RESUMEN
BACKGROUND: prior statin treatment has been shown to have favourable effects on short- and long-term prognosis in patients with acute coronary syndrome (ACS). There are limited data in older patients. The aim of this study was to investigate the association of previous statin therapy and presentation characteristics, infarct size and clinical outcome in older patients, with or without atherosclerotic cardiovascular disease (ASCVD), included in the Elderly-ACS 2 trial. METHODS: data on statin use pre-admission were available for 1,192 of the 1,443 patients enrolled in the original trial. Of these, 531 (44.5%) were already taking statins. Patients were stratified based on established ASCVD and statin therapy. ACS was classified as non-ST elevation or ST elevation myocardial infarction (STEMI). Infarct size was measured by peak creatine kinase MB (CK-MB). All-cause death in-hospital and within 1 year were the major end points. RESULTS: there was a significantly lower frequency of STEMI in statin patients, in both ASCVD and No-ASCVD groups. Peak CK-MB levels were lower in statin users (10 versus 25 ng/ml, P < 0.0001). There was lower all-cause death in-hospital and within 1 year for subjects with ASCVD already on statins independent of other baseline variables. There were no differences in all-cause death for No-ASCVD patients whether or not on statins. CONCLUSIONS: statin pretreatment was associated with more favourable ACS presentation and lower myocardial damage in older ACS patients both ASCVD and No-ASCVD. The incidence of all-cause death (in-hospital and within 1 year) was significantly lower in the statin treated ASCVD patients.
Asunto(s)
Síndrome Coronario Agudo , Inhibidores de Hidroximetilglutaril-CoA Reductasas , Infarto del Miocardio con Elevación del ST , Síndrome Coronario Agudo/diagnóstico , Síndrome Coronario Agudo/tratamiento farmacológico , Anciano , Humanos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Incidencia , Pronóstico , Infarto del Miocardio con Elevación del ST/diagnóstico , Infarto del Miocardio con Elevación del ST/tratamiento farmacológicoRESUMEN
BACKGROUND AND AIM: Elderly patients are at increased risk of hemorrhagic and thrombotic complications after an acute coronary syndrome (ACS). Frailty, comorbidities and low body weight have emerged as conditioning the prognostic impact of dual antiplatelet therapy (DAPT). The aim of the present study was to investigate the prognostic impact of body mass index (BMI) on clinical outcome among patients included in the Elderly-ACS 2 trial, a randomized, open-label, blinded endpoint study comparing low-dose (5 mg) prasugrel vs clopidogrel among elderly patients with ACS. METHODS AND RESULTS: Our population is represented by 1408 patients enrolled in the Elderly-ACS 2 trial. BMI was calculated at admission. The primary endpoint of this analysis was cardiovascular (CV) mortality. Secondary endpoints were all-cause death, recurrent MI, Bleeding Academic Research Consortium (BARC) type 2 or 3 bleeding, and re-hospitalization for cardiovascular reasons or stent thrombosis within 12 months after index admission. Patients were grouped according to median values of BMI (Asunto(s)
Síndrome Coronario Agudo/terapia
, Índice de Masa Corporal
, Clopidogrel/administración & dosificación
, Infarto del Miocardio sin Elevación del ST/terapia
, Intervención Coronaria Percutánea
, Inhibidores de Agregación Plaquetaria/administración & dosificación
, Clorhidrato de Prasugrel/administración & dosificación
, Infarto del Miocardio con Elevación del ST/terapia
, Síndrome Coronario Agudo/diagnóstico por imagen
, Síndrome Coronario Agudo/mortalidad
, Factores de Edad
, Anciano
, Anciano de 80 o más Años
, Causas de Muerte
, Clopidogrel/efectos adversos
, Comorbilidad
, Femenino
, Anciano Frágil
, Evaluación Geriátrica
, Hemorragia/inducido químicamente
, Hemorragia/mortalidad
, Humanos
, Italia
, Masculino
, Infarto del Miocardio sin Elevación del ST/diagnóstico por imagen
, Infarto del Miocardio sin Elevación del ST/mortalidad
, Intervención Coronaria Percutánea/efectos adversos
, Intervención Coronaria Percutánea/mortalidad
, Inhibidores de Agregación Plaquetaria/efectos adversos
, Clorhidrato de Prasugrel/efectos adversos
, Recurrencia
, Medición de Riesgo
, Factores de Riesgo
, Infarto del Miocardio con Elevación del ST/diagnóstico por imagen
, Infarto del Miocardio con Elevación del ST/mortalidad
, Factores de Tiempo
, Resultado del Tratamiento
RESUMEN
