Eduardo Pinar

Drug-Eluting Stent Thrombosis Results From the Multicenter Spanish Registry ESTROFA (Estudio ESpañol sobre TROmbosis de stents FArmacoactivos)

OBJECTIVES This study sought to assess the incidence, predictors, and outcome of drug-eluting stent(DES) thrombosis in real-world clinical practice. BACKGROUND The DES thromboses in randomized trials could not be comparable to those observed in clinical practice, frequently including off-label indications. METHODS We designed a large-scale, nonindustry-linked multicentered registry, with 20 centers in Spain. The participant centers provided follow-up data for their patients treated with DES, reporting a detailed standardized form in the event of any angiography-documented DES-associated thrombosis occurring. RESULTS Of 23,500 patients treated with DES, definite stent thrombosis(ST) developed in 301: 24 acute, 125 subacute, and 152 late. Of the late, 62 occurred >1 year(very late ST). The cumulative incidence was 2% at 3 years. Antiplatelet treatment had been discontinued in 95 cases(31.6%). No differences in incidences were found among stent types. Independent predictors for subacute ST analyzed in a subgroup of 14,120 cases were diabetes, renal failure, acute coronary syndrome, ST-segment elevation myocardial infarction, stent length, and left anterior descending artery stenting, and for late ST were ST-segment elevation myocardial infarction, stenting in left anterior descending artery, and stent length. Mortality at 1-year follow-up was 16% and ST recurrence 4.6%. Older age, left ventricular ejection fraction <45%, nonrestoration of Thrombolysis In Myocardial Infarction flow grade 3, and additional stenting were independent predictors for mortality. CONCLUSIONS The cumulative incidence of ST after DES implantation was 2% at 3 years. No differences were found among stent types. Patient profiles differed between early and late ST. Short-term prognosis is poor, especially when restoration of normal flow fails.

Anticoagulant and antiplatelet therapy use in 426 patients with atrial fibrillation undergoing percutaneous coronary intervention and stent implantation implications for bleeding risk and prognosis.

OBJECTIVES This study was designed to review outcomes in relation to antithrombotic therapy management strategies for patients with atrial fibrillation (AF) who undergo percutaneous coronary intervention (PCI) with stenting. BACKGROUND There is limited evidence on the optimal antithrombotic therapy management strategies for patients with AF who undergo PCI with stenting. METHODS We reviewed 426 patients (70.9% men, mean age 71.5 +/- 8.5 years) with AF undergoing PCI with stenting between 2001 and 2006. We recorded clinical and demographic characteristics of the patients, stroke risk factors, and antithrombotic therapy use before PCI and at discharge. Clinical follow-up was performed, and all bleeding episodes, thromboembolism, and major adverse cardiac events (MACE) (i.e., death, acute myocardial infarction, or target lesion revascularization) were recorded. RESULTS The most commonly associated comorbidities were hypertension (74.5%), diabetes mellitus (40.2%), chronic renal failure (14.9%), and congestive heart failure (26.7%); 80% of patients had >or=2 stroke risk factors. Of the drugs prescribed at discharge, aspirin plus clopidogrel were used in 174 patients (40.8%), whereas 213 patients (50%) were discharged with triple therapy (coumarins, aspirin, and clopidogrel). Complete follow-up was achieved in 87.5% (median 594 days; range 0 to 2,190). The incidence of adverse events was high (36.6%), with major bleeding in 12.3%, thromboembolic events in 4.2%, and MACE in 32.3%. All-cause mortality was high (22.6%). In a multivariate analysis, non-anticoagulation with coumarins increased mortality (17.8% vs. 27.8%; hazard ratio [HR] = 3.43; 95% confidence interval [CI] 1.61 to 7.54; p = 0.002) and MACE (26.5% vs. 38.7%; HR = 4.9; 95% CI 2.17 to 11.1; p < 0.01) In a Cox-regression analysis, non-anticoagulation (p < 0.01) and age (p = 0.02) were independent predictors of MACE. CONCLUSIONS Patients with AF undergoing PCI with stenting represent a high-risk population because of age, comorbidities, and presence of stroke risk factors. These patients have a high mortality and MACE rate, which is reduced by anticoagulation therapy.

