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Background Even when low-density lipoprotein-cholesterol (LDL-C) levels are lower than guideline thresholds, a residual risk of atherosclerosis remains. It is unknown whether triglyceride (TG) levels are associated with subclinical atherosclerosis and vascular inflammation regardless of LDL-C. Objectives This study sought to assess the association between serum TG levels and early atherosclerosis and vascular inflammation in apparently healthy individuals. Methods An observational, longitudinal, and prospective cohort study, including 3,754 middle-aged individuals with low to moderate cardiovascular risk from the PESA (Progression of Early Subclinical Atherosclerosis) study who were consecutively recruited between June 2010 and February 2014, was conducted. Peripheral atherosclerotic plaques were assessed by 2-dimensional vascular ultrasound, and coronary artery calcification (CAC) was assessed by noncontrast computed tomography, whereas vascular inflammation was assessed by fluorine-18 fluorodeoxyglucose uptake on positron emission tomography. Results Atherosclerotic plaques and CAC were observed in 58.0% and 16.8% of participants, respectively, whereas vascular inflammation was evident in 46.7% of evaluated participants. After multivariate adjustment, TG levels ≥150 mg/dl showed an association with subclinical noncoronary atherosclerosis (odds ratio [OR]: 1.35; 95% confidence interval [CI]: 1.08 to 1.68; p = 0.008). This association was significant for groups with high LDL-C (OR: 1.42; 95% CI: 1.11 to 1.80; p = 0.005) and normal LDL-C (OR: 1.85; 95% CI: 1.08 to 3.18; p = 0.008). No association was found between TG level and CAC score. TG levels ≥150 mg/dl were significantly associated with the presence of arterial inflammation (OR: 2.09; 95% CI: 1.29 to 3.40; p = 0.003). Conclusions In individuals with low to moderate cardiovascular risk, hypertriglyceridemia was associated with subclinical atherosclerosis and vascular inflammation, even in participants with normal LDL-C levels. (Progression of Early Subclinical Atherosclerosis [PESA]; NCT01410318), Central Illustration

Older patients who undergo coronary interventions are at greater risk of ischemic events and less likely to tolerate prolonged dual antiplatelet therapy (DAPT) due to bleeding risk. The COMBO biodegradable polymer sirolimus-eluting stent promotes rapid endothelialization through endothelial progenitor cell capture technology which may be advantageous in elderly patients. We compared 1-year clinical outcomes and DAPT cessation events in patients >75 versus ≤75 years from the MASCOT registry. MASCOT was a prospective, multicenter cohort study of all-comers undergoing attempted COMBO stenting. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, myocardial infarction (MI) not clearly attributed to a nontarget vessel or clinically driven target lesion revascularization. Bleeding was adjudicated using the Bleeding Academic Research Consortium criteria. Adjusted outcomes were analyzed using Cox regression methods. The study included 18% (n = 479) patients >75 years and 72% (n = 2,135) patients ≤75 years. One-year TLF occurred in 4.6% patients >75 years versus 3.1% patients ≤75years of age, p = 0.10; adj hazard ratio 1.36, 95% confidence intervals 0.77 to 2.38, p = 0.29. There were no significant differences in cardiac death (1.7% vs 1.3%, p = 0.55), MI (2.1% vs 1.2%, p = 0.14), target lesion revascularization (1.7% vs 1.4%, p = 0.60) and definite stent thrombosis (0.8% vs 0.4%, p = 0.19). Major Bleeding Academic Research Consortium 3,5 bleeding (3.1% vs 1.5%, p = 0.01) and DAPT cessation rates (32.4% vs 23.0%, p 75 years treated with COMBO stents had similar TLF but significantly greater incidence of bleeding than younger patients and DAPT cessation in one-third of patients over 1 year.

Resumen Introduccion y objetivos El objetivo es evaluar el impacto del acceso vascular en las complicaciones hemorragicas tras una intervencion coronaria percutanea en pacientes con alto riesgo de sangrado (ARS) a los 30 dias y a los 2 anos. Metodos El presente estudio es un subanalisis predefinido del estudio LEADERS FREE, que incluyo a 2.432 pacientes con ARS y en el que el stent farmacoactivo Biolimus A9 resulto superior al stent convencional en seguridad y eficacia. Resultados El acceso radial (AR) se utilizo en 1.454 pacientes (59,8%) y el femoral (AF), en 978 (40,2%), ambos a eleccion del operador. La seguridad y los beneficios del stent farmacoactivo sobre el convencional fueron independientes del acceso vascular. A los 30 dias y a los 2 anos, habian sufrido un sangrado mayor el 2,4 y el 7,5% de los pacientes con AR y el 4,6 y el 10,9% de los pacientes con AF (p = 0,003), la mayoria en ambos grupos (el 2,1 y el 7,0% del de AR; el 3,2 y el 9,4% del de AF) no relacionados con el sitio de acceso vascular. El AR se asocio con una reduccion significativa en las tasas ajustadas de sangrado mayor tanto a 30 dias (HR = 1,98; IC95%, 1,25-3,11; p = 0,003) como a 2 anos de seguimiento (HR = 1,51; IC95%, 1,14-2,01; p = 0,003). Conclusiones Los operadores prefirieron el AR en la mayoria de los pacientes con ARS, lo cual se asocio con una reduccion significativa del sangrado mayor. Asimismo, un numero significativo de sangrados en el seguimiento de esta poblacion son no relacionados con el acceso vascular.

