RESUMEN
BACKGROUND: The number of transarterial percutaneous procedures has risen over the years, consequently reducing puncture site related complications has become a necessity. To this end, the use of arterial closure devices has been growing progressively and their benefits have become a focus of research. The purpose of this study is to assess the safety and effectiveness of a suture-mediated closure device, Perclose ProGlide® (Abbott Vascular, Redwood City, CA), in patients with liver disease and hepatocellular carcinoma who underwent transarterial liver chemoembolization with drug-eluting beads. MATERIALS AND METHODS: A cohort of 253 hepatocellular carcinoma patients who underwent 449 procedures of transarterial liver chemoembolization with drug-eluting beads using the Perclose Proglide device was prospectively studied. The main endpoints evaluated were the technical success of the device, defined as complete hemostasis achieved within 3 min after the closure, and the incidence of puncture-site complications. The secondary endpoints evaluated were the correlation between epidemiological factors, coagulation profile and degree of liver disease, and the occurrence of complications. RESULTS: Technical success was achieved in 96% of the cases. Among patients who underwent repeated procedures using the same vascular access, this rate was 95.3%. Puncture-site complications were observed in 7 procedures (1.56%); 4 (0.89%) were due to hemorrhage, 2 (0.44%) hematomas and 2 (0.44%) pseudoaneurysms; 2 (0.44%) due to limb ischemia; and 1 (0.22%) due to arterial dissection. Among them, 3 cases required intervention. The statistical analysis of demographic characteristics, Child-Pugh classification, and coagulation status did not show a significant correlation with the occurrence of complications. Of the 449 procedures, only 4 (0.89%) needed hospitalization due to puncture-site complications. CONCLUSIONS: The use of Perclose Proglide is safe and effective in patients with liver disease and hepatocellular carcinoma who underwent transarterial liver chemoembolization with drug-eluting beads.
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Carcinoma Hepatocelular/tratamiento farmacológico , Cateterismo Periférico , Quimioembolización Terapéutica , Hemorragia/prevención & control , Técnicas Hemostáticas/instrumentación , Neoplasias Hepáticas/tratamiento farmacológico , Técnicas de Sutura/instrumentación , Dispositivos de Cierre Vascular , Adulto , Anciano , Anciano de 80 o más Años , Cateterismo Periférico/efectos adversos , Quimioembolización Terapéutica/efectos adversos , Femenino , Hemorragia/etiología , Técnicas Hemostáticas/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Punciones , Factores de Riesgo , Técnicas de Sutura/efectos adversos , Resultado del TratamientoRESUMEN
IMPORTANCE: The current recommendation is for at least 12 months of dual antiplatelet therapy after implantation of a drug-eluting stent. However, the optimal duration of dual antiplatelet therapy with specific types of drug-eluting stents remains unknown. OBJECTIVE: To assess the clinical noninferiority of 3 months (short-term) vs 12 months (long-term) of dual antiplatelet therapy in patients undergoing percutaneous coronary intervention (PCI) with zotarolimus-eluting stents. DESIGN, SETTING, AND PATIENTS: The OPTIMIZE trial was an open-label, active-controlled, 1:1 randomized noninferiority study including 3119 patients in 33 sites in Brazil between April 2010 and March 2012. Clinical follow-up was performed at 1, 3, 6, and 12 months. Eligible patients were those with stable coronary artery disease or history of low-risk acute coronary syndrome (ACS) undergoing PCI with zotarolimus-eluting stents. INTERVENTIONS: After PCI with zotarolimus-eluting stents, patients were prescribed aspirin (100-200 mg daily) and clopidogrel (75 mg daily) for 3 months (n = 1563) or 12 months (n = 1556), unless contraindicated because of occurrence of an end point. MAIN OUTCOMES AND MEASURES: The primary end point was net adverse clinical and cerebral events (NACCE; a composite of all-cause death, myocardial infarction [MI], stroke, or major bleeding); the expected event rate at 1 year was 9%, with a noninferiority margin of 2.7%. Secondary end points were major adverse cardiac events (MACE; a composite of all-cause death, MI, emergent coronary artery bypass graft surgery, or target lesion revascularization) and Academic Research Consortium definite or probable stent thrombosis. RESULTS: NACCE occurred in 93 patients receiving short-term and 90 patients receiving long-term therapy (6.0% vs 5.8%, respectively; risk difference, 0.17 [95% CI, -1.52 to 1.86]; P = .002 for noninferiority). Kaplan-Meier estimates demonstrated MACE rates at 1 year of 8.3% (128) in the short-term group and 7.4% (114) in the long-term group (HR, 1.12 [95% CI, 0.87-1.45]). Between 91 and 360 days, no statistically significant association was observed for NACCE (39 [2.6%] vs 38 [2.6%] for the short- and long-term groups, respectively; HR, 1.03 [95% CI, 0.66-1.60]), MACE (78 [5.3%] vs 64 [4.3%]; HR, 1.22 [95% CI, 0.88-1.70]), or stent thrombosis (4 [0.3%] vs 1 [0.1%]; HR, 3.97 [95% CI, 0.44-35.49]). CONCLUSIONS AND RELEVANCE: In patients with stable coronary artery disease or low-risk ACS treated with zotarolimus-eluting stents, 3 months of dual antiplatelet therapy was noninferior to 12 months for NACCE, without significantly increasing the risk of stent thrombosis. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01113372.
