RESUMEN
OBJECTIVES: The purpose of this study was to evaluate the frequency and predictors of stent thrombosis (ST) after stenting for ST-segment elevation myocardial infarction (STEMI). BACKGROUND: Stent thrombosis remains a major concern with STEMI patients treated with primary percutaneous coronary intervention. METHODS: Consecutive patients (N = 1,640) undergoing stenting for STEMI were prospectively enrolled in our database and followed for 1 to 15 years. Bare-metal stents were implanted from 1995 to 2002, and drug-eluting and bare-metal stents were implanted from 2003 to 2009. Stent thrombosis was defined as definite or probable. RESULTS: Our population had a high risk profile, including a high incidence of Killip class III to IV (11.5%) and STEMI due to ST (10.2%). Stent thrombosis occurred in 124 patients, including 42 with early ST (0 to 30 days), 35 with late ST (31 days to 1 year), and 47 with very late ST (>1 year). The frequency of ST was 2.7% at 30 days, 5.2% at 1 year, and 8.3% at 5 years. Independent predictors of early or late ST were STEMI due to ST (hazard ratio [HR]: 4.38, 95% confidence interval [CI]: 2.27 to 8.45), small stent size (HR: 2.44, 95% CI: 1.49 to 4.00), Killip class III to IV (HR: 2.39, 95% CI: 1.30 to 4.40), and reperfusion time ≤2 h (HR: 2.09, 95% CI: 1.03 to 4.24). Drug-eluting stent was the only independent predictor of very late ST (HR: 3.73, 95% CI: 1.81 to 7.88). CONCLUSIONS: Stent thrombosis after primary percutaneous coronary intervention is relatively frequent and continues to increase out to 5 years. New strategies are needed to prevent ST in STEMI patients, and targeted therapies are needed in patients identified at highest risk.
Asunto(s)
Angioplastia Coronaria con Balón/estadística & datos numéricos , Reestenosis Coronaria/etiología , Trombosis Coronaria/etiología , Stents Liberadores de Fármacos , Infarto del Miocardio/terapia , Anciano , Clopidogrel , Intervalos de Confianza , Reestenosis Coronaria/epidemiología , Reestenosis Coronaria/patología , Trombosis Coronaria/epidemiología , Trombosis Coronaria/patología , Femenino , Indicadores de Salud , Humanos , Estimación de Kaplan-Meier , Masculino , Infarto del Miocardio/mortalidad , Infarto del Miocardio/patología , Reperfusión Miocárdica , Inhibidores de Agregación Plaquetaria/uso terapéutico , Factores de Riesgo , Índice de Severidad de la Enfermedad , Ticlopidina/análogos & derivados , Ticlopidina/uso terapéutico , Factores de Tiempo , Estados Unidos/epidemiologíaRESUMEN
BACKGROUND: Whether thrombus aspiration and local glycoprotein IIb/IIIa administration reduce infarct size in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) has not been established in multicenter studies. DESIGN: INFUSE-AMI is a multicenter, open-label, controlled, single-blind randomized study enrolling 452 subjects with anterior STEMI and an occluded proximal or mid-left anterior descending artery with thrombosis in myocardial infarction 0, 1, or 2 grade flow undergoing primary PCI with bivalirudin anticoagulation. Subjects are randomized in a 2 × 2 factorial to one of the following 4 arms: (1) local infusion of abciximab using the ClearWay RX Local Therapeutic Infusion Catheter (ClearWay, Atrium Medical Corp, Hudson, NH) after aspiration with a 6F Export Aspiration Catheter (Medtronic, Inc, Minneapolis, MN), (2) local infusion of abciximab using the ClearWay RX Infusion Catheter and no aspiration, (3) no local infusion of abciximab and aspiration with a 6F Export Aspiration Catheter, or (4) no local infusion of abciximab and no aspiration. The primary end point is infarct size (percentage of total left ventricular mass) at 30 days measured by cardiac magnetic resonance imaging. Other secondary end points include microvascular obstruction by cardiac magnetic resonance imaging at 5 days, ST-segment resolution, angiographic myocardial perfusion, thrombus burden, angiographic complications, and clinical events through 1-year follow-up. Safety end points include major and minor bleeding. SUMMARY: INFUSE-AMI is testing the hypothesis that the intracoronary administration of an abciximab bolus with or without thrombus aspiration before stent implantation compared to no infusion with or without thrombus aspiration reduces infarct size among patients undergoing primary PCI for anterior STEMI who are treated with bivalirudin.
