Impacto pronóstico a diez años del fallo del vaso diana tras un IAMCEST. Perspectivas del ensayo EXAMINATION-EXTEND / Ten-year prognostic impact of target versus non-target vessel failure after STEMI. Insight from the EXAMINATION-EXTEND trial

Introducción y objetivos Se desconoce el impacto pronóstico de los diferentes tipos de eventos adversos tras el infarto agudo de miocardio con elevación del segmento ST (IAMCEST). El objetivo de este trabajo es evaluar los predictores a largo plazo del objetivo combinado orientado al paciente (POCE) y si tener un fallo del vaso diana (FVD) como primer evento puede influir en los resultados. Métodos El ensayo EXAMINATION-EXTEND aleatorizó a pacientes con IAMCEST a tratamiento con stents liberadores de everolimus o a stents convencionales, con un seguimiento de hasta 10 años. En la población del estudio, se evaluaron los predictores de POCE (combinado de mortalidad por cualquier causa, infarto de miocardio y cualquier revascularización). Se clasificó a los pacientes según el tipo de primer evento (FVD primero o FDV no primero) y comparado en términos de POCE posterior. El FVD se definió como el compuesto de muerte cardiaca, IAMCEST del vaso diana y revascularización del vaso diana. Resultados De los 1.498 pacientes del estudio, 529 (35,3%) tuvieron POCE durante el seguimiento a los 10 años. Los predictores independientes de POCE fueron la edad, la diabetes mellitus, el infarto de miocardio previo, la enfermedad arterial periférica y la enfermedad coronaria multivaso. El primer evento fue un FVD o no FVD en 296 y 233 casos respectivamente. No hubo diferencias estadísticamente significativas entre quienes tuvieron primero un FVD y los que tuvieron un evento no FVD en cuanto a POCE (el 21,7 frente al 39,3%; razón de tiempo, 1,79; IC95%, 0,87-3,67; p=0,12) o sus componentes individuales. Conclusiones En el seguimiento a 10 años, alrededor de un tercio de los pacientes con IAMCEST tuvo al menos 1 evento de POCE, cuyos predictores independientes fueron la edad, la diabetes mellitus y una mayor extensión de la enfermedad ateroesclerótica... (AU)

Introduction and objectivesAfter ST-segment myocardial infarction (STEMI), the impact of different adverse events on prognosis remains unknown. We aimed to assess very long-term predictors of patient-oriented composite endpoints (POCE) and investigate whether the occurrence of target vessel failure (TVF) vs a non-TVF event as the first event could potentially influence subsequent outcomes. Methods The EXAMINATION.EXTEND trial randomized STEMI patients to receive either an everolimus-eluting stent or a bare-metal stent. The follow-up period was 10 years. Predictors of POCE (a composite of all-cause death, any myocardial infarction, or any revascularization) were evaluated in the overall study population. The patients were stratified based on the type of first event (TVF-first vs non–TVF-first) and were compared in terms of subsequent POCE. TVF was defined as a composite of cardiac death, TV myocardial infarction, or TV revascularization. Results Out of the 1498 enrolled patients, 529 (35.3%) experienced a POCE during the 10-year follow-up. Independent predictors of POCE were age, diabetes mellitus, previous myocardial infarction, peripheral arterial disease, and multivessel coronary disease. The first event was a TVF in 296 patients and was a non-TVF in 233 patients. No significant differences were observed between TVF-first and non–TVF-first patients in terms of subsequent POCE (21.7% vs 39.3%, time ratio 1.79; 95%CI, 0.87-3.67; P=.12) or its individual components. Conclusions At the 10-year follow-up, approximately one-third of STEMI patients had experienced at least 1 POCE. Independent predictors of these events were age, diabetes, and more extensive atherosclerotic disease. The occurrence of a TVF or a non-TVF as the first event did not seem to influence subsequent outcomes. Trial registration number: NCT04462315. (AU)

Ten-year prognostic impact of target versus non-target vessel failure after STEMI. Insight from the EXAMINATION-EXTEND trial.

