES for patients with multivessel coronary artery disease seems to be safer and more efficacious than PCI using bare-metal stents, irrespective of the diabetic status of the patient. Hence, PCI using SES appears to be a valuable alternative to CABG for both diabetic and nondiabetic patients. (J Am Coll Cardiol 2008;52:1957-67) (C) 2008 by the American College of Cardiology Foundation

Introducción y objetivos: Actualmente se considera que los hallazgos ecocardiográficos son un componente esencial en el diagnóstico de la endocarditis infecciosa. La ecocardiografía transesofágica es más sensible que el estudio transtorácico para el diagnóstico de la endocarditis infecciosa y sus complicaciones. El objetivo del presente trabajo fue analizar qué factores estaban asociados a una mayor sensibilidad del ecocardiograma transtorácico en el diagnóstico de endocarditis infecciosa. La presencia de dichos factores en un paciente con ecocardiograma transtorácico normal haría poco necesaria la realización de un estudio transesofágico y orientaría al clínico a buscar localidades infecciosas alternativas en localizaciones diferentes al corazón. Métodos: 127 pacientes consecutivos ingresados en el hospital con el diagnóstico de endocarditis infecciosa fueron evaluados, analizándose variables clínicas, microbiológicas, factores de riesgo, datos evolutivos, complicaciones y ventana acústica del ecocardiograma transtorácico. Resultados: En el análisis univariado, la existencia de ventana acústica adecuada, la presencia de un soplo, valvulopatía degenerativa y hemocultivos positivos se asociaban de forma estadísticamente significativa a una mayor incidencia de ecocardiograma transtorácico positivo.Sin embargo, en el análisis multivariado sólo la presencia de soplo (RR 2.724; IC95% 1.071-6.926; p 0.035) y la existencia de una ventana acústica adecuada (RR 5.538; IC95% 2.75- 11.15; p < 0.001) fueron predictores independientes de mayor sensibilidad del estudio transtorácico. Conclusiones: La utilidad diagnóstica del estudio transtorácico es particularmente elevada en aquellos pacientes con presencia de soplo y adecuada ventana acústica. El aumento de la sensibilidad del ecocardiograma transtorácico cuando las imágenes son de buena calidad permite que en pacientes sin prótesis valvular, con baja sospecha clínica y estudio ecocardiográfico transtorácico negativo puedan buscarse focalidades infecciosas alternativas con seguridad.

Objetivo: El objetivo fue evaluar el grado de compromiso de las ramas que son enjauladas durante la implantación directa de stent. Pacientes y métodos: Se estudiaron 56 pacientes en los que se implantó al menos un stent coronario (58 stents) sin dilatación previa con balón y en los que se enjauló alguna rama secundaria. Se evaluó la tasa de pérdida de la rama, el efecto de la implantación del stent sobre el flujo de esta rama y los factores relacionados con estos hechos. Resultados: El vaso principal fue la descendente anterior en el 63%, la circunfleja en el 21%, la coronaria derecha en el 14% y el tronco principal de la coronaria izquierda en un caso. Se obtuvo éxito angiográfico sobre el vaso principal en todos los casos. Antes del procedimiento, el flujo a nivel de la rama secundaria era TIMI grado 3, 2 y 0 en 55 (95%), 2 (3%) y un caso (2%), respectivamente. Tras la implantación del stent, el flujo era TIMI grado 3, 2, 1 y 0 en 50 (86%), 1 (2%), 2 (3%) y 5 (9%) casos, respectivamente (p = 0.204). La incidencia de pérdida de la rama fue 12% (7/58); en un caso, se intentó con éxito recanalizar y dilatar ésta a través de los struts del stent, por lo que la tasa de pérdida de rama final fue 10% (6/ 58). Las ramas que se ocluyeron tenían un mayor grado de estenosis en el origen antes de la implantación del stent (30.2 ± 31.3% vs 16.8 ± 11.1%, p = 0.028). En los pacientes que se reevaluaron angiográficamente, a los 6.2 ±1.9 meses, el 50% de las ramas que se habían ocluido se encontraban permeables, y el 88% de las que no se comprometieron seguían permeables. Conclusiones: La tasa de oclusión de las ramas con la implantación directa de stent fue 12% en nuestra serie, cifra similar a la que ocurre con la implantación de stent tras dilatación con balón. Por tanto, la existencia de ramas localizadas en el segmento en el que va a implantarse el stent no tiene por qué condicionar la decisión o no de realizar una dilatación previa con balón.