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Síndrome Coronario Agudo/terapia , Aspirina/administración & dosificación , Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos , Inhibidores de Agregación Plaquetaria/administración & dosificación , Ticlopidina/análogos & derivados , Anciano , Aspirina/efectos adversos , Clopidogrel , Esquema de Medicación , Quimioterapia Combinada , Femenino , Hemorragia , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio , Inhibidores de Agregación Plaquetaria/efectos adversos , Riesgo , Sirolimus/administración & dosificación , Sirolimus/análogos & derivados , Accidente Cerebrovascular , Trombosis , Ticlopidina/administración & dosificación , Ticlopidina/efectos adversosRESUMEN
BACKGROUND: Current recommendations for antithrombotic therapy after drug-eluting stent (DES) implantation include prolonged dual antiplatelet therapy (DAPT) with aspirin and clopidogrel ≥12 months. However, the impact of such a regimen for all patients receiving any DES system remains unclear based on scientific evidence available to date. Also, several other shortcomings have been identified with prolonged DAPT, including bleeding complications, compliance, and cost. The second-generation Endeavor zotarolimus-eluting stent (E-ZES) has demonstrated efficacy and safety, despite short duration DAPT (3 months) in the majority of studies. Still, the safety and clinical impact of short-term DAPT with E-ZES in the real world is yet to be determined. METHODS: The OPTIMIZE trial is a large, prospective, multicenter, randomized (1:1) non-inferiority clinical evaluation of short-term (3 months) vs long-term (12-months) DAPT in patients undergoing E-ZES implantation in daily clinical practice. Overall, 3,120 patients were enrolled at 33 clinical sites in Brazil. The primary composite endpoint is death (any cause), myocardial infarction, cerebral vascular accident, and major bleeding at 12-month clinical follow-up post-index procedure. CONCLUSIONS: The OPTIMIZE clinical trial will determine the clinical implications of DAPT duration with the second generation E-ZES in real-world patients undergoing percutaneous coronary intervention.
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Aspirina/uso terapéutico , Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Inhibidores de Agregación Plaquetaria/uso terapéutico , Sirolimus/análogos & derivados , Ticlopidina/análogos & derivados , Adulto , Aspirina/efectos adversos , Brasil , Clopidogrel , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/complicaciones , Enfermedad de la Arteria Coronaria/mortalidad , Quimioterapia Combinada , Humanos , Inhibidores de Agregación Plaquetaria/efectos adversos , Periodo Posoperatorio , Estudios Prospectivos , Proyectos de Investigación , Sirolimus/administración & dosificación , Ticlopidina/efectos adversos , Ticlopidina/uso terapéutico , Factores de Tiempo , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: Although the release of cardiac biomarkers after percutaneous (PCI) or surgical revascularization (CABG) is common, its prognostic significance is not known. Questions remain about the mechanisms and degree of correlation between the release, the volume of myocardial tissue loss, and the long-term significance. Delayed-enhancement of cardiac magnetic resonance (CMR) consistently quantifies areas of irreversible myocardial injury. To investigate the quantitative relationship between irreversible injury and cardiac biomarkers, we will evaluate the extent of irreversible injury in patients undergoing PCI and CABG and relate it to postprocedural modifications in cardiac biomarkers and long-term prognosis. METHODS/DESIGN: The study will include 150 patients with multivessel coronary artery disease (CAD) with left ventricle ejection fraction (LVEF) and a formal indication for CABG; 50 patients will undergo CABG with cardiopulmonary bypass (CPB); 50 patients with the same arterial and ventricular condition indicated for myocardial revascularization will undergo CABG without CPB; and another 50 patients with CAD and preserved ventricular function will undergo PCI using stents. All patients will undergo CMR before and after surgery or PCI. We will also evaluate the release of cardiac markers of necrosis immediately before and after each procedure. Primary outcome considered is overall death in a 5-year follow-up. Secondary outcomes are levels of CK-MB isoenzyme and I-Troponin in association with presence of myocardial fibrosis and systolic left ventricle dysfunction assessed by CMR. DISCUSSION: The MASS-V Trial aims to establish reliable values for parameters of enzyme markers of myocardial necrosis in the absence of manifest myocardial infarction after mechanical interventions. The establishments of these indices have diagnostic value and clinical prognosis and therefore require relevant and different therapeutic measures. In daily practice, the inappropriate use of these necrosis markers has led to misdiagnosis and therefore wrong treatment. The appearance of a more sensitive tool such as CMR provides an unprecedented diagnostic accuracy of myocardial damage when correlated with necrosis enzyme markers. We aim to correlate laboratory data with imaging, thereby establishing more refined data on the presence or absence of irreversible myocardial injury after the procedure, either percutaneous or surgical, and this, with or without the use of cardiopulmonary bypass.