Background The COMBO drug-eluting stent combines sirolimus-elution from a biodegradable polymer with an anti-CD34+ antibody coating for early endothelialization. Objective We investigated for geographical differences in outcomes after percutaneous coronary intervention (PCI) with the COMBO stent among Asians and Europeans. Methods The COMBO Collaboration is a pooled patient-level analysis of the MASCOT and REMEDEE registries of all-comers undergoing attempted COMBO stent PCI. The primary outcome was 1-year target lesion failure (TLF), composite of cardiac death, target vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR). Results This study included 604 Asians (17.9%) and 2775 Europeans (82.1%). Asians were younger and included fewer females, with a higher prevalence of diabetes mellitus but lower prevalence of other comorbidities than Europeans. Asians had a higher prevalence of ACC/AHA C type lesions and received longer stent lengths. More Asians than Europeans were discharged on clopidogrel (86.5% vs 62.8%) rather than potent P2Y12 inhibitors. One-year TLF occurred in 4.0% Asians and 4.1% of Europeans, p = 0.93. The incidence of cardiac death was higher in Asians (2.8% vs. 1.3%, p = 0.007) with similar rates of TV-MI (1.5% vs. 1.2%, p = 0.54) and definite stent thrombosis (0.3% vs. 0.5%, p = 0.84) and lower incidence of TLR than Europeans (1.0% vs. 2.5%, p = 0.025). After adjustment, differences for cardiac death and TLR were no longer significant. Conclusions In the COMBO collaboration, although 1-year TLF was similar regardless of geography, Asians experienced higher rates of cardiac death and lower TLR than Europeans, while incidence of TV-MI and ST was similar in both regions. Adjusted differences did not reach statistical significance. Clinicaltrial.gov identifier-numbers NCT01874002 (REMEDEE Registry), NCT02183454 (MASCOT registry).

Introduction and objectives In de novo heart failure with reduced ejection fraction (HFrEF) current guidelines support, an initial double combination therapy with angiotensin converting enzyme inhibitors/angiotensin-receptor blockers and betablockers, only adding minerocorticoid receptor antagonists if after treatment optimization left ventricular ejection fraction (LVEF) is still under 40%. An initial triple combination therapy could be an attractive initial approach in the stability phase after an acute HF episode in debut HFrEF; which is what we describe in this report and analyze the factors related to the treatment with triple neurohormonal blockade (TNHB). Methods Retrospective study of patients discharged from our centre between January 2009 and January 2016 with de novo HFrEF after an acute HF episode with these criteria: 15–85 year-old, creatinine ≤2.5 mg/dL, potassium Results A total of 280 patients fulfilled the criteria, 58% of them were discharged on TNHB. Mean age was 65.4 ± 12.5 years, LVEF 29.8 ± 7.3% and median NT-ProBNP 2917 pg/mL. After a mean follow-up of 43.4 ± 26.6 months, 72 patients died (25.7%), with a mean survival of 76 months. Patients treated with TNHB had a better risk profile (they were younger, better creatinine and lower pulmonary pressures) but poorer LVEF (28.7 ± 7.4% vs. 31.4 ± 6.7%; P = .002). Mean survival on TNHB was better (months, 82.1 ± 3.0 vs. 68.6 ± 3.8; P = .007). Multivariate analysis showed that TNHB was an independent predictor of better survival (HR, 1.79; 1.05–3.05; P = .03). Conclusions TNHB is commonly used in debut HFrEF, especially in younger patients with worse LVEF. In our cohort TNHB was an independent factor related to better survival.

INTRODUCTION AND OBJECTIVES Health outcomes research is done from clinical registries or administrative databases. The aim of this work was to evaluate the concordance of the Minimum Basic Data Set (MBDS) with the DIOCLES (Descripcion de la Cardiopatia Isquemica en el Territorio Espanol) registry and to analyze the implications of use of the MBDS in the study of acute coronary syndrome in Spain. METHODS Through indirect identifiers, DIOCLES was linked with MBDS and unique matches were selected. Some of most relevant variables for risk adjustment of in-hospital mortality due to acute myocardial infarction were considered. Kappa coefficient was used to evaluate the concordance; sensitivity, specificity and positive and negative predictive values to measure the validity of the MBDS, and the area under ROC (receiver operating characteristic) curve to calculate its discrimination. The results were compared among hospitals quintiles according to their contribution to DIOCLES. The influence of unmatched episodes on results was assessed by a sensitivity analysis, using looser linking criteria. RESULTS Overall, 1539 (60.85%) unique matches were achieved. The prevalence was higher in DIOCLES (acute myocardial infarction: 71.09%; Killip 3-4: 9.17%; cerebrovascular accident: 0.97%; thrombolysis: 8.64%; angioplasty: 61.92% and coronary bypass: 1.75%) than in the MBDS (P < .001). The agreement level observed was almost perfect (κ = 0.863). The MBDS showed a sensitivity of 85.10% and a specificity of 98.31%. Most results were confirmed by using sensitivity analysis (79.95% episodes matched). CONCLUSIONS The MBDS can be a useful tool for outcomes research of acute coronary syndrome in Spain. The contrast of DIOCLES and MBDS with medical records could verify their validity.

