José Antonio Baz

Reperfusion therapy for ST elevation acute myocardial infarction in Europe: description of the current situation in 30 countries

Aims Patient access to reperfusion therapy and the use of primary percutaneous coronary intervention (p-PCI) or thrombolysis (TL) varies considerably between European countries. The aim of this study was to obtain a realistic contemporary picture of how patients with ST elevation myocardial infarction (STEMI) are treated in different European countries. Methods and results The chairpersons of the national working groups/societies of interventional cardiology in European countries and selected experts known to be involved in the national registries joined the writing group upon invitation. Data were collected about the country and any existing national STEMI or PCI registries, about STEMI epidemiology, and treatment in each given country and about PCI and p-PCI centres and procedures in each country. Results from the national and/or regional registries in 30 countries were included in this analysis. The annual incidence of hospital admission for any acute myocardial infarction (AMI) varied between 90–312/100 thousand/year, the incidence of STEMI alone ranging from 44 to 142. Primary PCI was the dominant reperfusion strategy in 16 countries and TL in 8 countries. The use of a p-PCI strategy varied between 5 and 92% (of all STEMI patients) and the use of TL between 0 and 55%. Any reperfusion treatment (p-PCI or TL) was used in 37–93% of STEMI patients. Significantly less reperfusion therapy was used in those countries where TL was the dominant strategy. The number of p-PCI procedures per million per year varied among countries between 20 and 970. The mean population served by a single p-PCI centre varied between 0.3 and 7.4 million inhabitants. In those countries offering p-PCI services to the majority of their STEMI patients, this population varied between 0.3 and 1.1 million per centre. In-hospital mortality of all consecutive STEMI patients varied between 4.2 and 13.5%, for patients treated by TL between 3.5 and 14% and for patients treated by p-PCI between 2.7 and 8%. The time reported from symptom onset to the first medical contact (FMC) varied between 60 and 210 min, FMC-needle time for TL between 30 and 110 min, and FMC-balloon time for p-PCI between 60 and 177 min. Conclusion Most North, West, and Central European countries used p-PCI for the majority of their STEMI patients. The lack of organized p-PCI networks was associated with fewer patients overall receiving some form of reperfusion therapy.

Everolimus-eluting stent versus bare-metal stent in ST-segment elevation myocardial infarction (EXAMINATION): 1 year results of a randomised controlled trial

BACKGROUND Everolimus-eluting stent (EES) reduces the risk of restenosis in elective percutaneous coronary intervention. However, the use of drug-eluting stent in patients with ST-segment elevation myocardial infarction (STEMI) is still controversial. Data regarding the performance of second-generation EES in this setting are scarce. We report the 1-year result of the EXAMINATION (clinical Evaluation of the Xience-V stent in Acute Myocardial INfArcTION) trial, comparing EES with bare-metal stents (BMS) in patients with STEMI. METHODS This multicentre, prospective, randomised, all-comer controlled trial was done in 12 medical centres in three countries. Between Dec 31, 2008, and May 15, 2010, we recruited patients with STEMI up to 48 h after the onset of symptoms requiring emergent percutaneous coronary intervention. Patients were randomly assigned (ratio 1:1) to receive EES or BMS. Randomisation was in blocks of four or six patients, stratified by centre and centralised by telephone. Patients were masked to treatment. The primary endpoint was the patient-oriented combined endpoint of all-cause death, any recurrent myocardial infarction, and any revascularisation at 1 year and was analysed by intention to treat. The secondary endpoints of the study included the device-oriented combined endpoint of cardiac death, target vessel myocardial infarction or target lesion revascularisation, and rates of all cause or cardiac death, recurrent myocardial infarction, target lesion or target vessel revascularisation, stent thrombosis, device and procedure success, and major and minor bleeding. This trial is registered with ClinicalTrials.gov, number NCT00828087. FINDINGS Of the 1504 patients randomised, 1498 patients were randomly assigned to receive EES (n=751) or BMS (n=747). The primary endpoint was similar in both groups (89 [11·9%] of 751 patients in the EES group vs 106 [14·2%] of 747 patients in the BMS group; difference -2·34 [95% CI -5·75 to 1·07]; p=0·19). Device-oriented endpoint (44 [5·9%] in the EES group vs 63 [8·4%] in the BMS group; difference -2·57 [95% CI -5·18 to 0·03]; p=0·05) did not differ between groups, although rates of target lesion and vessel revascularisation were significantly lower in the EES group (16 [2·1%] vs 37 [5·0%], p=0·003, and 28 [3·7%] vs 51 [6·8%], p=0·0077, respectively). Rates of all cause (26 [3·5%] for EES vs 26 [3·5%] for BMS, p=1·00) or cardiac death (24 [3·2%] for EES vs 21 [2·8%] for BMS, p=0·76) or myocardial infarction (10 [1·3%] vs 15 [2·0%], p=0·32) did not differ between groups. Stent thrombosis rates were significantly lower in the EES group (4 [0·5%] patients with definite stent thrombosis in the EES group vs 14 [1·9%] in the BMS group and seven [0·9%] patients with definite or probable stent thrombosis in the EES group vs 19 [2·5%] in the BMS group, both p=0·019). Although device success rate was similar between groups, procedure success rate was significantly higher in the EES group (731 [97·5%] vs 705 [94·6%]; p=0·0050). Finally, Bleeding rates at 1 year were comparable between groups (29 [3·9%] patients in the EES group vs 39 [5·2%] in the BMS group; p=0·19). INTERPRETATION The use of EES compared with BMS in the setting of STEMI did not lower the patient-oriented endpoint. However, at the stent level both rates of target lesion revascularisation and stent thrombosis were reduced in recipients of EES. FUNDING Spanish Heart Foundation.