BACKGROUND: Elderly patients are at elevated risk of both ischemic and bleeding complications after an acute coronary syndrome and display higher on-clopidogrel platelet reactivity compared with younger patients. Prasugrel 5 mg provides more predictable platelet inhibition compared with clopidogrel in the elderly, suggesting the possibility of reducing ischemic events without increasing bleeding. METHODS: In a multicenter, randomized, open-label, blinded end point trial, we compared a once-daily maintenance dose of prasugrel 5 mg with the standard clopidogrel 75 mg in patients >74 years of age with acute coronary syndrome undergoing percutaneous coronary intervention. The primary end point was the composite of mortality, myocardial infarction, disabling stroke, and rehospitalization for cardiovascular causes or bleeding within 1 year. The study was designed to demonstrate superiority of prasugrel 5 mg over clopidogrel 75 mg. RESULTS: Enrollment was interrupted, according to prespecified criteria, after a planned interim analysis, when 1443 patients (40% women; mean age, 80 years) had been enrolled with a median follow-up of 12 months, because of futility for efficacy. The primary end point occurred in 121 patients (17%) with prasugrel and 121 (16.6%) with clopidogrel (hazard ratio, 1.007; 95% confidence interval, 0.78-1.30; P=0.955). Definite/probable stent thrombosis rates were 0.7% with prasugrel versus 1.9% with clopidogrel (odds ratio, 0.36; 95% confidence interval, 0.13-1.00; P=0.06). Bleeding Academic Research Consortium types 2 and greater rates were 4.1% with prasugrel versus 2.7% with clopidogrel (odds ratio, 1.52; 95% confidence interval, 0.85-3.16; P=0.18). CONCLUSIONS: The present study in elderly patients with acute coronary syndromes showed no difference in the primary end point between reduced-dose prasugrel and standard-dose clopidogrel. However, the study should be interpreted in light of the premature termination of the trial. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01777503.
Asunto(s)
Síndrome Coronario Agudo/mortalidad , Síndrome Coronario Agudo/terapia , Clopidogrel/administración & dosificación , Infarto del Miocardio/mortalidad , Infarto del Miocardio/terapia , Clorhidrato de Prasugrel/administración & dosificación , Anciano , Anciano de 80 o más Años , Clopidogrel/efectos adversos , Supervivencia sin Enfermedad , Femenino , Hemorragia/inducido químicamente , Hemorragia/mortalidad , Humanos , Masculino , Intervención Coronaria Percutánea , Clorhidrato de Prasugrel/efectos adversos , Tasa de SupervivenciaAsunto(s)
Infecciones por Coronavirus/diagnóstico , Neumonía Viral/diagnóstico , Infarto del Miocardio con Elevación del ST/diagnóstico , Anciano , Anciano de 80 o más Años , Betacoronavirus/aislamiento & purificación , COVID-19 , Angiografía Coronaria , Infecciones por Coronavirus/complicaciones , Infecciones por Coronavirus/virología , Ecocardiografía , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pandemias , Neumonía Viral/complicaciones , Neumonía Viral/virología , Factores de Riesgo , SARS-CoV-2 , Infarto del Miocardio con Elevación del ST/complicacionesRESUMEN
BACKGROUND: Elderly patients display higher on clopidogrel platelet reactivity as compared with younger patients. Treatment with prasugrel 5mg has been shown to provide more predictable and homogenous antiplatelet effect, as compared with clopidogrel, suggesting the possibility of reducing ischemic events after an acute coronary syndrome (ACS) without increasing bleeding. STUDY DESIGN: The Elderly-ACS 2 study is a multicenter, randomized, parallel-group, open-label trial designed to demonstrate the superiority of a strategy of dual antiplatelet treatment using a reduced 5-mg daily dose of prasugrel over a standard strategy with a daily clopidogrel dose of 75mg in patients older than 74years with ACS (either ST- or non-ST-elevation myocardial infarction) undergoing early percutaneous revascularization. The primary end point is the composite of all-cause mortality, myocardial reinfarction, disabling stroke, and rehospitalization for cardiovascular causes or bleeding within 1 year. Taking advantage of the planned size of 2,000 patients, the secondary objective is to assess the prognostic impact of selected prerandomization variables (age, sex, diabetic status, serum creatinine level, electrocardiogram changes, abnormal troponin levels, basal and residual SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery [SYNTAX] score). CONCLUSION: The Elderly-ACS 2 study is a multicenter, randomized trial comparing a strategy of dual antiplatelet therapy with a reduced dose of prasugrel with a standard dose of clopidogrel in elderly patients with ACS undergoing percutaneous revascularization (the Elderly ACS 2 trial: NCT01777503).
