Economic Evaluation of Ticagrelor for Secondary Prevention Following Acute Coronary Syndromes

INTRODUCTION AND OBJECTIVES: To estimate the cost-effectiveness and cost-utility of ticagrelor in the treatment of patients with acute coronary syndromes (unstable angina or myocardial infarction with or without ST-segment elevation), including patients treated medically and those undergoing percutaneous coronary intervention or coronary artery bypass grafting. METHODS: A short-term decision tree and a long-term Markov model were used to simulate the evolution of patients' life-cycles. Clinical effectiveness data were collected from the PLATO trial and resource use data were obtained from the Hospital de Santa Marta database, disease-related group legislation and the literature. RESULTS: Ticagrelor provides increases of 0.1276 life years and 0.1106 quality-adjusted life years (QALYs) per patient. From a societal perspective these clinical gains entail an increase in expenditure of €610. Thus the incremental cost per life year saved is €4780 and the incremental cost per QALY is €5517. CONCLUSIONS: The simulation results show that ticagrelor reduces events compared to clopidogrel. The costs of ticagrelor are partially offset by lower costs arising from events prevented. The use of ticagrelor in clinical practice is therefore cost-effective compared to generic clopidogrel.

External Validation of the ProACS Score for Risk Stratification of Patients with Acute Coronary Syndromes

INTRODUCTION: The ProACS risk score is an early and simple risk stratification score developed for all-cause in-hospital mortality in acute coronary syndromes (ACS) from a Portuguese nationwide ACS registry. Our center only recently participated in the registry and was not included in the cohort used for developing the score. Our objective was to perform an external validation of this risk score for short- and long-term follow-up. METHODS: Consecutive patients admitted to our center with ACS were included. Demographic and admission characteristics, as well as treatment and outcome data were collected. The ProACS risk score variables are age (≥72 years), systolic blood pressure (≤116 mmHg), Killip class (2/3 or 4) and ST-segment elevation. We calculated ProACS, Global Registry of Acute Coronary Events (GRACE) and Canada Acute Coronary Syndrome risk score (C-ACS) risk scores for each patient. RESULTS: A total of 3170 patients were included, with a mean age of 64±13 years, 62% with ST-segment elevation myocardial infarction. All-cause in-hospital mortality was 5.7% and 10.3% at one-year follow-up. The ProACS risk score showed good discriminative ability for all considered outcomes (area under the receiver operating characteristic curve >0.75) and a good fit, similar to C-ACS, but lower than the GRACE risk score and slightly lower than in the original development cohort. The ProACS risk score provided good differentiation between patients at low, intermediate and high mortality risk in both short- and long-term follow-up (p<0.001 for all comparisons). CONCLUSIONS: The ProACS score is valid in external cohorts for risk stratification for ACS. It can be applied very early, at the first medical contact, but should subsequently be complemented by the GRACE risk score.

Validation of Two US Risk Scores for Percutaneous Coronary Intervention in a Single-Center Portuguese Population of Patients with Acute Coronary Syndrome

INTRODUCTION: New scores have been developed and validated in the US for in-hospital mortality risk stratification in patients undergoing coronary angioplasty: the National Cardiovascular Data Registry (NCDR) risk score and the Mayo Clinic Risk Score (MCRS). We sought to validate these scores in a European population with acute coronary syndrome (ACS) and to compare their predictive accuracy with that of the GRACE risk score. METHODS: In a single-center ACS registry of patients undergoing coronary angioplasty, we used the area under the receiver operating characteristic curve (AUC), a graphical representation of observed vs. expected mortality, and net reclassification improvement (NRI)/integrated discrimination improvement (IDI) analysis to compare the scores. RESULTS: A total of 2148 consecutive patients were included, mean age 63 years (SD 13), 74% male and 71% with ST-segment elevation ACS. In-hospital mortality was 4.5%. The GRACE score showed the best AUC (0.94, 95% CI 0.91-0.96) compared with NCDR (0.87, 95% CI 0.83-0.91, p=0.0003) and MCRS (0.85, 95% CI 0.81-0.90, p=0.0003). In model calibration analysis, GRACE showed the best predictive power. With GRACE, patients were more often correctly classified than with MCRS (NRI 78.7, 95% CI 59.6-97.7; IDI 0.136, 95% CI 0.073-0.199) or NCDR (NRI 79.2, 95% CI 60.2-98.2; IDI 0.148, 95% CI 0.087-0.209). CONCLUSION: The NCDR and Mayo Clinic risk scores are useful for risk stratification of in-hospital mortality in a European population of patients with ACS undergoing coronary angioplasty. However, the GRACE score is still to be preferred.

