RESUMEN
OBJECTIVES: We assessed the potential for percutaneous coronary intervention (PCI) of a chronic total occlusion (CTO) to decrease myocardial ischemia and established objective criteria to predict post-procedure improvement. BACKGROUND: Optimal treatment for CTO of coronary arteries is controversial, and selection criteria for PCI of CTO are subjective. METHODS: All patients undergoing CTO PCI at a single center between 2002 and 2007 were included if myocardial perfusion imaging (MPI) was performed within 12 ± 3 months before and a follow-up study within 12 ± 3 months after PCI. Average summed difference scores were calculated and converted to percent ischemic myocardium to classify patients as having normal/minimal, mild, moderate, or severe ischemia. A significant improvement in ischemia following PCI was classified as an absolute ≥5% decrease in ischemic myocardium. Receiver operating characteristic (ROC) curves were used to identify ischemic thresholds predictive of decreased and increased ischemic burden on follow-up MPI. RESULTS: In 301 patients, average baseline ischemic burden was 13.1% ± 11.9% and decreased to 6.9% ± 6.5% (P < 0.001) during follow-up. Overall, 53.5% of patients met criteria for improvement following PCI. These patients were more likely to be male, without diabetes, with CTO in the left anterior descending artery, and classified as having high ischemic burden at baseline. ROC analysis identified a baseline 12.5% ischemic burden as optimal in identifying those most likely to have a significantly decreased ischemic burden post-PCI. Those with a baseline ischemic burden less than 6.25% were more likely to have an increased ischemic burden post-PCI. CONCLUSIONS: Ischemic burden is reduced following CTO PCI, and the decrease is greater at high ischemic burden. A threshold of 12.5% ischemic burden is suggested as a criterion for performing PCI in the setting of CTO.
Asunto(s)
Angioplastia Coronaria con Balón , Circulación Coronaria , Oclusión Coronaria/terapia , Isquemia Miocárdica/terapia , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/mortalidad , Enfermedad Crónica , Angiografía Coronaria , Oclusión Coronaria/complicaciones , Oclusión Coronaria/diagnóstico , Oclusión Coronaria/mortalidad , Oclusión Coronaria/fisiopatología , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Missouri , Isquemia Miocárdica/diagnóstico , Isquemia Miocárdica/etiología , Isquemia Miocárdica/mortalidad , Isquemia Miocárdica/fisiopatología , Imagen de Perfusión Miocárdica/métodos , Selección de Paciente , Tomografía de Emisión de Positrones , Valor Predictivo de las Pruebas , Curva ROC , Sistema de Registros , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Factores de Tiempo , Tomografía Computarizada de Emisión de Fotón Único , Resultado del TratamientoRESUMEN
AIMS: We compared epicardial and microvascular reperfusion, infarct size, and clinical outcomes after primary and rescue PCI with and without GuardWire distal protection in patients with LAD vs. non-LAD acute myocardial infarction (AMI). In the general AMI population undergoing primary PCI, the use of GuardWire did not yield higher reperfusion success, reduced infarct size, or enhanced event-free survival. Whether GuardWire is beneficial in patients with AMI in certain territories of the coronary circulation is unknown. METHODS AND RESULTS: In the EMERALD trial, 501 patients with AMI were randomised to PCI with vs. without distal protection. The outcomes were analysed as a function of culprit vessel (LAD vs. non-LAD) and the use of GuardWire. Patients with LAD vs. non-LAD infarcts had significantly (P< or =0.0001) lower rates of final TIMI flow grade 3 (85.2% vs. 94.4%), myocardial blush grade 3 (40.1% vs. 67.6%), and complete ST-segment resolution (35.1% vs. 79.6%). Patients with LAD infarcts also had larger infarct size (25.8+/-21.8% vs. 11.3_13.7%, p<0.0001) and a trend towards higher rates of 6-month mortality (5.5% vs. 2.1%, p=0.09) and new-onset severe heart failure (3.5% vs. 1.1%, p=0.08). Rates of reperfusion were not related to GuardWire use in patients with LAD infarcts. In patients with non-LAD infarcts, the use of GuardWire was associated with a trend towards better epicardial and microvascular reperfusion. CONCLUSIONS: Myocardial infarction in the territory of the LAD is associated with worse epicardial and microvascular reperfusion and worse 6-month clinical outcomes. Use of the GuardWire showed a trend towards better epicardial and microvascular flow in patients with a non-LAD infarct-related artery.