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Puente de Arteria Coronaria/efectos adversos , Enfermedad de la Arteria Coronaria/terapia , Forma MB de la Creatina-Quinasa/sangre , Cardiopatías/diagnóstico , Imagen por Resonancia Cinemagnética , Miocardio , Intervención Coronaria Percutánea/efectos adversos , Proyectos de Investigación , Troponina I/sangre , Biomarcadores/sangre , Distribución de Chi-Cuadrado , Puente de Arteria Coronaria Off-Pump/efectos adversos , Enfermedad de la Arteria Coronaria/sangre , Enfermedad de la Arteria Coronaria/patología , Enfermedad de la Arteria Coronaria/cirugía , Fibrosis , Cardiopatías/sangre , Cardiopatías/patología , Cardiopatías/fisiopatología , Humanos , Modelos Logísticos , Análisis Multivariante , Miocardio/metabolismo , Miocardio/patología , Necrosis , Intervención Coronaria Percutánea/instrumentación , Valor Predictivo de las Pruebas , Estudios Prospectivos , Stents , Volumen Sistólico , Factores de Tiempo , Resultado del Tratamiento , Regulación hacia Arriba , Disfunción Ventricular Izquierda/diagnóstico , Disfunción Ventricular Izquierda/etiología , Disfunción Ventricular Izquierda/fisiopatología , Función Ventricular IzquierdaRESUMEN
INTRODUCTION AND OBJECTIVES: The Stents Coated With the Biodegradable Polymer on Their Abluminal Faces and Elution of Sirolimus Versus Biolimus Elution for the Treatment of de Novo Coronary Lesions - DESTINY Trial is a non-inferiority randomized study that compared the Inspiron™ sirolimus-eluting stent (SES) with the control Biomatrix™ Flex biolimus-eluting stent (BES). Previous reports in the first year showed similar outcomes for both stents, in clinical, angiographic, optical coherence tomography, and intravascular ultrasound assessments. The present analysis aims to compare the clinical performance of these two biodegradable polymer drug-eluting stents five years after the index procedure. METHODS: A total of 170 patients (194 lesions) were randomized in a 2:1 ratio for treatment with SES or BES, respectively. The primary endpoint for the present study was the five-year rate of combined major adverse cardiac events, defined as cardiac death, myocardial infarction, or target lesion revascularization. RESULTS: At five years, the primary endpoint occurred in 12.5% and 17.9% of the SES and BES groups, respectively (p=0.4). There was no definite or probable stent thrombosis among patients treated with the novel SES stent during the five years of follow-up, and no stent thrombosis after the first year in the BES group. CONCLUSIONS: The novel Inspiron™ stent had similar good clinical performance in long-term follow-up when compared head-to-head with the control latest-generation Biomatrix™ Flex biolimus-eluting stent.
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Enfermedad de la Arteria Coronaria , Stents Liberadores de Fármacos , Implantes Absorbibles , Enfermedad de la Arteria Coronaria/cirugía , Humanos , Polímeros , Diseño de Prótesis , Resultado del TratamientoRESUMEN
BACKGROUND/PURPOSE: This study sought to determine the diagnostic accuracy of 320-row computed tomography (320CT) for characterizing coronary atherosclerotic plaques in comparison with optical coherence tomography (OCT). METHODS/MATERIALS: From 32 patients, 42 coronary segments were evaluated and co-registered by both 320CT and OCT. 320CT vulnerable plaque characteristics included low attenuation plaque (LAP) (<30HU), napkin-ring sign (NRS), positive remodeling (PR) and spotty calcification (SC). The presence of macrophage, neovascularization and cholesterol crystals was also determined by OCT. RESULTS: Minimal lumen area was 2.78⯱â¯1.23â¯mm by OCT and 3.29⯱â¯1.49â¯mm by 320CT (pâ¯<â¯0.001). Noncalcified plaques were classified accordingly by both methods in 88.2% of the cases (pâ¯=â¯0.005). There was no association between any 320CT plaque type and OCT fibroatheroma (pâ¯=â¯0.62). The combination of 2 or more of the 320CT vulnerable plaque characteristics was associated with the presence of macrophage (74.2 vs. 25.8%; pâ¯=â¯0.034) and cholesterol crystals (85.7 vs. 14.3%; pâ¯=â¯0.04), but not with neovascularization (pâ¯=â¯0.65). The presence of all four characteristics demonstrated an accuracy of 75.1% for detecting OCT fibroatheroma. CONCLUSIONS: 320CT is useful for non-invasive evaluation of calcified and noncalcified tissue characteristics of coronary atheroma. The combination of all four 320CT vulnerable plaque characteristics provided the highest accuracy for detecting fibroatheromas. SUMMARY: 320CT is useful for non-invasive evaluation of calcified and noncalcified tissue characteristics of coronary atheroma. The combination of all 320CT vulnerable plaque characteristics (low attenuation plaque (<30HU), napkin-ring sign, positive remodeling and spotty calcification) provided the highest accuracy for detecting fibroatheromas compared to optical coherence tomography.