Increased Major Bleeding Complications Related to Triple Antithrombotic Therapy Usage in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Artery Stenting

BACKGROUND The optimal antithrombotic therapy strategy for atrial fibrillation (AF) patients who undergo percutaneous coronary intervention with stent implantation (PCI-S) is unknown. We assessed the safety of antithrombotic therapy strategies in AF patients with indication for oral anticoagulation (OAC) undergoing PCI-S. METHODS We studied consecutive AF patients with indication for OAC who underwent PCI-S. We compared patients that received triple antithrombotic therapy (TT) [aspirin, clopidogrel, and coumadin] against other regimes (non-TT) after PCI-S. The primary end point was defined as the occurrence of major bleeding complications that were termed as early major bleeding (EMB) [< or = 48 h] or late major bleeding (LMB) [> 48 h]. Clinical follow-up was performed, and complications were recorded. RESULTS We studied 104 patients (mean age +/- SD, 72 +/- 8 years; 70% men); TT was used in 51 patients (49%). TT was associated with a higher incidence of LMB (21.6% vs non-TT, 3.8%; p = 0.006) but not of EMB (5.8% vs non-TT, 11.3%; p = 0.33). In multivariate analyses, glycoprotein (GP) IIb/IIIa inhibitor use (hazard ratio [HR], 13.5; 95% confidence interval [CI], 1.7 to 108.3; p = 0.014) and PCI-S of three vessels or left main artery disease (HR, 7.9; 95% CI, 1.6 to 39.2; p = 0.01) were independent predictors for EMB. TT use (HR, 7.1; 95% CI, 1.5 to 32.4; p = 0.012), the occurrence of EMB (HR, 6.7; 95% CI, 1.8 to 25.3; p = 0.005), and baseline anemia (HR, 3.8; 95% CI, 1.2 to 12.5; p = 0.027) were independent predictors for LMB. No differences in major cardiovascular events were observed in patients treated with TT vs non-TT (25.5% vs 21.0%; p = 0.53). CONCLUSION A high rate of major bleeding is observed in AF patients with indication for OAC undergoing PCI-S who receive TT. GP IIb/IIIa inhibitor use and multivessel/left main artery disease during PCI-S were independent predictors for EMB, while TT use, occurrence of EMB, and baseline anemia were independent predictors for LMB.

Absorb Bioresorbable Vascular Scaffold Versus Everolimus-Eluting Metallic Stent in ST-Segment Elevation Myocardial Infarction: 1-Year Results of a Propensity Score Matching Comparison: The BVS-EXAMINATION Study (Bioresorbable Vascular Scaffold-A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction)

OBJECTIVES The purpose of this study was to compare the 1-year outcome between bioresorbable vascular scaffold (BVS) and everolimus-eluting metallic stent (EES) in ST-segment elevation myocardial infarction (STEMI) patients. BACKGROUND The Absorb BVS (Abbott Vascular, Santa Clara, California) is a polymeric scaffold approved for treatment of stable coronary lesions. Limited and not randomized data are available on its use in ST-segment elevation myocardial infarction (STEMI) patients. METHODS This study included 290 consecutive STEMI patients treated by BVS, compared with either 290 STEMI patients treated with EES or 290 STEMI patients treated with bare-metal stents (BMS) from the EXAMINATION (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction) trial, by applying propensity score matching. The primary endpoint was a device-oriented endpoint (DOCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization, at 1-year follow-up. Device thrombosis, according to the Academic Research Consortium criteria, was also evaluated. RESULTS The cumulative incidence of DOCE did not differ between the BVS and EES or BMS groups either at 30 days (3.1% vs. 2.4%, hazard ratio [HR]: 1.31 [95% confidence interval (CI): 0.48 to 3.52], p = 0.593; vs. 2.8%, HR: 1.15 [95% CI: 0.44 to 2.30], p = 0.776, respectively) or at 1 year (4.1% vs. 4.1%, HR: 0.99 [95% CI: 0.23 to 4.32], p = 0.994; vs. 5.9%, HR: 0.50 [95% CI: 0.13 to 1.88], p = 0.306, respectively). Definite/probable BVS thrombosis rate was numerically higher either at 30 days (2.1% vs. 0.3%, p = 0.059; vs. 1.0%, p = 0.324, respectively) or at 1 year (2.4% vs. 1.4%, p = 0.948; vs. 1.7%, p = 0.825, respectively), as compared with EES or BMS. CONCLUSIONS At 1-year follow-up, STEMI patients treated with BVS showed similar rates of DOCE compared with STEMI patients treated with EES or BMS, although rate of scaffolds thrombosis, mostly clustered in the early phase, was not negligible. Larger studies with longer follow-up are needed to confirm our findings.