Asunto(s)
Angioplastia Coronaria con Balón/métodos , Infarto del Miocardio/cirugía , Anciano , Angioplastia/métodos , Presión Sanguínea , Bradicardia/epidemiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Infarto del Miocardio/mortalidad , Infarto del Miocardio/patología , Infarto del Miocardio/fisiopatología , Complicaciones Posoperatorias/epidemiología , Ensayos Clínicos Controlados Aleatorios como Asunto , Stents , Análisis de Supervivencia , Sobrevivientes , Taquicardia/epidemiología , Insuficiencia del Tratamiento , Resultado del TratamientoRESUMEN
Coronary chronic total occlusions (CTOs) are commonly encountered complex lesions identified in 15% of all patients referred for coronary angiography. Chronic total occlusion remains the most powerful predictor of referral for coronary bypass surgery. The benefits of CTO percutaneous coronary intervention (PCI) include symptom relief, improved left ventricular function, and potentially a survival advantage associated with success when compared with failed CTO-PCI. Data from the NCDR (National Cardiovascular Data Registry) suggest that CTO-PCI attempt rates in the U.S. have not changed over the past 5 years despite significant advances in techniques and technology, some of which we review here. Additionally, these data highlight a major disparity in attempt rates based on operator PCI volume. Remaining barriers to attempting CTO-PCI in the U.S. include operator inexperience, the perception of increased risk of CTO-PCI, and financial disincentives to operators and hospitals. To overcome operator inexperience, participation in CTO clubs, the invitation of guest operators, and a dedicated CTO day can be implemented at institutions committed to learning advanced CTO-PCI techniques so that operators can overcome the barriers and offer patients access to percutaneous therapy when it is clinically indicated.
Asunto(s)
Angioplastia Coronaria con Balón , Oclusión Coronaria/terapia , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/economía , Angioplastia Coronaria con Balón/educación , Angioplastia Coronaria con Balón/mortalidad , Angioplastia Coronaria con Balón/estadística & datos numéricos , Enfermedad Crónica , Competencia Clínica , Oclusión Coronaria/economía , Oclusión Coronaria/mortalidad , Oclusión Coronaria/fisiopatología , Análisis Costo-Beneficio , Educación de Postgrado en Medicina , Costos de la Atención en Salud , Disparidades en Atención de Salud , Humanos , Selección de Paciente , Recuperación de la Función , Medición de Riesgo , Resultado del Tratamiento , Estados Unidos , Función Ventricular IzquierdaRESUMEN
OBJECTIVE: The aim of this article is to examine whether clopidogrel and ticlopidine treatments produce similar clinical outcomes for patients receiving primary stenting for acute myocardial infarction (AMI). BACKGROUND: Prior studies have yielded conflicting results on the relative safety and efficacy of clopidogrel and ticlopidine after stent implantation, warranting an evaluation in primary stenting for AMI. METHODS: In the multicenter, prospective CADILLAC trial, patients undergoing primary infarct stenting were treated at operator discretion with either ticlopidine (931 patients) or clopidogrel (163 patients) and then followed for 1 year. Baseline clinical and angiographic characteristics were comparable except for baseline TIMI 0/1 flow (72.5% clopidogrel vs. 63.9% ticlopidine, P = 0.04). RESULTS: Patients receiving clopidogrel had more recurrent ischemia in hospital (6.1 vs. 2.8%, P = 0.02) and at 30 days (10.5 vs. 5.8%, P = 0.02), more moderate and severe bleeding at 30 days (7.4 vs. 2.7%, P = 0.002), and similar rates of stent thrombosis out to 1 year (P = 0.11). By multivariable analysis, clopidogrel use was an independent predictor for recurrent ischemia in hospital (P = 0.0002), and at 30 days (P = 0.012); and of moderate and severe bleeding in hospital (P = 0.002), and at 30 days (P = 0.001). CONCLUSIONS: Despite thienopyridines similarities, their efficacy may be different within the first 30 days of primary stenting for AMI. A prospective, randomized trial is required to confirm these findings.
Asunto(s)
Angioplastia Coronaria con Balón/instrumentación , Infarto del Miocardio/terapia , Inhibidores de Agregación Plaquetaria/uso terapéutico , Stents , Ticlopidina/análogos & derivados , Ticlopidina/uso terapéutico , Abciximab , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Anticuerpos Monoclonales/uso terapéutico , Aspirina/uso terapéutico , Clopidogrel , Angiografía Coronaria , Quimioterapia Combinada , Europa (Continente) , Femenino , Hemorragia/inducido químicamente , Humanos , Fragmentos Fab de Inmunoglobulinas/uso terapéutico , Masculino , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Infarto del Miocardio/diagnóstico por imagen , Infarto del Miocardio/tratamiento farmacológico , Isquemia Miocárdica/etiología , Inhibidores de Agregación Plaquetaria/efectos adversos , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Retrospectivos , Medición de Riesgo , Trombosis/etiología , Ticlopidina/efectos adversos , Factores de Tiempo , Resultado del Tratamiento , Estados UnidosRESUMEN
BACKGROUND: Advances in coronary angioplasty and adjunct pharmacology have improved patient outcomes after primary percutaneous coronary intervention (PCI) in acute myocardial infarction (AMI). However, several areas for improvement remain. Hemorrhagic complications, which are common in patients receiving intense anticoagulant and antiplatelet agents during primary PCI to suppress ischemia, have been strongly associated with early and late mortality. Moreover, restenosis after bare-metal stents (BMSs) frequently results in symptom recurrence and the need for repeat rehospitalization and revascularization procedures. Newer pharmacologic agents and drug-eluting stents may address both of these issues. STUDY DESIGN: In the HORIZONS-AMI trial, 3,602 patients with AMI undergoing primary PCI were prospectively randomized to unfractionated heparin plus routine use of glycoprotein (GP) IIb/IIIa inhibitors versus the direct thrombin inhibitor bivalirudin plus provisional use of GP IIb/IIIa inhibitors reserved for predefined thrombotic complications. In a second randomization, 3,011 eligible patients were randomly assigned to either a polymer-based paclitaxel-eluting stent or to an otherwise identical BMS. The study was powered for the assessment of sequential safety and efficacy end points for each specific randomization, with clinical end points assessed at 30 days, 1 year, and then annually for 5 years. SUMMARY: The ongoing HORIZONS-AMI trial will determine whether bivalirudin monotherapy reduces bleeding complications and improves overall event-free survival compared with unfractionated heparin plus the routine use of GP IIb/IIIa inhibitors in patients undergoing primary PCI for AMI. Furthermore, this study will determine whether paclitaxel-eluting stents safely reduce rates of ischemic target lesion revascularization compared with BMSs in the setting of primary PCI.