Estratégia Sistematicamente Invasiva nas Síndromes Coronárias Agudas sem Supradesnivelamento do Segmento ST: Será a Idade um Factor Limitante?

Introdução: A estratégia terapêutica sistematicamente invasiva das síndromes coronárias agudas (SCA) é actualmente aceite como segura e eficaz, sendo crescentes as evidências da sua superioridade em relação a uma atitude conservadora. O doente idoso, atendendo à sua maior susceptibilidade, é frequentemente excluído deste tipo de abordagem, o que poderá limitar os potenciais benefícios. Objectivo: Avaliar a influência da idade nas características e evolução clínica dos doentes com SCA tratados segundo uma estratégia invasiva, e se esta limita a sua adopção. Métodos: Estudaram-se retrospectivamente 203 doentes internados por SCA (não seleccionados e consecutivos), considerados de risco intermédio/elevado após estratificação e que efectuaram terapêutica com inibidores das glicoproteínas IIb/IIIa. Destes doentes 45 tinham idade 75 anos e constituíram o grupo intitulado de Idoso, os restantes constituíram o grupo Não Idoso. Foram analisadas e comparadas as características dos dois grupos, a terapêutica realizada e a evolução clínica que apresentaram. Resultados: A percentagem de mulheres no grupo idoso é bastante superior, embora a diferença não atinja significado estatístico. Das outras características estudadas as que apresentam diferenças significativas são a existência de história familiar de doença coronária e o tabagismo, que são menos frequentes entre os idosos. Houve uma tendência não significativa para cateterizar menos os idosos, sendo que os dois grupos são semelhantes em relação à terapêutica de revascularização adoptada. No total as complicações hemorrágicas foram mais frequentes no grupo Idoso, mas a diferença em relação às hemorragias significativas não teve valor estatístico. A mortalidade intra hospitalar foi maior nos idosos, mas diminuiu e não teve significado estatístico quando considerados apenas os doentes cateterizados. Conclusão: Nesta população os idosos tiveram um número maior de complicações hemorrágicas não significativas e a sua maior mortalidade não esteve associada à adopção de uma atitude invasiva. Desta forma sugere-se que a idade, por si só, não limita a adopção de uma estratégia sistematicamente invasiva.

Impacto da Combinação de Terapêutica Farmacológica na Mortalidade em Doentes com Síndrome Coronária Aguda

INTRODUCTION: Conventional risk stratification after acute myocardial infarction is usually based on the extent of myocardial damage and its clinical consequences. However, nowadays, more aggressive therapeutic strategies are used, both pharmacological and invasive, with the aim of changing the course of the disease. OBJECTIVES: To evaluate whether the number of drugs administered can influence survival of these patients, based on recent clinical trials that demonstrated the benefit of each drug for survival after acute coronary events. METHODS: This was a retrospective analysis of 368 consecutive patients admitted to our ICU during 2002 for acute coronary syndrome. A score from 1 to 4 was attributed to each patient according to the number of secondary prevention drugs administered--antiplatelets, beta blockers, angiotensin-converting enzyme inhibitors and statins--independently of the type of association. We evaluated mortality at 30-day follow-up. RESULTS: Mean age was 65 +/- 13 years, 68% were male, and 43% had ST-segment elevation acute myocardial infarction. Thirty-day mortality for score 1 to 4 was 36.8%, 15.6%, 7.8% and 2.5% respectively (p < 0.001). The use of only one or two drugs resulted in a significant increase in the risk of death at 30 days (OR 4.10, 95% CI 1.69-9.93, p = 0.002), when corrected for other variables. There was a 77% risk reduction associated with the use of three or four vs. one or two drugs. The other independent predictors of death were diabetes, Killip class on admission and renal insufficiency. CONCLUSIONS: The use of a greater number of secondary prevention drugs in patients with acute coronary syndromes was associated with improved survival. A score of 4 was a powerful predictor of mortality at 30-day follow-up

Aderência às Recomendações para o Tratamento das Síndromes Coronárias Agudas: Evolução ao Longo do Tempo