Asunto(s)
Síndrome Coronario Agudo/terapia , Aspirina/uso terapéutico , Infarto del Miocardio/terapia , Intervención Coronaria Percutánea , Inhibidores de Agregación Plaquetaria/uso terapéutico , Clorhidrato de Prasugrel/administración & dosificación , Antagonistas del Receptor Purinérgico P2Y/uso terapéutico , Ticlopidina/análogos & derivados , Anciano , Anciano de 80 o más Años , Causas de Muerte , Clopidogrel , Quimioterapia Combinada , Intervención Médica Temprana , Femenino , Hemorragia/inducido químicamente , Humanos , Masculino , Mortalidad , Infarto del Miocardio/epidemiología , Readmisión del Paciente , Recurrencia , Accidente Cerebrovascular/epidemiología , Ticlopidina/uso terapéutico , Resultado del TratamientoRESUMEN
Background: Slow pathway (SP) ablation is the cornerstone for atrioventricular nodal reentry tachycardia (AVNRT) treatment, and a low-voltage bridge offers a good target during mapping using low x-ray exposure. We aimed to assess a new tool to identify SP by activation mapping using the last CARTO3® version, i.e., CARTO PRIME® V7 (Biosense Webster, Diamond Bar, CA, USA). Methods and results: Right atrial septum and triangle of Koch 3D-activation map were obtained from intracardiac contact mapping during low x-ray CARTO 3® procedure. In 60 patients (mean age 60.3 ± 14.7, 61% females) undergoing ablation for AVNRT, an automatic activation map using a DECANAV® mapping catheter and CARTO® Confidense™, Coherent, and FAM DX software modules were obtained. The SP was identified in all patients as the latest atrioventricular node activation area; RF catheter ablation (RFCA) in that region elicited junctional beats. The mean procedural time was 150.3 ± 48.3â min, the mean fluoroscopy time exposure was 2.9 ± 2â min, the mean dose-area product (DAP) was 16.5 ± 2.7â cGy/cm2. The mean number of RF applications was 3.9 ± 2, the mean ablation index was 428.6 ± 96.6, and the mean contact force was 8 ± 2.8â g. There were no adverse event during the procedure, and no AVNRT recurrences occurred during a mean follow-up of 14.3 ± 8.3 months. Conclusion: Ablation of the SP by automatic mapping using Confidense™, Coherent, and FAM DX software modules is an innovative, safe, and effective approach to AVNRT ablation. The CARTO3® V7 system shows on a 3D map the latest AV node activation area during sinus rhythm allowing low fluoroscopy time and highly effective RFCA.
RESUMEN
BACKGROUND: Drug-coated balloons (DCB) represent 1 of the most promising innovations in interventional cardiology and may represent a valid alternative to drug-eluting stents. Currently, some sirolimus-coated balloons (SCB) are being investigated for several coronary artery disease applications. OBJECTIVES: This study sought to understand the role of a novel SCB for the treatment of coronary artery disease. METHODS: EASTBOURNE (All-Comers Sirolimus-Coated Balloon European Registry) is a prospective, multicenter, investigator-driven clinical study that enrolled real-world patients treated with SCB. Primary endpoint was target lesion revascularization (TLR) at 12 months. Secondary endpoints were procedural success, myocardial infarction (MI), all-cause death, and major adverse clinical events (a composite of death, MI, and TLR). All adverse events were censored and adjudicated by an independent clinical events committee. RESULTS: A total population of 2,123 patients (2,440 lesions) was enrolled at 38 study centers in Europe and Asia. The average age was 66.6 ± 11.3 years, and diabetic patients were 41.5%. De novo lesions (small vessels) were 56%, in-stent restenosis (ISR) 44%, and bailout stenting occurred in 7.7% of the patients. After 12 months, TLR occurred in 5.9% of the lesions, major adverse clinical events in 9.9%, and spontaneous MI in 2.4% of the patients. The rates of cardiac/all-cause death were 1.5% and 2.5%, respectively. The primary outcome occurred more frequently in the ISR cohort (10.5% vs 2.0%; risk ratio: 1.90; 95% CI: 1.13-3.19). After multivariate Cox regression model, the main determinant for occurrence of the primary endpoint was ISR (OR: 5.5; 95% CI: 3.382-8.881). CONCLUSIONS: EASTBOURNE, the largest DCB study in the coronary field, shows the safety and efficacy of a novel SCB in a broad population of coronary artery disease including small vessels and ISR patients at mid-term follow-up. (The All-Comers Sirolimus-Coated Balloon European Registry [EASTBOURNE]; NCT03085823).
Asunto(s)
Angioplastia Coronaria con Balón , Enfermedad de la Arteria Coronaria , Reestenosis Coronaria , Infarto del Miocardio , Humanos , Persona de Mediana Edad , Anciano , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/complicaciones , Angioplastia Coronaria con Balón/efectos adversos , Sirolimus/efectos adversos , Resultado del Tratamiento , Infarto del Miocardio/complicaciones , Sistema de Registros , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/etiologíaRESUMEN
Multivessel coronary disease is frequent in older patients who underwent coronary angiography for acute coronary syndrome. Whether a complete revascularization or a culprit-only approach is preferable in these patients is still debated. We included consecutive patients aged ≥85 years, presenting with acute coronary syndrome and showing multivessel coronary disease at coronary angiography. Patients were grouped according to complete (residual SYNTAX score [RSS] 0 to 8) or incomplete (RSS >8) revascularization. Primary end point was the rate of major adverse cardiovascular events (MACEs, the composite of cardiovascular death, re-myocardial infarction [re-MI], clinically driven percutaneous coronary intervention, and rehospitalization because of cardiac disease) at 2 years follow-up. A total of 166 patients met the criteria for enrollment; 108 patients had a final RSS 0 to 8 (complete revascularization) and 58 patients had a final RSS >8 (incomplete revascularization). The rate of MACE was reduced in patients who underwent complete revascularization (35.2% vs 51.7%, p = 0.039, adjusted hazard ratio 0.60, 95% confidence interval 0.37 to 0.98, p = 0.04), a difference mainly driven by a reduction in re-MI (8.3% vs 19.0%, p = 0.045), clinically driven percutaneous coronary intervention (2.8% vs 19.0%, p <0.001), and rehospitalization for cardiac disease (9.3% vs 24.1%, p = 0.009). Other independent predictors of MACE were active malignancy, previous MI, left ventricle ejection fraction <35% (increasing risk of events), and radial access (reducing risk of events). In conclusion, in patients aged ≥85 years, a complete revascularization is associated with a better prognosis, especially in terms of nonfatal events.