Resumen Introduccion y objetivos La investigacion de resultados en salud utiliza tanto registros clinicos como bases de datos administrativas. El objetivo de este trabajo es evaluar la concordancia del Conjunto Minimo Basico de Datos (CMBD) con el registro DIOCLES (Descripcion de la Cardiopatia Isquemica en el Territorio Espanol) y su utilidad en la investigacion de resultados del sindrome coronario agudo en Espana. Metodos Mediante identificadores indirectos, se vinculo el DIOCLES con el CMBD y se seleccionaron los emparejamientos unicos. Considerando algunas de las variables mas relevantes para ajustar por riesgo la mortalidad intrahospitalaria por infarto agudo de miocardio, se calculo la concordancia interobservadores, la sensibilidad, la especificidad y los valores predictivos positivo y negativo para medir la validez del CMBD, y el area bajo la curva ROC (receiver operating characteristic) para determinar su discriminacion. Los resultados se compararon entre quintiles de hospitales segun su contribucion a DIOCLES. El impacto de los emparejamientos fallidos se evaluo mediante un analisis de sensibilidad con criterios de vinculacion mas laxos. Resultados Se lograron 1.539 (60,85%) emparejamientos unicos. Entre los episodios emparejados, la prevalencia fue mayor en el DIOCLES (infarto agudo de miocardio, el 71,09%; Killip 3-4, el 9,17%; accidente cerebrovascular, el 0,97%; trombolisis, el 8,64%; angioplastia, el 61,92%, y bypass, el 1,75%) que en el CMBD (p Conclusiones El CMBD puede ser un instrumento util para la investigacion de resultados del sindrome coronario agudo en Espana. El contraste de DIOCLES y CMBD con las historias clinicas podria verificar su validez.

Objectives The aim of this study was to evaluate 1-year clinical safety and efficacy of the dual-therapy COMBO stent in a large, all-comers patient-level pooled cohort. Background The COMBO stent (OrbusNeich Medical, Fort Lauderdale, Florida) is a novel stent with abluminal sirolimus elution from a biodegradable polymer and a luminal pro-healing anti-CD34+ antibody layer, which attracts circulating endothelial progenitor cells. These endothelial progenitor cells can quickly mature into normal endothelium, providing rapid endothelialization. Methods The MASCOT (Multinational Abluminal Sirolimus Coated biO-engineered stenT) (N = 2,614, 61 global sites) and REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coatED bio-Engineered StEnt Post Market Registry) (N = 1,000, 9 European sites) registries are 2 prospective, multicenter studies evaluating clinical outcomes after attempted COMBO stent placement in all-comer patients undergoing percutaneous coronary intervention. In this patient-level pooled analysis we analyzed 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Furthermore, we determined predictors of 1-year TLF. Results A total of 3,614 patients (63.5 ± 11.2 years of age; 23.8% women) were included in this analysis. The prevalence of diabetes mellitus was 29.3%, and 54.3% patients presented with acute coronary syndrome. The primary endpoint of 1-year TLF occurred in 140 (3.9%) patients, with incidence of cardiac death in 1.6%, target vessel myocardial infarction in 1.2%, clinically driven target lesion revascularization in 2.2%, and definite stent thrombosis in 0.5% patients. Insulin-treated diabetes mellitus, chronic renal failure, and American College of Cardiology/American Heart Association lesion type B2/C were independent predictors of 1-year TLF. Conclusions In this large patient-level pooled analysis of patients treated with the dual-therapy COMBO stent excellent results at 1-year were observed. (MASCOT - Post Marketing Registry [MASCOT]; NCT02183454; Prospective Registry to Assess the Long-term Safety and Performance of the COMBO Stent [REMEDEE Reg]; NCT01874002)

In patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (pPCI), lack of ST-segment resolution (STR) is associated with poor prognosis at short- and long-term follow-up. The aim of this study was to evaluate the role of STR on very long-term outcomes in patients with STEMI treated with pPCI included in the EXAMINATION (Evaluation of the Xience-V Stent in Acute Myocardial Infarction) trial. Patients were stratified according to the presence of STR 50% and STR >= 70%, respectively. In both cases, this difference was mainly driven by a significant increase in the rate of all-cause death and any revascularization. After multivariable adjustment, STR < 70%, but not STR < 50%, resulted as a 5-year independent predictor of POCE (adjusted HR 1.338, 95% CI 1.008 to 1.778, p = 0.044). In conclusion, in patients with STEM!, the evaluation of 70% STR after pPCI provides independent prognostic information at 5-year follow-up and it can be used to identify patients at high risk of very long-term cardiovascular events. (C) 2018 Elsevier Inc. All rights reserved.

Objectives This study sought to investigate the effect of post-dilatation on angiographic and intracoronary imaging parameters in the setting of primary percutaneous coronary intervention comparing the everolimus-eluting bioresorbable scaffold (BRS) with the everolimus-eluting metallic stent (EES). Background Routine post-dilatation of BRS has been suggested to improve post-procedural angiographic and subsequent device-related clinical outcomes. Methods In the ABSORB STEMI TROFI II trial, 191 patients with ST-segment elevation myocardial infarction were randomly assigned to treatment with BRS (n = 95) or EES (n = 96). Minimal lumen area and healing score as assessed by optical coherence tomography at 6 months were compared between BRS- and EES-treated patients stratified according to post-dilatation status. Results Primary percutaneous coronary intervention with post-dilatation was performed in 48 (50.5%) BRS- and 25 (25.5%) EES-treated lesions. There were no differences in baseline characteristics and post-procedural minimal lumen diameter between groups. In the BRS group, lesions with post-dilatation were associated with a trend toward a smaller minimal lumen area at 6 months (5.07 ± 1.68 mm2 vs. 5.72 ± 1.77 mm2; p = 0.09) and significantly larger angiographic late lumen loss (0.28 ± 0.34 mm vs. 0.12 ± 0.25 mm; p = 0.02), whereas no difference was observed in the EES arm (5.46 ± 2.18 mm2 vs. 5.55 ± 1.77 mm2; p = 0.85). The neointimal healing score was low and comparable between groups with and without post-dilation (BRS: 1.55 ± 2.61 vs. 1.92 ± 2.17; p = 0.48; EES: 2.50 ± 3.33 vs. 2.90 ± 4.80; p = 0.72). Conclusions In the setting of selected patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention with BRS or EES, post-dilatation did not translate into larger lumen area or improved arterial healing at follow-up. (ABSORB STEMI: The TROFI II; NCT01986803)

