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

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

Resumen Introduccion y objetivos El periodo de uso recomendado del tratamiento antiagregante plaquetario combinado doble tras implante de stents farmacoactivos va de los 6 a los 12 meses o mas. Ensayos recientes indican que es seguro utilizar un tratamiento antiagregante plaquetario combinado doble durante 6 meses, si bien ciertas limitaciones de estos estudios hacen que sea escasa la aplicabilidad de esta estrategia de tratamiento antiagregante plaquetario combinado doble de menor duracion en la practica clinica real. Metodos Se puso en marcha un registro con la inscripcion de pacientes consecutivos a los que se habia implantado stent farmacoactivo de nueva generacion seguido de una prescripcion de 6 meses de tratamiento antiagregante plaquetario combinado doble. Se realizo una igualacion por puntuacion de propension con una cohorte historica de pacientes tratados con stents farmacoactivos de segunda generacion que recibieron luego 12 meses de tratamiento antiagregante plaquetario combinado doble del registro ESTROFA-2. El tamano muestral se calculo para el criterio de no inferioridad y el objetivo principal fue la combinacion de muerte cardiaca, infarto de miocardio, revascularizacion o hemorragia mayor a los 12 meses. Resultados Se incluyo en el analisis a 1.286 pacientes de cada grupo, que no presentaban diferencias significativas en sus caracteristicas basales. Se produjeron episodios del objetivo principal en el 5,0 y el 6,6% de los pacientes en los grupos de 6 y de 12 meses respectivamente (p = 0,001 para no inferioridad). La incidencia de trombosis del stent definitiva o probable fue del 0,5 y el 0,7% en los grupos de tratamiento de 6 y 12 meses respectivamente (p = 0,4). Los episodios de hemorragia mayor fueron menos en el grupo de 6 meses que en el de 12 (el 0,8 y el 1,4%; p = 0,2). Conclusiones En pacientes seleccionados de este amplio estudio multicentrico, la seguridad y la eficacia de 6 meses de tratamiento antiagregante plaquetario combinado doble despues del implante de stents farmacoactivos de nueva generacion fueron no inferiores a las observadas con 12 meses de tratamiento antiagregante plaquetario combinado doble.

Introduction and objectives The recommendation for dual antiplatelet therapy following drug-eluting stent implantation ranges from 6 months to 12 months or beyond. Recent trials have suggested the safety of a 6-month dual antiplatelet therapy regimen, yet certain caveats to these studies limit the applicability of this shorter duration dual antiplatelet therapy strategy in real world settings. Methods A registry was constructed with consecutive recruitment of patients undergoing new-generation drug-eluting stent implantation and prescribed 6 months of dual antiplatelet therapy. Propensity score matching was undertaken with a historical cohort of patients treated with second-generation drug-eluting stents who received 12 months of dual antiplatelet therapy from the ESTROFA-2 registry. The sample size was calculated using a noninferiority basis and the primary endpoint was the combination of cardiac death, myocardial infarction, revascularization, or major bleeding at 12 months. Results The analysis included 1286 patients in each group, with no significant differences in baseline characteristics. The primary endpoint occurred in 5.0% and 6.6% in the 6-month and 12-month groups, respectively ( P = .001 for noninferiority). The incidence of definite or probable stent thrombosis was 0.5% and 0.7% in the 6-month and 12-month groups, respectively ( P = .4). Major bleeding events were lower in the 6-month group than in the 12-month group (0.8% vs 1.4%; P = .2) Conclusions In selected patients in this large multicenter study, the safety and efficacy of a 6-month dual antiplatelet therapy regimen after implantation of new-generation drug-eluting stents appeared to be noninferior to those of a 12-month dual antiplatelet therapy regimen.

Background Stem cell–based therapy has emerged as a potential therapy in acute myocardial infarction (AMI). Although various approaches have been studied, intracoronary injection of bone marrow autologous mononuclear cells (BMMC) and the ability of granulocyte colony-stimulating factor (G-CSF) to mobilize endogenous cells have attracted the most attention. Objectives This study compares, for the first time, the efficacy of BMMC injection, G-CSF mobilization, and the combination of both with standard treatment. Methods On Day 1 after primary percutaneous coronary intervention, 120 patients were randomized to a 1) intracoronary BMMC injection; 2) mobilization with G-CSF; 3) both (BMMC injection plus G-CSF); or 4) conventional treatment (control group). G-CSF, 10 μg/kg/day subcutaneously, was started Day 1 and maintained for 5 days. BMMC injection was performed on Days 3 to 5. Our primary endpoint was absolute change in 12-month left ventricular ejection fraction (LVEF) and left ventricular end-systolic volume (LVESV) relative to baseline measured by cardiac magnetic resonance. Results The mean change in LVEF between baseline and follow-up for all patients was 4 ± 6% (p = 0.006). Change in LVEF and LVESV over time did not differ significantly among the 4 groups. Patients actively treated with any stem cell approach showed similar changes in LVEF and LVESV versus control subjects, with a small but significant reduction in infarct area (p = 0.038). Conclusions In our study, 3 different bone marrow–derived stem cell approaches in AMI did not result in improvement of LVEF or volumes compared with standard AMI care (Trial of Hematopoietic Stem Cells in Acute Myocardial Infarction [TECAM]; NCT00984178 )

AIMS: The aim of this study was to observe the percentage of thromboembolic and haemorrhagic events over a 2-year follow-up in patients with non-valvular atrial fibrillation (NVAF) undergoing closure of the left atrial appendage (LAA) with an occlusion device. Observed events and CHADS2 (congestive heart failure, hypertension, age, diabetes, stroke history), CHA2DS2-VASc (also adding: vascular disease and sex) and HAS-BLED (hypertension, abnormal liver/renal function, stroke history, bleeding predisposition, labile international normalised ratios, elderly, drugs/alcohol use)-predicted events were compared. METHODS: LAA closure with an occlusion device was performed in 167 NVAF patients contraindicated for oral anticoagulants and recruited from 12 hospitals between 2009 and 2013. At least two transoesophageal echocardiograms were performed in the first 6 months postimplantation. Antithrombotics included clopidogrel and aspirin. Patients were monitored for death, stroke, major and relevant bleeding and hospitalisation for concomitant conditions. Mean age was 74.68±8.58, median follow-up was 24 months, 5.38% had intraoperative complications and implantation was successful in 94.6% of subjects. Mortality during follow-up was 10.8%, mostly (9.5%) non-cardiac related. Bleeding occurred in 10.1% of subjects, 5.7% major and 4.4% minor though relevant, and 4.4% suffered stroke. Major bleeding and stroke/transient ischaemic attack events within 2 years (annual event rates, 290 patients/year) were less frequent than expected from CHADS2 (2.4% vs 9.6%), CHA2DS2-VASc (2.4% vs 8.3%) and HAS-BLED (3.1% vs 6.6%) risk scores (p