Introdução: O tratamento das Síndromes Coronárias Agudas (SCA) sofreu várias alterações muito rápidas nos últimos anos, traduzido nas múltiplas propostas de recomendações pelo ACC/AHA/ESC, baseados na evidência clínica. Avaliamos a implementação destas recomendações, comparando uma população de doentes de 2002, com uma população de 2005. Métodos: Estudo retrospectivo de 368 doentes admitidos em 2002 e 420 doentes admitidos em 2005 por SCA (com e sem elevação do segmento ST). Analisaram-se características clínicas e estratégias de tratamento. Resultados: Não se verificaram diferenças em termos de idade, sexo masculino, factores de risco para doença coronária ou história prévia de revascularização miocárdica. Verificou-se uma redução de doentes com antecedentes de enfarte do miocárdico e insuficiência renal e aumento da apresentação como enfarte com elevação do segmento ST. O tratamento com clopidogrel (6% versus 87%), bloqueador-beta(54% versus 79%), inibidores da enzima de conversão da angiotensina (72% versus 84%) e estatinas (78% versus 91%) aumentou (para todos p<0,001). Por outro lado, verificou-se um pequeno decréscimo na utilização de ácido acetilsalicílico (98% versus 95%, p=0,039) (com maior utilização de clopidogrel) e a ticlopidina deixou de ser utilizada (46% versus 0%, p<0,001). Os antagonistas dos receptores da glicoproteína IIb/IIIa não se alteraram significativamente (66% versus 67%, p=NS). Aumentaram as intervenções coronárias percutâneas (53% versus 67%, p<0,001). Não se verificou diferença em termos de mortalidade hospitalar (8,2% versus 6,4%) e aos 30 dias (9,0% versus. 8,6%), com redução ao 1ºano de seguimento (17,1% versus 11,7%, p=0,039). As estatinas e os bloqueadores beta são preditores independentes de mortalidade, com efeito de protecção. Conclusões: Entre 2002 e 2005, o tratamento das SCA melhorou significativamente de acordo com as recomendações existentes, traduzindo-se numa melhoria da mortalidade ao 1º ano de seguimento.

Position Statement on Bioresorbable Vascular Scaffolds in Portugal

BACKGROUND: Bioresorbable vascular scaffolds (BVS) were recently approved for percutaneous coronary intervention in Europe. The aim of this position statement is to review the information and studies on available BVS, to stimulate discussion on their use and to propose guidelines for this treatment option in Portugal. METHODS AND RESULTS: A working group was set up to reach a consensus based on current evidence, discussion of clinical case models and individual experience. The evidence suggests that currently available BVS can produce physiological and clinical improvements in selected patients. There are encouraging data on their durability and long-term safety. Initial indications were grouped into three categories: (a) consensual and appropriate - young patients, diabetic patients, left anterior descending artery, long lesions, diffuse disease, and hybrid strategy; (b) less consensual but possible - small collateral branches, stabilized acute coronary syndromes; and (c) inappropriate - left main disease, tortuosity, severe calcification. CONCLUSION: BVS are a viable treatment option based on the encouraging evidence of their applicability and physiological and clinical results. They should be used in appropriate indications and will require technical adaptations. Outcome monitoring and evaluation is essential to avoid inappropriate use. It is recommended that medical societies produce clinical guidelines based on high-quality registries as soon as possible.

A Terapêutica Crónica com Nitratos está Associada a uma Diferente Apresentação Clínica de Síndroma Coronária Aguda?

A terapêutica com nitratos pode induzir pré-condicionamento isquémico, com consequente aumento da tolerância a isquémia. No contexto de síndromes coronárias agudas (SCA), os nitratos podem condicionar uma diferente forma de apresentação, com maior protecção. Objectivos: Estudar numa população de doentes com SCA se a administração crónica prévia ao evento, de nitratos condiciona a forma de apresentação do SCA. Métodos: Estudo de 287 doentes (65 +- 13 anos, 66% sexo masculino) admitidos no nosso serviço por SCA (com e sem elevação do segmento ST) no primeiro semestre de 2005. Destes, 8% estavam sob terapêutica com nitratos prévia à admissão. Neste grupo 27% apresentaram-se como SCA com elevação do segmento ST e no grupo sem nitratos, este valor foi de 58% (p=0,005). Por análise univariada, a utilização de nitratos foi preditora da ocorrência preferencial de "SCA sem elevação do segmento ST" (OR 0,27, IC 95% 0,10-0,71, p=0,005). Após correcção para variáveis potencialmente influentes (idade, sexo, revascularização prévia, tabagismo) por análise multivariada de regressão logística, a terapêutica com nitratos foi preditora limiar da apresentação clínica "SCA sem elevação do segmento ST" (OR 0,37, IC 95% 0,13-1,04), p=0,059. Conclusão: A utilização prévia à ocorrência de SCA associou-se com um desvio da apresentação para a forma de SCA sem elevação do segmento ST. Este achado pode ser justificado pela hipótese de que os nitratos podem induzir um pré-condicionamento farmacológico, reduzindo a extensão transmural do enfarte.