ObjectivesWe sought to assess the efficacy of vascular brachytherapy (VBT) combined with stenting for the primary prevention of restenosis.BackgroundIntravascular brachytherapy after stent implantation for de novo lesions has been abandoned for the present. We revisited this procedure by optimizing all procedural steps—the use of glycoprotein IIb/IIIa blockers, direct stenting, adequate radiation coverage, avoidance of edge damage, source centering, intravascular ultrasound-guided dosimetry, and continuation of a dual anti-platelet regimen for one year.MethodsThe Beta-Radiation Investigation with Direct stenting and Galileo in Europe (BRIDGE) study is a multicenter, randomized controlled trial evaluating the long-term efficacy of VBT with P-32 (20 Gy at 1 mm in the coronary wall) after direct stenting. The primary end point was angiographic intra-stent late loss; secondary end points were six months binary restenosis and neo-intimal hyperplasia. Patients (n = 112) with de novo lesions (2.5 to 4.0 mm in diameter up to 15 mm long) were randomized to either VBT or no-VBT.ResultsAt six months, intra-stent loss was 0.43 and 0.84 mm (p < 0.001) in the irradiated and control groups, respectively. Intra-stent neo-intimal volume was reduced from 36 mm3to 10 mm3. However, in the irradiated group there were six late occlusions as well as eight restenoses outside the stented and peri-stented area at the fall-off dose edges of the irradiated area. Accordingly, the target vessel revascularization and major adverse cardiac and cerebrovascular events rates at one year in the VBT group (20.4% and 25.9%, respectively) were higher than in the control group (12.1% and 17.2%, respectively).ConclusionsDespite the optimization of pre-, peri-, and post-procedural factors and despite the relative efficacy of the brachytherapy for the prevention of the intra-stent neo-intimal hyperplasia, the clinical outcome of the irradiated group was less favorable than that of the control group.

Antiplatelet therapy is the cornerstone of treatment for patients with acute coronary syndromes and/or undergoing percutaneous coronary interventions. Clopidogrel, in combination with aspirin, is currently the antiplatelet treatment of choice for prevention of stent thrombosis, and clinical trials have shown that, in high-risk patients, prolonged dual antiplatelet treatment is more effective than aspirin alone in preventing major cardiovascular events. However, despite the use of clopidogrel, a considerable number of patients continue to have cardiovascular events. Numerous in vitro studies have shown that individual responsiveness to clopidogrel is not uniform in all patients and is subject to inter- and intraindividual variability. Notably, there is a growing degree of evidence that recurrence of ischemic complications may be attributed to poor response to clopidogrel. The mechanisms leading to poor clopidogrel effects are not fully elucidated and are likely multifactorial. Although the gold standard definition to assess antiplatelet drug response has not been fully established, there is sufficient evidence to support that persistence of enhanced platelet reactivity despite the use of clopidogrel is a clinically relevant entity. This paper reviews the impact of individual response variability to clopidogrel on clinical outcomes and current and future directions for its management.

ObjectivesWe compared the risk of stent thrombosis (ST) after drug-eluting stents (DES) versus bare-metal stents (BMS), and tested the hypothesis that the risk of DES thrombosis is related to stent length.BackgroundWhether DES increase the risk of ST remains unclear. Given the very low restenosis rate after drug-eluting stenting, longer stents are frequently implanted for the same lesion length in comparison to BMS.MethodsWe included in a meta-analysis 10 randomized studies comparing DES and BMS. Overall, 5,030 patients were included (2,602 were allocated to DES and 2,428 to BMS). The risk of thrombosis after DES versus BMS was compared, and the relationship between the rate of DES thrombosis and stent length was evaluated.ResultsIncidence of ST was not increased in patients receiving DES (0.58% vs. 0.54% for BMS; odds ratio: 1.05; 95% confidence interval [CI]: 0.51 to 2.15; p = 1.000). The overall rate of ST did not differ significantly between patients receiving sirolimus- or paclitaxel-eluting stents (0.57% vs. 0.58%; p = 1.000). We found a significant relation between the rate of ST and the stented length (Y = −1.455 + 0.121 X; 95% CI for beta: 0.014 to 0.227; R = 0.716; p = 0.031). In patients with DES, mean stented length was longer in those suffering ST (23.4 ± 8.1 mm vs. 21.3 ± 4.1 mm, p = 0.025).ConclusionsDrug-eluting stents do not increase the risk of ST, at least under appropriate anti-platelet therapy. The risk of ST after DES implantation is related to stent length.