Asunto(s)
Angioplastia Coronaria con Balón/métodos , Anticoagulantes/uso terapéutico , Infarto del Miocardio/terapia , Complejo GPIIb-IIIa de Glicoproteína Plaquetaria/antagonistas & inhibidores , Stents , Adulto , Anciano , Terapia Combinada , Angiografía Coronaria , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Stents Liberadores de Fármacos , Estudios de Seguimiento , Heparina de Bajo-Peso-Molecular/uso terapéutico , Hirudinas/administración & dosificación , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/diagnóstico por imagen , Infarto del Miocardio/mortalidad , Fragmentos de Péptidos/administración & dosificación , Complejo GPIIb-IIIa de Glicoproteína Plaquetaria/uso terapéutico , Probabilidad , Estudios Prospectivos , Proteínas Recombinantes/administración & dosificación , Valores de Referencia , Proyectos de Investigación , Medición de Riesgo , Tasa de Supervivencia , Trombosis/prevención & control , Factores de TiempoRESUMEN
OBJECTIVES: This study compared the survival benefit of opening a chronic total occlusion (CTO) of the left anterior descending (LAD), left circumflex (LCX), or right coronary artery (RCA). BACKGROUND: Previous analyses demonstrate improved survival following successful percutaneous coronary intervention (PCI) for CTO. METHODS: Eligible patients underwent attempted CTO PCI in a single vessel. Procedural success rates were calculated for each vessel. The primary end point was survival at 5 years, compared across target vessel groups stratified by procedural success. RESULTS: There were 2,608 patients included. The LAD was the target vessel in 936 (36%), the LCX in 682 (26%), and the RCA in 990 (38%) patients. Angiographic success rates for LAD were 77%, LCX 76%, and RCA 72%. Baseline demographics and comorbidities were well matched, though there were significantly more males in the LCX compared with LAD or RCA groups (80% vs. 75% and 73%, respectively, p = 0.005). Procedural success compared with failure was associated with improved 5-year survival in the LAD (88.9% vs. 80.2%, p < 0.001) group, but not in the LCX (86.1% vs. 82.1%, p = 0.21) and RCA groups (87.7% vs. 84.9%, p = 0.23). In multivariable analysis, CTO PCI success in the LAD group remained associated with decreased mortality risk (HR: 0.61, 95% CI: 0.42 to 0.89). CONCLUSIONS: The data suggest that PCI for CTO of the LAD, but not LCX or RCA, is associated with improved long-term survival. This information may assist in selecting patients for attempted CTO PCI.
Asunto(s)
Angioplastia Coronaria con Balón/mortalidad , Oclusión Coronaria/mortalidad , Oclusión Coronaria/terapia , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Enfermedad Crónica , Angiografía Coronaria , Oclusión Coronaria/diagnóstico por imagen , Femenino , Cardiopatías/etiología , Cardiopatías/mortalidad , Mortalidad Hospitalaria , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Selección de Paciente , Inhibidores de Agregación Plaquetaria/uso terapéutico , Modelos de Riesgos Proporcionales , Sistema de Registros , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
Diabetes mellitus is strongly associated with increased cardiovascular morbidity and mortality in patients with ST-segment elevation myocardial infarction. It is unknown whether myocardial perfusion is decreased in diabetic compared with nondiabetic patients after primary percutaneous coronary intervention (PCI), which may contribute to their worse prognosis. We compared myocardial perfusion and infarct sizes between diabetic and nondiabetic patients undergoing PCI for acute ST-segment elevation myocardial infarction in the EMERALD trial. EMERALD was a prospective, randomized, multicenter study evaluating distal embolic protection during primary PCI in ST-segment elevation myocardial infarction. End points included final myocardial blush grade, complete ST-segment resolution (STR) 30 minutes after PCI, and final infarct size as determined by technetium-99m single proton emission computed tomography measured between days 5 and 14. Of 501 patients, 62 (12%) had diabetes mellitus. Diabetic patients had impaired myocardial perfusion after PCI as measured by myocardial blush grade 0/1 (34% vs 16%, p = 0.002) and lower rates of complete 30-minute STR (45% vs 65%, p = 0.005). Infarct size (median 20% vs 11%, p = 0.005), development of new onset severe congestive heart failure (12% vs 4%, p = 0.016), and 30-day mortality (10% vs 1%, p <0.0001) were also greater in diabetic patients. After multivariate adjustment, diabetes remained associated with lack of complete STR and mortality at 6 months. Use of distal protection devices did not improve outcomes in diabetic or nondiabetic patients. In conclusion, in patients with ST-segment elevation myocardial infarction undergoing primary PCI, diabetes is independently associated with decreased myocardial reperfusion, larger infarct, development of congestive heart failure, and decreased survival.