Background Thrombolysis is still used when primary angioplasty is delayed for a long time, but 25%–30% of patients require rescue angioplasty (RA). There are no established recommendations for antithrombotic management in RA. This registry analyzes regimens for antithrombotic management. Methods A retrospective, multicenter, observational registry of consecutive patients treated with RA at 8 hospitals. All variables were collected and follow-up took place at 6 months. Results The study included 417 patients. Antithrombotic therapy in RA was: no additional drugs 22.3%, unfractionated heparin (UFH) 36.6%, abciximab 15.5%, abciximab plus UFH 10.5%, bivalirudin 5.7%, enoxaparin 4.3%, and others 4.7%. Outcomes at 6 months were: mortality 9.1%, infarction 3.3%, definite or probable stent thrombosis 4.3%, revascularization 1.9%, and stroke 0.5%. Mortality was related to cardiogenic shock, age > 75 years, and anterior location. The stent thrombosis rate was highest with bivalirudin (12.5% at 6 months). The incidence of bleeding at admission was high (14.8%), but most cases were not severe (82% BARC ≤2). Variables independently associated with bleeding were: femoral access (OR 3.30; 95% CI 1.3–8.3: p = 0.004) and post-RA abciximab infusion (OR 2.26; 95% CI 1.02–5: p = 0.04). Conclusions Antithrombotic treatment regimens in RA vary greatly, predominant strategies consisting of no additional drugs or UFH 70 U/kg. No regimen proved predictive of mortality, but bivalirudin was related to more stent thrombosis. There was a high incidence of bleeding, associated with post-RA abciximab infusion and femoral access.

Background The effect of intracoronary adenosine (ADO) on ST-segment elevation myocardial infarction (STEMI) size and adverse remodeling is not well established. Methods In a double-blind trial, 201 patients with STEMI were randomized to receive percutaneous coronary intervention (PCI) within 6hours of symptom onset, 4.5mg ADO or saline immediately prior to reperfusion. Primary end-point: percentage of total myocardial necrotic mass by cardiac magnetic resonance (CMR) 2–7days post-reperfusion. Secondary end-points: changes in left ventricular volumes and ejection fraction (LVEF) at baseline and at 6months. Results Baseline CMR could not be performed in 20 patients. Overall, no significant differences were observed between ADO and placebo regarding infarct size (20.8% vs. 22.5%; p =0.40). However, infarct size was significantly reduced (19.4% vs. 25.7%; p for interaction=0.031) in those with ischemia duration below the median (200min). CMR at 6months, performed in 138 patients, did not show statistically significant differences between groups in the rate of LVEF increase (3.3units (SD 9.6) in ADO group vs. 1.5units (SD 9) in placebo group; p =0.25). In the subgroup analysis, among patients with ischemia time below 200min, the increase in LVEF was slightly higher with ADO (3.59% vs. 0.43%; p for interaction=0.06). Conclusions Although our study failed to demonstrate that intracoronary administration of ADO prior to PCI limits infarct size, in patients receiving early PCI ADO might enhance myocardial salvage and has a favorable effect on LVEF evolution, which may help to reconcile apparently contradictory results of previous studies. Clinical trial registration http://clinicaltrials.gov (NCT00781404).

Resumen Introduccion y objetivos La regurgitacion mitral sintomatica tiene un pronostico desfavorable sin tratamiento quirurgico. Sin embargo, segun el registro europeo de enfermedad cardiaca valvular, no se intervino al 49% de los pacientes en esa situacion. El tratamiento percutaneo de la regurgitacion mitral con MitraClip® se ha demostrado seguro y eficaz anadido al tratamiento medico en este perfil de pacientes. El objetivo de este trabajo es describir la experiencia inicial con MitraClip® en Espana. Metodos Estudio observacional retrospectivo que incluye a todos los pacientes tratados desde noviembre 2011 hasta julio 2013 por los cuatro hospitales espanoles con mayor numero de implantes. Resultados Se trato a 62 pacientes (el 77,4% varones), principalmente con regurgitacion mitral funcional restrictiva (85,4%), de gravedad grado III (37%) o IV (63%), fraccion de eyeccion media del 36 ± 14% y clase funcional de la New York Heart Association III (37%) o IV (63%). En el 98% de los pacientes, se implanto con exito el dispositivo. Al ano, el 81,2% tenia regurgitacion mitral ≤ 2 y el 90,9% en clase funcional de la New York Heart Association ≤ II . Hubo un solo caso de mortalidad periprocedimiento (sepsis 20 dias despues del implante) y otros 3 fallecimientos en el seguimiento (media, 9,1 meses). Fue necesario implantar un nuevo dispositivo por dehiscencia parcial del previo a 2 pacientes y se sometio a trasplante cardiaco a otros 2. Conclusiones El tratamiento con MitraClip® en Espana se ha dirigido principalmente a pacientes con insuficiencia mitral funcional, disfuncion ventricular sistolica significativa y elevado riesgo quirurgico, y se perfila como una opcion segura de tratamiento con capacidad de reducir la regurgitacion mitral y mejorar la capacidad funcional.

Percutaneous transluminal septal ablation is an alternative treatment in patients with hypertrophic obstructive cardiomyopathy. However, due to the relatively new introduction of this technique, there is no information on its very long term results (10 years).The present study included consecutive patients treated in 5 centers between 1998 and 2003. We analyzed clinical, hemodynamic, and echocardiographic data at baseline and follow-up.A total of 45 patients were included; there were 31 (69%) women, the mean age was 62.4 (14) years, and 39 patients (86.6%) showed functional class III or IV. Septal thickness was 21.8 (3.5) mm, the peak resting gradient on echocardiography was 77 (39) mmHg, and mitral regurgitation was at least moderate in 22 patients (48.8%). During hospitalization, permanent pacemaker implantation was required in 3 patients and ventricular perforation (by pacing lead) occurred in 1 patient, requiring surgery. After a follow-up of 12.3 years (11.0-13.5 years), 2 patients (4.4%) died from cardiac causes (heart failure and posttransplantation), 3 patients required an implantable cardioverter-defibrillator (1 for primary prevention and 2 due to sustained ventricular tachycardia after cardiac surgery), and 2 underwent cardiac surgery (due to endocarditis and mitral regurgitation). In the last clinical review, functional class was I-II in 39 patients (86.6%) (P.0001), the peak resting gradient was 16 (23) mmHg (P.0001), and mitral regurgitation was absent or mild in 34 patients (75.5%) (P.03).The results of this study suggest that septal ablation is safe and effective in the very long term. The procedure was not associated with a significant incidence of sudden death or symptomatic ventricular arrhythmias.