INTRODUCTION AND OBJECTIVES: After ST-segment myocardial infarction (STEMI), the impact of different adverse events on prognosis remains unknown. We aimed to assess very long-term predictors of patient-oriented composite endpoints (POCE) and investigate whether the occurrence of target vessel failure (TVF) vs a non-TVF event as the first event could potentially influence subsequent outcomes. METHODS: The EXAMINATION-EXTEND trial randomized STEMI patients to receive either an everolimus-eluting stent or a bare-metal stent. The follow-up period was 10 years. Predictors of POCE (a composite of all-cause death, any myocardial infarction, or any revascularization) were evaluated in the overall study population. The patients were stratified based on the type of first event (TVF-first vs non-TVF-first) and were compared in terms of subsequent POCE. TVF was defined as a composite of cardiac death, TV myocardial infarction, or TV revascularization. RESULTS: Out of the 1498 enrolled patients, 529 (35.3%) experienced a POCE during the 10-year follow-up. Independent predictors of POCE were age, diabetes mellitus, previous myocardial infarction, peripheral arterial disease, and multivessel coronary disease. The first event was a TVF in 296 patients and was a non-TVF in 233 patients. No significant differences were observed between TVF-first and non-TVF-first patients in terms of subsequent POCE (21.7% vs 39.3%, time ratio 1.79; 95%CI, 0.87-3.67;P=.12) or its individual components. CONCLUSIONS: At the 10-year follow-up, approximately one-third of STEMI patients had experienced at least 1 POCE. Independent predictors of these events were age, diabetes, and more extensive atherosclerotic disease. The occurrence of a TVF or a non-TVF as the first event did not seem to influence subsequent outcomes. TRIAL REGISTRATION NUMBER: NCT04462315.

Impact of Age at the Time of the First ST-Elevation Myocardial Infarction on 10-Year Outcomes (from the EXAMINATION-EXTEND Trial).

The aim of this substudy of the EXAMINATION-EXTEND was to analyze 10-year outcomes according to the patient's age at the time of the first ST-elevation myocardial infarction (STEMI). Of 1,498 patients with STEMI included in the EXAMINATION-EXTEND study, those with a previous history of coronary ischemic even or ischemic stroke were excluded from this analysis. The remaining 1,375 patients were divided into 4 age groups: <55, 55 to 65, 65 to 75, and >75 years. The primary end point was 10-year patient-oriented composite end point (POCE) of all-cause death, any MI, or any revascularization. At 10-year follow-up, patients aged <55 years (adjusted hazard ratio [HR] 0.24, 95% confidence interval [CI] 0.18 to 0.31, p = 0.001), 55 to 65 years (adjusted HR 0.26, 95% CI 0.20 to 0.34, p = 0.001), and 65 to 75 years (adjusted HR 0.38, 95% CI 0.30 to 0.50, p = 0.001) showed lower risk of POCE than those aged >75 years, led by a lower incidence of all-cause death (<55 : 6% vs 55 to 65: 11.9% vs 65 to 75: 25.7% vs >75 years: 61.6%, p = 0.001). Cardiac death was more prevalent in the older group (<55: 3.7% vs 55 to 65: 5.8% vs 65 to 75: 10.9% vs >75 years: 35.5%, p = 0.001). In the landmark analyses, between 5- and 10-year follow-up, young patients exhibited a higher incidence of any revascularization (<55: 7.4% vs 55 to 65: 4.9% vs 65 to 75: 1.8% vs >65 years: 1.6%, p = 0.001). In conclusion, in patients with a first STEMI, advanced age was associated with high rates of POCE at 10-year follow-up due to all-cause and cardiac death. Conversely, younger patients exhibited a high risk of revascularization at long-term follow-up.

Impact of Diabetes on 10-Year Outcomes Following ST-Segment-Elevation Myocardial Infarction: Insights From the EXAMINATION-EXTEND Trial.

Background Long-term outcomes of ST-segment-elevation myocardial infarction in patients with diabetes have been barely investigated. The objective of this analysis from the EXAMINATION-EXTEND (10-Years Follow-Up of the EXAMINATION trial) trial was to compare 10-year outcomes of patients with ST-segment-elevation myocardial infarction with and without diabetes. Methods and Results Of the study population, 258 patients had diabetes and 1240 did not. The primary end point was patient-oriented composite end point of all-cause death, any myocardial infarction, or any revascularization. Secondary end points were the individual components of the primary combined end point, cardiac death, target vessel myocardial infarction, target lesion revascularization, and stent thrombosis. All end points were adjusted for potential confounders. At 10 years, patients with diabetes showed a higher incidence of patient-oriented composite end point compared with those without (46.5% versus 33.0%; adjusted hazard ratio [HR], 1.31 [95% CI, 1.05-1.61]; P=0.016) mainly driven by a higher incidence of any revascularization (24.4% versus 16.6%; adjusted HR, 1.61 [95% CI, 1.19-2.17]; P=0.002). Specifically, patients with diabetes had a higher incidence of any revascularization during the first 5 years of follow-up (20.2% versus 12.8%; adjusted HR, 1.57 [95% CI, 1.13-2.19]; P=0.007) compared with those without diabetes. No statistically significant differences were found with respect to the other end points. Conclusions Patients with ST-segment-elevation myocardial infarction who had diabetes had worse clinical outcome at 10 years compared with those without diabetes, mainly driven by a higher incidence of any revascularizations in the first 5 years. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT04462315.