ObjectivesThe study sought to assess the diagnostic efficiency of optical coherence tomography (OCT) in identifying hemodynamically severe coronary stenoses as determined by fractional flow reserve (FFR). Concomitant OCT and intravascular ultrasound (IVUS) area measurements were performed in a subgroup of patients to compare the diagnostic efficiency of both techniques.BackgroundThe value of OCT to determine stenosis severity remains unsettled.MethodsSixty-one stenoses with intermediate angiographic severity were studied in 56 patients. Stenoses were labeled as severe if FFR ≤0.80. OCT interrogation was performed in all cases, with concomitant IVUS imaging in 47 cases.ResultsAngiographic stenosis severity was 50.9 ± 8% diameter stenosis with 1.28 ± 0.3 mm minimal lumen diameter. FFR was ≤0.80 in 28 (45.9%) stenoses. An overall moderate diagnostic efficiency of OCT was found (area under the curve [AUC]: 0.74; 95% confidence interval [CI]: 0.61 to 0.84), with sensitivity/specificity of 82%/63% associated with an optimal cutoff value of 1.95 mm2. Comparison of the results in patients with simultaneous IVUS and OCT imaging revealed no significant differences in the diagnostic efficiency of OCT (AUC: 0.70; 95% CI: 0.55 to 0.83) and IVUS (AUC. 0.63; 95% CI: 0.47 to 0.77; p = 0.19). Sensitivity/specificity for IVUS was 67%/65% for an optimal cutoff value of 2.36 mm2. In the subgroup of small vessels (reference diameter

ObjectivesA meta-analysis of 11 randomized trials was done to compare stenting versus balloon angioplasty (BA) in small coronary vessels.BackgroundRandomized studies on coronary stenting (CS) in small vessels have yielded controversial results.MethodsEleven randomized trials on CS versus BA in small vessels, including angiographic re-evaluation at six months, were analyzed.ResultsThe BeStent (Medtronic Instent, Minneapolis, Minnesota) was used in four studies, the Multi-Link (Guidant, Advanced Cardiovascular Systems Inc., Santa Clara, California) in three trials, and the NIR (Boston Scientific Corp., Boston, Massachusetts), JoStent (Jomed International AB, Helsingborg, Sweden), Tenax (Biotronik, Berlin, Germany), and BioDivysio (Abbott Vascular Devices, Redwood City, California) in the remaining four trials. Overall, 3,541 patients were included (1,672 allocated to BA and 1,869 to stent). The rate of cross-over from balloon to stent in the pooled population was 19%, and unsuccessful stent deployment occurred in 2% of the patients allocated to stent. The pooled rates of restenosis were 25.8% and 34.2% in patients allocated to stent and balloon, respectively (p = 0.003) (risk ratio [RR] 0.77; 95% confidence interval [CI] 0.65 to 0.92). A smaller reference vessel diameter at baseline was associated with a higher risk reduction in the restenosis rate (y = −3.551 + 1.826 [x]; p = 0.012). Patients allocated to stent had lower rates of major adverse cardiac events (15.0% vs. 21.8%, p = 0.002; RR 0.70; 95% CI 0.57 to 0.87) and new target vessel revascularizations (12.5% vs. 17.0%, p = 0.004; RR 0.75, 95% CI 0.61 to 0.91).ConclusionsElective stenting is superior to provisional stenting in small coronary arteries. This benefit is more evident in smaller coronary arteries.