Asunto(s)
Síndrome Coronario Agudo , Enfermedad de la Arteria Coronaria , Infarto del Miocardio , Intervención Coronaria Percutánea , Síndrome Coronario Agudo/complicaciones , Anciano , Angiografía Coronaria/efectos adversos , Enfermedad de la Arteria Coronaria/complicaciones , Humanos , Infarto del Miocardio/etiología , Intervención Coronaria Percutánea/efectos adversos , Factores de Tiempo , Resultado del TratamientoRESUMEN
Hemoglobin (Hb) levels have emerged as a useful tool for risk stratification and the prediction of outcome after myocardial infarction. We aimed at evaluating the prognostic impact of this parameter among patients in advanced age, where the larger prevalence of anemia and the higher rate of comorbidities could directly impact on the cardiovascular risk. METHODS: All the patients in the ELDERLY-2 trial, were included in this analysis and stratified according to the values of hemoglobin at admission. The primary endpoint of this study was cardiovascular mortality within one year. The secondary endpoints were all-cause mortality, MI, Bleeding Academic Research Consortium (BARC) type 2-3 or 5 bleeding, any stroke, re-hospitalization for cardiovascular event or stent thrombosis (probable or definite) within 12 months after index admission. RESULTS: We included in our analysis 1364 patients, divided in quartiles of Hb values (<12.2; 12.2-13.39; 13.44-14.49; ≥ 4.5 g/dl). At a mean follow- up of 330.4 ± 99.9 days cardiovascular mortality was increased in patients with lower Hb (HR[95%CI] = 0.76 [0.59-0.97], p = 0.03). Results were no more significant after correction for baseline differences (adjusted HR[95%CI] = 1.22 [0.41-3.6], p = 0.16). Similar results were observed for overall mortality. At subgroup analysis, (according to Hb median values) a significant interaction was observed only with the type of antiplatelet therapy, but not with major high-risk subsets of patients. CONCLUSIONS: Among elderly patients with acute coronary syndrome managed invasively, lower hemoglobin at admission is associated with higher cardiovascular and all-cause mortality and major ischemic events, mainly explained by the higher risk profile.
Asunto(s)
Síndrome Coronario Agudo , Intervención Coronaria Percutánea , Síndrome Coronario Agudo/diagnóstico , Síndrome Coronario Agudo/tratamiento farmacológico , Anciano , Clopidogrel , Hemorragia/epidemiología , Hospitalización , Humanos , Intervención Coronaria Percutánea/efectos adversos , Inhibidores de Agregación Plaquetaria , Clorhidrato de Prasugrel , Resultado del TratamientoRESUMEN
BACKGROUND: Worse outcomes have been reported for women, compared with men, after an acute coronary syndrome (ACS). Whether this difference persists in elderly patients undergoing similar invasive treatment has not been studied. We investigated sex-related differences in 1-year outcome of elderly acute coronary syndrome patients treated by percutaneous coronary intervention (PCI). METHODS: Patients 75 years and older successfully treated with PCI were selected among those enrolled in 3 Italian multicenter studies. Cox regression analysis was used to assess the independent predictive value of sex on outcome at 12-month follow-up. RESULTS: A total of 2035 patients (44% women) were included. Women were older and most likely to present with ST-elevation myocardial infarction (STEMI), diabetes, hypertension, and renal dysfunction; men were more frequently overweight, with multivessel coronary disease, prior myocardial infarction, and revascularizations. Overall, no sex disparity was found about all-cause (8.3% vs 7%, P = .305) and cardiovascular mortality (5.7% vs 4.1%, P = .113). Higher cardiovascular mortality was observed in women after STEMI (8.8%) vs 5%, P = .041), but not after non ST-elevation-ACS (3.5% vs 3.7%, P = .999). A sensitivity analysis excluding patients with prior coronary events (N = 1324, 48% women) showed a significantly higher cardiovascular death in women (5.4% vs 2.9%, P = .025). After adjustment for baseline clinical variables, female sex did not predict adverse outcome. CONCLUSIONS: Elderly men and women with ACS show different clinical presentation and baseline risk profile. After successful PCI, unadjusted 1-year cardiovascular mortality was significantly higher in women with STEMI and in those with a first coronary event. However, female sex did not predict cardiovascular mortality after adjustment for the different baseline variables.