Asunto(s)
Angioplastia Coronaria con Balón , Complicaciones de la Diabetes/terapia , Electrocardiografía , Infarto del Miocardio/terapia , Reperfusión Miocárdica , Anciano , Complicaciones de la Diabetes/mortalidad , Complicaciones de la Diabetes/fisiopatología , Femenino , Insuficiencia Cardíaca/etiología , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/mortalidad , Infarto del Miocardio/fisiopatología , Estudios Prospectivos , Tomografía Computarizada de Emisión de Fotón ÚnicoRESUMEN
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.
Asunto(s)
Angioplastia Coronaria con Balón , Circulación Coronaria/fisiología , Infarto del Miocardio/terapia , Miocardio/patología , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/patología , Infarto del Miocardio/fisiopatología , Reperfusión Miocárdica , Estudios Prospectivos , Factores de Tiempo , Resultado del TratamientoRESUMEN
We evaluated the utility of a routine postprocedure course of unfractionated heparin after primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) in patients not receiving glycoprotein IIb/IIIa inhibitors. In the CADILLAC study, 2,082 patients with AMI who underwent primary PCI were randomized to receive stents versus percutaneous transluminal coronary angioplasty (PTCA), each with or without abciximab. In a subset of 976 patients who did not receive abciximab, we compared outcomes of patients who received postprocedural heparin (n = 758; 78%; median duration 2 days) with those who did not. In 421 patients treated with PTCA, postprocedural heparin use was associated with lower in-hospital major adverse cardiac events (MACEs; 5.3% vs 11.4%, p = 0.069), 1-year MACEs (22% vs 31%, p = 0.08), and decreased in-hospital moderate/severe bleeding (2.3% vs 8.9%, p = 0.01). By multivariate analyses, heparin use correlated with freedom from in-hospital and 1-year MACEs in patients after PTCA. In contrast, in 555 patients who underwent stenting, postprocedural heparin use was associated with increased bleeding and hospitalization costs without a decrease in early or late MACEs. In conclusion, in patients with AMI treated with coronary stenting without glycoprotein IIb/IIIa inhibitors, routine postprocedural heparin was not associated with any significant benefits and may be safely omitted. However, in a subset of patients treated with PTCA, postprocedural heparin use was independently associated with fewer in-hospital and 1-year MACEs.
Asunto(s)
Angioplastia Coronaria con Balón , Anticoagulantes/administración & dosificación , Heparina/administración & dosificación , Infarto del Miocardio/terapia , Complejo GPIIb-IIIa de Glicoproteína Plaquetaria/antagonistas & inhibidores , Abciximab , Anticuerpos Monoclonales/farmacología , Anticoagulantes/uso terapéutico , Estudios Cruzados , Femenino , Estudios de Seguimiento , Heparina/uso terapéutico , Humanos , Fragmentos Fab de Inmunoglobulinas/farmacología , Masculino , Persona de Mediana Edad , Resultado del TratamientoRESUMEN
The objectives of this study were to evaluate angiographic and clinical outcomes among patients with diabetes mellitus (DM) who underwent percutaneous coronary intervention (PCI) for a chronic total occlusion (CTO). We compared them with matched patients undergoing PCI of a non-CTO lesion. All patients had documented DM. Matching was performed using a propensity score for CTO. There were 506 patients with DM and CTO who were matched with a non-CTO group. Results showed that angiographic success rates were lower with CTO (75% vs. 93%, p<0.001). In-hospital major adverse cardiac event (MACE - death, urgent bypass surgery, Q-wave myocardial infarction or target vessel revascularisation) rates were equivalent (CTO 3.2% vs. non-CTO 2.6%, p=0.57). Survival was not different five years after revascularisation of CTO (75%) vs. non-CTO (79%) (p=0.20). In addition, when DM patients with CTO were analysed according to angiographic success of PCI, there were no significant differences in either in-hospital (success 1.6% vs. failure 2.4%, p=0.7) or 1-year mortality (success 22.2% vs. failure 26.8%, p=0.3). We conclude that PCI of CTO is safe in patients with DM. Angiographic failure is not associated with an increase in MACE rates or mortality as compared to matched non-CTO patients. However, there is not a measurable improvement in survival in this DM-CTO population.