BackgroundIt is widely accepted that edema occurs early in the ischemic zone and persists in stable form for at least 1 week after myocardial ischemia/reperfusion. However, there are no longitudinal studies covering from very early (minutes) to late (1 week) reperfusion stages confirming this phenomenon.ObjectivesThis study sought to perform a comprehensive longitudinal imaging and histological characterization of the edematous reaction after experimental myocardial ischemia/reperfusion.MethodsThe study population consisted of 25 instrumented Large-White pigs (30 kg to 40 kg). Closed-chest 40-min ischemia/reperfusion was performed in 20 pigs, which were sacrificed at 120 min (n = 5), 24 h (n = 5), 4 days (n = 5), and 7 days (n = 5) after reperfusion and processed for histological quantification of myocardial water content. Cardiac magnetic resonance (CMR) scans with T2-weighted short-tau inversion recovery and T2-mapping sequences were performed at every follow-up stage until sacrifice. Five additional pigs sacrificed after baseline CMR served as controls.ResultsIn all pigs, reperfusion was associated with a significant increase in T2 relaxation times in the ischemic region. On 24-h CMR, ischemic myocardium T2 times returned to normal values (similar to those seen pre-infarction). Thereafter, ischemic myocardium-T2 times in CMR performed on days 4 and 7 after reperfusion progressively and systematically increased. On day 7 CMR, T2 relaxation times were as high as those observed at reperfusion. Myocardial water content analysis in the ischemic region showed a parallel bimodal pattern: 2 high water content peaks at reperfusion and at day 7, and a significant decrease at 24 h.ConclusionsContrary to the accepted view, myocardial edema during the first week after ischemia/reperfusion follows a bimodal pattern. The initial wave appears abruptly upon reperfusion and dissipates at 24 h. Conversely, the deferred wave of edema appears progressively days after ischemia/reperfusion and is maximal around day 7 after reperfusion.

ObjectivesWe studied the efficacy of intracoronary brachytherapy (ICB) after successful coronary stenting in diabetic patients with de novo lesions.BackgroundIntracoronary brachytherapy has proven effective in preventing recurrences in patients with in-stent restenosis. However, the role of ICB for the treatment of de novo coronary stenoses remains controversial.MethodsNinety-two patients were randomized to either ICB or no radiation after stenting. Primary end points were in-stent mean neointimal area (primary end point of efficacy) and minimal luminal area of the entire vessel segment (primary end point of effectiveness), as assessed by intravascular ultrasound at six-month follow-up. Quantitative coronary angiography analysis was performed at the target, injured, irradiated, and entire vessel segments.ResultsAt follow-up, the in-stent mean neointimal area was 52% smaller in the ICB group (p < 0.0001). However, there was no difference in the minimal luminal area of the vessel segment (4.5 ± 2.4 mm2vs. 4.4 ± 2.1 mm2). Restenosis rates increased progressively by the analyzed segment in the ICB group: target (7.1% vs. 20.9%, p = 0.07), injured (9.5% vs. 20.9%, p = NS), irradiated (14.3% vs. 20.9%, p = NS), and vessel segment (23.8% vs. 25.6%, p = NS). At one year, 1 cardiac death, 6 myocardial infarctions (MIs) (3 due to late stent thrombosis), and 10 target vessel revascularizations (TVRs) (6 due to the edge effect) occurred in the ICB group, whereas in the nonradiation group, there were 11 TVRs and no deaths or MIs.ConclusionsIntracoronary brachytherapy significantly inhibited in-stent neointimal hyperplasia after stenting in diabetic patients. However, clinically this was counteracted by the occurrence of the edge effect and late stent thrombosis.