Resumen Introduccion y objetivos La ablacion septal percutanea es una alternativa terapeutica en la miocardiopatia hipertrofica obstructiva. Debido a su introduccion relativamente reciente, no hay informacion sobre eficacia y seguridad a muy largo plazo. Este estudio multicentrico evalua sus resultados en seguimiento superior a 10 anos. Metodos Se incluyo consecutivamente a pacientes tratados con ablacion septal en cinco centros entre 1998 y 2003. Se han analizado datos clinicos, hemodinamicos y ecocardiograficos basales y de seguimiento. Resultados Se ha incluido a 45 pacientes (media de edad, 62,4 ± 14 anos), de los que 31 eran mujeres y 39 (86,6%) estaban en clase funcional III - IV . El grosor del septo era 21,8 ± 3,5 mm; el gradiente maximo basal por ecocardiografia, 77 ± 39 mmHg, y la insuficiencia mitral era de grado al menos moderado en 22 pacientes (48,8%). Durante la hospitalizacion, 3 casos precisaron implante de marcapasos definitivo y 1 paciente sufrio perforacion ventricular por electrodo de marcapasos, que requirio cirugia. Tras seguimiento de 12,3 (11,0-13,5) anos, 2 pacientes (4,4%) sufrieron muerte cardiaca (insuficiencia cardiaca y postrasplante); 3, implante de desfibrilador automatico implantable (1 caso por prevencion primaria y 2 por taquicardia ventricular sostenida tras cirugia cardiaca), y 2, cirugia cardiaca (endocarditis e insuficiencia mitral). En la ultima evaluacion clinica, la clase funcional era I - II en 39 (86,6%) (p Conclusiones Estos resultados a mas de 10 anos indican seguridad y eficacia a muy largo plazo para la ablacion septal. No hubo incidencia significativa de arritmias ventriculares sintomaticas o muerte subita.

Objectives The aim of this study was to determine whether drug-eluting stents (DES) are superior to bare-metal stents (BMS) in octogenarian patients with angina. Background Patients ≥80 years of age frequently have complex coronary disease warranting DES but have a higher risk of bleeding from prolonged dual antiplatelet therapy. Methods This multicenter randomized trial was conducted in 22 centers in the United Kingdom and Spain. Patients ≥80 years of age underwent stent placement for angina. The primary endpoint was a 1-year composite of death, myocardial infarction, cerebrovascular accident, target vessel revascularization, or major hemorrhage. Results In total, 800 patients (83.5 ± 3.2 years of age) were randomized to BMS (n = 401) or DES (n = 399) for treatment of stable angina (32%) or acute coronary syndrome (68%). Procedural success did not differ between groups (97.7% for BMS vs. 95.4% for DES; p = 0.07). Thirty-eight percent of patients had ≥2-vessel percutaneous coronary intervention, and 66% underwent complete revascularization. Patients who received BMS had shorter stent implants (24.0 ± 13.4 mm vs. 26.6 ± 14.3 mm; p = 0.01). Rates of dual antiplatelet therapy at 1 year were 32.2% for patients in the BMS group and 94.0% for patients in the DES group. The primary endpoint occurred in 18.7% of patients in the BMS group versus 14.3% of patients in the DES group (p = 0.09). There was no difference in death (7.2% vs. 8.5%; p = 0.50), major hemorrhage (1.7% vs. 2.3%; p = 0.61), or cerebrovascular accident (1.2% vs. 1.5%; p = 0.77). Myocardial infarction (8.7% vs. 4.3%; p = 0.01) and target vessel revascularization (7.0% vs. 2.0%; p = 0.001) occurred more often in patients in the BMS group. Conclusions BMS and DES offer good clinical outcomes in this age group. DES were associated with a lower incidence of myocardial infarction and target vessel revascularization without increased incidence of major hemorrhage. (Xience or Vision Stent–Management of Angina in the Elderly [XIMA]; ISRCTN92243650 )

Objectives This study sought to investigate the clinical impact of the use of intravascular ultrasound (IVUS) during revascularization of patients with left main coronary artery (LM) disease with drug-eluting stents (DES). Background Whether the use of IVUS during the procedure adds a clinical benefit remains unclear. There is only 1 previous observational study, with relevant limitations, supporting the value of this strategy. Methods We performed a patient-level pooled analysis of 4 registries of patients with LM disease treated with DES in Spain. A propensity score-matching method was used to obtain matched pairs of patients with and without IVUS guidance. Results A total of 1,670 patients were included, and 505 patients (30.2%) underwent DES implantation under IVUS guidance (IVUS group). By means of the matching method, 505 patients without the use of IVUS during revascularization were selected (no-IVUS group). Survival free of cardiac death, myocardial infarction, and target lesion revascularization at 3 years was 88.7% in the IVUS group and 83.6% in the no-IVUS group (p = 0.04) for the overall population, and 90% and 80.7%, respectively (p = 0.03), for the subgroups with distal LM lesions. The incidence of definite and probable thrombosis was significantly lower in the IVUS group (0.6% vs. 2.2%; p = 0.04). Finally, IVUS-guided revascularization was identified as an independent predictor for major adverse events in the overall population (hazard ratio: 0.70, 95% confidence interval: 0.52 to 0.99; p = 0.04) and in the subgroup with distal lesions (hazard ratio: 0.54, 95% confidence interval: 0.34 to 0.90; p = 0.02). Conclusions The results of this pooled analysis show an association of IVUS guidance during percutaneous coronary intervention with better outcomes in patients with LM disease undergoing revascularization with DES.

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.

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

Vascular complications in transcatheter aortic valve implantation using transfemoral approach are related to higher mortality. Complete percutaneous approach is currently the preferred technique for vascular access. However, some centers still perform surgical cutdown. Our purpose was to determine complications related to vascular access technique in the population of the Spanish TAVI National Registry. From January 2010 to July 2015, 3,046 patients were included in this Registry. Of them, 2,465 underwent transfemoral approach and were treated with either surgical cutdown and closure (cutdown group, n = 632) or percutaneous approach (puncture group, n = 1,833). Valve Academic Research Consortium-2 definitions were used to assess vascular and bleeding complications. Propensity matching resulted in 615 matched pairs. Overall, 30-day vascular complications were significantly higher in the puncture group (109 [18%] vs 42 [6.9%]; relative risk [RR] 2.60; 95% confidence interval [CI] 1.85 to 3.64, p

Objectives This study sought to evaluate second-generation drug-eluting stent (DES) thrombosis in clinical practice. Background First-generation DES are associated with a significant incidence of late thrombosis. There is paucity of data regarding real practice late thrombosis incidence and predictors with second-generation DES, zotarolimus-eluting stent (ZES), and everolimus-eluting stents (EES). Methods A prospective, large-scale, non-industry-linked multicenter registry was designed. Complete clinical-procedural data and systematic follow-up of all patients treated with these stents was reported in a dedicated registry supported by the Spanish Working Group on Interventional Cardiology. Results From 2005 to 2008, 4,768 patients were included in 34 centers: 2,549 treated with ZES, and 2,219 with EES. The cumulative incidence of definite/probable thrombosis for ZES was 1.3% at 1 year and 1.7% at 2 years and for EES 1.4% at 1 year and 1.7% at 2 years (p = 0.8). The increment of definite thrombosis between the first and second year was 0.2% and 0.25%, respectively. In a propensity score analysis, the incidence remained very similar. Ejection fraction (adjusted hazard ratio [HR]: 0.97; 95% confidence interval [CI]: 0.95 to -0.99; p = 0.008), stent diameter (adjusted HR: 0.37; 95% CI: 0.17to 0.81; p = 0.01) and bifurcations (adjusted HR: 2.1; 95% CI: 1.14 to 3.7; p = 0.02) emerged as independent predictors of thrombosis. In the subgroup of patients with bifurcations, the use of ZES was independently associated with a higher thrombosis rate (adjusted HR: 4; 95% CI: 1.1 to 13; p = 0.03). Conclusions In a real practice setting, the incidence of thrombosis at 2 years with ZES and EES was low and quite similar. The incidence of very late thrombosis resulted lower than was reported in registries of first-generation DES. In the subset of bifurcations, the use of ZES significantly increased the risk of thrombosis.