Asunto(s)
Angioplastia Coronaria con Balón , Enfermedad Coronaria/terapia , Angiopatías Diabéticas/terapia , Anciano , Estudios de Casos y Controles , Angiografía Coronaria , Enfermedad Coronaria/complicaciones , Enfermedad Coronaria/mortalidad , Angiopatías Diabéticas/complicaciones , Angiopatías Diabéticas/mortalidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Resultado del TratamientoRESUMEN
OBJECTIVES: We examined the prognostic implications of the absolute level and rate of increase of creatine kinase (CK) elevation after primary percutaneous coronary intervention (PCI). BACKGROUND: Peak creatine kinase (CK(peak)) and the rate of CK increase are related to reperfusion success and clinical outcomes after thrombolytic therapy for acute myocardial infarction (AMI). The utility of routine serial CK monitoring after primary PCI, in which normal antegrade blood flow is restored in most patients, is unknown. METHODS: In the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trial, 1,529 patients with AMI randomized to either stenting or balloon angioplasty, each with or without abciximab, had CK levels determined at baseline and at 8 +/- 1 h, 16 +/- 1 h, and 24 +/- 1 h after PCI. RESULTS: The CK(peak) occurred at baseline in 3.9% of patients, at 8 +/- 1 h in 69.6%, at 16 +/- 1 h in 20.0%, and at 24 +/- 1 h in 6.5%. The CK levels at all post-procedural time points were significantly higher in patients who died compared with the one-year survivors, as was CK(peak) (mean, 2,865 U/l vs. 1,885 U/l, respectively, p < or = 0.001). By multivariate analysis, CK(peak) was a significant predictor of one-year mortality (hazard ratio = 2.15, p = 0.0002), independent from post-PCI Thrombolysis In Myocardial Infarction (TIMI) flow. Both the improvement in left ventricular ejection fraction from baseline to seven months and its absolute level were inversely correlated with CK(peak) (p < 0.001 for both). In contrast, the time to CK(peak) was not an independent predictor of mortality or myocardial recovery. CONCLUSIONS: The CK(peak) after primary PCI is a powerful predictor of one-year mortality independent of other clinical and angiographic measures.
Asunto(s)
Angioplastia Coronaria con Balón , Creatina Quinasa/sangre , Infarto del Miocardio/sangre , Infarto del Miocardio/terapia , Femenino , Humanos , Masculino , Persona de Mediana Edad , PronósticoRESUMEN
Baseline features, management, and outcomes of patients who had acute myocardial infarction (AMI) and were excluded from randomized trials of primary percutaneous coronary intervention (PCI) have not been well described. We examined the baseline features and outcomes of patients who had AMI and were excluded due to angiographic ineligibility from a randomized trial of primary PCI. The CADILLAC trial evaluated 4 primary PCI strategies in patients who had AMI without cardiogenic shock. Of 2,681 patients who consented, 599 (22.3%) were subsequently excluded from randomization due to protocol-specified angiographic findings. These patients were enrolled in a formal in-hospital registry and were treated at the discretion of attending physicians. Registry versus randomized patients were older (median age 61.9 vs 59.0 years, p = 0.002), more frequently had 3-vessel disease (52.4% vs 15.6%, p = 0.0001), and more frequently had lower left ventricular ejection fraction (45% vs 50%, p = 0.002). Registry patients were treated with PCI (n = 234), coronary artery bypass grafting (n = 136), or medically only (n = 226). In-hospital mortality rate among all patients who consented was 2.2% and was higher among registry than among randomized patients (4.0% vs 1.6%, relative risk 2.45, p = 0.001). Within the registry, covariate-adjusted risk of mortality was lower among patients who were treated by PCI compared with those who were treated medically (odds ratio 0.21, p=0.03). In conclusion, angiographic ineligibility for randomization in a large, prospective, primary PCI trial was associated with numerous high-risk demographic characteristics and higher short-term mortality. Nonetheless, the overall survival of patients who were referred for primary PCI was excellent, and performance of primary PCI versus medical therapy was associated with increased survival among excluded patients.
Asunto(s)
Angioplastia Coronaria con Balón/métodos , Consentimiento Informado , Infarto del Miocardio/terapia , Anciano , Angiografía Coronaria , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Infarto del Miocardio/diagnóstico por imagen , Infarto del Miocardio/mortalidad , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto , Tasa de Supervivencia , Resultado del TratamientoRESUMEN
Randomized clinical trials have shown that paclitaxel-eluting stents significantly reduce restenosis after percutaneous coronary intervention. The impact of lesion calcification on the efficacy of paclitaxel-eluting stents is unknown. In the TAXUS-IV trial, 1,314 patients who underwent percutaneous coronary intervention were randomly assigned to a bare-metal or paclitaxel-eluting stent. By core laboratory analysis, 247 lesions (19%) were moderately or severely calcified. At the 9-month angiographic follow-up examination, the paclitaxel-eluting stent had significantly reduced the amount of late loss compared with the control stent (0.26 +/- 0.56 vs 0.51 +/- 0.48 mm, p = 0.015) within the analysis segment in the calcific lesions. The analysis segment restenosis rate was similar in patients with calcified and noncalcified lesions after paclitaxel-eluting stent implantation (7.5% vs 8.0%, respectively; p = 1.0). The rate of ischemia-driven target lesion revascularization (TLR) at 1 year was reduced by 56% in patients with calcified lesions (11.9% vs 5.1%, p = 0.09) and by 75% in noncalcified lesions (15.7% vs 4.3%, p <0.0001). By interaction testing, the efficacy of the paclitaxel-eluting stent in reducing TLR at 1 year was similar in the calcified and noncalcified lesions (p = 0.30). Moreover, by multivariate analysis, implantation of the paclitaxel-eluting stent was a powerful independent predictor of freedom from TLR, with similar hazard ratios for efficacy in calcified and noncalcified lesions (0.30 and 0.26, respectively). In conclusion, implantation of paclitaxel-eluting stents in patients with de novo coronary lesions significantly reduced restenosis in patients with and without calcified lesions.