ObjectivesThis study sought to assess the long-term clinical outcome of patients with spontaneous coronary artery dissection (SCD) managed with a conservative strategy.BackgroundSCD is a rare, but challenging, clinical entity.MethodsA prospective protocol, including a conservative management strategy, was followed. Revascularization was only considered in cases with ongoing/recurrent ischemia. Inflammatory/immunologic markers were systematically obtained.ResultsForty-five consecutive patients (incidence 0.27%) were studied during a 6-year period. Of these, 27 patients (60%) had “isolated” SCD (I-SCD), and 18 had SCD associated with coronary artery disease (A-SCD). Age was 53 ± 11 years, and 26 patients were female. Most patients presented with an acute myocardial infarction. SCD had a diffuse angiographic pattern (length: 31 ± 23 mm). In 11 patients, the diagnosis was confirmed by intracoronary imaging techniques. Sixteen patients (35%) required revascularization during initial admission. One patient died after surgery, but no additional patient experienced recurrent myocardial infarction. No significant inflammatory/immunologic abnormalities were detected. At follow-up (median 730 days), only 3 patients presented with adverse events (1 died of congestive heart failure, and 2 required revascularization). No patient experienced a myocardial infarction or died suddenly. Event-free survival was similar (94% and 88%, respectively) in patients with I-SCD and A-SCD. Notably, at angiographic follow-up, spontaneous “disappearance” of the SCD image was found in 7 of 13 (54%) patients.ConclusionsIn this large prospective series of consecutive patients with SCD, a “conservative” therapeutic strategy provided excellent long-term prognosis. Clinical outcome was similar in patients with I-SCD and A-SCD. The natural history of SCD includes spontaneous healing with complete resolution.

ObjectivesThe goal of this trial was to study the long-term effects of intravenous (IV) metoprolol administration before reperfusion on left ventricular (LV) function and clinical events.BackgroundEarly IV metoprolol during ST-segment elevation myocardial infarction (STEMI) has been shown to reduce infarct size when used in conjunction with primary percutaneous coronary intervention (pPCI).MethodsThe METOCARD-CNIC (Effect of Metoprolol in Cardioprotection During an Acute Myocardial Infarction) trial recruited 270 patients with Killip class ≤II anterior STEMI presenting early after symptom onset (

BackgroundThe prospective, randomized FREEDOM (Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes) trial found coronary artery bypass graft surgery (CABG) was associated with better clinical outcomes than percutaneous coronary intervention (PCI) in patients with diabetes and multivessel disease, managed with or without insulin.ObjectivesIn this subgroup analysis of the FREEDOM trial, we examined the association of long-term clinical outcomes after revascularization in patients with insulin-treated diabetes mellitus (ITDM) compared with patients not treated with insulin.MethodsA total of 1,850 FREEDOM subjects had an index revascularization procedure performed: 956 underwent PCI with drug-eluting stents (DES), and 894 underwent CABG. A total of 602 patients (32.5%) had ITDM (PCI/DES n = 325, 34%; CABG n = 277, 31%). Subjects were classified according to ITDM versus non-ITDM, with comparison of PCI/DES versus CABG for each group. Interaction analyses were performed for treatment by diabetes mellitus (DM) status alone and for treatment by DM status by coronary lesion complexity. Analyses were performed for the primary outcome composite of death/stroke/myocardial infarction (MI) using all available follow-up data.ResultsThe overall 5-year event rate of death/stroke/MI was significantly higher in ITDM versus non-ITDM patients (28.7% vs. 19.5%, p < 0.001), which persisted even after adjustment for multiple baseline factors, angiographic complexity, and revascularization treatment group (death/stroke/MI hazard ratio [HR]: 1.35, 95% confidence interval [CI]: 1.06 to 1.73, p = 0.014). With respect to the primary composite endpoint, CABG was superior to PCI/DES in both DM types and the magnitude of treatment effect was similar (interaction p = 0.40) for ITDM (PCI vs. CABG HR: 1.21; 95% CI: 0.87 to 1.69) and non-ITDM patients (PCI vs. CABG HR: 1.46; 95% CI 1.10 to 1.94), even after adjusting for the angiographic SYNTAX score level. Based on 5-year event rates, the number needed to treat with CABG versus PCI to prevent 1 event is 12.7 in ITDM and 13.2 in non-ITDM.ConclusionsIn patients with diabetes and multivessel coronary artery disease, the rate of major adverse cardiovascular events (death, MI, or stroke) is higher in patients treated with insulin than in those not treated with insulin. Furthermore, we did not detect a significant difference in the magnitude of PCI versus CABG treatment effect for patients treated with insulin and those not treated with insulin. (Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes [FREEDOM]; NCT00086450).