Sex Differences in 10-Year Outcomes Following STEMI: A Subanalysis From the EXAMINATION-EXTEND Trial.

BACKGROUND: Short-term outcomes following ST-segment elevation myocardial infarction (STEMI) in women are worse than in men, with a higher mortality rate. It is unknown whether sex plays a role in very long term outcomes. OBJECTIVES: The aim of this study was to assess whether very long term outcomes following STEMI treatment are influenced by sex. METHODS: EXAMINATION-EXTEND (10-Year Follow-Up of the EXAMINATION Trial) was an investigator-driven 10-year follow-up of the EXAMINATION (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction) trial, which randomly 1:1 assigned 1,498 patients with STEMI to receive either everolimus-eluting stents or bare-metal stents. The present study was a subanalysis according to sex. The primary endpoint was the composite patient-oriented endpoint (all-cause death, any myocardial infarction, or any revascularization) at 10 years. Secondary endpoints were individual components of the primary endpoint. All endpoints were adjusted for age. RESULTS: Among 1,498 patients with STEMI, 254 (17%) were women. Overall, women were older, with more arterial hypertension and less smoking history than men. At 10 years, no difference was observed between women and men for the patient-oriented composite endpoint (40.6% vs 34.2%; adjusted HR: 1.14; 95% CI: 0.91-1.42; P = 0.259). There was a trend toward higher all-cause death in women vs men (27.6% vs 19.4%; adjusted HR: 1.30; 95% CI: 0.99-1.71; P = 0.063), with no difference in cardiac death or other endpoints. CONCLUSIONS: At very long term follow-up, there were no differences in the combined patient-oriented endpoint between women and men, with a trend toward higher all-cause death in women not driven by cardiac death. The present findings underline the need for focused personalized medicine in women after percutaneous revascularization aimed at both cardiovascular and sex-specific risk factor control and targeted treatment. (10-Years Follow-Up of the EXAMINATION Trial [EXAMINAT10N]; NCT04462315).

Magnesium-based resorbable scaffold vs permanent metallic sirolimus-eluting stent in patients with ST-segment elevation myocardial infarction: 3-year results of the MAGSTEMI randomised controlled trial.

BACKGROUND: The long-term safety and performance of magnesium-based bioresorbable scaffolds (MgBRS) in ST-segment-elevation myocardial infarction (STEMI) patients are uncertain. AIMS: The aim of this study was to report the 3-year clinical outcomes of the MAGSTEMI trial. METHODS: This investigator-driven, multicentre, randomised, single-blind, controlled trial randomised STEMI patients 1:1 to MgBRS or to permanent metallic sirolimus-eluting stents (SES) at 11 academic centres. The main secondary endpoints included device-oriented composite endpoints (DoCE) and patient-oriented composite endpoints (PoCE), their individual components, any bleeding, and device thrombosis rate. All endpoints were defined according to the Academic Research Consortium. Events were adjudicated by an independent committee. RESULTS: Three-year clinical follow-up was obtained in 142 (90.0%) patients. At 3-year follow-up, MgBRS were associated with a higher rate of DoCE than SES (13 [17.6%] vs 5 [6.6%], diff -11.0 [95% CI: -21.3 to -0.7]; p=0.038). This difference was driven by an increased incidence of DoCE within the first year of follow-up. In the landmark analysis, there was no difference between 1 and 3 years (0 [0.0%] vs 1 [1.4%]; p=1.000). The difference in the rate of DoCE was driven by a higher incidence of target lesion revascularisation (TLR) in the MgBRS group compared to SES (12 [16.2%] vs 4 [5.3%]; diff -10.9% [95% CI: -20.7 to -1.2]; p=0.030). The difference in TLR was observed during the first year, with no further differences observed between 1 and 3 years (0 [0.0%] vs 1 [1.4%]; p=1.000). CONCLUSIONS: At 3-year follow-up, MgBRS were associated with a higher rate of TLR, which was clustered within the first year, compared to SES.

Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial.

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

10-Year Follow-Up of Patients With Everolimus-Eluting Versus Bare-Metal Stents After ST-Segment Elevation Myocardial Infarction.