Asunto(s)
Angioplastia Coronaria con Balón/instrumentación , Antineoplásicos Fitogénicos/uso terapéutico , Calcinosis/terapia , Materiales Biocompatibles Revestidos , Estenosis Coronaria/terapia , Paclitaxel/farmacología , Stents , Calcinosis/complicaciones , Calcinosis/diagnóstico por imagen , Angiografía Coronaria , Estenosis Coronaria/diagnóstico por imagen , Estenosis Coronaria/etiología , Femenino , Estudios de Seguimiento , Humanos , Masculino , Metales , Persona de Mediana Edad , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVES: We sought to determine the relationship between cigarette smoking and outcomes after mechanical reperfusion therapy in acute myocardial infarction (AMI). BACKGROUND: Prior studies have found that smokers with AMI have lower mortality rates and a more favorable response to fibrinolytic therapy than nonsmokers. The impact of cigarette smoking in patients undergoing primary percutaneous coronary intervention has not been examined. METHODS: In the CADILLAC trial, 2082 patients with AMI were randomized to percutaneous transluminal coronary angioplasty +/- abciximab versus stenting +/- abciximab. Data on smoking status were prospectively collected and follow-up continued for 1 year. RESULTS: At the time of presentation, 638 (31%) patients had never smoked, 546 (26%) were former smokers, and 898 (45%) were currently smoking. In comparison to nonsmokers, current smokers were younger, more often men, and less frequently had diabetes, hypertension, prior AMI, and triple-vessel coronary disease. Procedural success rates were unrelated to smoking status. Mortality was lowest in current smokers, intermediate in former smokers, and highest in nonsmokers at 30 days (1.3% vs 1.7% vs 3.5%, respectively, P = .02) and 1 year (2.9% vs 3.7% vs 6.6%, P = .0008). After multivariate correction for differences in baseline variables, however, current smoking status was no longer protective from late mortality (hazard ratio 0.96, 95% CI 0.52-1.76, P = .89). CONCLUSIONS: The "smoker's paradox" extends to patients undergoing primary PCI for AMI, with increased survival seen in current smokers, an effect entirely explained by differences in baseline risk and not smoking status per se. The deleterious effects of smoking are expressed in the occurrence of AMI nearly a decade earlier than in nonsmokers, with similar age-adjusted risk, mandating intensive primary and secondary cigarette-cessation efforts.
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Angioplastia Coronaria con Balón , Infarto del Miocardio/terapia , Fumar/efectos adversos , Abciximab , Anciano , Anticuerpos Monoclonales/uso terapéutico , Anticoagulantes/uso terapéutico , Comorbilidad , Angiografía Coronaria , Femenino , Estudios de Seguimiento , Humanos , Fragmentos Fab de Inmunoglobulinas/uso terapéutico , Masculino , Persona de Mediana Edad , Mortalidad , Infarto del Miocardio/diagnóstico por imagen , Inhibidores de Agregación Plaquetaria/uso terapéutico , Estudios Prospectivos , Recurrencia , Riesgo , Cese del Hábito de Fumar , Stents , Accidente Cerebrovascular/epidemiología , Análisis de Supervivencia , Resultado del TratamientoRESUMEN
CONTEXT: Atheromatous and thrombotic embolization during percutaneous coronary intervention (PCI) in acute myocardial infarction is common and may result in microcirculatory dysfunction, the prevention of which may improve reperfusion success, reduce infarct size, and enhance event-free survival. OBJECTIVE: To determine whether protection of the distal microcirculation from thromboembolic debris liberated during primary PCI results in improved reperfusion and decreased infarct size. DESIGN, SETTING, AND PATIENTS: Prospective randomized controlled trial at 38 academic and community-based institutions in 7 countries enrolling 501 patients aged 18 years or older with ST-segment elevation myocardial infarction (STEMI) presenting within 6 hours of symptom onset and undergoing primary PCI or rescue intervention after failed thrombolysis. INTERVENTIONS: Patients were randomized between May 20, 2002, and November 21, 2003, to receive PCI with a balloon occlusion and aspiration distal microcirculatory protection system vs angioplasty without distal protection. MAIN OUTCOME MEASURES: Coprimary end points were ST-segment resolution (STR) measured 30 minutes after PCI by continuous Holter monitoring and infarct size measured by technetium Tc 99m sestamibi imaging between days 5 and 14. Secondary end points included major adverse cardiac events. RESULTS: Among 252 patients assigned to distal protection, aspiration was performed in 97% (242/251), all angioplasty balloon inflations were fully protected in 79% (193/245), and visible debris was retrieved from 73% (182/250). Complete STR was achieved in a similar proportion reperfused with vs without distal protection (63.3% [152/240] vs 61.9% [148/239], respectively; absolute difference, 1.4% [95% confidence interval, -7.7% to 10.5%; P = .78]), and left ventricular infarct size was similar in both groups (median, 12.0% [n = 229] vs 9.5% [n = 208], respectively; P = .15). Major adverse cardiac events at 6 months occurred with similar frequency in the distal protection and control groups (10.0% vs 11.0%, respectively; P = .66). CONCLUSIONS: A distal balloon occlusion and aspiration system effectively retrieves embolic debris in most patients with acute STEMI undergoing emergent PCI. Nonetheless, distal embolic protection did not result in improved microvascular flow, greater reperfusion success, reduced infarct size, or enhanced event-free survival.