La tomografia de coherencia optica es una nueva tecnica de diagnostico intracoronario, con una alta resolucion, superior a la de otras tecnicas como la ecografia intravascular. Se estudio mediante tomografia de coherencia optica el resultado tras implantar stent en 6 pacientes sometidos a intervencionismo coronario, con una imagen angiografica normal tras la revascularizacion. Se observo protrusion de material al stent en todos los pacientes, microdisecciones en los bordes del stent en 4 pacientes y mala posicion del stent en 4 pacientes. En 2 pacientes, se observo formacion de pequenos trombos alrededor del cateter de tomografia. La tomografia de coherencia optica permite detectar zonas de resultado suboptimo tras el intervencionismo coronario, a pesar de una adecuada imagen angiografica.

Optical coherence tomography is a new intracoronary diagnostic technique that has a higher resolution than other techniques, such as intravascular ultrasound. We used optical coherence tomography to study outcomes after stent implantation in 6 patients who had undergone percutaneous coronary intervention, and in whom angiography showed normal results after revascularization. Material was observed to protrude through the stent struts in all patients, small dissections were seen at the stent edges in four patients, and there was incomplete stent apposition in 4 patients. In 2 patients, small amounts of thrombus were observed to form around the tomography catheter. With optical coherence tomography, it was possible to detect areas in which the results of percutaneous coronary intervention were suboptimal, despite a satisfactory appearance on angiography.

Primary angioplasty is the best reperfusion treatment in ST elevated myocardial infarction. The prevalence of very elderly patients (> 75 years) undergoing primary angioplasty is progressively increasing as population is ageing. The benefit of the new generation drug-eluting stents over bare metal

Stem cell-based therapy has emerged as a potential therapy in acute myocardial infarction (AMI). Although various approaches have been studied, intracoronary injection of bone marrow autologous mononuclear cells (BMMC) and the ability of granulocyte colony-stimulating factor (G-CSF) to mobilize endogenous cells have attracted the most attention.This study compares, for the first time, the efficacy of BMMC injection, G-CSF mobilization, and the combination of both with standard treatment.On Day 1 after primary percutaneous coronary intervention, 120 patients were randomized to a 1) intracoronary BMMC injection; 2) mobilization with G-CSF; 3) both (BMMC injection plus G-CSF); or 4) conventional treatment (control group). G-CSF, 10 μg/kg/day subcutaneously, was started Day 1 and maintained for 5 days. BMMC injection was performed on Days 3 to 5. Our primary endpoint was absolute change in 12-month left ventricular ejection fraction (LVEF) and left ventricular end-systolic volume (LVESV) relative to baseline measured by cardiac magnetic resonance.The mean change in LVEF between baseline and follow-up for all patients was 4 ± 6% (p = 0.006). Change in LVEF and LVESV over time did not differ significantly among the 4 groups. Patients actively treated with any stem cell approach showed similar changes in LVEF and LVESV versus control subjects, with a small but significant reduction in infarct area (p = 0.038).In our study, 3 different bone marrow-derived stem cell approaches in AMI did not result in improvement of LVEF or volumes compared with standard AMI care (Trial of Hematopoietic Stem Cells in Acute Myocardial Infarction [TECAM]; NCT00984178).

To determine the feasibility and safety of early posthrombolysis coronary stenting and the incidence of further reocclusion, we followed 99 consecutive patients with acute myocardial infarction thrombolyzed with rt-PA 2.0 ± 0.8 hr after onset. Culprit artery was stented 14.0 ± 7.0 hr after thrombolysis. All patients underwent clinical and angiographic follow-up at 1 and 6 months. Angiographic success was achieved in 99% of cases. Neither major cardiac events nor bleeding or vascular complications occurred during hospital stay. At 30 days, no events occurred and normal flow persisted in all stented arteries. At 6 months, only one artery reoccluded (1%), resulting in a nonfatal reinfarction. Restenosis rate was 21%. Contribution of the infarcted area to left ventricular function significantly increased from baseline to 30-day and to 6-month evaluations. Thus, early posthrombolysis stenting is a safe strategy with a low reocclusion rate, which seems to allow functional recovery of the infarcted area. Further studies are necessary to define its impact on survival and cost-effectiveness. Cathet Cardiovasc Intervent 2002;55:467–476. © 2002 Wiley-Liss, Inc.

It has been estimated that 15-25% of patients who undergo percutaneous or surgical coronary angioplasty are diabetics. The indications for coronary revascularization and initial results of the procedure do not differ substantially between patients with diabetes mellitus and non-diabetics. However, the long-term results of both percutaneous and surgical coronary angioplasty are less favorable in diabetics in terms of mortality and the need for new revascularization procedures. The development and widespread use of stents and glycoprotein IIb/IIIa receptor inhibiting drugs have improved the clinical evolution of diabetics treated with angioplasty. Currently available data show that the adminisration of glycoprotein IIb/IIIa inhibitors to patients undergoing coronary angioplasty is especially useful in diabetics and improves short-term and long-term results, decreasing one-year mortality by 45%. There seem to be indications for the routine use of glycoprotein IIb/IIIa inhibitors in diabetics treated with angioplasty. While the use of stents has improved long-term and short-term results in diabetics, the success rates of angioplasty in diabetics are still lower than in nondiabetics. Diabetes is still an independent predictor of restenosis and long-term events after stenting interventions. Analysis of the studies comparing percutaneous and surgical revascularization in diabetic patients with multivessel disease shows that surgery is superior in terms of long-term mortality and need for new revascularization procedures. Stenting has improved, but not substantially, the results of multivessel angioplasty in diabetics. Therefore, the indications for angioplasty in multivessel diabetics should be evaluated individually. Factors that contribute to the less favorable post-angioplasty evolution of diabetic patients are more rapid progression of atherosclerosis and, especially, a higher rate of restenosis. New angioplasty techniques, such as brachytherapy and drug-eluting stents, are likely to significantly improve the results of percutaneous interventions