BACKGROUND: Outcomes data for a durable-polymer everolimus-eluting stent (EES) at extended long-term follow-up in patients with ST-segment elevation myocardial infarction (STEMI) are unknown. OBJECTIVES: The aim of this study was to assess the 10-year outcomes of patients enrolled in the EXAMINATION (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction) trial. METHODS: The EXAMINATION-EXTEND (10-Years Follow-Up of the EXAMINATION Trial) study is an investigator-driven 10-year follow-up of the EXAMINATION trial, which randomly assigned 1,498 patients with STEMI in a 1:1 ratio to receive either EES (n = 751) or bare-metal stents (n = 747). The primary endpoint was a patient-oriented composite endpoint of all-cause death, any myocardial infarction, or any revascularization. Secondary endpoints included a device-oriented composite endpoint of cardiac death, target vessel myocardial infarction, or target lesion revascularization; the individual components of the combined endpoints; and stent thrombosis. RESULTS: Complete 10-year clinical follow-up was obtained in 94.5% of the EES group and 95.9% of the bare-metal stent group. Rates of the patient-oriented composite endpoint and device-oriented composite endpoint were significantly reduced in the EES group (32.4% vs. 38.0% [hazard ratio: 0.81; 95% confidence interval: 0.68 to 0.96; p = 0.013] and 13.6% vs. 18.4% [hazard ratio: 0.72; 95% confidence interval: 0.55 to 0.93; p = 0.012], respectively), driven mainly by target lesion revascularization (5.7% vs. 8.8%; p = 0.018). The rate of definite stent thrombosis was similar in both groups (2.2% vs. 2.5%; p = 0.590). No differences were found between the groups in terms of target lesion revascularization (1.4% vs. 1.3%; p = 0.963) and definite or probable stent thrombosis (0.6% vs. 0.4%; p = 0.703) between 5 and 10 years. CONCLUSIONS: At 10-year follow-up, EES demonstrated confirmed superiority in combined patient- and device-oriented composite endpoints compared with bare-metal stents in patients with STEMI requiring primary percutaneous coronary intervention. Between 5- and 10-year follow-up, a low incidence of adverse cardiovascular events related to device failure was found in both groups. (10-Years Follow-Up of the EXAMINATION Trial; NCT04462315).

Magnesium-Based Resorbable Scaffold Versus Permanent Metallic Sirolimus-Eluting Stent in Patients With ST-Segment Elevation Myocardial Infarction: The MAGSTEMI Randomized Clinical Trial.

BACKGROUND: The use of poly-l-lactide acid-based bioresorbable scaffolds is limited in daily clinical practice because of safety concerns and lack of physiological benefit. Magnesium-based bioresorbable scaffold (MgBRS) presents a short resorption period (<1 year) and have the potential of being thromboresistant and exhibiting early restoration of vasomotor function. To date, however, no randomized clinical trial has investigated the performance of MgBRS. Therefore, this study aimed to compare the in-stent/scaffold vasomotion between MgBRS and permanent metallic sirolimus-eluting stent (SES) at 12-month follow-up in ST-segment-elevation myocardial infarction patients. METHODS: This investigator-driven, multicenter, randomized, single-blind, controlled trial randomized ST-segment-elevation myocardial infarction patients 1:1 to SES or MgBRS at 11 academic centers. The primary end point was the rate of increase (≥3%) after nitroglycerin in mean lumen diameter of the in-stent/scaffold segment at 12 months with superiority of MgBRS over SES in the as-treated population. The main secondary end points included angiographic parameters of restenosis, device-oriented composite end point, their individual components, and device thrombosis rate. Besides, endothelial-dependent vasomotor response to acetylcholine (ie, endothelial function) was also assessed in a subgroup of patients (n=69). RESULTS: Between June 2017 and June 2018, 150 ST-segment-elevation myocardial infarction patients were randomized (MgBRS, n=74; SES, n=76). At 1 year, the primary end point was significantly higher in the MgBRS arm (56.5% versus 33.8%; P=0.010). Conversely, late lumen loss was significantly lower in the SES group (in-segment: 0.39±0.49mm versus 0.02±0.27mm, P<0.001; in-device: 0.61±0.55mm versus 0.06±0.21mm; P<0.001). The device-oriented composite end point was higher in the MgBRS arm driven by an increase in ischemia-driven target lesion revascularization rate (12[16.2%] versus 4[5.2%], P=0.030). Definite thrombosis rate was similar between groups (1[1.4%] in the MgBRS arm versus 2[2.6%] in the SES group; P=1.0). Endothelial function assessment at device segment evidenced a more pronounced vasoconstrictive response to maximal dose of acetylcholine in the MgBRS arm (-8.3±3.5% versus -2.4±1.3% in the SES group, P=0.003). CONCLUSIONS: When compared to SES, MgBRS demonstrated a higher capacity of vasomotor response to pharmacological agents (either endothelium-independent or endothelium-dependent) at 1 year. However, MgBRS was associated with a lower angiographic efficacy, a higher rate of target lesion revascularization, without thrombotic safety concerns. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03234348.