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Angiografía por Tomografía Computarizada , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Vasos Coronarios/diagnóstico por imagen , Tomografía Computarizada Multidetector , Placa Aterosclerótica , Tomografía de Coherencia Óptica , Calcificación Vascular/diagnóstico por imagen , Anciano , Colesterol/análisis , Enfermedad de la Arteria Coronaria/metabolismo , Enfermedad de la Arteria Coronaria/patología , Vasos Coronarios/química , Vasos Coronarios/patología , Cristalización , Femenino , Fibrosis , Humanos , Macrófagos/patología , Masculino , Persona de Mediana Edad , Neovascularización Patológica , Valor Predictivo de las Pruebas , Pronóstico , Sistema de Registros , Reproducibilidad de los Resultados , Estudios Retrospectivos , Calcificación Vascular/metabolismo , Calcificación Vascular/patologíaRESUMEN
OBJECTIVES: We tested two novel drug-eluting stents (DES), covered with a biodegradable-polymer carrier and releasing paclitaxel or sirolimus, which were compared against a bare metal stent (primary objective). The DES differed by the drug, but were identical otherwise, allowing to compare the anti-restenosis effects of sirolimus versus paclitaxel (secondary objective). BACKGROUND: The efficacy of novel DES with biodegradable polymers should be tested in the context of randomized trials, even when using drugs known to be effective, such as sirolimus and paclitaxel. METHODS: Overall, 274 patients with de novo coronary lesions in native vessels scheduled for stent implantation were randomly assigned (2:2:1 ratio) for the paclitaxel (n = 111), sirolimus (n = 106), or bare metal stent (n = 57) groups. Angiographic follow-up was obtained at 9 months and major cardiac adverse events up to 12 months. RESULTS: Both paclitaxel and sirolimus stents reduced the 9-month in-stent late loss (0.54-0.44 mm, 0.32-0.43 mm, vs. 0.90-0.45 mm respectively), and 1-year risk of target vessel revascularization and combined major adverse cardiac events (P < 0.05 for both, in all comparisons), compared with controls. Sirolimus stents had lower late loss than paclitaxel stents (P < 0.01), but similar 1-year clinical outcomes. There were no differences in the risk of death, infarction, or stent thrombosis among the study groups. CONCLUSION: Both novel DES were effective in reducing neointimal hyperplasia and 1-year re-intervention, compared to bare metal stents. Our findings also suggest that sirolimus is more effective than paclitaxel in reducing angiographic neointima, although this effect was not associated with better clinical outcomes.
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Angioplastia Coronaria con Balón/instrumentación , Fármacos Cardiovasculares/administración & dosificación , Enfermedades Cardiovasculares/prevención & control , Materiales Biocompatibles Revestidos , Estenosis Coronaria/terapia , Stents Liberadores de Fármacos , Metales , Paclitaxel/administración & dosificación , Sirolimus/administración & dosificación , Stents , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/mortalidad , Brasil/epidemiología , Enfermedades Cardiovasculares/diagnóstico por imagen , Enfermedades Cardiovasculares/etiología , Enfermedades Cardiovasculares/mortalidad , Angiografía Coronaria , Reestenosis Coronaria/etiología , Reestenosis Coronaria/prevención & control , Estenosis Coronaria/diagnóstico por imagen , Estenosis Coronaria/mortalidad , Femenino , Humanos , Hiperplasia , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Infarto del Miocardio/etiología , Infarto del Miocardio/prevención & control , Modelos de Riesgos Proporcionales , Diseño de Prótesis , Medición de Riesgo , Trombosis/etiología , Trombosis/prevención & control , Factores de Tiempo , Resultado del TratamientoRESUMEN
INTRODUCTION AND OBJECTIVES: Acute kidney injury (AKI) is frequently observed after transcatheter aortic valve implantation (TAVI) and is associated with higher mortality. However, the impact of AKI on long-term outcomes remains controversial. Therefore, we sought to evaluate the impact of AKI on short- and long-term outcomes following TAVI using the Valve Academic Research Consortium 2 criteria. METHODS: Consecutive patients (n = 794) with severe aortic stenosis who underwent TAVI were included in a multicenter Brazilian registry. Logistic regression analysis was used to identify predictors of AKI. Four-year outcomes were determined as Kaplan-Meier survival curves, and an adjusted landmark analysis was used to test the impact of AKI on mortality among survivors at 12 months. RESULTS: The incidence of AKI after TAVI was 18%. Independent predictors of AKI were age, diabetes mellitus, major or life-threatening bleeding and valve malpositioning. Acute kidney injury was independently associated with higher risk of all-cause death (adjusted HR, 2.8; 95%CI, 2.0-3.9; P < .001) and cardiovascular mortality (adjusted HR, 2.9; 95%CI, 1.9-4.4; P < .001) over the entire follow-up period. However, when considering only survivors at 12 months, there was no difference in both clinical endpoints (adjusted HR, 1.2; 95%CI, 0.5-2.4; P = .71, and HR, 0.7; 95%CI, 0.2-2.1; P = .57, respectively). CONCLUSIONS: Acute kidney injury is a frequent complication after TAVI. Older age, diabetes, major or life-threatening bleeding, and valve malpositioning were independent predictors of AKI. Acute kidney injury is associated with worse short- and long-term outcomes. However, the major impact of AKI on mortality is limited to the first year after TAVI.