Asunto(s)
Síndrome Coronario Agudo , Intervención Coronaria Percutánea , Medición de Riesgo , Factores Sexuales , Síndrome Coronario Agudo/diagnóstico , Síndrome Coronario Agudo/mortalidad , Síndrome Coronario Agudo/cirugía , Anciano , Femenino , Humanos , Hipertensión/epidemiología , Italia/epidemiología , Masculino , Mortalidad , Sobrepeso/epidemiología , Intervención Coronaria Percutánea/métodos , Intervención Coronaria Percutánea/estadística & datos numéricos , Pronóstico , Medición de Riesgo/métodos , Medición de Riesgo/estadística & datos numéricos , Factores de Riesgo , Infarto del Miocardio con Elevación del ST/diagnóstico , Infarto del Miocardio con Elevación del ST/epidemiología , Índice de Severidad de la EnfermedadRESUMEN
AIMS: The purpose of the EASTBOURNE registry is to evaluate the immediate and long-term clinical performance of a novel sirolimus-coated balloon (SCB) in a real-world population of patients with coronary artery disease. We here present the prespecified interim analysis after the enrollment of the first 642 patients who obtained 1-year clinical follow-up. METHODS: EASTBOURNE is a prospective, international, multicenter, all-comer investigator-driven clinical registry, which is enrolling consecutive patients treated with SCB at 42 European and Asiatic centers. Primary study endpoint is target-lesion revascularization (TLR) at 12 months. Secondary endpoints are procedural success and major adverse cardiac events through 36 months. RESULTS: Diabetes mellitus was present in 41% of patients. Acute coronary syndrome was present in 45% of patients and de novo lesions were 55%; 83% of the in-stent restenosis (ISR) patients had drug-eluting stents restenosis. Lesion predilatation was performed in 95% of the cases and bailout stenting occurred in 7.5%. So far, 642 patients have a complete 12-month follow-up. TLR occurred in 2.5%, myocardial infarction in 2.3%, total death in 1% and major adverse cardiac events in 5.8% of patients. A prespecified analysis of comparison between ISR and de-novo lesions showed a significantly higher occurrence of TLR in the ISR population (5.4 vs. 0.2%, Pâ=â0.0008). CONCLUSION: The current interim analysis of 12-month follow-up of the EASTBOURNE registry shows good immediate performance and an adequate and encouraging safety profile through 12 months for this novel SCB.
Asunto(s)
Angioplastia Coronaria con Balón/instrumentación , Materiales Biocompatibles Revestidos , Enfermedad de la Arteria Coronaria/cirugía , Stents Liberadores de Fármacos , Sistema de Registros , Sirolimus/farmacología , Anciano , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico , Femenino , Estudios de Seguimiento , Humanos , Inmunosupresores/farmacología , Masculino , Estudios Prospectivos , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Chronic kidney disease is common in patients admitted with acute coronary syndrome and its prevalence dramatically increases with age. Understanding the determinants of adverse outcomes in this extremely high-risk population may be useful for the development of specific treatment strategies and planning of secondary prevention modalities. AIM: The aim of this study was to assess the impact of baseline renal function and acute kidney injury on one-year outcome of elderly patients with acute coronary syndrome treated with percutaneous coronary intervention. METHODS: Patients aged 75 years and older with acute coronary syndrome undergoing successful percutaneous coronary intervention were selected among those enrolled in three Italian multicentre studies. Based on the baseline estimated glomerular filtration rate (eGFR) calculated using the Cockcroft-Gault formula ([(140-age) × body weight × 0.85 if female]/(72 × serum creatinine)* 1.73 m2 of body surface area), patients were classified as having none or mild (eGFR ≥60 ml/min/1.73 m2), moderate (eGFR 30-59 ml/min/1.73 m2) or severe (eGFR <30 ml/min/1.73 m2) renal dysfunction. Acute kidney injury was defined according to the Acute Kidney Injury Network classification. All-cause and cardiovascular mortality, non-fatal myocardial infarction, rehospitalisation for cardiovascular causes, stroke and type 2, 3 and 5 Bleeding Academic Research Consortium bleedings were analysed up to 12 months. RESULTS: A total of 1904 patients were included. Of these, 57% had moderate and 11% severe renal dysfunction. At 12 months, patients with renal dysfunction had higher rates (P < 0.001) of all-cause (4.5%, 7.5% and 17.8% in patients with none or mild, moderate and severe renal dysfunction, respectively) and cardiovascular mortality (2.8%, 5.2% and 10.2%, respectively). After multivariable adjustment, severe renal dysfunction was associated with a higher risk of all-cause (hazard ratio (HR) 2.86, 95% confidence interval (CI) 1.52-5.37, P = 0.001) and cardiovascular death (HR 3.11, 95% CI 1.41-6.83, P = 0.005), whereas non-fatal events were unaffected. Acute kidney injury incidence was significantly higher in ST-elevation myocardial infarction versus non-ST-elevation acute coronary syndrome patients (11.7% vs. 7.8%, P = 0.036) and in those with reduced baseline renal function (P < 0.001), and it was associated with increased mortality independently from baseline renal function and clinical presentation. CONCLUSIONS: Baseline renal dysfunction is highly prevalent and is associated with higher mortality in elderly acute coronary syndrome patients undergoing percutaneous coronary intervention. Acute kidney injury occurs more frequently among ST-elevation myocardial infarction patients and those with pre-existing renal dysfunction and is independently associated with one-year mortality.