MAGnesium-based bioresorbable scaffold and vasomotor function in patients with acute ST segment elevation myocardial infarction: The MAGSTEMI trial: Rationale and design.

AIM: Use of a Bioresorbable Scaffolds (BRS) either in clinical practice or in the setting of an acute myocardial infarction (MI) is controversial. Despite an overall high rate of thrombosis, vascular healing response following BRS implantation tend to superiority as compared to metallic drug-eluting stent in ST-segment elevation myocardial infarction (STEMI) patients. We sought to compare the in-stent/scaffold vasomotion between metallic BRS and sirolimus eluting stent (SES) at 12-month angiographic follow-up in the setting of patients with STEMI treated by primary PCI. STUDY DESIGN: This is an investigator-driven, prospective, multicenter, randomized, single blind, two-arm, controlled trial (ClinicalTrials.gov number: NCT03234348). This trial will randomize ~148 patients 1:1 to SES or BRS. Primary end-point is the in-stent/scaffold change in mean lumen diameter after nitroglycerin administration at 12-month angiographic follow-up. Besides, patient-oriented combined endpoint of all-cause death, any MI, and any revascularization, together with scaffold/stent thrombosis rate and device-oriented endpoint of cardiac death, target vessel (TV)-MI and TVR at 1 year will be also evaluated. Clinical follow-up will be scheduled yearly up to 5 years. CONCLUSION: This trial will shed light on the vascular vasomotion following BRS implantation in the complex scenario of STEMI.

Evaluation of a 'color coding' system for the assessment of patients undergoing primary percutaneous coronary intervention.

AIMS: The reduction of delay times as well as the rate of false alarms (FA) have become some of the main points of the different infarction networks. We propose a simple way of classifying patients derived for primary PCI (pPCI) into well-defined simple groups by colors, where we can assess real delays of each clinical presentation, define the FA and, furthermore, establish their immediate and short term prognosis. METHODS AND RESULTS: Prospective study of STEMI consecutive patients derived for pPCI during 2014. Patients were categorized into one of the 3 predesigned groups [(i) Green: diagnostic-ECG with compatible clinical presentation for pPCI; (ii) Yellow: LBBB, pacemaker rate or non-diagnostic ECG; and (iii) Red: very complex patients], always before performing the angiography in 518 patients. Delay times were highest in the Yellow group, with much longer first medical contact (FMC) to balloon time (median Green 118'; Yellow 163'; Red 130'; p<0.001) mainly due to higher times from the first medical contact to the diagnosis and team activation (median Green 30'; Yellow 70'; Red 39'; p<0.001). In the whole cohort, pPCI was performed in 80.2% of patients, with 11.9% of FA. The Green group had only a 2.5% FA rate, in contrast to the Yellow group where FA were 43.2%. CONCLUSIONS: This simple classification differentiates the 3 very clear groups in which delay times and prognosis are very different. This classification allows us to measure, evaluate and compare the performance of each of our pPCI networks with others and within different periods of times.

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.

Miocardio rescatado tras angioplastia coronaria de rescate: cuantificación mediante resonancia magnética cardiaca / Reduction in 28 days and 6 months of acute myocardial infarction Mortality From 1995 to 2005. Data from PRIAMHO I, II and MASCARA registries

Introducción y objetivos. Cuando la fibrinolisis fracasa en pacientes con infarto de miocardio con elevación del ST, está indicadad la realización de una intervención coronaria percutánea (ICP) de rescate. Sin embargo, hay pocas evidencias sobre la cantidad del miocardio en riesgo que realmente puede rescatarse tras una ICP de rescate. Métodos. Se realizó resonancia magnética cardiaca en un plazo de 6 días a 50 pacientes consecutivos. La necrosis miocárdica se definió mediante la extensión de la captación tardía de contraste; el miocardio en riesgo, mediante la extensión del edema, y la cantidad de miocardio rescatado, mediante la diferencia entre el miocardio en riesgo y la necrosis miocárdica. Finalmente, el índice de miocardio rescatado (IMR) se obtuvo a partir de la fracción área en riesgo – tamaño de infarto/área en riesgo. Resultados. La media de tiempo transcurrido entre el inicio del dolor y la administración del fármaco fibrinolítico fue de 176 ± 113min; el tiempo de lisis-ICP de rescate fue de 209±122min; el tiempo de inicio del dolor-ICP fue de 390±152min. El área en riesgo fue del 37±13% y el tamaño del infarto, del 34,5±13%. El miocardio rescatado fue un 3±4% y el IMR, 9±8. El miocardio rescatado y el IMR fueron similares en los pacientes con una arteria permeable a la llegada al laboratorio de cateterismo (Thrombolysis in Myocardial Infarction [TIMI] 3) y en los que tenían un flujo TIMI ≤ 2 (el 3,3±3,6% y 8,2±6,9 [p=0,8] en los casos de TIMI 0-2 frente al 3±3,7% y 10,8±10,9 [p=0,31] en los de TIMI 3). No se observaron diferencias significativas entre los pacientes a los que se efectuó la ICP de rescate en un plazo corto y aquellos a los se intervino tras un intervalo mayor. Conclusiones. La cantidad de miocardio rescatado tras una ICP de rescate cuantificada mediante resonancia magnética cardiaca es muy pequeña. El largo tiempo entre el inicio del dolor y la apertura de la arteria relacionada con el infarto es la causa más probable de este efecto mínimo de la ICP de rescate (AU)