Pode a Presença de Anemia na Admissão Melhorar a Capacidade Preditiva do Score GRACE para Mortalidade a Curto e Médio Prazo após Síndrome Coronária Aguda?

Introdução: Nos doentes admitidos com síndrome coronária aguda (SCA), a presença de anemia é um fator predizente de prognóstico. Contudo, os diversos scores de risco após SCA não incluem este fator. Objetivos: Avaliar se a presença de anemia na admissão em doentes com SCA tem valor acrescido relativamente ao score GRACE na predição de mortalidade a curto e médio prazo. Métodos: Entre janeiro 2005 e dezembro 2008, avaliaram-se os doentes admitidos consecutivamente na nossa Unidade de Cuidados Intensivos por SCA e incluídos no registo de SCA do centro. Em todos os doentes foram colhidos dados demográficos, antropométricos, fatores de risco para doença coronária, dados clínicos e laboratoriais da admissão, incluindo hemoglobina. Foram identificados os doentes com anemia (hemoglobina < 12 g/dL nas mulheres e < 13 g/dL nos homens). Os doentes foram divididos em risco baixo, intermédio e alto: < 126, 126-154 e > 154 para o score GRACE, respetivamente. Analisou-se a ocorrência de morte intra-hospitalar, aos 30 dias e ao primeiro ano de seguimento. Resultados: Incluíram-se 1423 doentes, com idade média de 64 ± 13 anos, 69% do sexo masculino,identificando-se a presenc¸a de anemia na admissão em 27,7% dos doentes. Estes doentes eram mais idosos, com predomínio do sexo feminino, mais hipertensos e diabéticos, maior número com história prévia de enfarte, com pior classe de Killip na admissão e score GRACE mais alto. Pelo contrário, eram menos fumadores, com menor apresentação como enfarte com supradesnivelamento ST e receberam menos bloqueadores beta, estatinas e angioplastia coronária. Tiveram também mais complicações hemorrágicas durante o internamento. A mortalidade intra-hospitalar (10 versus 4%), aos 30 dias (12 versus 5%) e ao primeiro ano (15 versus 6%) foram superiores no grupo com anemia (p < 0,001). Na análise bivariada, a presença de anemia é fator predizente de mortalidade intra-hospitalar (OR 2,46, IC 95% 1,57-3,85, p < 0,001), aos 30 dias (OR 2,47, IC 95% 1,65-3,69, p < 0,001) e ao primeiro ano (OR 2,66, IC 95% 1,83-3,86, p < 0,001), não se mantendo, contudo, esta associação após ajuste para outras variáveis. Associando a presença de anemia ao score GRACE, diferencia apenas para a mortalidade ao primeiro ano(com maior mortalidade) os grupos de risco intermédio e alto do score GRACE (6,7 versus 2,3%, p = 0,024; 23,4 versus 15,6%, p = 0,022, respetivamente), com uma tendência para diferenciar a mortalidade aos 30 dias no grupo de risco alto de score (19,6 versus 13,5%, p = 0,056). Conclusão: Os nossos dados confirmam que a anemia é um fator predizente importante de mortalidade a curto e médio prazo após SCA, contudo, não significativo quando ajustado ou incluído no score GRACE. Contudo, a sua combinação com o score GRACE pode melhorar a estratificação de risco, em particular no alto risco.