Registro Español de Hemodinámica y Cardiología Intervencionista. XVI Informe Oficial de la Sección de Hemodinámica y Cardiología Intervencionista de la Sociedad Española de Cardiología (1990-2006)

Se presentan los resultados del Registro de Actividad de la Seccion de Hemodinamica y Cardiologia Intervencionista de la Sociedad Espanola de Cardiologia del ano 2006. Se recogen los datos de 135 hospitales, de los cuales 125 realizan su actividad predominante en adultos y 10 atienden exclusivamente a pacientes pediatricos. Se realizaron 126.196 estudios diagnosticos, con 113.228 coronariografias, lo que representa un aumento del 7,6% respecto al ano 2005 y una tasa de 2.560 coronariografias/millon de habitantes. Se realizaron 57.041 procedimientos intervencionistas coronarios, con un incremento del 7,8% respecto al 2005 y una tasa de 1.293 intervenciones/millon de habitantes. Se implantaron 90.006 stents, de los cuales el 59,3% fueron farmacoactivos. Se llevaron a cabo 10.067 procedimientos de intervencionismo en el infarto agudo de miocardio, lo que supone un incremento del 20,6% respecto al ano anterior y representa el 17,6% del total de las intervenciones coronaries percutaneas. El intervencionismo no coronario mas frecuente se realiza en las cardiopatias congenitas del adulto, como el cierre de la comunicacion interauricular, que es el de mayor numero, 334 procedimientos. La valvuloplastia mitral, con 431 casos tratados, apenas presenta cambios respecto al anterior Registro, y su exito esta en el 93,6%. La via de acceso radial se usa cada vez mas y mantiene el aumento de anos anteriores. Es de destacar el alto grado de participacion de los diferentes centros en el actual Registro, que hace que sea un referente internacional de la actividad hemodinamica en nuestro pais.

Registro Español de Hemodinámica y Cardiología Intervencionista. XVII Informe Oficial de la Sección de Hemodinámica y Cardiología Intervencionista de la Sociedad Española de Cardiología (1990-2007)

Se presentan los resultados del Registro de Actividad de la Seccion de Hemodinamica y Cardiologia Intervencionista de la Sociedad Espanola de Cardiologia del ano 2007. Se recogen los datos de 129 hospitales que realizan su actividad predominante en adultos; de esos centros, 74 realizan actividad publica y 55, privada. Se realizaron 136.231 estudios diagnosticos, con 122.260 coronariografias, lo que representa un aumento del 7,9% respecto al ano 2006 y una tasa de 2.725 coronariografias/ millon de habitantes. Los procedimientos intervencionistas coronarios practicados fueron 60.457, con un incremento del 6% respecto al 2006 y una tasa de 1.347 intervenciones/millon de habitantes. Se implantaron 94.966 stents, de los que el 57,7% fueron farmacoactivos. Se llevaron a cabo 11.322 procedimientos de intervencionismo en el infarto agudo de miocardio, lo que supone un incremento del 12,5% respecto al ano anterior y el 18,7% del total de intervenciones coronarias percutaneas. El intervencionismo no coronario mas frecuente se realiza en las cardiopatias congenitas del adulto; el cierre de la comunicacion interauricular es el de mayor numero, con 334 procedimientos. La valvuloplastia mitral, con 367 casos tratados y una tasa de exito del 90,7%, es el procedimiento percutaneo valvular mas realizado. Este ano han avanzado los procedimientos de implante de valvulas percutaneas, pues se ha implantado 18 valvulas entre pulmonares y aorticas. La via de acceso radial alcanza el 40% tanto en el diagnostico como en el intervencionismo. Es de destacar el alto grado de participacion de los diferentes centros en el actual Registro, que hace que sea un referente internacional de la actividad hemodinamica en nuestro pais.