Acute myocardial infarction (AMI) is a common cause of hospital discharges and readmissions. Readmissions may indicate poor patient care and avoidable health expenditure, being key in quality improvement strategies. Our aim was to analyse cardiac diseases (CDs) readmissions in patients with AMI in Spain.A retrospective analysis of 33,538 hospital discharges with AMI being the "principal diagnosis" at hospitals of the Spanish National Health System in 2012 was performed using administrative data. We developed a logistic regression model and calculated 30-day, 3-month and 1-year CDs risk-standardized readmission rates (RSRRs) using a multivariate mixed model.Variables of the model (AMI location, age, previous angina pectoris/myocardial infarction or acute coronary syndrome, chronic kidney disease, rheumatic valvular disease, diabetes mellitus, vascular disease, female sex, chronic pulmonary disease, and anemia) were able to predict 30-day, 3-month and 1-year readmission rates and RSRRs after AMI (5.4%, 9.3% and 20.2%, respectively). For RSRRs the area under the ROC curve was 0.74 (p=0.0037), 0.77 (p=0.0041), and 0.73 (p=0.0025) for 1, 3months and 1-year readmission rate, respectively. Angioplasty, cardiology as the medical unit responsible for the discharge and a higher volume of activity (204 AMI) were all significantly (p0.001) associated with lower mortality, risk of development of heart failure and RSRRs.Angioplasty, cardiology as the medical unit responsible for the discharge and a higher volume of activity explain variability in CDs readmission rates after AMI, which can have implications for strategies to reduce readmissions rates.

Introduction and objectives To analyze the association between the development of network systems of care for ST-segment elevation myocardial infarction (STEMI) in the autonomous communities (AC) of Spain and the regional rate of percutaneous coronary intervention (PCI) and in-hospital mortality. Methods From 2003 to 2012, data from the minimum basic data set of the Spanish taxpayer-funded health system were analyzed, including admissions from general hospitals. Diagnoses of STEMI and related procedures were codified by the International Diseases Classification. Discharge episodes (n = 302 471) were distributed in 3 groups: PCI (n = 116 621), thrombolysis (n = 46 720), or no reperfusion (n = 139 130). Results Crude mortality throughout the evaluation period was higher for the no-PCI or thrombolysis group (17.3%) than for PCI (4.8%) and thrombolysis (8.6%) (P < .001). For the aggregate of all communities, the PCI rate increased (21.6% in 2003 vs 54.5% in 2012; P < .001) with a decrease in risk-standardized mortality rates (10.2% in 2003; 6.8% in 2012; P < .001). Significant differences were observed in the PCI rate across the AC. The development of network systems was associated with a 50% increase in the PCI rate (P < .001) and a 14% decrease in risk-standardized mortality rates (P < .001). Conclusions From 2003 to 2012, the PCI rate in STEMI substantially increased in Spain. The development of network systems was associated with an increase in the PCI rate and a decrease in in-hospital mortality.

BackgroundThe COMBO stent is a biodegradable-polymer sirolimus-eluting stent with endothelial progenitor cell capture technology for faster endothelialization. ObjectiveWe analyzed COMBO stent outcomes in relation to bleeding risk using the PARIS bleeding score. MethodsMASCOT was an international registry of all-comers undergoing attempted COMBO stent implantation. We stratified patients as low bleeding-risk (LBR) for PARIS score≤3 and intermediate-to-high (IHBR) for score>3 based on baseline age, body mass index, anemia, current smoking, chronic kidney disease and need for triple therapy. Primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, myocardial infarction (MI) not clearly attributed to a non-target vessel or clinically-driven target lesion revascularization (TLR). Bleeding was adjudicated using the Bleeding Academic Research Consortium (BARC) definition. Dual antiplatelet therapy (DAPT) cessation was independently adjudicated. Results The study included 56% (n=1270) LBR and 44% (n=1009) IHBR patients. Incidence of 1-year TLF was higher in IHBR patients (4.1% vs. 2.6%, p=0.047) driven by cardiac death (1.7% vs. 0.7%, p=0.029) with similar rates of MI (1.8% vs. 1.1%, p=0.17), TLR (1.5% vs. 1.6%, p=0.89) and definite/ probable stent thrombosis (1.2% vs. 0.6%, p=0.16). Incidence of 1-year major BARC 3 or 5 bleeding was significantly higher in IHBR patients (2.3% vs. 0.9%, p=0.0094), as was the incidence of DAPT cessation (29.3% vs. 22.8%, p Conclusion Patients with intermediate-to-high PARIS bleeding risk in the MASCOT registry experienced greater incidence of 1-year TLF, major bleeding and DAPT cessation than LBR patients, without significant differences in stent thrombosis.