Safety and Effectiveness of the Genous Endothelial Progenitor Cell-Capture Stent: Follow-Up to 5 Years

AIMS: To evaluate the long-term clinical outcomes following percutaneous coronary intervention (PCI) with the Genous stent in an unselected population. METHODS: All patients admitted to a single center who underwent PCI using the GS exclusively, between May 2006 and May 2012, were enrolled, and a clinical follow-up of up to 60 months was carried out. The primary endpoint of major adverse cardiac event (MACE) rate was defined as the composite of cardiac death, acute myocardial infarction (AMI), and target lesion revascularization (TLR). RESULTS: Of the 450 patients included (75.1% male; 65.5 ± 11.7 years), 28.4% were diabetic and acute coronary syndrome was the reason for PCI in 76.4%. Angioplasty was performed in 524 lesions using 597 Genous stents, with angiographic success in 97.1%. At a median of 36 months of follow-up (range, 1-75 months), MACE, AMI, TLR, stent restenosis (SR), and stent thrombosis (ST) rates were 15.6%, 8.4%, 4.4%, 3.8%, and 2.2%, respectively. Between 12 and 24 months, the TLR, SR, and ST rates practically stabilized, up to 60 months. Bifurcation lesions were independently associated with MACE, TLR, and SR. CONCLUSION: This is the first study reporting clinical results with the Genous stent up to 60 months. The Genous stent was safe and effective in the long-term, in an unselected population.

The Prognostic Impact of Renal Failure in Patients with ST-Segment Elevation Acute Myocardial Infarction

INTRODUCTION: Renal insufficiency (RI) is associated with higher morbidity and mortality in patients (P) with coronary artery disease and in P submitted to angioplasty. In ST-segment elevation acute myocardial infarction (STEAMI), this impact has not been well demonstrated. AIM: To evaluate the impact of RI in P with STEAMI. METHODS: We evaluated 160 P admitted with STEAMI, mean age of 62+/-14 years, 76% male. We determined creatinine levels on admission. RI was defined as a level >1.5 mg/dl. Analysis of clinical, electrocardiographic and laboratory variables was performed, in relation to the endpoint defined as the occurrence of death at 30-day follow-up. RESULTS: There were 16 deaths (10%) at 30-day follow-up. P with RI (n=21) were older (68+/-11 vs 61+/-14 years, p<0.001), more often had diabetes (57 vs 24 %, p=0.004) and presented more often with Killip class > or =2 (57 vs 12%, p<0.001). The use of statins (62 vs 83%, p=0.05) and beta-blockers (24 vs 65%, p<0.001) was lower in P with RI. Mortality was higher in RI P (62 vs 2%, p<0.001). The univariate predictors of death were age > or =75 years, diabetes, Killip class > or =2 on admission, RI, non-use of statins and beta-blockers and use of diuretics. In multivariate analysis, independent predictors of death at 30 days were RI (HR 29.6, 95% CI 6.3-139.9, p<0.001) and non-use of beta-blockers (HR 0.13, 95% CI 0.02-1.01, p=0.01). CONCLUSION: In P admitted for STEAMI, the presence of RI was an independent predictor of death at 30 days whereas the usage of beta-blockers was protective.

Effects of Acute Autonomic Modulation on Atrial Conduction Delay and Local Electrograms Duration in Paroxysmal Atrial Fibrillation

Slowed atrial conduction may contribute to reentry circuits and vulnerability for atrial fibrillation (AF). The autonomic nervous system (ANS) has modulating effects on electrophysiological properties. However, complex interactions of the ANS with the arrhythmogenic substrate make it difficult to understand the mechanisms underlying induction and maintenance of AF. AIM: To determine the effect of acute ANS modulation in atrial activation times in patients (P) with paroxysmal AF (PAF). METHODS AND RESULTS: 16P (9 men; 59±14years) with PAF, who underwent electrophysiological study before AF ablation, and 15P (7 men; 58±11years) with atrioventricular nodal reentry tachycardia, without documentation or induction of AF (control group). Each group included 7P with arterial hypertension but without underlying structural heart disease. The study was performed while off drugs. Multipolar catheters were placed at the high right atrium (HRA), right atrial appendage (RAA), coronary sinus (CS) and His bundle area (His). At baseline and with HRA pacing (600ms, shortest propagated S2) we measured: i) intra-atrial conduction time (IACT, between RAA and atrial deflection in the distal His), ii) inter-atrial conduction time (interACT, between RAA and distal CS), iii) left atrial activation time (LAAT, between atrial deflection in the distal His and distal CS), iv) bipolar electrogram duration at four atrial sites (RAA, His, proximal and distal CS). In the PAF group, measurements were also determined during handgrip and carotid sinus massage (CSM), and after pharmacological blockade of the ANS (ANSB). AF was induced by HRA programmed stimulation in 56% (self-limited - 6; sustained - 3), 68.8% (self-limited - 6; sustained - 5), and 50% (self-limited - 5; sustained - 3) of the P, in basal, during ANS maneuvers, and after ANSB, respectively (p=NS). IACT, interACT and LAAT significantly lengthened during HRA pacing in both groups (600ms, S2). P with PAF have longer IACT (p<0.05), a higher increase in both IACT, interACT (p<0.01) and electrograms duration (p<0.05) with S2, and more fragmented activity, compared with the control group. Atrial conduction times and electrograms duration were not significantly changed during ANS stimulation. Nevertheless, ANS maneuvers increased heterogeneity of the local electrograms duration. Also, P with sustained AF showed longer interACT and LAAT during CSM. CONCLUSION: Atrial conduction times, electrograms duration and fractionated activity are increased in PAF, suggesting a role for conduction delays in the arrhythmogenic substrate. Acute vagal stimulation is associated with prolonged interACT and LAAT in P with inducible sustained AF and ANS modulation may influence the heterogeneity of atrial electrograms duration.