RESUMEN
BACKGROUND: Chronic kidney disease is common in patients admitted with acute coronary syndrome and its prevalence dramatically increases with age. Understanding the determinants of adverse outcomes in this extremely high-risk population may be useful for the development of specific treatment strategies and planning of secondary prevention modalities. AIM: The aim of this study was to assess the impact of baseline renal function and acute kidney injury on one-year outcome of elderly patients with acute coronary syndrome treated with percutaneous coronary intervention. METHODS: Patients aged 75 years and older with acute coronary syndrome undergoing successful percutaneous coronary intervention were selected among those enrolled in three Italian multicentre studies. Based on the baseline estimated glomerular filtration rate (eGFR) calculated using the Cockcroft-Gault formula ([(140-age) × body weight × 0.85 if female]/(72 × serum creatinine)* 1.73 m2 of body surface area), patients were classified as having none or mild (eGFR ≥60 ml/min/1.73 m2), moderate (eGFR 30-59 ml/min/1.73 m2) or severe (eGFR <30 ml/min/1.73 m2) renal dysfunction. Acute kidney injury was defined according to the Acute Kidney Injury Network classification. All-cause and cardiovascular mortality, non-fatal myocardial infarction, rehospitalisation for cardiovascular causes, stroke and type 2, 3 and 5 Bleeding Academic Research Consortium bleedings were analysed up to 12 months. RESULTS: A total of 1904 patients were included. Of these, 57% had moderate and 11% severe renal dysfunction. At 12 months, patients with renal dysfunction had higher rates (P < 0.001) of all-cause (4.5%, 7.5% and 17.8% in patients with none or mild, moderate and severe renal dysfunction, respectively) and cardiovascular mortality (2.8%, 5.2% and 10.2%, respectively). After multivariable adjustment, severe renal dysfunction was associated with a higher risk of all-cause (hazard ratio (HR) 2.86, 95% confidence interval (CI) 1.52-5.37, P = 0.001) and cardiovascular death (HR 3.11, 95% CI 1.41-6.83, P = 0.005), whereas non-fatal events were unaffected. Acute kidney injury incidence was significantly higher in ST-elevation myocardial infarction versus non-ST-elevation acute coronary syndrome patients (11.7% vs. 7.8%, P = 0.036) and in those with reduced baseline renal function (P < 0.001), and it was associated with increased mortality independently from baseline renal function and clinical presentation. CONCLUSIONS: Baseline renal dysfunction is highly prevalent and is associated with higher mortality in elderly acute coronary syndrome patients undergoing percutaneous coronary intervention. Acute kidney injury occurs more frequently among ST-elevation myocardial infarction patients and those with pre-existing renal dysfunction and is independently associated with one-year mortality.
RESUMEN
BACKGROUND: Despite recent improvements in percutaneous coronary revascularization and antithrombotic therapies for the treatment of acute coronary syndromes, the outcome is still unsatisfactory in high-risk patients, such as the elderly and patients with diabetes. The aim of the current study was to investigate the prognostic impact of diabetes on clinical outcome among patients included in the Elderly-ACS 2 trial, a randomized, open-label, blinded endpoint study carried out at 32 centers in Italy. METHODS: Our population is represented by 1443 patients included in the Elderly-ACS 2 trial. Diabetes was defined as known history of diabetes at admission. The primary endpoint of this analysis was cardiovascular mortality, while secondary endpoints were all-cause death, recurrent myocardial infarction, Bleeding Academic Research Consortium type 2 or 3 bleeding, and rehospitalization for cardiovascular event or stent thrombosis within 12 months after index admission. RESULTS: Diabetes was present in 419 (29%) out of 1443 patients. Diabetic status was significantly associated with major cardiovascular risk factors and history of previous coronary disease, presentation with non-ST segment elevation myocardial infarction (Pâ=â0.01) more extensive coronary disease (Pâ=â0.02), more advanced Killip class at presentation (Pâ=â0.003), use at admission of statins (Pâ=â0.004) and diuretics at discharge (Pâ<â0.001). Median follow-up was 367 days (interquartile range: 337-378 days). Diabetic status was associated with an absolute increase in the rate of cardiovascular mortality as compared with patients without diabetes [5.5 vs. 3.3%, hazard ratio (HR) 1.7 (0.99-2.8), Pâ=â0.054], particularly among those treated with clopidogrel [HR (95% confidence interval (CI))â=â1.89 (0.93-3.87), Pâ=â0.08]. However, this difference disappeared after correction for baseline differences [Adjusted HR (95% CI) 1.1(0.4-2.9), Pâ=â0.86]. Similar findings were observed for other secondary endpoints, except for bleeding complications, significantly more frequent in diabetic patients [HR (95% CI) 2.02 (1.14-3.6), Pâ=â0.02; adjusted HR (95% CI)â=â2.1 (1.01-4.3), Pâ=â0.05]. No significant interaction was observed between type of dual antiplatelet therapy, diabetic status and outcome. CONCLUSION: Among elderly patients with acute coronary syndromes, diabetic status was associated with higher rates of comorbidities, more severe cardiovascular risk profile and major bleeding complications fully accounting for the absolute increase in mortality. In fact, diabetes mellitus did not emerge as an independent predictor of survival in advanced age.