BACKGROUND No medium-term data are available on the random comparison between everolimus-eluting bioresorbable vascular scaffolds and everolimus-eluting metallic stents. The study aims to demonstrate two mechanistic properties of the bioresorbable scaffold: increase in luminal dimensions as a result of recovered vasomotion of the scaffolded vessel. METHODS The ABSORB II trial is a prospective, randomised, active-controlled, single-blind, parallel two-group, multicentre clinical trial. We enrolled eligible patients aged 18-85 years with evidence of myocardial ischaemia and one or two de-novo native lesions in different epicardial vessels. We randomly assigned patients (2:1) to receive treatment with an everolimus-eluting bioresorbable scaffold (Absorb; Abbott Vascular, Santa Clara, CA, USA) or treatment with an everolimus-eluting metallic stent (Xience; Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetes status and number of planned target lesions. At 3 year follow-up, the primary endpoint was superiority of the Absorb bioresorbable scaffold versus the Xience metallic stent in angiographic vasomotor reactivity after administration of intracoronary nitrate. The co-primary endpoint is the non-inferiority of angiographic late luminal loss. For the endpoint of vasomotion, the comparison was tested using a two-sided t test. For the endpoint of late luminal loss, non-inferiority was tested using a one-sided asymptotic test, against a non-inferiority margin of 0·14 mm. The trial is registered at ClinicalTrials.gov, number NCT01425281. FINDINGS Between Nov 28, 2011, and June 4, 2013, we enrolled 501 patients and randomly assigned them to the Absorb group (335 patients, 364 lesions) or the Xience group (166 patients, 182 lesions). The vasomotor reactivity at 3 years was not statistically different (Absorb group 0·047 mm [SD 0·109] vs Xience group 0·056 mm [0·117]; psuperiority=0·49), whereas the late luminal loss was larger in the Absorb group than in the Xience group (0·37 mm [0·45] vs 0·25 mm [0·25]; pnon-inferiority=0·78). This difference in luminal dimension was confirmed by intravascular ultrasound assessment of the minimum lumen area (4·32 mm(2) [SD 1·48] vs 5·38 mm(2) [1·51]; p

Objectives This registry evaluated the safety and clinical outcomes of the Combo stent in an all-comers population in routine clinical practice. We report 1-year results. Background Limitations of current generation drug-eluting stents (DES) are 3-fold: stent thrombosis, neoatherosclerosis related to impaired healing, and repeat revascularization due to (late-) in-stent restenosis. The Combo stent combines an abluminal biodegradable coating eluting sirolimus and a luminal anti-CD34+ antibody layer to attract endothelial progenitor cells in order to promote vessel healing, thus preventing neointima formation and restenosis. Methods The REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coatED bio-Engineered StEnt) post-market registry was an international, multicenter, prospective trial that evaluated clinical outcomes after deployment of the Combo stent, in an all-comers population of patients treated with a Combo stent in the setting of routine clinical care. Clinical endpoints were target lesion failure (TLF), defined as a composite of cardiac death, nonfatal myocardial infarction (MI), or target lesion revascularization (TLR). Results Between June 2013 and March 2014, a total of 1,000 patients were included in the registry, 49.9% of whom presented with acute coronary syndrome. Mean age was 65 ± 11 years old (range: 34 to 94 years of age), and 74% of patients were male; 58.9% of 1,255 lesions were American Heart Association type B2 or C lesions. The primary endpoints were 5.7% TLF, 1.7% cardiac death, 0.7% target vessel MI, and 4.4% TLR. Definite stent thrombosis occurred in 0.5% of subjects; no thrombosis occurred after 9 days post-stenting. Conclusions This registry showed excellent 1-year results of novel Combo bioengineered stent technology in an all-comers patient population. (Prospective Registry to Assess the Long-term Safety and Performance of the Combo Stent [REMEDEE]; NCT01874002 )

Treatment of patients with in-stent restenosis (ISR) remains a challenge. This study sought to compare the efficacy of everolimus-eluting stents (EESs) and drug-eluting balloons (DEBs) with paclitaxel in patients with ISR. A pooled analysis of the Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent (RIBS IV) and Restenosis Intra-Stent of Bare-Metal Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent (RIBS V) randomized trials was performed using patient-level data. In both trials, EESs were compared with DEBs in patients with ISR (RIBS V included 189 patients with bare-metal ISR; RIBS IV included 309 patients with drug-eluting ISR). Inclusion and exclusion criteria were identical in both trials. A total of 249 patients were allocated to EES and 249 to DEB. Clinical follow-up at 1 year was obtained in all (100%) patients and late angiography (median 249 days) in 91% of eligible patients. Compared with patients treated with DEBs, patients treated with EESs obtained better short-term results (postprocedural minimal lumen diameter 2.28 ± 0.5 vs 2.12 ± 0.4 mm, p