OBJECTIVE The purpose of this study was to test the hypothesis that stent implantation in de novo coronary artery lesions would result in lower restenosis rates and better long-term clinical outcomes than balloon angioplasty. BACKGROUND Placement of an intracoronary stent, as compared with balloon angioplasty, has proven to reduce the rate of restenosis. However, the long-term clinical benefit of stenting over angioplasty has not been assessed in large randomized trials. METHODS We randomly assigned 452 patients with either stable (129 patients) or unstable (323 patients) angina pectoris to elective stent implantation (229 patients) or standard balloon angioplasty (223 patients). Coronary angiography was performed at baseline, immediately after the procedure and six months later. End points were the rate of restenosis at six months and a composite of death, myocardial infarction (MI) and target vessel revascularization over four years of follow-up. RESULTS Procedural success rate was achieved in 84% and 95% (balloon angioplasty vs. stent, respectively). The increase in the minimal luminal diameter was greater in the stent group both after the intervention (2.02 ± 0.6 mm vs. 1.43 ± 0.6 mm in the angioplasty group; p CONCLUSIONS Patients who received an intracoronary stent showed a lower rate of restenosis than those treated with conventional balloon angioplasty. The benefit of stenting was maintained four years after implantation, as manifested by a significant reduction in the need for repeat revascularization.

Current guidelines on valvular heart disease recommend double valve replacement when significant aortic stenosis and mitral regurgitation (MR) occur simultaneously [(1,2)][1]. Given the higher risk of combined mitro-aortic surgery, transcatheter aortic valve replacement (TAVR) has emerged as a good

Introduccion y objetivos Las necesidades asistenciales de las unidades coronarias obligan a acelerar el alta de los pacientes menos graves y esto podria influir sobre su pronostico. Nuestro objetivo ha sido: a) analizar las caracteristicas y la evolucion durante el primer mes de los pacientes con infarto de miocardio dados de alta de la unidad coronaria muy precozmente, y b) definir el perfil de un grupo de pacientes con bajo riesgo de complicaciones que podrian ser dados de alta precozmente. Pacientes y metodos Estudio de 978 pacientes consecutivamente ingresados por infarto de miocardio. Se estudian las caracteristicas basales, la estancia en la unidad coronaria y en el hospital y el estado vital al mes en dos grupos (separados por la estancia en la unidad coronaria de dos dias). Se analiza un subgrupo de pacientes con bajo riesgo de mortalidad al mes y se investiga en ellos las complicaciones que pudo originar el alta precoz de la unidad coronaria. Resultados Fallecieron 73 pacientes en los dos primeros dias; de los supervivientes, en 336 la estancia fue igual o inferior a 2 dias (grupo A) y en 569 fue mayor de 2 dias (grupo B). En el grupo A fue significativamente mas frecuente el antecedente de dislipemia, de clase Killip I al ingreso, de infarto no complicado en la unidad coronaria y el uso de betabloqueantes y menos frecuente, el infarto agudo de miocardio con onda Q, la localizacion anterior y el uso de fibrinoliticos. En el primer mes tras el alta de la unidad coronaria, fallecieron 10 pacientes del grupo A y 18 del grupo B, siendo la tasa de «muerte o reingreso en la UC» a los 30 dias similar en ambos grupos (grupo A = 13% y grupo B = 13%). En un analisis de regresion multiple se observo que la clase Killip en el momento del ingreso y la presencia de complicaciones se relacionaron de forma independiente con la estancia en la unidad coronaria. Se definio un subgrupo de pacientes de bajo riesgo (Killip I al ingreso, sin complicaciones en la unidad coronaria y edad inferior a 71 anos) compuesto por 378 pacientes que no tuvieron mortalidad a los 30 dias y cuya tasa de reingreso al mes fue del 4% (n = 16). Aquellos casos con una estancia igual o inferior a 2 dias reingresaron mas frecuentemente durante la primera semana (grupo A = 9/197 [5%] y grupo B = 1/181 [0,5%]; p = 0,034). Conclusiones En pacientes seleccionados con infarto agudo de miocardio es posible el alta muy precoz de la unidad coronaria con bajo riesgo de muerte. En estos pacientes es previsible una tasa de reingreso en torno al 5% en los dias siguientes al alta.

Introduction and objectives Symptomatic mitral regurgitation has an unfavorable prognosis unless treated by surgery. However, the European registry of valvular heart disease reports that 49% of patients with this condition do not undergo surgery. Percutaneous treatment of mitral regurgitation with MitraClip ® has been proved a safe, efficient adjunct to medical treatment in patients with this profile. The objective of the present study is to describe initial experience of MitraClip ® therapy in Spain. Methods Retrospective observational study including all patients treated between November 2011 and July 2013 at the 4 Spanish hospitals recording the highest numbers of implantations. Results A total of 62 patients (77.4% men) were treated, mainly for restrictive functional mitral regurgitation (85.4%) of grade III (37%) or grade IV (63%), mean (standard deviation) ejection fraction 36% (14%), and New York Heart Association functional class III (37%) or IV (63%). Device implantation was successful in 98% of the patients. At 1 year, 81.2% had mitral regurgitation ≤ 2 and 90.9% were in New York Heart Association functional class ≤ II. One periprocedural death occurred (sepsis at 20 days post-implantation) and another 3 patients died during follow-up (mean, 9.1 months). Two patients needed a second implantation due to partial dehiscence of the first device and 2 others underwent heart transplantation. Conclusions In Spain, MitraClip ® therapy has principally been aimed at patients with functional mitral regurgitation, significant systolic ventricular dysfunction, and high surgical risk. It is considered a safe alternative treatment, which can reduce mitral regurgitation and improve functional capacity.

The aim of this study was to determine whether drug-eluting stents (DES) are superior to bare-metal stents (BMS) in octogenarian patients with angina.Patients ≥80 years of age frequently have complex coronary disease warranting DES but have a higher risk of bleeding from prolonged dual antiplatelet therapy.This multicenter randomized trial was conducted in 22 centers in the United Kingdom and Spain. Patients ≥80 years of age underwent stent placement for angina. The primary endpoint was a 1-year composite of death, myocardial infarction, cerebrovascular accident, target vessel revascularization, or major hemorrhage.In total, 800 patients (83.5 ± 3.2 years of age) were randomized to BMS (n = 401) or DES (n = 399) for treatment of stable angina (32%) or acute coronary syndrome (68%). Procedural success did not differ between groups (97.7% for BMS vs. 95.4% for DES; p = 0.07). Thirty-eight percent of patients had ≥2-vessel percutaneous coronary intervention, and 66% underwent complete revascularization. Patients who received BMS had shorter stent implants (24.0 ± 13.4 mm vs. 26.6 ± 14.3 mm; p = 0.01). Rates of dual antiplatelet therapy at 1 year were 32.2% for patients in the BMS group and 94.0% for patients in the DES group. The primary endpoint occurred in 18.7% of patients in the BMS group versus 14.3% of patients in the DES group (p = 0.09). There was no difference in death (7.2% vs. 8.5%; p = 0.50), major hemorrhage (1.7% vs. 2.3%; p = 0.61), or cerebrovascular accident (1.2% vs. 1.5%; p = 0.77). Myocardial infarction (8.7% vs. 4.3%; p = 0.01) and target vessel revascularization (7.0% vs. 2.0%; p = 0.001) occurred more often in patients in the BMS group.BMS and DES offer good clinical outcomes in this age group. DES were associated with a lower incidence of myocardial infarction and target vessel revascularization without increased incidence of major hemorrhage. (Xience or Vision Stent-Management of Angina in the Elderly [XIMA]; ISRCTN92243650).