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Lesión Renal Aguda/epidemiología , Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Sistema de Registros , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Lesión Renal Aguda/etiología , Anciano de 80 o más Años , Brasil/epidemiología , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Masculino , Pronóstico , Estudios Retrospectivos , Factores de Riesgo , Factores de TiempoRESUMEN
AIMS: Three-vessel and left main coronary artery disease (CAD) have important prognostic implications. Consequently, numerous risk scores have been developed to stratify patients with complex CAD. The aim of the present study was to compare the predictive performance of six risk scores for occurrence of fouryear all-cause mortality. METHODS AND RESULTS: From March 2008 to December 2012, 348 consecutive patients with complex CAD undergoing percutaneous coronary intervention (PCI) in a tertiary centre in São Paulo, Brazil, were analysed. Four-year mortality was assessed. The scores compared were: baseline SYNTAX score (SS), residual SYNTAX score (rSS), ACEF score, clinical SYNTAX score (cSS), SYNTAX revascularisation index (SRI) and SYNTAX score II (SSII). SSII had the best predictive performance, AUC 0.82, Brier score 0.10, surpassing all the other scores for long-term mortality prediction. Moreover, SSII discriminated well PCI patients in risk groups with p<0.01 for four-year all-cause mortality. The ACEF score (AUC 0.77) and the cSS (AUC 0.78) were significantly better than the SS (AUC 0.65), SRI (AUC 0.60) or the rSS (AUC 0.55). CONCLUSIONS: For patients with complex CAD treated by PCI, the combination of baseline clinical and angiographic factors provided better risk assessment. The SSII demonstrated the most precise predictive performance for long-term mortality.
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Puente de Arteria Coronaria/mortalidad , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/mortalidad , Intervención Coronaria Percutánea/mortalidad , Anciano , Angiografía Coronaria/métodos , Puente de Arteria Coronaria/efectos adversos , Enfermedad de la Arteria Coronaria/terapia , Femenino , Humanos , Masculino , Intervención Coronaria Percutánea/efectos adversos , Valor Predictivo de las Pruebas , Pronóstico , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
AIMS: We sought to present a series of 13 pregnancy-associated spontaneous coronary artery dissection (P-SCAD), their angiographic and multimodal imaging findings, acute phase treatment, and outcomes. METHODS AND RESULTS: Between 2005 and 2015, 13 cases of P-SCAD were collected from a database of 11 tertiary hospitals. The mean age was 33.8 ± 3.7 years; most patients had no risk factors for coronary artery disease, and the majority were multiparous. P-SCAD occurred during the puerperium in 12 patients with a median time of 10 days. Only one patient presented with P-SCAD in the 37th week of pregnancy, and she was the only patient who died in this series. Six patients (46%) presented with ST-segment elevation acute myocardial infarction (STEMI), six (46%) presented with non-STEMI, and one presented with unstable angina; one-third of women had cardiogenic shock. In 12 patients, the dissection involved the left anterior descending or circumflex artery, and it extended to the left main coronary artery in 6 patients. Intravascular ultrasound or optical coherence tomography helped to confirm diagnosis and guide treatment in 46% of cases. Seven women were managed clinically; percutaneous coronary intervention was performed in five cases, and coronary artery bypass grafting was performed in one patient. CONCLUSION: In these 13 cases of P-SCAD, clinical presentation commonly included acute myocardial infarction and cardiogenic shock. Multivessel dissections and involvement of the left coronary artery and left main coronary artery were highly prevalent. Clinicians must be aware of angiographic appearances of P-SCAD for prompt diagnosis and management in these high-risk patients.