Summary Background Incomplete revascularisation is common after percutaneous coronary intervention and is associated with increased mortality and adverse cardiovascular events. We aimed to assess whether adjunctive anti-ischaemic pharmacotherapy with ranolazine would improve the prognosis of patients with incomplete revascularisation after percutaneous coronary intervention. Methods We performed this multicentre, randomised, parallel-group, double-blind, placebo-controlled, event-driven trial at 245 centres in 15 countries in Europe, Israel, Russia, and the USA. Patients (aged ≥18 years) with a history of chronic angina with incomplete revascularisation after percutaneous coronary intervention (defined as one or more lesions with ≥50% diameter stenosis in a coronary artery ≥2 mm diameter) were randomly assigned (1:1), via an interactive web-based block randomisation system (block sizes of ten), to receive either twice-daily oral ranolazine 1000 mg or matching placebo. Randomisation was stratified by diabetes history (presence vs absence) and acute coronary syndrome presentation (acute coronary syndrome vs non-acute coronary syndrome). Study investigators, including all research teams, and patients were masked to treatment allocation. The primary endpoint was time to first occurrence of ischaemia-driven revascularisation or ischaemia-driven hospitalisation without revascularisation. Analysis was by intention to treat. This study is registered at ClinicalTrials.gov, number NCT01442038. Findings Between Nov 3, 2011, and May 27, 2013, we randomly assigned 2651 patients to receive ranolazine (n=1332) or placebo (n=1319); 2604 (98%) patients comprised the full analysis set. After a median follow-up of 643 days (IQR 575–758), the composite primary endpoint occurred in 345 (26%) patients assigned to ranolazine and 364 (28%) patients assigned to placebo (hazard ratio 0·95, 95% CI 0·82–1·10; p=0·48). Incidence of ischaemia-driven revascularisation and ischaemia-driven hospitalisation did not differ significantly between groups. 189 (14%) patients in the ranolazine group and 137 (11%) patients in the placebo group discontinued study drug because of an adverse event (p=0·04). Interpretation Ranolazine did not reduce the composite rate of ischaemia-driven revascularisation or hospitalisation without revascularisation in patients with a history of chronic angina who had incomplete revascularisation after percutaneous coronary intervention. Further studies are warranted to establish whether other treatment could be effective in improving the prognosis of high-risk patients in this population. Funding Gilead Sciences, Menarini.

Background Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) remains a major challenge. Objectives This study evaluated the comparative efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients presenting with DES-ISR. Methods The 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. Results A 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 Conclusions In 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)

ResumenIntroduccion y objetivos El tratamiento invasivo y farmacologico del infarto agudo de miocardio con elevacion del segmento ST comporta una reduccion de los eventos isquemicos, no asi de las complicaciones hemorragicas. El objetivo del estudio es evaluar en estos pacientes los resultados clinicos y las complicaciones hemorragicas comparando el acceso femoral frente al radial. Metodos Se evaluo a la poblacion del estudio Examination, que es un ensayo clinico multicentrico aleatorizado que incluyo a 1.498 pacientes con infarto agudo de miocardio con elevacion del segmento ST remitidos para angioplastia de emergencia. Sobre esta poblacion, efectuamos un subanalisis en el que se analizaron dos grupos segun el tipo de acceso (femoral frente a radial). Se establecio como objetivo primario la variable compuesta por: muerte por cualquier causa, infarto de miocardio, revascularizacion y hemorragia. Resultados El acceso fue por via femoral en 825 pacientes (55%) y por via radial en 673 (45%). Se observo mas hemorragias (mayores y menores) con acceso femoral que con acceso radial (el 5,9 frente al 2,8%; p

[Figure][1] The Spanish Society of Cardiology (SSC) recently launched a strategy for cardiovascular disease health care quality improvement named SEC-CALIDAD (SSC-Quality). The RECALCAR (REcursos y CALidad en CARdiologia) registry is a key element of this strategy. Although Spain has a

Objectives This study sought to assess the 2-year outcomes of the population included in the EXAMINATION (Everolimus-Eluting Stents Versus Bare-Metal Stents in ST-Segment Elevation Myocardial Infarction) trial beyond the 1-year prescription period of dual antiplatelet therapy. Background The EXAMINATION trial compared the performance of everolimus-eluting stents (EES) versus bare-metal stents (BMS) in an all-comer ST-segment elevation myocardial infarction (STEMI) population. Methods This was a multicenter, multinational, prospective, randomized, single-blind, controlled trial in patients with STEMI. The primary endpoint, which was the combined endpoint of all-cause death, any recurrent myocardial infarction, and any revascularization, and the endpoints target lesion revascularization and stent thrombosis were assessed at 2 years. Results Between December 31, 2008, and May 15, 2010, 1,498 patients were randomized to receive EES (n = 751) or BMS (n = 747). Compliance with dual antiplatelet regimen was reduced at 2 years to a similar degree (17.3% vs. 17.2%, p = 0.91). At 2 years, the primary endpoint occurred in 108 (14.4%) patients of the EES group and in 129 (17.3%) patients of the BMS group (p = 0.11). Rate of target lesion revascularization was significantly lower in the EES group than in the BMS group (2.9% vs. 5.6%; p = 0.009). Rates of definite and definite or probable stent thrombosis were also significantly reduced in the EES group (0.8% vs. 2.1%; p = 0.03, and 1.3% vs. 2.8%; p = 0.04, respectively). Conclusions The 2-year follow-up of the EXAMINATION trial confirms the safety and efficacy of the EES compared with BMS in the setting of STEMI. Specifically, both rates of target lesion revascularization and stent thrombosis were reduced in recipients of EES without any signs of late attrition for either of these endpoints. (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction: EXAMINATION Study; NCT00828087 )