This study sought to investigate the clinical impact of the use of intravascular ultrasound (IVUS) during revascularization of patients with left main coronary artery (LM) disease with drug-eluting stents (DES).Whether the use of IVUS during the procedure adds a clinical benefit remains unclear. There is only 1 previous observational study, with relevant limitations, supporting the value of this strategy.We performed a patient-level pooled analysis of 4 registries of patients with LM disease treated with DES in Spain. A propensity score-matching method was used to obtain matched pairs of patients with and without IVUS guidance.A total of 1,670 patients were included, and 505 patients (30.2%) underwent DES implantation under IVUS guidance (IVUS group). By means of the matching method, 505 patients without the use of IVUS during revascularization were selected (no-IVUS group). Survival free of cardiac death, myocardial infarction, and target lesion revascularization at 3 years was 88.7% in the IVUS group and 83.6% in the no-IVUS group (p = 0.04) for the overall population, and 90% and 80.7%, respectively (p = 0.03), for the subgroups with distal LM lesions. The incidence of definite and probable thrombosis was significantly lower in the IVUS group (0.6% vs. 2.2%; p = 0.04). Finally, IVUS-guided revascularization was identified as an independent predictor for major adverse events in the overall population (hazard ratio: 0.70, 95% confidence interval: 0.52 to 0.99; p = 0.04) and in the subgroup with distal lesions (hazard ratio: 0.54, 95% confidence interval: 0.34 to 0.90; p = 0.02).The results of this pooled analysis show an association of IVUS guidance during percutaneous coronary intervention with better outcomes in patients with LM disease undergoing revascularization with DES.

Objectives. This study was designed to evaluate the effect of an antithrombotic regimen without full early anticoagulation on subacute occlusion, bleeding, hospital stay and restenosis after elective coronary stenting. Background. Subacute occlusion is a major limitation of stenting. Aggressive antithrombotic therapy is not fully prophylactic against this complication, carries risk of bleeding, prolongs hospital stay and reduces cost-effectiveness. Methods. We studied 110 consecutive patients (121 lesions) who underwent elective Palmaz-Schatz stenting. Intravenous heparin was given only during the procedure. After stenting, patients took aspirin, dipyridamole, dextran, warfarin and low molecular weight heparin (enoxaparin, 40 mg subcutaneously daily, stopped when an international normalized ratio of 2 to 3 was achieved). The first 52 patients (group A) underwent coronary angiography 24 h after stenting, and hospital stay was extended until an international normalized ratio of 2 to 3.5 was achieved. The remaining 58 patients (group B) were discharged 24 h after stenting. Clinical and angiographic follow-up were performed 1 and 6 months after stenting for all patients. Results. In group A the activated partial thromboplastin time remained normal (30 ± 6.2 s [mean ±SD]) during enoxaparin administration, and hospital stay was 9.1 ± 4.3 days. In group B hospital stay was 27 ± 8 h. No major cardiac events occurred within the first month in patients from both groups. At 1 and 30 days all stented lesions remained patent. Only two patients (1.8%, 95% confidence interval [CI] 0.32% to 7%) developed bleeding. At 6 months, the restenosis rate was 22% (95% CI 15% to 30%). Conclusions. After coronary stenting with optimal angiographic results, this new antithrombotic regimen prevented subacute stent occlusion and bleeding, with a brief hospital stay. No detrimental effect on the previously reported restenosis rate was observed.

The evidences of therapy with drug-eluting stents (DES) in ST-elevation myocardial infarction are mostly based on trials performed with first-generation DES. There is paucity of data with long-term follow up with second-generation DES in this setting. The ESTROFA-MI is a multicenter retrospective

Background— A catheter-based approach after fibrinolysis is recommended if fibrinolysis is likely to be successful in patients with acute ST-elevation myocardial infarction. We designed a 2×2 randomized, open-label, multicenter trial to evaluate the efficacy and safety of the paclitaxel-eluting stent and tirofiban administered after fibrinolysis but before catheterization to optimize the results of this reperfusion strategy. Methods and Results— We randomly assigned 436 patients with acute ST-elevation myocardial infarction to (1) bare-metal stent without tirofiban, (2) bare-metal stent with tirofiban, (3) paclitaxel-eluting stent without tirofiban, and (4) paclitaxel-eluting stent with tirofiban. All patients were initially treated with tenecteplase and enoxaparin. Tirofiban was started 120 minutes after tenecteplase in those patients randomly assigned to tirofiban. Cardiac catheterization was performed within the first 3 to 12 hours after inclusion, and stenting (randomized paclitaxel or bare stent) was applied to the culprit artery. The primary objectives were the rate of in-segment binary restenosis of paclitaxel-eluting stent compared with that of bare-metal stent and the effect of tirofiban on epicardial and myocardial flow before and after mechanical revascularization. At 12 months, in-segment binary restenosis was similar between paclitaxel-eluting stent and bare-metal stent (10.1% versus 11.3%; relative risk, 1.06; 95% confidence interval, 0.74 to 1.52; P =0.89). However, late lumen loss (0.04±0.055 mm versus 0.27±0.057 mm, P =0.003) was reduced in the paclitaxel-eluting stent group. No evidence was found of any association between the use of tirofiban and any improvement in the epicardial and myocardial perfusion. Major bleeding was observed in 6.1% of patients receiving tirofiban and in 2.7% of patients not receiving it (relative risk, 2.22; 95% confidence interval, 0.86 to 5.73; P =0.14). Conclusions— This trial does not provide evidence to support the use of tirofiban after fibrinolysis to improve epicardial and myocardial perfusion. Compared with bare-metal stent, paclitaxel-eluting stent significantly reduced late loss but appeared not to reduce in-segment binary restenosis. Clinical Trial Registration— URL: http://clinicaltrials.gov . Unique identifier: NCT00306228.