Registro Español de Hemodinámica y Cardiología Intervencionista. XVIII Informe Oficial de la Sección de Hemodinámica y Cardiología Intervencionista de la Sociedad Española de Cardiología (1990-2008)

Introduccion y objetivos La Seccion de Hemodinamica y Cardiologia Intervencionista presenta un informe anual con los datos del registro de actividad estatal. El actual corresponde al ano 2008. Esta informacion permite saber la distribucion nacional del intervencionismo cardiaco y ofrece datos para compararlo con el de otros paises. Metodos Los centros proporcionan sus datos de forma voluntaria. La informacion es analizada por la Junta directiva de la Seccion de Hemodinamica. Resultados Enviaron sus datos 131 hospitales (74 centros publicos y 57 privados) que realizan su actividad predominantemente en adultos. Se realizaron 136.458 estudios diagnosticos, con 123.031 coronariografias, sin apenas cambios respecto al ano anterior, con una tasa de 2.658 coronariografias por millon de habitantes. Los procedimientos intervencionistas coronarios aumentaron un 2,2% y llegaron a los 61.810, con una tasa de 1.334 intervenciones por millon de habitantes. Se implantaron 101.753 stents, de los cuales el 58,2% eran farmacoactivos. Se llevaron a cabo 12.079 procedimientos en el infarto agudo de miocardio, lo que supone un incremento del 6,7% respecto a 2007 y representa el 20,6% del total de intervenciones coronarias percutaneas. El intervencionismo mas frecuente en las cardiopatias congenitas del adulto es el cierre de la comunicacion interauricular (305 procedimientos). La valvuloplastia mitral (con 371 casos tratados y exito en el 96%) es el procedimiento valvular mas realizado. Se han implantado 151 valvulas aorticas percutaneas. Conclusiones El aumento mas importante en la actividad ha tenido lugar en relacion con el infarto agudo de miocardio con elevacion del segmento ST y el implante percutaneo de valvulas; los demas procedimientos tanto diagnosticos como terapeuticos aumentaron ligeramente.

Spanish Cardiac Catheterization and Coronary Intervention Registry. 18th Official Report of the Spanish Society of Cardiology Working Group on Cardiac Catheterization and Interventional Cardiology (1990-2008)

INTRODUCTION AND OBJECTIVES Each year the Spanish Society of Cardiology Working Group on Cardiac Catheterization and Interventional Cardiology reports on the data contained in a national registry of procedures performed. The present report is for the year 2008. It contains information on the scope of interventional cardiology in Spain and provides data for use in comparisons with other countries. METHODS Hospitals provided data voluntarily. The information was analyzed by the steering committee of the Working Group. RESULTS Data were submitted by 131 hospitals (74 public and 57 private) that performed relevant procedures, mainly in adults. In total, 136,458 diagnostic procedures were carried out, of which 123,031 involved coronary angiography. Numbers were little changed from the previous year, with an overall rate of 2658 coronary angiograms per million population. The number of percutaneous coronary interventions increased by 2.2% to 61,810, with a rate of 1334 per million inhabitants. In addition, 101,753 stents were implanted, of which 58.2% were drug-eluting. The number of procedures carried out for acute myocardial infarction was 12,079, which makes up 20.6% of all percutaneous coronary interventions and is an increase of 6.7% relative to 2007. The most common intervention in adults with congenital heart disease was closure of an atrial septal defect, which was performed in 305 cases. The most common valve procedure was mitral valvuloplasty, which was performed in 371 cases with a success rate of 96%. Further, 151 aortic percutaneous valves were implanted. CONCLUSIONS The most significant increases in activity were in procedures for ST-segment elevation myocardial infarction and percutaneous valve implantation. The rates of all other diagnostic and therapeutic procedures changed only slightly.