Background Transcatheter aortic valve implantation (TAVI) is the recommended therapy for patients with severe aortic stenosis who are not suitable candidates for surgery. The aim of this study was to describe early experience and long-term follow-up with the CoreValve self-expanding aortic prosthesis at 42 Ibero-American hospitals. Methods Multiple centre observational study including 1220 consecutive patients with symptomatic severe aortic stenosis who are not suitable candidates for surgery and underwent transcatheter aortic valve implantation with the self-expanding Medtronic CoreValve System between December 2007 and May 2012. Results The registry included 1220 consecutive patients with a mean age of 80.8±6.3years and a mean logistic euroSCORE of 17.8%±13%. The procedural success rate was 96.1%. Hospital mortality was 7.3% and combined end-point was 21.3%. Aortic regurgitation after TAVI was present in 24.5% (Sellers grade≥2). The estimated 1-year and 2-year survival rates were 82.1% and 73.4% respectively. The following issues were significant independent risk factors for hospital mortality: acute kidney failure (odds ratio 3.55); stroke (odds ratio 5.72); major bleeding (odds ratio 2.64) and euroSCORE (odds ratio 1.02). Long-term predictors of mortality were diabetes mellitus (hazard ratio 1.59, 95% confidence interval 1.09–2.31), severe chronic obstructive pulmonary disease (hazard ratio 1.85, 95% confidence interval 1.85–2.88), and functional classes NYHA III–IV (hazard ratio 1.31, 95% confidence interval 1.01–1.70). Conclusions Transcatheter aortic valve implantation constitutes a safe and viable therapeutic option for high operative risk patients with severe aortic stenosis. Long-term prognosis is conditioned by associate comorbidities.

Background Few data are available about safety of second generation drug eluting stents in an all-comer ST elevation myocardial infarction (STEMI) population. We sought to investigate the predictors and clinical implications of 1-year stent thrombosis (ST) in patients with STEMI, included in the EXAMINATION trial. Methods and results The EXAMINATION trial is an all-comer prospective, randomized 1:1 controlled trial, testing everolimus-eluting stent (EES) vs. cobalt chromium bare metal stent (BMS) in STEMI patients. It included 1498 patients, randomized to EES (n=751) or BMS (n=747). At 1year, definite/probable stent thrombosis, defined according to ARC criteria, occurred in 26 patients (1.73%), including 18 definite and 8 probable events. The incidence of ST was lower in patients treated with EES than in those treated with BMS (HR 0.16, 95% CI 0.03–0.29, p=0.017). Patients with ST have higher 1-year rates of cardiac death (30.8% vs. 2.5%, p Conclusions ST had low frequency in the first year after implantation of EES/BMS in STEMI patients, but it is associated with adverse events. BMS implantation, lack of ST-segment resolution and high Killip class on admission were independent predictors of 1-year ST.

ObjectivesThe aim of this study was to use angiography and grayscale and intravascular ultrasound–virtual histology to assess coronary lesions that caused events during a median follow-up period of 3.4 years.BackgroundVulnerable plaque-related events are assumed to be the result of substantial progression of insignificant lesions.MethodsIn the PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree) study, 697 patients with acute coronary syndromes underwent treatment of all culprit lesions followed by 3-vessel imaging to assess the natural history of culprit and untreated nonculprit (NC) lesions. Future adverse cardiovascular events adjudicated to NC lesions were divided into those with versus without substantial lesion progression (SLP) (≥20% angiographic diameter stenosis increase).ResultsNC lesion events occurred in 72 patients, 44 (61%) with and 28 (39%) without SLP. Myocardial infarctions (n = 6) occurred only in patients with SLP. Conversely, patients without SLP presented only with unstable or increasing angina requiring rehospitalization. Lesions with versus without SLP occurred later (median time to event 401 vs. 223 days, p = 0.07); were less severe at baseline (median diameter stenosis 26.4% vs. 53.8%, p < 0.0001) but more severe at the time of the event (mean diameter stenosis 73.8% vs. 56%, p < 0.0001); and had comparable baseline median plaque burden (68.7% vs. 70.1%, p = 0.17), minimum luminal area (3.7 vs. 4.0 mm2, p = 0.60), and intravascular ultrasound–virtual histology phenotype (83.3% vs. 90.9%, p = 0.68; classified as fibroatheromas at baseline).ConclusionsNC lesions responsible for future cardiovascular events showed angiographic increase during 3.4 years of follow-up, whereas SLP underlay many but not all of them. NC events due to lesions with SLP were angiographically less severe and presented with a delayed time course but were otherwise indistinguishable from NC events that were not associated with SLP.

BackgroundThe aim of this study was investigate the relationship between ABCB1 and ABCC3 gene expressions in peripheral blood cells (PBC) and the response to clopidogrel in patients with coronary arterial disease (CAD).MethodsTwenty-six male CAD patients (50–70years) under treatment with clopidogrel (75mg/day) for at least 5days were selected. Blood samples were obtained to evaluate platelet reactivity and ABCB1 and ABCC3 mRNA expression. Platelet reactivity was measured in P2Y12 Reaction Units (PRU) using VerifyNow. RNA was extracted from PBC and mRNA levels were measured by qPCR, using GAPD as a reference gene.ResultsPlatelet response to clopidogrel was categorized in to PRU quartiles. Individuals with PRU values within the first quartile (Q1, 260) were considered non-responders. ABCC3 was 1.7 times more expressed in Q4 than in Q1 PRU group (p=0.048). Moreover, CAD patients with low ABCC3 expression (Qe1

Pre-clinical results of a novel open-cell, thin strut, durable polymer, laser cut cobalt chromium sirolimus-eluting stent (Angiolite) were promising. We evaluated the 24-month clinical outcomes associated with percutaneous coronary intervention (PCI) with the Angiolite stent. This was a prospective