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Anomalías de los Vasos Coronarios/diagnóstico por imagen , Anomalías de los Vasos Coronarios/terapia , Imagen Multimodal/métodos , Complicaciones Cardiovasculares del Embarazo/diagnóstico por imagen , Resultado del Embarazo , Enfermedades Vasculares/congénito , Adulto , Angiografía por Tomografía Computarizada/métodos , Angiografía Coronaria/métodos , Anomalías de los Vasos Coronarios/mortalidad , Bases de Datos Factuales , Femenino , Estudios de Seguimiento , Edad Gestacional , Mortalidad Hospitalaria , Humanos , Intervención Coronaria Percutánea/métodos , Intervención Coronaria Percutánea/mortalidad , Periodo Posparto , Embarazo , Complicaciones Cardiovasculares del Embarazo/terapia , Estudios Retrospectivos , Medición de Riesgo , Muestreo , Centros de Atención Terciaria , Ultrasonografía Intervencional/métodos , Enfermedades Vasculares/diagnóstico por imagen , Enfermedades Vasculares/mortalidad , Enfermedades Vasculares/terapiaRESUMEN
AIMS: We sought to examine the feasibility and reproducibility of a new video densitometric (VD) quantification of aortic regurgitation (AR) on aortography, and its long-term clinical impact. METHODS AND RESULTS: Using dedicated video densitometry software, AR after TAVI was quantified, and inter- and intra-observer reproducibility was investigated in 182 aortograms of the Brazilian TAVI registry. The aortograms were analysed using two software algorithms: 1) the quantitative regurgitation analysis (qRA) index interrogating the entire left ventricle (LV), and 2) a new method with the left ventricle outflow tract (LVOT) as a region of interest (ROI) (LVOT-AR). LVOT-AR was feasible in 64.8% vs. 29.7% of aortograms, compared with qRA index. Using the LVOT-AR, inter-observer variability was low (mean difference±standard deviation [SD]: 0.01±0.05, p=0.53), and the two observers' measurements were highly correlated (r=0.95, p<0.001). Patients with LVOT-AR >0.17 had a significantly higher one-year all-cause mortality risk compared with patients with LVOT-AR ≤0.17 (37.1% vs. 11.2%, p=0.0008). CONCLUSIONS: This study proposes an alternative methodology for AR assessment after TAVI by using the LVOT method (LVOT-AR) of VD angiography. The assessment of LVOT-AR is feasible, reproducible and potentially predictive of one-year mortality.
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Insuficiencia de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/terapia , Válvula Aórtica/diagnóstico por imagen , Aortografía/métodos , Cateterismo Cardíaco/efectos adversos , Densitometría , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Anciano , Anciano de 80 o más Años , Algoritmos , Válvula Aórtica/fisiopatología , Insuficiencia de la Válvula Aórtica/etiología , Insuficiencia de la Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/fisiopatología , Área Bajo la Curva , Brasil , Cateterismo Cardíaco/instrumentación , Cateterismo Cardíaco/métodos , Cateterismo Cardíaco/mortalidad , Estudios de Factibilidad , Femenino , Prótesis Valvulares Cardíacas , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/métodos , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Humanos , Masculino , Variaciones Dependientes del Observador , Valor Predictivo de las Pruebas , Curva ROC , Interpretación de Imagen Radiográfica Asistida por Computador , Sistema de Registros , Reproducibilidad de los Resultados , Estudios Retrospectivos , Factores de Riesgo , Resultado del TratamientoRESUMEN
BACKGROUND: The Inspiron™ sirolimus-eluting stent (SES) is a low-dose, ultra-thin-strut cobalt-chromium stent abluminally coated with biodegradable polymers (BP). Previous results from the INSPIRON-I trial, a first-in-man study, have proven the efficacy of the novel stent in reducing neointimal proliferation. The present report aims at evaluating the long-term clinical outcomes of patients enrolled into the INSPIRON-I trial (Clinical Trials Gov. identifier: NCT01093391). METHODS: A total of 57 patients (60 lesions) were randomly allocated in a 2:1 ratio to treatment with the Inspiron™ SES vs. its equivalent Cronus™ bare metal stent (BMS, both by Scitech Medical™, Aparecida de Goiânia, Goiás, Brazil), in four tertiary centers. The primary endpoint of the present analysis was the occurrence of major adverse cardiac events (MACE) [death, myocardial infarction (MI), target vessel revascularization (TVR) and/or target lesion revascularization (TLR)] at 4 years. RESULTS: Baseline clinical and angiographic characteristics of both groups were similar. After 4 years, the primary endpoint occurred in 7.9% vs. 23.5% of patients in Inspiron and control groups respectively (P=0.11). The rate of death/MI was similar between the groups, but there was a significant decrease in the risk of repeat revascularization in the Inspiron group compared to the control arm TLR (0.0% vs. 23.5% respectively, P=0.02). There were no stent thromboses in the study population. CONCLUSIONS: The novel Inspiron™ SES showed a sustained safe and effective clinical profile after 4-year of follow-up, with very low adverse events and null stent thrombosis (ST) occurrence.