ObjectivesThe aim of this research was to evaluate the plaque prolapse (PP) phenomenon after bare-metal (BMS) and drug-eluting stent (DES) implantation in patients with diabetes mellitus using 3-dimensional volumetric intravascular ultrasound (IVUS).BackgroundPlaque prolapse has been observed in up to 22% of patients treated with BMS. Diabetic patients have a larger atherothrombotic burden and may be more prone to have PP. However, the incidence of PP and its clinical impact after DES implantation is unknown.MethodsThree-dimensional IVUS was performed after intervention and at 9-month follow-up in 168 patients with diabetes (205 lesions) treated with bare BX Velocity stents ((BX Velocity/Sonic, Cordis, Johnson & Johnson) (BMS, n = 65), sirolimus-eluting stents (Cypher, Cordis) (SES, n = 69), and paclitaxel-eluting stents (Taxus, Boston Scientific, Natick, Massachusetts) (PES, n = 71). Intravascular ultrasound data at the sites of PP were compared with stented segments without PP in each lesion. Outcomes were evaluated at 9- and 12-month follow-up.ResultsThere were 42 sites of PP (BMS = 11, SES = 11, PES = 20, p = NS) in 34 stented segments of 205 (16.6%) lesions. Plaque prolapse was more frequent in the right coronary artery and in chronic total occlusion lesions. Post-procedure PP volume was 1.95 mm3in BMS, 2.96 mm3in SES, and 4.53 mm3in PES. At follow-up, tissue volume increased at PP sites in both BMS and PES, but not after SES. Neointimal proliferation was similar between PP and non-PP sites. Stent thrombosis and restenosis rates were similar between PP and non-PP lesions.ConclusionsThe incidence of PP after implantation of new generation tubular stents in patients with diabetes remains high. Drug-eluting stent implantation was not associated with increased risk of PP. Plaque prolapse was not associated with stent thrombosis or increased neointimal proliferation.

OBJECTIVESThis study sought to investigate the influence of stent design on the long-term angiographic outcome.BACKGROUNDThe proportional relationship between vessel injury and late luminal loss in percutaneous revascularization should be best appreciated in coronary stenting, where recoil and shrinkage are theoretically minimal. It is unclear whether all stent designs can counterbalance this reactive loss by achieving a large initial luminal gain (bigger is better).METHODSIn 523 lesions successfully stented, the long-term angiographic results of slotted-tube (n = 331), coil (n = 85), multicellular (n = 70) and self-expandable mesh (n = 37) stent designs were compared using the angiographic gain-loss relationship (GLR).RESULTSRestenosis rate was 10% for multicellular, 20% for slotted-tube, 46% for coil and 49% for self-expandable designs (p = 0.001). At a difference with other designs, no significant GLR was found in coil stents, suggesting additional mechanisms of luminal loss (i.e., plaque protrusion, stent compression) to neointimal proliferation. Significant differences in late loss between stents were found within each quartile of luminal gain, suggesting a specific role of design in luminal loss. Multivariate analysis identified use of coil and self-expandable stents, vessel size, minimal luminal diameter preintervention, luminal gain and stent length as variables with independent predictive value for several indices of angiographic long-term outcome.CONCLUSIONSThe analysis of GLR: 1) demonstrates that stent design influences late luminal loss; 2) challenges the applicability of the widely accepted “bigger is better” approach to all stent designs; and 3) appears as a valuable tool in assessing long-term stent performance.