Asunto(s)
Síndrome Coronario Agudo/terapia , Diabetes Mellitus/epidemiología , Infarto del Miocardio sin Elevación del ST/terapia , Intervención Coronaria Percutánea , Infarto del Miocardio con Elevación del ST/terapia , Síndrome Coronario Agudo/diagnóstico por imagen , Síndrome Coronario Agudo/mortalidad , Factores de Edad , Anciano , Anciano de 80 o más Años , Comorbilidad , Trombosis Coronaria/epidemiología , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/mortalidad , Femenino , Estado de Salud , Hemorragia/epidemiología , Humanos , Italia/epidemiología , Masculino , Infarto del Miocardio sin Elevación del ST/diagnóstico por imagen , Infarto del Miocardio sin Elevación del ST/mortalidad , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/instrumentación , Intervención Coronaria Percutánea/mortalidad , Recurrencia , Medición de Riesgo , Factores de Riesgo , Infarto del Miocardio con Elevación del ST/diagnóstico por imagen , Infarto del Miocardio con Elevación del ST/mortalidad , Stents , Factores de Tiempo , Resultado del TratamientoRESUMEN
Background Elderly patients have high ischemic and bleeding rates after acute coronary syndrome; however, the occurrence of these complications over time has never been studied. This study sought to characterize average daily ischemic rates ( ADIRs ) and average daily bleeding rates ( ADBRs ) over 1 year in patients aged >74 years with acute coronary syndrome undergoing percutaneous coronary intervention who were randomized in the Elderly ACS 2 trial, comparing low-dose prasugrel (5 mg daily) with clopidogrel (75 mg daily). Methods and Results ADIRs and ADBRs were calculated as the total number of events, including recurrent events, divided by the number of patient-days of follow-up and assessed within different clinical phases: acute (0-3 days), subacute (4-30 days), and late (31-365 days). Generalized estimating equations were used to test the least squares mean differences for the pairwise comparisons of ADIRs and ADBRs and the pairwise comparison of clopidogrel versus prasugrel effects. Globally, ADIRs were 2.6 times (95% CI, 2.4-2.9) higher than ADBRs . ADIRs were significantly higher in the clopidogrel arm than in the low-dose prasugrel arm in the subacute phase ( Padj<0.001) without a difference in ADBRs ( Padj=0.35). In the late phase, ADIRs remained significantly higher with clopidogrel ( Padj<0.001), whereas ADBRs were significantly higher with low-dose prasugrel ( Padj<0.001). Conclusions Ischemic burden was greater than bleeding burden in all clinical phases of 1-year follow-up of elderly patients with acute coronary syndrome treated with percutaneous coronary intervention. Low-dose prasugrel reduced ischemic events in the subacute and chronic phases compared with clopidogrel, whereas bleeding burden was lower with clopidogrel in the late phase. Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unique identifier: NCT 01777503.