RESUMEN
AIMS: To evaluate the outcomes of patients treated with a new drug-eluting stent formulation with low doses of sirolimus, built in an ultra-thin-strut platform coated with biodegradable abluminal coating. METHODS: This study is a randomized trial that tested the main hypothesis that the angiographic late lumen loss of the novel sirolimus-eluting stent is noninferior compared with commercially available biolimus-eluting stent. A final study population comprising 170 patients with one or two de novo lesions was randomized in the ratio 2:1 for sirolimus-eluting stent or biolimus-eluting stent, respectively. The primary endpoint was 9-month angiographic in-stent late lumen loss. Adverse clinical events were prospectively collected for 1 year. RESULTS: After 9 months, the novel sirolimus-eluting stent was shown noninferior compared with the biolimus stent for the primary endpoint (angiographic in-stent late lumen loss: 0.20 ± 0.29 mm vs. 0.15 ± 0.20 mm, respectively; P value for noninferiority <0.001). The 1-year incidence of death, myocardial infarction, repeat revascularization, and stent thrombosis remained low and not significantly different between the groups. CONCLUSIONS: The present randomized trial demonstrates that the tested novel sirolimus-eluting stent was angiographically noninferior in comparison with a last-generation biolimus-eluting stent.
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Implantes Absorbibles , Fármacos Cardiovasculares/administración & dosificación , Materiales Biocompatibles Revestidos , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/terapia , Vasos Coronarios/diagnóstico por imagen , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea/instrumentación , Sirolimus/análogos & derivados , Anciano , Brasil , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Reestenosis Coronaria/etiología , Trombosis Coronaria/etiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/etiología , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Valor Predictivo de las Pruebas , Estudios Prospectivos , Diseño de Prótesis , Sirolimus/administración & dosificación , Factores de Tiempo , Resultado del TratamientoRESUMEN
Direct stenting may reduce costs, procedure times, and injury to the vessel wall, positively influencing acute and late results. This study was designed to demonstrate 6-month clinical outcome equivalence between direct and standard stenting techniques. Four hundred eleven patients (425 lesions) were randomized in 7 sites to undergo direct (210 patients, 216 lesions) or conventional (201 patients, 209 lesions) stent implantation. Lesions with severe calcification were excluded. Angiographic success rate was 100% in the direct stent group (2.8% requiring balloon predilation) and 98.6% in the predilation group (p = 0.12). Direct stenting was associated with decreased use of balloons (0.15 vs 1.09 balloons/lesion treated) and with a trend toward a reduction of procedure time (22.7 +/- 15.0 vs 25.6 +/- 18.2 minutes; p = 0.073). Fluoroscopy time and contrast volume were not different between groups. At 6-month follow-up, the incidences of death (direct [1.4%] vs predilation [2.5%]), myocardial infarction (5.3% vs 5.0%), and target vessel revascularization (8.2% vs 10.5%) were similar in both groups. Major adverse cardiac event-free survival rate was 87.5% for those who underwent the direct stent technique and 85.5% for patients who underwent predilation (p = 0.0002 for equivalence). In conclusion, direct stenting is at least equivalent to the standard technique in terms of 6-month clinical outcomes when performed on selected coronary lesions without significant calcification. This strategy is associated with decreased use of balloons, but, in general, does not significantly reduce procedure times.
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Angioplastia de Balón , Estenosis Coronaria/cirugía , Stents , Brasil , Distribución de Chi-Cuadrado , Angiografía Coronaria , Estenosis Coronaria/mortalidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/epidemiología , Tasa de Supervivencia , Resultado del TratamientoRESUMEN
AIMS: The INSPIRON-I trial is a first-in-man evaluation of the safety and efficacy of the Inspiron drug-eluting stent, a sirolimus-eluting stent with abluminal biodegradable polymer coating and thin cobalt-chromium alloy. METHODS AND RESULTS: This is a randomised, multicentre comparison between Inspiron and a stent with the same metallic structure but without polymer coating or drug elution (Cronus). The primary objective was to evaluate the in-segment late loss (LLL) at six months. Secondary endpoints included percent in-stent obstruction as measured by intravascular ultrasound (IVUS) at six months and major adverse cardiac events (MACE). Fifty-eight patients were enrolled (60 lesions), 39 for Inspiron and 19 for Cronus. Baseline clinical and angiographic characteristics of both groups were similar. At six months, the in-segment LLL was reduced in the Inspiron group compared to the control group (0.19±0.16 mm vs. 0.58±0.4 mm, respectively; p<0.001), as well as the percent neointimal obstruction (7.8±7.1% vs. 26.5±11.4%; p<0.001). At two-year follow-up, incidence of MACE was similar between groups (7.9 vs. 21.1%, respectively; p=0.20), with lower target lesion revascularisation for Inspiron (0 vs. 21.1%, respectively; p=0.01) and no stent thrombosis. CONCLUSIONS: Sirolimus eluted from an abluminal biodegradable polymer on a cobalt-chromium alloy proved effective in reducing restenosis at six months.