This study sought to evaluate second-generation drug-eluting stent (DES) thrombosis in clinical practice.First-generation DES are associated with a significant incidence of late thrombosis. There is paucity of data regarding real practice late thrombosis incidence and predictors with second-generation DES, zotarolimus-eluting stent (ZES), and everolimus-eluting stents (EES).A prospective, large-scale, non-industry-linked multicenter registry was designed. Complete clinical-procedural data and systematic follow-up of all patients treated with these stents was reported in a dedicated registry supported by the Spanish Working Group on Interventional Cardiology.From 2005 to 2008, 4,768 patients were included in 34 centers: 2,549 treated with ZES, and 2,219 with EES. The cumulative incidence of definite/probable thrombosis for ZES was 1.3% at 1 year and 1.7% at 2 years and for EES 1.4% at 1 year and 1.7% at 2 years (p = 0.8). The increment of definite thrombosis between the first and second year was 0.2% and 0.25%, respectively. In a propensity score analysis, the incidence remained very similar. Ejection fraction (adjusted hazard ratio [HR]: 0.97; 95% confidence interval [CI]: 0.95 to -0.99; p = 0.008), stent diameter (adjusted HR: 0.37; 95% CI: 0.17to 0.81; p = 0.01) and bifurcations (adjusted HR: 2.1; 95% CI: 1.14 to 3.7; p = 0.02) emerged as independent predictors of thrombosis. In the subgroup of patients with bifurcations, the use of ZES was independently associated with a higher thrombosis rate (adjusted HR: 4; 95% CI: 1.1 to 13; p = 0.03).In a real practice setting, the incidence of thrombosis at 2 years with ZES and EES was low and quite similar. The incidence of very late thrombosis resulted lower than was reported in registries of first-generation DES. In the subset of bifurcations, the use of ZES significantly increased the risk of thrombosis.

Background We tried to evaluate a putative negative effect on coronary atherosclerosis in patients receiving intracoronary infusion of unfractionated bone marrow mononuclear cells (BMMC) following an acute ST-elevation myocardial infarction. Peripheral blood mononuclear cells or enriched CD133 + BMMC have been associated with accelerated atherosclerosis of the distal segment of the infarct related artery (IRA). Methods Thirty-seven patients with ST-elevation myocardial infarction from the TECAM pilot study underwent intracoronary infusion of autologous BMMC 9 ± 3.1 days after onset of symptoms. We compared angiographic changes from baseline to 9 months of follow-up in the distal non-stented segment of the IRA, as well as in the contralateral coronary artery, with a matched control group. A subgroup of 15 treated patients underwent additional IVUS within the distal segment of the IRA. Results No difference between stem cell and control group were found regarding changes in minimum lumen diameter (0.006 ± 0.42 vs 0.06 ± 0.41 mm, P = ns) and the percentage of stenosis (−2.68 ± 12.33% vs −1.78 ± 8.75%, P = ns) at follow-up. Likewise, no differences were seen regarding changes in the contralateral artery (minimum lumen diameter −0.004 ± 0.54 mm vs −0.06 ± 0.35 mm, P = ns). In the intravascular ultrasound substudy, no changes were demonstrated comparing baseline versus follow-up in maximum area stenosis and plaque volume. Conclusions In this pilot study , analysis of a subgroup of patients found that intracoronary injection of unfractionated BMMC in patients with acute ST-elevation myocardial infarction was not associated with accelerated atherosclerosis progression at mid term. Prospective, randomised studies in large cohorts with long-term angiographic and intravascular ultrasound follow-up are necessary to determine the safety of this therapy.

The aims of this study were to assess the safety of drug-eluting stent (DES) use and to compare the incidence of in-stent restenosis (ISR) and neointimal hyperplasia formation according to the type of stent implanted (DES vs bare-metal stents [BMS]) in patients who underwent intracoronary bone marrow mononuclear cell transplantation after acute ST elevation myocardial infarction. Fifty-nine patients with successfully revascularized ST elevation myocardial infarction (37 using BMS and 22 using DES) underwent paired angiographic examinations at baseline and 6 to 9 months after the intracoronary injection of 91 million +/- 56 million autologous bone marrow mononuclear cells. A subgroup of 30 patients also underwent serial intravascular ultrasound examinations. Off-line angiographic assessment showed 4 cases of binary ISR, primarily in BMS (3 cases), and no major adverse cardiac events were associated with stent type (mean follow-up period 41 +/- 10 months). At follow-up, angiographic late luminal loss was significantly lower in patients with DES than in those patients with BMS (0.35 +/- 0.66 vs 0.71 +/- 0.38 mm, p = 0.011). Multivariate analysis identified the use of DES (beta = -0.32, 95% confidence interval [CI] -0.57 to -0.26, p = 0.03) and a smaller baseline reference vessel diameter (beta = 0.29, 95% CI 0.04 to 0.54, p = 0.02) as independent predictors of lower late loss. Moreover, intravascular ultrasound showed a significant reduction of in-stent neointimal hyperplasia formation related to DES use compared with BMS use (Delta neointimal hyperplasia volume 5.4 mm(3) [95% CI 2.7 to 28.1] vs 35.9 mm(3) [95% CI 22.0 to 43.6], p = 0.035). In conclusion, these findings suggest that the use of DES is safe and may prevent ISR and neointimal hyperplasia formation in patients who undergo intracoronary bone marrow mononuclear cell transplantation after a successfully revascularized ST elevation myocardial infarction.

Optical coherence tomography is a new intracoronary diagnostic technique that has a higher resolution than other techniques, such as intravascular ultrasound. We used optical coherence tomography to study outcomes after stent implantation in six patients who had undergone percutaneous coronary intervention, and in whom angiography showed normal results after revascularization. Material was observed to protrude through the stent struts in all patients, small dissections were seen at the stent edges in four patients, and there was incomplete stent apposition in four patients. In two patients, small amounts of thrombus were observed to form around the tomography catheter. With optical coherence tomography, it was possible to detect areas in which the results of percutaneous coronary intervention were suboptimal, despite a satisfactory appearance on angiography.

Higher angiographic perfusion score (APS) following percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) has been shown to be associated with improved clinical outcomes. The association between APS after STEMI and left ventricular remodeling as assessed by volumetric parameters derived from left ventriculography has not been assessed.The APS (the arithmetic sum of the TIMI Flow Grade (TFG) and TIMI Myocardial Perfusion grade (TMPG) before and after percutaneous coronary intervention (PCI), range of 0-12) was assessed in 168 patients from the GRACIA-2 trial. Left ventriculograms performed in the 30 degrees right anterior oblique projection were obtained among 148 patients at initial angiography (prior to PCI) and at 6 weeks. The association of APS with markers of left ventricular remodeling at 6-weeks was examined using left ventricular ejection fraction, delta end systolic volume, delta stroke volume and wall motion index.Full perfusion (APS 10-12), as compared to partial perfusion (APS 4-9) or failed perfusion (APS 0-3), was associated with a greater left ventricular ejection fraction (61.6% +/- 10.0 vs. 56.9% +/- 12.5 vs. 49.8% +/- 16.9, P = 0.015), a decrease in left ventricular end systolic volume indicating favorable remodeling (mean -4.1 cc +/- 17.3 vs. +2.0 cc +/- 17.3 vs. +9.8 cc +/- 16.1, P = 0.015), a greater improvement in left ventricular stroke volume (mean +13.7 cc +/- 17.1 vs. +6.7 cc +/- 15.5 vs. +1.2 cc +/- 13.4, P = 0.009) and a decreased wall motion index (number of chords in the hypokinetic region) (mean 15.1 +/- 16.4 vs. 21.4 +/- 20.5 vs. 32.9 +/- 22.1, P = 0.026) at 6 weeks.In conclusion, among patients treated with combined reperfusion and revascularization strategies for STEMI, higher APS is associated with more favorable markers of left ventricular remodeling and improved 6-week left ventricular function.