Introduction and objectives. To determine whether mortality from acute myocardial infarction has reduced in Spain and the possibly related therapeutic factors. Methods. Nine thousand, nine hundred and forty-nine patients with ST-segment elevation myocardial infarction admitted to the Coronary Care Unit were identified from PRIAMHO I, II and MASCARA registries performed in 1995, 2000 and 2005, with a 6 month follow-up. Results. From 1995 to 2005 patients were increasingly more likely to have hypertension, hyperlipidemia and anterior infarction, but age of onset and the proportion of females did not increase. Twenty-eight-day mortality rates were 12.6%, 12.3% and 6% in 1995, 2000 and 2005 respectively, and 15.3%, 14.6% and 9.4% at 6 months (both P-trend <.001). Multivariate analysis was performed and the adjusted odds ratio for 28-day mortality for an infarction occuring in 2005 (compared with 1995) was 0.62 (95% confidence interval: 0.44-0.88) whereas the adjusted hazard ratio for mortality at 6 months was 0.40 (95% confidence interval: 0.24-0.67). Other variables independently associated with lower mortality at 28 days were: reperfusion therapy, and the use of anti-thrombotic treatment, beta-blockers and angiotensin-converting enzyme inhibitors. The 28-day-6-month period had an independent protective effect on the following therapies: coronary reperfusion, and prescription of antiplatelet agents, beta-blockers and lipid lowering drugs upon discharge. Conclusions. Twenty-eight-day and six-month mortality rates fell among patients with ST-elevation myocardial infarction in Spain from 1995 to 2005. The possibly related therapeutic factors were the following: more frequent reperfusion therapy and increased use of anti-thrombotic drugs, beta-blockers, angiotensin-converting enzyme inhibitors and lipid lowering drugs (AU)

[Minimum salvaged myocardium after rescue percutaneous coronary intervention: quantification by cardiac magnetic resonance]. / Miocardio rescatado tras angioplastia coronaria de rescate: cuantificación mediante resonancia magnética cardiaca.

INTRODUCTION AND OBJECTIVES: When fibrinolysis fails in patients with ST elevation myocardial infarction, they are referred for a rescue percutaneous coronary intervention (PCI). However, there is still no evidence of how much myocardium potentially at risk we can actually salvage after rescue PCI. METHODS: Fifty consecutive patients. Cardiac magnetic resonance was performed within 6 days. Myocardial necrosis was defined by the extent of abnormal late enhancement, myocardium at risk by extent of edema, and the amount of salvaged myocardium by the difference between myocardium at risk and myocardial necrosis. Finally, myocardial salvage index (MSI) resulted from the fraction (area-at-risk minus infarct-size)/area-at-risk. RESULTS: The mean time elapsed between pain onset and fibrinolitic agent administration was 176 ± 113 min; time lysis-rescue=PCI 209 ± 122 min; time pain onset-PCI = 390 ± 152 min. The area at risk was 37% ± 13% and infarct size 34.5% ± 13%. Salvaged myocardium was 3% ± 4% and MSI 9 ± 8. Salvaged myocardium and MSI were similar between patients with the artery open on arrival at the catheterization lab (Thrombolysis in Myocardial Infarction [TIMI] 3) and those with TIMI flow ≤ 2 (3.3% ± 3.6% and 8.2 ± 6.9 in TIMI 0-2 vs 3.0% ± 3.7% and 10.8 ± 10.9 in TIMI 3; P=.80 and 0.31, respectively). No significant difference was observed between patients who went through rescue PCI within a shorter time and those with longer delay times. CONCLUSIONS: The myocardial salvage after rescue PCI quantified by cardiac magnetic resonance is very small. The long delay times between pain onset and the opening of the infarct-related artery with PCI are most probably the reason for such a minimal effect of rescue PCI.