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Angioplastia Coronaria con Balón , Infarto del Miocardio/terapia , Succión , Anciano , Electrocardiografía Ambulatoria , Femenino , Humanos , Masculino , Microcirculación , Persona de Mediana Edad , Infarto del Miocardio/diagnóstico por imagen , Infarto del Miocardio/fisiopatología , Estudios Prospectivos , Radiofármacos/uso terapéutico , Tecnecio Tc 99m Sestamibi , Tromboembolia , Tomografía Computarizada de Emisión de Fotón ÚnicoRESUMEN
We sought to determine the benefits of stent implantation and abciximab in patients with diabetes mellitus and acute myocardial infarction (AMI) who underwent primary angioplasty. In a 2-by-2 factorial design, 2,082 patients with AMI were randomly assigned to balloon angioplasty versus stenting, with or without abciximab. Diabetes was present in 346 patients (16.6%). The primary end point was the composite incidence of death, disabling stroke, reinfarction, and ischemic target vessel revascularization (TVR). The primary end point at 1 year occurred significantly more frequently in diabetic than nondiabetic patients (21.9% vs 16.8%, p <0.02), driven by increased rates of death (6.1% vs 3.9%, p = 0.04) and TVR (16.4% vs 12.7%, p = 0.07). Among patients with diabetes, TVR at 1 year was significantly reduced with routine stenting compared with balloon angioplasty (10.3% vs 22.4%, p = 0.004), with no differences in death, reinfarction, or stroke. Angiographic restenosis was also greatly reduced in diabetics randomized to stenting (21.1% vs 47.6%, p = 0.009). No beneficial effects were apparent with abciximab in diabetic patients at 1 year. Despite the improved outcomes with stenting in patients with diabetes, 1-year mortality remained increased in diabetic patients who received stents compared with nondiabetics (8.2% vs 3.6%, p = 0.005). Thus, routine stent implantation in diabetic patients with AMI significantly reduces restenosis and enhances survival free from TVR, independent of abciximab use, although survival remains reduced compared with survival in nondiabetic patients regardless of reperfusion modality.
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Angioplastia Coronaria con Balón , Anticuerpos Monoclonales/uso terapéutico , Complicaciones de la Diabetes/terapia , Fragmentos Fab de Inmunoglobulinas/uso terapéutico , Infarto del Miocardio/terapia , Complejo GPIIb-IIIa de Glicoproteína Plaquetaria/uso terapéutico , Stents , Abciximab , Anciano , Terapia Combinada , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/complicacionesRESUMEN
The Driver Registry was a prospective, multicenter, nonrandomized study to evaluate the clinical safety and efficacy of the Driver cobalt-chromium alloy stent. Use of the cobalt-chromium alloy in place of stainless steel offers enhanced visibility and radial strength with thinner structural elements. The registry enrolled 298 patients with symptomatic ischemic heart disease attributable to de novo or restenotic nonstented native lesions of a single vessel amenable to percutaneous stenting. The primary composite end point was the incidence of major adverse cardiac events (death, myocardial infarction, emergency bypass surgery, or target lesion revascularization) 180 days after enrollment. Quantitative coronary angiography was performed before and after the index stent deployment and repeated at 6 months in 83 patients. Mean patient age was 62.6 years, mean reference vessel diameter was 3.07 mm before the procedure, and mean lesion length was 11.04 mm. Fifty-one patients received multiple stents. Angiographic success rate was 100% and procedural success rate was 98.3%. Cumulative incidence of major adverse cardiac events was 5.7% and target lesion revascularization was 3.4% at 180 days. In-stent late loss was 0.94 mm at 180 days, and no subacute stent thromboses were observed. This registry demonstrated the safety and efficacy of this novel coronary stent platform.
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Estenosis Coronaria/cirugía , Stents , Aleaciones de Cromo , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Diseño de Prótesis , Factores de TiempoRESUMEN
BACKGROUND: The optimal percutaneous interventional strategy for dealing with significant non-culprit lesions in patients with multivessel disease (MVD) with acute myocardial infarction (AMI) at presentation remains controversial. METHODS: A total of 820 patients treated with primary angioplasty for AMI between 1998 and 2002 were classified in groups of patients with single vessel disease (SVD) or MVD (> or =70% stenosis of > or =2 coronary arteries). Patients with MVD were subdivided in 3 groups on the basis of the revascularization strategy: 1) patients undergoing percutaneous coronary intervention (PCI) of the infarct-related artery (IRA) only; 2) patients undergoing PCI of both the IRA and non-IRA(s) during the initial procedure; and 3) patients undergoing PCI of the IRA followed by staged, in-hospital PCI of the non-IRA(s). Procedural, 30-day, and 1-year outcomes are reported. RESULTS: At 1 year, compared with patients with SVD, patients with MVD had a higher incidence of re-infarction (5.9% vs 1.6%, P =.003), revascularization (18% vs 9.6%, P <.001), mortality (12% vs 3.2%, P <.001), and major adverse cardiac events (MACEs; 31% vs 13%, P <.001). In patients with MVD, compared with PCI restricted to the IRA only, multivessel PCI was associated with higher rates of re-infarction (13.0% vs 2.8%, P <.001), revascularization (25% vs 15%, P =.007), and MACEs (40% vs 28%, P =.006). Multivessel PCI was an independent predictor of MACEs at 1 year (odds ratio = 1.67, P =.01). CONCLUSIONS: These data suggest that in patients with MVD, PCI should be directed at the IRA only, with decisions about PCI of non-culprit lesions guided by objective evidence of residual ischemia at late follow-up. Further studies are needed to confirm these findings.