It has been estimated that 15-25% of patients who undergo percutaneous or surgical coronary angioplasty are diabetics. The indications for coronary revascularization and initial results of the procedure do not differ substantially between patients with diabetes mellitus and non-diabetics. However, the long-term results of both percutaneous and surgical coronary angioplasty are less favorable in diabetics in terms of mortality and the need for new revascularization procedures. The development and widespread use of stents and glycoprotein IIb/IIIa receptor inhibiting drugs have improved the clinical evolution of diabetics treated with angioplasty. Currently available data show that the administration of glycoprotein IIb/IIIa inhibitors to patients undergoing coronary angioplasty is especially useful in diabetics and improves short-term and long-term results, decreasing one-year mortality by 45%. There seem to be indications for the routine use of glycoprotein IIb/IIIa inhibitors in diabetics treated with angioplasty. While the use of stents has improved long-term and short-term results in diabetics, the success rates of angioplasty in diabetics are still lower than in non-diabetics. Diabetes is still an independent predictor of restenosis and long-term events after stenting interventions. Analysis of the studies comparing percutaneous and surgical revascularization in diabetic patients with multivessel disease shows that surgery is superior in terms of long-term mortality and need for new revascularization procedures. Stenting has improved, but not substantially, the results of multivessel angioplasty in diabetics. Therefore, the indications for angioplasty in multivessel diabetics should be evaluated individually. Factors that contribute to the less favorable post-angioplasty evolution of diabetic patients are more rapid progression of atherosclerosis and, especially, a higher rate of restenosis. New angioplasty techniques, such as brachytherapy and drug-eluting stents, are likely to significantly improve the results of percutaneous interventions in diabetics, thus allowing the indications for angioplasty in diabetics to be extended even further in the near future.

To determine the feasibility and safety of early posthrombolysis coronary stenting and the incidence of further reocclusion, we followed 99 consecutive patients with acute myocardial infarction thrombolyzed with rt-PA 2.0 +/- 0.8 hr after onset. Culprit artery was stented 14.0 +/- 7.0 hr after thrombolysis. All patients underwent clinical and angiographic follow-up at 1 and 6 months. Angiographic success was achieved in 99% of cases. Neither major cardiac events nor bleeding or vascular complications occurred during hospital stay. At 30 days, no events occurred and normal flow persisted in all stented arteries. At 6 months, only one artery reoccluded (1%), resulting in a nonfatal reinfarction. Restenosis rate was 21%. Contribution of the infarcted area to left ventricular function significantly increased from baseline to 30-day and to 6-month evaluations. Thus, early posthrombolysis stenting is a safe strategy with a low reocclusion rate, which seems to allow functional recovery of the infarcted area. Further studies are necessary to define its impact on survival and cost-effectiveness.

The objective of this study was to compare the initial and long-term outcome of elderly and younger patients after coronary stent implantation.The evolutions of 76 patients aged75 years and of 860 patients agedor =75 years who underwent consecutive stenting (from June 1991 to June 1997) were compared in a cohort study.The elderly patients had lower left ventricular ejection fractions (0.58 +/- 0.14 vs 0.61 +/- 0.13; P =.03) and more frequently had unstable angina (78.9% vs 55.3%; P.0001), previous heart failure (10.5% vs 4.9%; P =.03), and multivessel disease (68.4% vs 58.3%; P =.08). After the procedure, the elderly patients showed a higher inhospital mortality rate (6.6% vs 2.4%; P =.03) and myocardial infarction rate (5.3% vs 1.7%; P =.04). The long-term follow-up period (mean, 3.2 +/- 1.4 years; median, 3.0 years) showed in the elderly a higher mortality rate (15.4% vs 5.8%; P =.006), a lower rate of repeat revascularization (9.2% vs 19.7%; P =.04), and a similar incidence rate of major adverse cardiac events (27.7% vs 28.2%; P =.93). Multivariate analysis of the elderly group identified female gender (hazard ratio, 2.19; 95% CI, 1.18 to 4.06; P =.012) and presence of multivessel disease (hazard ratio, 2.35; 95% CI, 1.05 to 5.26; P =.037) as independent predictors of further events.Patients aged75 years have a less favorable baseline profile and higher inhospital and 3-year mortality rates. However, the incidence rate of major adverse cardiac events in the long term is acceptable and similar to that of younger patients.

Objectives. We sought to analyze right ventricular contractility during dobutamine infusion in patients with right coronary artery disease and to elucidate whether the development of right ventricular asynergy aids in characterizing a right coronary artery stenosis.Background. Clinical investigations are emphasizing the importance of right ventricular function in patients with coronary artery disease. Thus, prognosis of patients with inferior myocardial infarction is influenced by right ventricular function. This study describes the echocardiographic and electrocardiographic findings during dobutamine-atropine echocardiography in patients with right coronary artery disease.Methods. We studied 31 patients with isolated right coronary artery disease and no previous myocardial infarction. Six patients with poor acoustic window were excluded (feasibility 80%). The remaining 25 patients underwent dobutamine-atropine echocardiography. A right coronary artery stenosis located before the origin of the right ventricular branches was considered proximal; otherwise, it was considered distal.Results. Right ventricular asynergy during dobutamine-atropine testing developed in 17 patients (sensitivity 68%); 14 had proximal and 3 had distal right coronary artery disease. The following segments were involved: inferior (n = 17), lateral (n = 5) and outflow tract (n = 1). No patient showed anterior asynergy. All 17 patients had left ventricular asynergy as well. Ischemia-free time was 10.7 ± 6.2 (mean ± SD) min for the right ventricle and 8.9 ± 5.2 min for the left ventricle (p < 0.05). Ischemic ST changes were recorded in 15 patients (in standard leads in 14 and in right precordial leads in 8). All patients with right precordial changes showed ST elevation and had right ventricular asynergy (sensitivity and specificity for right ventricular asynergy 47% and 100%, respectively). A control group of 25 patients with no right coronary artery disease (5 with no disease, 15 with left anterior descending and 5 with left circumflex coronary artery disease) underwent dobutamine echocardiography. Right ventricular asynergy developed in two patients with left anterior descending artery stenosis (specificity 92%); in both, the anterior wall was affected.Conclusions. Echocardiography during dobutamine infusion is a reliable technique for assessing right ventricular dysfunction in patients with right coronary artery disease. Right ventricular contractility can be assessed during dobutamine echocardiography in selected patients.