ObjectivesA predefined intravascular ultrasound (IVUS) substudy was performed to evaluate the vascular effects of sirolimus-eluting stent (SES) versus bare-metal stent (BMS).BackgroundThe Diabetes and Sirolimus-Eluting Stent (DIABETES) trial is a prospective, multicenter, randomized, controlled trial aimed at demonstrating the efficacy of the SES compared with BMS in diabetic patients.MethodsSerial intravascular ultrasound analyses were performed in 140 lesions (SES = 75; BMS = 65) immediately after stent implantation and at nine-month follow-up. Vessel, luminal, and stent mean areas and volumes were evaluated at both edges and within the stented segment. Qualitative assessment of residual dissections and stent apposition were also performed.ResultsBaseline clinical and angiographic characteristics were similar between groups. At 9 months, in-stent neointimal hyperplasia (NIH) mean area and volume were significantly reduced in the SES group (median NIH area 0.01 mm2[0.0 to 0.1] vs. 2.0 mm2[1.0 to 2.9] and median NIH volume 0.11 mm3[0 to 2.1] vs. 35.3 mm3[16.6 to 62.6]; both p < 0.0001). In the SES group, stent edges evidenced significant increase in lumen dimensions mainly due to significant increase in vessel volume, whereas those of the BMS group presented vessel shrinkage leading to significant lumen reduction. Late acquired incomplete stent apposition was observed in 11 lesions (14.7%) in the SES group and 0 in the BMS group (p = 0.001). At one year, no stent thromboses occurred in malapposed stents.ConclusionsThe SES implantation effectively inhibits NIH in diabetic patients. The antirestenotic effect of SES is also appreciated at the stent edges. Late acquired stent malapposition is a frequent phenomenon in diabetic patients treated with SES.

Significant mitral regurgitation (MR) is frequent in patients with severe aortic stenosis (AS). In these cases, concomitant mitral valve repair or replacement is usually performed at the time of surgical aortic valve replacement (SAVR). Transcatheter aortic valve replacement (TAVR) has recently been considered as an alternative for patients at high or prohibitive surgical risk. However, concomitant significant MR in this setting is typically left untreated. Moderate to severe MR after aortic valve replacement is therefore a relevant entity in the TAVR era. The purpose of this review is to present the current knowledge on the clinical impact and post-procedural evolution of concomitant significant MR in patients with severe AS who have undergone aortic valve replacement (SAVR and TAVR). This information could contribute to improving both the clinical decision-making process in and management of this challenging group of patients.

ObjectivesThis study sought to assess clinical, angiographic, and intravascular ultrasound (IVUS) findings in patients developing coronary aneurysms (CANs) after drug-eluting stent (DES) implantation.BackgroundThe long-term safety of DES remains unsettled.MethodsThis study analyzed 1,197 consecutive patients with late angiographic evaluation after DES implantation. In 15 patients (1.25%, 95% confidence interval: 0.58 to 1.93), CANs developed at follow-up. Analyses included quantitative angiography and volumetric IVUS.ResultsDES developing CANs were more frequently implanted during acute myocardial infarction and were longer than those without this outcome. The elapsed time from DES implantation to CAN diagnosis was 313 ± 194 days. Angiographically, maximal CAN diameter measured 5.1 ± 1.2 mm. On IVUS, CAN external elastic lamina area was 32 ± 13.1 mm2and incomplete apposition area was 12.1 ± 8.6 mm2. Two patients presented with acute myocardial infarction secondary to DES thrombosis. Four additional patients presented with unstable angina and underwent CAN aggressive dilation (3 were also treated for concomitant in-stent restenosis). Dual antiplatelet therapy was recommended in the remaining 9 patients who were asymptomatic at CAN diagnosis, but 1 of them eventually died of cardiogenic shock after a CAN-related myocardial infarction. After a mean follow-up of 399 ± 347 days, the 1-year event-free survival was 49 ± 14% and was related to CAN size on IVUS. In 2 patients, CANs disappeared at repeated late angiography and IVUS showed abluminal CAN thrombosis.ConclusionsAfter DES implantation, CANs are rare and may be detected in asymptomatic patients. However, CANs are frequently associated with adverse clinical events as a result of DES restenosis and DES thrombosis. Further studies are required to determine the implications of this distinct new entity.