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Angioplastia Coronaria con Balón/métodos , Estenosis Coronaria/terapia , Infarto del Miocardio/terapia , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Angiografía Coronaria , Estenosis Coronaria/complicaciones , Estenosis Coronaria/patología , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Infarto del Miocardio/etiología , Infarto del Miocardio/mortalidad , Recurrencia , Resultado del TratamientoRESUMEN
OBJECTIVES: We sought to examine the effect of intravenous beta-blockers administered before primary percutaneous coronary intervention (PCI) on survival and myocardial recovery after acute myocardial infarction (AMI). BACKGROUND: Studies of primary PCI but not thrombolysis have suggested that beta-blocker administration before reperfusion may enhance survival. Whether oral beta-blocker use before admission modulates this effect is unknown. METHODS: The Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trial randomized 2082 AMI patients to either stenting or balloon angioplasty, each +/- abciximab. In accordance with the protocol, intravenous beta-blockers were administered before PCI in the absence of contraindications. RESULTS: A total of 1136 patients (54.5%, BB+ group) received beta-blockers before PCI, whereas 946 (45.5%, BB- group) did not. The 30-day mortality was significantly lower in the BB+ group than in the BB- group (1.5% vs. 2.8%, p = 0.03), an effect entirely limited to patients who had not been receiving beta-blockers before admission (1.2% vs. 2.9%, p = 0.007). In contrast, no survival benefit with pre-procedural beta-blockers was observed in patients receiving beta-blockers at home (3.3% vs. 1.9%, respectively, p = 0.47). By multivariate analysis, pre-procedural beta-blocker use was an independent predictor of lower 30-day mortality among patients without previous beta-blocker therapy (relative risk = 0.38 [95% confidence interval 0.17 to 0.87], p = 0.02). The improvement in left ventricular ejection fraction from baseline to seven months was also greater after intravenous beta-blockers (3.8% vs. 1.3%, p = 0.01), an effect limited to patients not receiving oral beta-blockers before admission. CONCLUSIONS: In patients with AMI undergoing primary PCI, myocardial recovery is enhanced and 30-day mortality is reduced with pre-procedural intravenous beta-blockade, effects confined to patients untreated with oral beta-blocker medication before admission.
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Antagonistas Adrenérgicos beta/administración & dosificación , Angioplastia Coronaria con Balón/métodos , Infarto del Miocardio/terapia , Premedicación , Antagonistas Adrenérgicos beta/uso terapéutico , Anciano , Femenino , Humanos , Infusiones Intravenosas , Masculino , Persona de Mediana Edad , Infarto del Miocardio/tratamiento farmacológico , Infarto del Miocardio/fisiopatología , Cuidados Preoperatorios , Recuperación de la Función/efectos de los fármacos , Volumen Sistólico/efectos de los fármacos , Análisis de Supervivencia , Resultado del TratamientoRESUMEN
UNLABELLED: Prompt myocardial reperfusion is the therapeutic goal for patients presenting with acute myocardial infarction (AMI). However, there remains a paucity of clinical data from single centers solely dedicated to a catheter-based reperfusion strategy. Therefore, we sought to identify significant predictors of in-hospital mortality, to determine the changing profile of patient demographics and to identify the mortality trend over time. METHODS: Consecutive patients who underwent percutaneous coronary intervention (PCI) for an AMI between January of 1982 and December of 1999 were included in this multivariable analysis (excluding cardiogenic shock). AMI was defined as an evolving myocardial infarction within the preceding 24 hours. The primary endpoint for this analysis was in-hospital mortality. RESULTS: There were 2,745 patients identified in this study, of which 8.3% (n = 228) were non-survivors. The significant multivariable predictors of in-hospital mortality included creatinine > 1.5 mg/dl [relative risk (RR), 5.7; 95% confidence interval (CI) 4.0 8.1], ejection fraction < 40% (RR, 6.6; 95% CI, 4.3 10.0), multivessel disease (RR, 2.8; 95% CI, 1.9 4.2), female (RR, 2.3; 95% CI, 1.6 3.1) and age > 70 years (RR, 1.6; 95% CI, 1.1 2.2). The incidence of patients with these high-risk characteristics increased in recent years; thus, the unadjusted slope of the mortality trend over 20 years was not significant. However, following adjustment for the temporal shift in high-risk variables, there was a significant reduction in the adjusted in-hospital mortality rate (RR, 0.89; 95% CI 0.8 0.98; p = 0.017). Despite the changing risk profile, the short-term mortality continues to improve for patients undergoing AMI PCI.