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Síndrome Coronario Agudo/tratamiento farmacológico , Clopidogrel/efectos adversos , Hemorragia/inducido químicamente , Infarto del Miocardio/etiología , Clorhidrato de Prasugrel/efectos adversos , Síndrome Coronario Agudo/cirugía , Anciano , Clopidogrel/administración & dosificación , Relación Dosis-Respuesta a Droga , Femenino , Estudios de Seguimiento , Hemorragia/epidemiología , Humanos , Incidencia , Italia/epidemiología , Masculino , Infarto del Miocardio/epidemiología , Intervención Coronaria Percutánea , Inhibidores de Agregación Plaquetaria/administración & dosificación , Inhibidores de Agregación Plaquetaria/efectos adversos , Clorhidrato de Prasugrel/administración & dosificación , Pronóstico , Antagonistas del Receptor Purinérgico P2Y/administración & dosificación , Antagonistas del Receptor Purinérgico P2Y/efectos adversos , Estudios Retrospectivos , Método Simple Ciego , Tasa de Supervivencia/tendencias , Factores de TiempoAsunto(s)
Angioplastia Coronaria con Balón , Enfermedad de la Arteria Coronaria , Sistema de Registros , Sirolimus , Humanos , Enfermedad de la Arteria Coronaria/terapia , Sirolimus/uso terapéutico , Sirolimus/administración & dosificación , Resultado del Tratamiento , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/métodos , Masculino , Femenino , Persona de Mediana Edad , Anciano , Stents Liberadores de FármacosRESUMEN
INTRODUCTION: Acute coronary syndromes (ACS) have been classified according to the finding of ST-segment elevation on the presenting electrocardiogram, with different treatment strategies and practice guidelines. However, a comparative description of the clinical characteristics and outcomes of acute coronary syndrome elderly patients undergoing percutaneous coronary intervention during index admission has not been published so far. METHODS: Retrospective cohort study of patients enrolled in the Elderly ACS-2 multicenter randomized trial. Main outcome measures were crude cumulative incidence and cause-specific hazard ratio (cHR) of cardiovascular death, noncardiovascular death, reinfarction, and stroke. RESULTS: Of 1443 ACS patients aged >75 years (median age 80 years, interquartile range 77-84), 41% were classified as ST-elevation myocardial infarction (STEMI), and 59% had non-ST-elevation ACS (NSTEACS) (48% NSTEMI and 11% unstable angina). As compared with those with NSTEACS, STEMI patients had more favorable baseline risk factors, fewer prior cardiovascular events, and less severe coronary disease, but lower ejection fraction (45% vs 50%, P < .001). At a median follow-up of 12 months, 51 (8.6%) STEMI patients had died, vs 39 (4.6%) NSTEACS patients. After adjusting for sex, age, and previous myocardial infarction, the hazard among the STEMI group was significantly higher for cardiovascular death (cHR 1.85; 95% confidence interval [CI], 1.02-3.36), noncardiovascular death (cHR 2.10; 95% CI, 1.01-4.38), and stroke (cHR 4.8; 95% CI, 1.7-13.7). CONCLUSIONS: Despite more favorable baseline characteristics, elderly STEMI patients have worse survival and a higher risk of stroke compared with NSTEACS patients after percutaneous coronary intervention.
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Síndrome Coronario Agudo/terapia , Electrocardiografía , Infarto del Miocardio/terapia , Intervención Coronaria Percutánea/efectos adversos , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Femenino , Humanos , Masculino , Estudios Retrospectivos , Accidente Cerebrovascular/etiología , Resultado del TratamientoRESUMEN
: Ventricular septal defect (VSD) has been reported as a rare complication after transcatheter aortic valve implantation (TAVI), presenting with signs of heart failure. Furthermore, left ventricular outflow tract obstruction (LVOTO) may worsen after TAVI, especially in cases of severe left ventricular hypertrophy and small cavity. However, the simultaneous appearance of VSD and LVOT after TAVI has not been reported before. We report a case of combined VSD and LVOTO after TAVI.
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Estenosis de la Válvula Aórtica/cirugía , Defectos del Tabique Interventricular/etiología , Prótesis Valvulares Cardíacas/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Obstrucción del Flujo Ventricular Externo/etiología , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Ecocardiografía , Femenino , Humanos , Complicaciones PosoperatoriasAsunto(s)
Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Anciano , Puente de Arteria Coronaria/efectos adversos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/cirugía , Humanos , Intervención Coronaria Percutánea/efectos adversos , Pronóstico , Resultado del TratamientoRESUMEN
A high prevalence of mitral annular calcium (MAC) is expected in patients undergoing transcatheter aortic valve implantation (TAVI); however, data regarding the prevalence of MAC and impact on risk of cardiovascular events are lacking. To determine the prevalence of MAC and its association with clinical outcomes in patients undergoing TAVI, we retrospectively analyzed 424 patients who underwent transfemoral TAVI from 2007 to 2015 and whose preoperative computed tomography images were available for assessment of MAC. Severe circumferential MAC (SC-MAC) was defined as calcification involving at least the whole posterior annulus alone or with the attachment of the anterior leaflet. Clinical outcomes were examined according to Valve Academic Research Consortium-2 criteria up to 2 years. SC-MAC was found in 17.7% of patients. Patients with SC-MAC were more likely to be female, with a higher prevalence of atrial fibrillation and peripheral artery disease. There were no differences between the groups regarding age, functional class, prevalence of diabetes, kidney disease, and operative risk. Female gender and peripheral artery disease were independent predictors of SC-MAC. SC-MAC did not appear to be associated with periprocedural and 30-day outcomes. At 2 years' follow-up, patients with SC-MAC had significantly higher cardiovascular and all-cause mortality rates. SC-MAC was an independent predictor of cardiovascular mortality during follow-up. In conclusion, SC-MAC is a frequent finding in the TAVI population and appears to be an independent predictor of cardiovascular mortality at 2 years' follow-up.