ObjectivesOur purpose was to evaluate long-term mortality and identify factors associated with 1-year mortality in patients who underwent elective percutaneous coronary intervention (PCI).BackgroundWhile long-term outcomes in PCI patients have been reported previously, limited data are currently available regarding the comparative long-term outcomes in PCI patients who receive enoxaparin versus intravenous unfractionated heparin (UFH).MethodsWe conducted a follow-up analysis of clinical outcomes at 1 year in patients enrolled in the STEEPLE (SafeTy and Efficacy of Enoxaparin in Percutaneous coronary intervention patients, an internationaL randomized Evaluation) trial of 3,528 patients undergoing elective PCI. Patients were randomized to receive either intravenous 0.50-mg/kg or 0.75-mg/kg enoxaparin or intravenous UFH during elective PCI procedures. All-cause mortality at 1 year after index PCI was the main outcome measure.ResultsMortality rates were 1.4%, 2.0%, and 1.5% from 1 month to 1 year, and 2.3%, 2.2%, and 1.9% from randomization to 1 year, after index PCI in patients receiving 0.50 mg/kg enoxaparin, 0.75 mg/kg enoxaparin, and UFH, respectively. Multivariate analysis identified nonfatal myocardial infarction and/or urgent target vessel revascularization up to 30 days after index PCI (hazard ratio: 3.5, 95% confidence interval: 1.7 to 7.3; p < 0.001), and major bleeding within 48 h (hazard ratio: 3.0, 95% confidence interval: 1.1 to 8.5; p = 0.04) as the strongest independent risk factors for 1-year mortality.ConclusionsThe 1-year mortality rates were low and comparable between patients receiving enoxaparin and UFH during elective PCI. Periprocedural ischemic or bleeding events were the strongest independent predictors of 1-year mortality. (The STEEPLE Trial; NCT00077844)

Patients with pre-existing respiratory diseases in the setting of COVID-19 may have a greater risk of severe complications and even death.A retrospective, multicenter, cohort study with 5847 COVID-19 patients admitted to hospitals. Patients were separated in two groups, with/without previous lung disease. Evaluation of factors associated with survival and secondary composite end-point such as ICU admission and respiratory support, were explored.1,271 patients (22%) had a previous lung disease, mostly COPD. All-cause mortality occurred in 376 patients with lung disease (29.5%) and in 819 patients without (17.9%) (Previous lung disease is a risk factor for mortality in patients with COVID-19. Older age, male gender, home oxygen therapy, and respiratory failure on admission were associated with an increased mortality. Efforts must be done to identify respiratory patients to set measures to improve their clinical outcomes.Los pacientes con enfermedades respiratorias preexistentes pueden tener en el contexto de la covid-19 un mayor riesgo de complicaciones graves e incluso de muerte.Estudio de cohortes multicéntrico y retrospectivo de 5.847 pacientes con covid-19 ingresados en hospitales. Los pacientes se separaron en 2 grupos, sin y con enfermedad pulmonar previa. Se evaluaron factores asociados con la supervivencia y criterios combinados de valoración secundarios, como el ingreso en la UCI y la necesidad de asistencia respiratoria.Mil doscientos setenta y un (1.271) pacientes (22%) tenían una enfermedad pulmonar previa, principalmente EPOC. La mortalidad por todas las causas ocurrió en 376 pacientes con enfermedad pulmonar (29,5%) y en 819 pacientes sin enfermedad pulmonar (17,9%; p 0,001). Las curvas de Kaplan-Meier mostraron que los pacientes con enfermedades pulmonares tenían una peor supervivencia a los 30 días (HR: 1,78; IC del 95%: 1,58-2,01; p 0,001) y la EPOC tenía una mortalidad de casi el 40%. La regresión de Cox multivariante mostró que la enfermedad pulmonar previa seguía siendo un factor de riesgo de mortalidad (HR: 1,21; IC del 95%: 1,02-1,44; p = 0,02). Las variables asociadas de forma independiente con el riesgo de muerte por todas las causas en pacientes con enfermedades pulmonares fueron la saturación de oxígeno inferior al 92% al ingreso (HR: 4,35; IC del 95%: 3,08-6,15) y el dímero D elevado (HR: 1,84; IC del 95%: 1,27-2,67). La edad menor de 60 años (HR: 0,37; IC del 95%: 0,21-0,65) se asoció con una disminución del riesgo de muerte.La enfermedad pulmonar previa es un factor de riesgo de muerte en pacientes con covid-19. La edad avanzada, el sexo masculino, la oxigenoterapia domiciliaria y la insuficiencia respiratoria al ingreso se asociaron con un aumento de la mortalidad. Se deben realizar esfuerzos para identificar a los pacientes respiratorios y establecer medidas para mejorar sus resultados clínicos.