Asunto(s)
Angioplastia Coronaria con Balón , Anticuerpos Monoclonales/administración & dosificación , Trombosis Coronaria/cirugía , Fragmentos Fab de Inmunoglobulinas/administración & dosificación , Infarto del Miocardio/terapia , Inhibidores de Agregación Plaquetaria/administración & dosificación , Trombectomía , Abciximab , Antitrombinas/uso terapéutico , Oclusión Coronaria/orina , Determinación de Punto Final , Hirudinas , Humanos , Infusiones Intraarteriales , Imagen por Resonancia Cinemagnética , Infarto del Miocardio/patología , Selección de Paciente , Fragmentos de Péptidos/uso terapéutico , Proteínas Recombinantes/uso terapéutico , Proyectos de Investigación , Trombectomía/métodosRESUMEN
OBJECTIVES: The purpose of this study was to assess the frequency of very late stent thrombosis (VLST) after stenting with bare-metal stents (BMS) and drug-eluting stents (DES) for ST-segment elevation myocardial infarction (STEMI). BACKGROUND: Stent thrombosis occurs more frequently after stenting for STEMI than after elective stenting, but there are little data regarding VLST. METHODS: Consecutive patients (n = 1,463) who underwent stenting for STEMI were prospectively enrolled in our database. BMS were implanted exclusively from 1995 to 2002, and DES and BMS were implanted from 2003 to 2009. Follow-up was obtained at 1 to 15 years. RESULTS: BMS patients (n = 1,095) were older and had more shock, whereas DES patients (n = 368) had more diabetes and smaller vessels. Stent thrombosis occurred in 107 patients, of which 42 were VLST (>1 year). Stent thrombosis continued to increase to at least 11 years with BMS and to at least 4.5 years with DES. Stent thrombosis rates with BMS versus DES were similar at 1 year (5.1% and 4.0%, respectively) but increased more with DES after the first year (1.9%/year vs. 0.6%/year, respectively). Landmark analysis (>1 year) found DES had a higher frequency of VLST (p < 0.001) and reinfarction (p = 0.003). DES was the only significant independent predictor of VLST (hazard ratio: 3.79, 95% confidence interval: 1.64 to 8.79, p = 0.002). CONCLUSIONS: VLST after primary PCI for STEMI occurs with relatively high frequency to at least 11 years with BMS and to at least 4.5 years with DES. Very late stent thrombosis and reinfarction (>1 year) were more frequent with DES. New strategies are needed to manage this problem.
Asunto(s)
Angioplastia Coronaria con Balón/instrumentación , Fármacos Cardiovasculares/administración & dosificación , Stents Liberadores de Fármacos , Metales , Infarto del Miocardio/terapia , Stents , Trombosis/etiología , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/mortalidad , Distribución de Chi-Cuadrado , Femenino , Estudios de Seguimiento , Humanos , Estimación de Kaplan-Meier , Modelos Logísticos , Masculino , Infarto del Miocardio/mortalidad , North Carolina , Paclitaxel/administración & dosificación , Puntaje de Propensión , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Diseño de Prótesis , Recurrencia , Sistema de Registros , Medición de Riesgo , Factores de Riesgo , Sirolimus/administración & dosificación , Factores de Tiempo , Resultado del TratamientoRESUMEN
The impact of time to treatment on outcomes after primary percutaneous coronary intervention (PCI) is controversial, and there are few data about time to treatment and infarct size. The EMERALD trial randomly assigned 501 high-risk patients with ST-elevation myocardial infarction undergoing primary PCI to stenting with or without GuardWire (Medtronic, Santa Rosa, California) distal protection. Infarct size using sestamibi imaging at 5 to 14 days and clinical outcomes were examined by time to treatment. There were no differences in outcomes between distal protection and control patients. Shorter time to reperfusion (<2 vs 2 to 3 vs >3 to 4 vs >4 hours) was associated with smaller infarct size (2% vs 9% vs 12% vs 11%, p=0.026), trends for better myocardial blush (p=0.08), and lower 6-month mortality rates (0% vs 0% vs 2.4% vs 5.3%, p=0.06). Incremental delays in reperfusion after 2 hours had little impact on infarct size. Shorter time to reperfusion impacted on infarct size in patients with anterior infarction (0% vs 17% vs 20.5% vs 30.5%, p=0.026), but not nonanterior infarction (3% vs 7% vs 7.5% vs 10%, p=0.23, p=0.022 for interaction). In conclusion, very early reperfusion with primary PCI is associated with smaller infarct size and has a much greater impact in anterior versus nonanterior infarction. Incremental delays in reperfusion after 2 hours have less effect on infarct size. These data have implications regarding the triage of patients for primary PCI.