Comparación de los stents liberadores de fármaco y los convencionales en puentes de safena. Resultados inmediatos y a largo plazo

ntroduccion y objetivos. Los stents farmacoactivos (SLF) consiguen reducir la reestenosis en vasos nativos. Sin embargo, los resultados en safenas son mas confusos. Se comparan los resultados de dichos dispositivos con los de los stents convencionales (SC) en estenosis de novo. Metodos. Se estudiaron las intervenciones en safenas con SLF en cinco centros desde el inicio de su uso hasta julio de 2007 y se compararon con una cohorte historica de SC en dos de los centros. Se analizan los resultados intrahospitalarios y a largo plazo y predictores de supervivencia y revascularizacion. Resultados. Se incluyo a 98 pacientes y 107 estenosis con SLF y 113 pacientes y 130 estenosis con SC. Habia diferencias basales, con mayor edad y menor frecuencia de trombo en los SLF. Tambien se encontraron diferencias en el procedimiento con mayor longitud de stent y menos implante directo y diametro de stent en SLF. La ausencia de mortalidad cardiaca a los 12, 24 y 30 meses fue: SLF, 95% ± 2%, 91% ± 3% y 89% ± 3%; SC, 95% ± 2%, 90% ± 3% y 87% ± 3% (p = 0,66), y la ausencia de revascularizacion del vaso tratado: 90% ± 3%, 86% ± 4% y 83% ± 4% en SLF y 94% ± 2%, 87% ± 3% y 87% ± 3% en SC (p = 0,49). El unico predictor de mortalidad cardiaca fue la fraccion de eyeccion y no se encontraron predictores de nueva revascularizacion. Conclusiones. En nuestra serie los SLF en safenas no se asociaron a disminucion de mortalidad ni revascularizacion del vaso tratado. El unico predictor de mortalidad cardiaca fue la fraccion de eyeccion, y no se encontraron predictores de nueva revascularizacion

Comparison of Drug-Eluting and Bare Metal Stents in Saphenous Vein Grafts. Immediate and Long-Term Results

INTRODUCTION AND OBJECTIVES Drug-eluting stents (DES) reduce the restenosis rate in native vessels. However, results in saphenous vein grafts (SVG) are less clear. The aim of this study was to compare DES and bare metal stents (BMS) in de novo stenosis in SVG. METHODS The study included all percutaneous interventions involving a DES in SVG carried out at five centers up until July 2007. Findings were compared with those in a historical cohort that used conventional stents at two centers. The study analyzed in-hospital and long-term outcomes and predictors of survival and revascularization. RESULTS The study included 107 stenoses treated with DESs in 98 patients and 130 stenoses treated with BMS in 113 patients. The DES group was older at baseline and had thrombus less often. There were also procedural differences: in the DES group, stents were longer, direct stenting was used less, and the stent diameter was smaller. The proportion of patients who experienced cardiac death by 12, 24 and 30 months was 95%+/-2%, 91%+/-3% and 89%+/-3%, respectively, in the DES group and 95%+/-2%, 90%+/-3% and 87%+/-3% in the BMS group (P=.66). The proportion without target vessel revascularization at 12, 24 and 30 months was 90%+/-3%, 86%+/-4% and 83%+/-4%, respectively, in the DES group and 94%+/-2%, 87%+/-3% and 87%+/-3% in the BMS group (P=.49). The only predictor of cardiac death was the ejection fraction. There was no predictor of revascularization. CONCLUSIONS In our series, using DESs in SVGs was not associated with a reduction in mortality or target vessel revascularization. The only predictor of cardiac death was the ejection fraction. There was no predictor of revascularization.