Rescue angioplasty: characteristics and results in a single-center experience.

PURPOSE AND METHODS: Rescue angioplasty (RA) has demonstrated its efficacy for the treatment of failed thrombolysis after acute myocardial infarction (AMI). We analyzed clinical, angiographic, and procedural characteristics, and prognosis at 30 days of prospective cohort of unselected patients admitted for RA. RESULTS: From August 2004 to August 2009, 361 patients were included in a single center. The median time pain to the thrombolysis was 140 minutes (interquartile range [IQR] 90-210), delay transfer 100 minutes (IQR 65-120); pain to PCI was 330 minutes (IQR 270-400). Initial flow TIMI 3 (Thrombolysis in Myocardial Infarction) was presented in 102 (28.3%) of cases and blush grade 3 in 88 (24.4%). After the procedure, TIMI 3 flow was achieved in 286 (79.2%) and blush grade 3 in 256 (71%) (P < 0.001 and P < 0,001, respectively). A glycoprotein IIb/IIIa receptor inhibitor (Abciximab) was used in 115 patients (32%). Stents were implanted in 339 (94%) of patients, 137 (38%) of which were drug-eluting stent. Complete ST segment resolution was observed in 202 (64.5%) patients in 12-lead electrocardiogram (ECG) and procedural success was 77.6%. Adverse cardiac events and death after 30 days follow-up were 13.6% and 10.7%, respectively. Target vessel revascularization at 30 days was 1.9%. CONCLUSIONS: Routine application of RA in patients with persistent ST elevation 90 minutes after thrombolysis is a useful technique for achieving revascularization of the affected artery. In-hospital mortality remains high especially in patients with cardiac shock, despite new interventional techniques available, and adjunctive antithrombotic therapy.

Predictors of death after coronary stenting with sirolimus-eluting stent in high-risk patients.

BACKGROUND: Long-term safety of drug eluting stents (DES) is under evaluation. Whether late mortality with DES may be higher than with bare metal stents is controversial and factors influencing death after DES implantation are not well known. The present observational registry analyses predictors of death during follow up after coronary stenting with sirolimus-eluting stents (SES). METHODS: We performed an analysis of the causes of death on 233 patients included in a prospective registry that evaluated angiographic and clinical outcomes after SES implantation in complex scenarios. We analysed the relation of death with: 1) clinical, angiographic and procedural variables, and 2) clinical events, after a median follow up of 3.7 [3.4-3.9] years. We performed Cox regression analysis to assess predictors of mortality. RESULTS: Nineteen patients (8.1%) died. Survival free of death was 91.85%. Two deaths (0.8%) were due to ictus, 2 (0.8%) were due to cancer, 2 (0.8%) were of unknown causes--not cardiac--and 13 (5.6%) were cardiac. After multivariate analysis independent predictors of death were depressed left ventricular function (HR 10.8 [3.31-35.14], p=0.0001), age (HR 1.1 [1.04-1.19], p=0.001), AMI during follow up (HR 7.03 [2.04-24.29], p=0.002), proximal LAD lesions (HR 0.15 [0.04-0.59], p=0.006), female gender (HR 3.54 [1.18-10.57], p=0.023), renal insufficiency (HR 5.82 [1.25-27.11], p=0.025) and IIb-IIIa inhibitors (HR 0.31 [0.09-1.03], p=0.054). CONCLUSIONS: Mortality after SES implantation seems to be related to basal conditions of the patient, use of IIb-IIIa inhibitors, left ventricular dysfunction and progression of disease.

Observance of antiplatelet therapy after stent implantation in patients under chronic oral anticoagulant treatment.