Does Metabolic Syndrome Predict Significant Angiographic Coronary Artery Disease?

INTRODUCTION: Metabolic syndrome (MS) is an independent predictor of acute cardiovascular events. However, few studies have addressed the relationship between MS and stable angiographic coronary artery disease (CAD), which has a different pathophysiological mechanism. We aimed to study the independent predictors for significant CAD, and to analyze the impact of MS (by the AHA/NHLBI definition) on CAD. METHODS: We prospectively included 300 patients, mean age 64±9 years, 59% male, admitted for elective coronary angiography (suspected ischemic heart disease), excluding patients with known cardiac disease. All patients underwent assessment of demographic, anthropometric, and laboratory data and risk factors, and subsequently underwent coronary angiography. RESULTS: In the study population, 23.0% were diabetic, 40.5% had MS (and no diabetes) and 36.7% had neither diagnosis. Significant CAD was present in 51.3% of patients. CAD patients were older and more frequently male and diabetic, with increased triglycerides and glucose and lower HDL cholesterol. Abdominal obesity was also less prevalent. MS was not associated with the presence of CAD (OR 0.94, 95% CI 0.59-1.48, p=0.778). Of the MS components, the most important predictors of CAD were increased glucose and triglycerides. Abdominal obesity was associated with a lower risk of CAD. In a multivariate logistic regression model for CAD, independent predictors of CAD were age, male gender, glucose and triglycerides. Body mass index had a protective effect. CONCLUSIONS: Although MS is associated with cardiovascular events, the same was not found for stable angiographically proven CAD. Age, gender, diabetes and triglycerides are the most influential factors for CAD, with abdominal obesity as a protective factor.

Safety and Effectiveness of the Genous™ Endothelial Progenitor Cell-Capture Stent in the First Year Following ST-Elevation Acute Myocardial Infarction: A Single Center Experience and Review of the Literature

PURPOSE: The Genous™ stent (GS) is designed to accelerate endothelization, which is potentially useful in the pro-thrombotic environment of ST-elevation acute myocardial infarction (STEMI). We aimed to evaluate the safety and effectiveness of the GS in the first year following primary percutaneous coronary intervention (PCI) and to compare our results with the few previously published studies. METHODS AND MATERIALS: All patients admitted to a single center due to STEMI that underwent primary PCI using exclusively GS, between May 2006 and January 2012, were enrolled. The primary study endpoints were major adverse cardiac events (MACEs), defined as the composite of cardiac death, acute myocardial infarction and target vessel revascularization, at one and 12months. RESULTS: In the cohort of 109 patients (73.4% male, 59 ±12years), 24.8% were diabetic. PCI was performed in 116 lesions with angiographic success in 99.1%, using 148 GS with median diameter of 3.00mm (2.50-4.00) and median length of 15mm (9-33). Cumulative MACEs were 2.8% at one month and 6.4% at 12months. Three stent thromboses (2.8%), all subacute, and one stent restenosis (0.9%) occurred. These accounted for the four target vessel revascularizations (3.7%). At 12months, 33.9% of patients were not on dual antiplatelet therapy. CONCLUSIONS: GS was safe and effective in the first year following primary PCI in STEMI, with an apparently safer profile comparing with the previously published data. SUMMARY: We report the safety and effectiveness of the Genous™ stent (GS) in the first year following primary percutaneous coronary intervention in ST-elevation acute myocardial infarction. A comprehensive review of the few studies that have been published on this subject was included and some suggest a less safe profile of the GS. Our results and the critical review included may add information and reinforce the safety and effectiveness of the GS in ST-elevation in acute myocardial infarction.