Interruption of blood flow during compression and radial artery occlusion after transradial catheterization.

Objectives: To analyze the possible relationship between compression after transradial catheterization and radial artery occlusion. Background: Radial artery occlusion is an important concern of transradial catheterization. Interruption of radial artery flow during compression might influence the rate of radial artery occlusion at follow‐up. Methods: A prospective study including 275 consecutive patients undergoing transradial catheterization was conducted. Arterial sheaths were removed immediately after procedures and conventional compressive dressings were left in place for 2 hr. The pulse oximeter signal in the index finger during ipsilateral ulnar compression was used for the assessment of radial artery flow. Results: Radial artery flow was absent in 174 cases (62%) immediately after entry‐site compression. After 2 hr of conventional hemostasis, radial artery flow was absent in 162 cases (58%) before bandage removal. At 7‐day follow‐up, 12 patients (4.4%) had absent pulsations and radial artery flow was absent in 29 cases (10.5%). Patients with an occluded radial artery at follow‐up had significantly smaller arterial diameters at baseline (2.23 ± 0.4 mm vs. 2.40 ± 0.5 mm; P = 0.032) and more frequently had absent flow during hemostasis (90% vs. 54%, P < 0.001). Stepwise logistic regression analysis revealed that absent flow before compressive bandages removal was the only independent predictor of radial artery occlusion at follow‐up (OR = 6.7; IC 95%: 1.95‐22.9; P = 0.002). Conclusions: Flow‐limiting compression is a frequent finding during conventional hemostasis after transradial catheterization. Absence of radial artery flow during compression represents a strong predictor of radial artery occlusion.

Prospective application of pre-defined intravascular ultrasound criteria for assessment of intermediate left main coronary artery lesions results from the multicenter LITRO study.

OBJECTIVES This study is a prospective validation of 6 mm(2) as a minimum lumen area (MLA) cutoff value for revascularization of left main coronary artery (LMCA) lesions. BACKGROUND Lesions involving the LMCA are prognostically relevant. Angiography has important limitations in the evaluation of LMCA lesions with intermediate severity. An MLA of 6 mm(2) assessed by intravascular ultrasound has been proposed as a cutoff value to determine lesion severity, but there are no large studies evaluating the prospective application and safety of this approach. METHODS We have designed a multicenter, prospective study. Consecutive patients with intermediate lesions in unprotected LMCA were evaluated with intravascular ultrasound. An MLA <6 mm(2) was used as criterion for revascularization. RESULTS A total of 354 patients were included in 22 centers. LMCA revascularization was performed in 90.5% (152 of 168) of patients with an MLA <6 mm(2) and was deferred in 96% (179 of 186) of patients with an MLA of 6 mm(2) or more. A large scatter was observed between both groups regarding angiographic parameters. In a 2-year follow-up period, cardiac death-free survival was 97.7% in the deferred group versus 94.5% in the revascularized group (p = 0.5), and event-free survival was 87.3% versus 80.6%, respectively (p = 0.3). In the 2-year period, only 8 (4.4%) patients in the deferred group required subsequent LMCA revascularization, none with an infarction. CONCLUSIONS Angiographic measurements are not reliable in the assessment of intermediate LMCA lesions. An MLA of 6 mm(2) or more is a safe value for deferring revascularization of the LMCA, given the application of the clinical and angiographic inclusion criteria used in this study.

Background, Incidence, and Predictors of Antiplatelet Therapy Discontinuation During the First Year After Drug-Eluting Stent Implantation

Background— Predictors of antiplatelet therapy discontinuation (ATD) during the first year after drug-eluting stent implantation are poorly known. Methods and Results— This was a prospective study with 3-, 6-, 9-, and 12-month follow-up of patients receiving at least 1 drug-eluting stent between January and April 2008 in 29 hospitals. Individual- and hospital-level predictors of ATD were assessed by hierarchical-multinomial regression analysis. ATD could be assessed in 1622 candidates for follow-up (82.5%). A total of 234 patients (14.4%) interrupted at least 1 antiplatelet therapy drug, predominantly clopidogrel (n=182, 11.8%). Bleeding events or invasive procedures led to ATD in 109 patients. This was predicted by renal impairment (odds ratio [OR] 2.81, 95% confidence interval [CI] 1.48 to 5.34), prior major hemorrhage (OR 3.77, 95% CI 1.41 to 10.03), and peripheral arterial disease (OR 1.78, 95% CI 1.01 to 3.15). Medical decisions led to ATD in 70 patients; this was predicted by long-term use of anticoagulant therapy (OR 3.88, 95% CI 1.26 to 11.98), undergoing the procedure in a private hospital (OR 13.3, 95% CI 1.69 to 105), and not receiving instructions about medication (OR 2.8, 95% CI 1.23 to 6.36). Thirty-nine patients interrupted ATD on their own initiative, mainly immigrants (OR 3.78, 95% CI 1.2 to 11.98) and consumers of psychotropic drugs (OR 2.58, 95% CI 1.3 to 5.12). Conclusions— ATD during the first year after drug-eluting stent implantation is based mainly on patient decision or a medical decision not associated with major bleeding events or major surgical procedures. Individual- and hospital-level variables are important to predict ATD.

Thrombosis of Second-Generation Drug-Eluting Stents in Real Practice: Results From the Multicenter Spanish Registry ESTROFA-2 (Estudio Español Sobre Trombosis de Stents Farmacoactivos de Segunda Generacion-2)

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.

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.