PURPOSE: Patients undergoing coronary stenting must take dual antiplatelet therapy during a variable period. The combination of chronic oral anticoagulants (COA) with antiplatelet therapy has been related to an increased risk of hemorrhage. The aim of this study was to evaluate the level of the antiplatelet therapy observance in those patients and the incidence of adverse events after 1 year. METHODS: Patients with prior COA treatment with coronary lesions suitable for stenting were included. Clinical assessment was performed on admission, with follow-up at 1, 6, and 12 months. Antiplatelet and COA treatment, adverse cardiac events, and hemorrhagic episodes were registered. RESULTS: A total of 70 patients were included. Mean age was 70.5 +/- 8.7 years. The most common cause of COA was atrial fibrillation. Conventional stents were used in 40% and drug-eluting stents (DES) in 60%. Treatment at discharge was: ASA + clopidogrel + COA 64.2%, ASA + clopidogrel 25.4%, COA + clopidogrel 7.5%, and COA + ASA 3%. Observance of antiplatelet and COA therapy at 1-6-12 month follow-up after conventional stent was: COA 73.1-70.8-69.6%; ASA 92.3-75.4-65.2%; clopidogrel 92.3-62.5-43.5%. In patients receiving DES, it was: COA 76.9-78.9-80.6%, ASA 79.5-65.8-55.7%, and clopidogrel 94.9-84.2-61.1%. Dual antiplatelet therapy in patients with DES over these periods was taken in 79.5-51.4-27.8%, respectively. The incidence of adverse events was minor bleeding 11.4%, major bleeding 8.6%, myocardial infarction 4.3%, stent thrombosis 1.4%, and death 12.8%. CONCLUSIONS: There is a great variability in the treatment prescribed at discharge. Low observance with dual antiplatelet therapy has been detected in these patients, particularly after DES implantation, and they present a very high rate of complications in the follow-up.

Isolated single left coronary artery.

Single coronary artery is an extremely rare congenital anomaly with a very low incidence in the general population. We present a 65-year-old woman with atypical chest pain and a single left coronary artery discovered in the cath lab. No coronary lesions were found. Such anomaly has been previously described before only in twelve patients.

One-year results of unprotected left main disease treatment with paclitaxel-eluting stents: results of a multicenter registry.

BACKGROUND: Preliminary data suggest that drug-eluting stents might have a role in selected cases of unprotected left main stenosis (ULMS). The purpose of this study was to determine the rates of death, myocardial infarction, and repeated revascularization in a multicenter, prospective series of patients with ULMS treated with paclitaxel-eluting stents. METHODS: A prospective registry was initiated in March 2003 through December 2004 in five tertiary centers including all patients with a significant (>50%) stenosis in ULMS treated with at least one paclitaxel-eluting stent. There were no clinical or angiographic exclusion criteria. Clinical follow-up was obtained at 6 and 12 months. RESULTS: A total of 100 patients were included. Mean age was 67.6 +/- 11.4 years and 36% were diabetics. Distal left main was affected in 53% of patients. Implantation of two stents was required in only 15%. Angiographic success was achieved in all cases. Significant periprocedural CK-MB elevation occurred in 5 patients and there was 1 intraprocedural death. At a median 9 months follow-up, cardiac death occurred in 7%, the majority of which (4%) in patients with ST-elevation myocardial infarction and cardiogenic shock before stent implantation. Only 3 patients (3%) required repeated target-vessel revascularization, all repeated angioplasty procedures. CONCLUSION: Percutaneous treatment of unprotected left main lesions with paclitaxel-eluting stents is associated with acceptable mid-term results in selected patients, with very low rates of repeated revascularization.

Sirolimus-Eluting Stents vs Uncoated Stents for the Treatment of Proximal Left Anterior Descending Coronary Artery Stenosis.

Sirolimus-eluting stents (SES) have demonstrated low incidence of target vessel revascularizations in several anatomic scenarios, including proximal left anterior descending coronary artery (pLAD) lesions. The aim of present study was to compare the efficacy of SES with bare metal stents (BMS) for the treatment of such lesions. 96 patients with severe pLAD stenosis treated with SES were included. Clinical follow-up were performed during a 24 month period. A 98 patient sample with pLAD lesions treated with BMS was taken as control group. Death, angiographic restenosis, new target lesion revascularization (TLR) and target vessel failure (TVF) were registered. Clinical, angiographic and procedural variables were analysed to identify predictors of TVF and TLR. Angiographic procedural success was 100% in SES group vs 99% in BMS group (p=1.0). At 2.5 years, the cumulative rate of TVF was 9.4% in SES group vs 16.3% in BMS group (p=0.15), and the rate of TLR was 5.2% in SES group vs 12.2% in control group (p=0.08). The probabilities of cumulative TVF and TLR free survival were in BMS group 83.7% and 87.8%, and in SES group 90.6% and 94.8%, respectively. After multivariate analysis only SES utilization was found as independent protective factor against TVF and TLR (HR 0.38, 95%CI [0.15-0.94] p=0.037 and HR 0.21, 95%CI [0.06-0.66] p=0.008, respectively), and diabetes as independent predictor of TFV and TLR (HR 2.37, 95%CI [1.07-5.24] p=0.034 and HR 3.57, 95%CI [1.29-9.87] p=0.014, respectively). This study demonstrates that SES utilization is safe and effective in the tretament of pLAD lesions with a better clinical outcome than BMS in a long-term follow-up.