Objectives We sought to assess the long-term effectiveness and safety of sirolimus-eluting stents (SES) in patients with in-stent restenosis (ISR). Background Treatment of patients with ISR remains a challenge. The long-term outcome of patients with ISR treated with SES remains unknown. Methods The RIBS-II (Restenosis Intra-stent: Balloon angioplasty vs. elective sirolimus-eluting Stenting) study was a randomized trial conducted in 150 patients with ISR (76 SES, 74 balloon angioplasty [BA]). The long-term (>1 year) clinical outcome and pre-specified subgroup analyses were pre-defined secondary study end points. Results At 1 year, the event-free survival (death, myocardial infarction, target vessel revascularization [TVR]) was better in the SES group (88% vs. 69%, p 3 years) clinical follow-up was obtained in 97% of patients (median 3.3 years). After the first year, 3 patients died (1 SES, 2 BA), 5 suffered myocardial infarction (4 SES, 1 BA), and 7 required TVR (4 SES, 3 BA). At last follow-up, definitive/probable/possible stent thrombosis was similar in both groups (2/2/1 SES vs. 1/0/3 BA, p = NS). At 4 years, the event-free survival was 76% in the SES arm and 65% in the BA arm (p = 0.019). On multivariate analysis, SES implantation was an independent predictor of event-free survival. Subgroup analyses were consistent with the main outcome measure. Conclusions In patients with ISR, SES implantation remains effective and safe at very long-term clinical follow-up.

The aim of this study was to evaluate the safety of transradial catheterization without prior withdrawal of oral anticoagulation. In total, 183 patients on long-term acenocoumarol treatment who underwent transradial catheterization were included in a prospective study. In 135 patients, the coumarin derivative was continued without interruption before and during catheterization and, in 48, the drug was stopped 48 hours in advance. No severe thromboembolic or hemorrhagic complications occurred. At 7-day follow-up, the rate of occurrence of hematomas >3 cm in size was 5.5% in the group that continued anticoagulant treatment, and 10.4% in the group that stopped oral anticoagulation (P=.31). The transradial approach appears to be a safe option for patients receiving long-term coumarin treatment and could be the technique of choice because it avoids the drawbacks and complications associated with the withdrawal of oral anticoagulation.

Introduction and objectives Tako-tsubo-like transient left ventricular apical ballooning has been described in Japan, but few cases have been reported in Western countries. We report one of the first series outside Japan, which provides new information on the coronary anatomy of this disorder. Patients and Methods From January 1998 to February 2003 we observed 11 patients with a clinical suspicion of acute myocardial infarction, normal coronary arteries, and transient tako-tsubo-like systolic left ventricular apical ballooning. We compared the coronary artery anatomy in these 11 patients with that in 44 controls matched for age and sex: 22 with normal coronary arteries and 22 with acute myocardial infarction related with an obstructive thrombus in the left anterior descending coronary artery. Results As in Japanese patients, tako-tsubo syndrome in Caucasian patients frequently occurs in women in their seventh or eighth decades of life, and is usually preceded by emotional or physical stress. The left anterior descending in our patients with tako-tsubo syndrome was longer overall, and its recurrent diaphragmatic segment was longer, than in controls. To compare these groups we designed a measure termed recurrent segment index (left anterior descending recurrent segment length/total left anterior descending length x 100). In tako-tsubo syndrome this index was 22.3 (1.5)%, vs 10.9 (6.7)% in normal controls (P Conclusions All our patients with tako-tsubo syndrome had a left anterior descending with a long recurrent segment. The identical ventriculographic findings in patients with tako-tsubo syndrome and those with acute myocardial infarction with a long recurrent segment may be due to a common etiology.

Introduccion y objetivos El sindrome de disfuncion ventricular transitoria tako-tsubo ha sido descrito en Japon y se han publicado casos aislados en Occidente. Mostramos una de las primeras series descritas fuera de Japon y presentamos nueva informacion sobre su anatomia coronaria. Pacientes y metodo Entre enero de 1998 y abril de 2003 identificamos a 11 pacientes con sospecha de infarto agudo de miocardio, arterias coronarias normales y disfuncion ventricular transitoria tipo tako-tsubo. Estudiamos la anatomia coronaria de estos 11 pacientes, asi como de 44 controles ajustados por edad y sexo: 22 con coronarias normales y 22 con infarto agudo de miocardio en relacion con oclusion en la arteria coronaria descendente anterior. Resultados Al igual que en los pacientes japoneses, el sindrome tako-tsubo en pacientes caucasicos generalmente ocurre en mujeres en la septima u octava decadas de la vida y con frecuencia se precede de estres emocional o fisico. La arteria coronaria descendente anterior de nuestros pacientes con sindrome tako-tsubo tiene mayor longitud y un segmento diafragmatico (recurrente) mas largo que la de los controles. Para compararlos disenamos un indice de recurrencia ([segmento recurrente de descendente anterior/longitud total de la descendente anterior] × 100). En los pacientes con sindrome tako-tsubo, este indice fue del 22,3 ± 1,5%, en controles normales fue del 10,9 ± 6,7% (p Conclusiones Todos nuestros pacientes con sindrome tako-tsubo presentan una descendente anterior con un gran segmento recurrente. La morfologia identica de la ventriculografia de los pacientes con sindrome tako-tsubo y los controles con infarto con un elevado indice de recurrencia de la descendente anterior puede deberse a una etiopatogenia comun.