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Implantes Absorbibles , Angioplastia Coronaria con Balón/instrumentación , Fármacos Cardiovasculares/administración & dosificación , Aleaciones de Cromo , Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos , Sirolimus/administración & dosificación , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/mortalidad , Brasil , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/mortalidad , Estenosis Coronaria/diagnóstico , Estenosis Coronaria/etiología , Estenosis Coronaria/prevención & control , Femenino , Humanos , Masculino , Persona de Mediana Edad , Neointima , Estudios Prospectivos , Diseño de Prótesis , Método Simple Ciego , Factores de Tiempo , Resultado del Tratamiento , Ultrasonografía IntervencionalRESUMEN
BACKGROUND: Transcatheter aortic valve implantation (TAVI) was established as an important alternative for high-risk patients with severe aortic stenosis. However, there are few data in the literature regarding coronary obstruction, that although rare, is a potentially fatal complication. OBJECTIVE: Evaluate this complication in Brazil. METHODS: We evaluated all patients presenting coronary obstruction from the Brazilian Registry of TAVI. Main baseline and procedural characteristics, management of the complication, and clinical outcomes were collected from all patients. RESULTS: From 418 consecutive TAVI procedures, coronary obstruction occurred in 3 cases (incidence of 0.72%). All patients were women, without prior coronary artery bypass grafting (CABG), and with mean age of 85 ± 3 years, logistic EuroSCORE of 15 ± 6% and STS-PROM score of 9 ± 4%. All of the cases were performed with balloon-expandable Sapien XT prosthesis. In one patient, with pre-procedural computed tomography data, coronary arteries presented a low height and a narrow sinus of Valsalva. All patients presented with clinically significant severe maintained hypotension, immediately after valve implantation, and even though coronary angioplasty with stent implantation was successfully performed in all cases, patients died during hospitalization, being two periprocedurally. CONCLUSION: Coronary obstruction following TAVI is a rare but potentially fatal complication, being more frequent in women and with the balloon-expandable prosthesis. Anatomical factors might be related with its increased occurrence, highlighting the importance of a good pre-procedural evaluation of the patients in order to avoid this severe complication.
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Bioprótesis/efectos adversos , Oclusión Coronaria/etiología , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Anciano de 80 o más Años , Angioplastia , Estenosis de la Válvula Aórtica/cirugía , Cateterismo Cardíaco/efectos adversos , Stents Liberadores de Fármacos , Resultado Fatal , Femenino , Humanos , Complicaciones Posoperatorias , Factores de Riesgo , Resultado del TratamientoRESUMEN
OBJECTIVES: The aim of this study was to evaluate the impact of intravascular ultrasound (IVUS) guidance on the final volume of contrast agent used in patients undergoing percutaneous coronary intervention (PCI). BACKGROUND: To date, few approaches have been described to reduce the final dose of contrast agent in PCIs. We hypothesized that IVUS might serve as an alternative imaging tool to angiography in many steps during PCI, thereby reducing the use of iodine contrast. METHODS: A total of 83 patients were randomized to angiography-guided PCI or IVUS-guided PCI; both groups were treated according to a pre-defined meticulous procedural strategy. The primary endpoint was the total volume contrast agent used during PCI. Patients were followed clinically for an average of 4 months. RESULTS: The median total volume of contrast was 64.5 ml (interquartile range [IQR]: 42.8 to 97.0 ml; minimum, 19 ml; maximum, 170 ml) in the angiography-guided group versus 20.0 ml (IQR: 12.5 to 30.0 ml; minimum, 3 ml; maximum, 54 ml) in the IVUS-guided group (p < 0.001). Similarly, the median volume of contrast/creatinine clearance ratio was significantly lower among patients treated with IVUS-guided PCI (1.0 [IQR: 0.6 to 1.9] vs. 0.4 [IQR: 0.2 to 0.6, respectively; p < 0.001). In-hospital and 4-month outcomes were not different between patients randomized to angiography-guided and IVUS-guided PCI. CONCLUSIONS: Thoughtful and extensive use of IVUS as the primary imaging tool to guide PCI is safe and markedly reduces the volume of iodine contrast compared with angiography-alone guidance. The use of IVUS should be considered for patients at high risk of contrast-induced acute kidney injury or volume overload undergoing coronary angioplasty. (Minimizing cOntrast utiliZation With IVUS Guidance in coRonary angioplasTy [MOZART]; NCT01947335).
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Medios de Contraste , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/terapia , Yohexol/análogos & derivados , Intervención Coronaria Percutánea/métodos , Ácidos Triyodobenzoicos , Ultrasonografía Intervencional , Lesión Renal Aguda/sangre , Lesión Renal Aguda/inducido químicamente , Lesión Renal Aguda/diagnóstico , Lesión Renal Aguda/prevención & control , Anciano , Biomarcadores/sangre , Medios de Contraste/efectos adversos , Angiografía Coronaria/efectos adversos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Creatinina/sangre , Femenino , Humanos , Yohexol/efectos adversos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Ácidos Triyodobenzoicos/efectos adversosRESUMEN
Introducción y objetivos: El daño renal agudo (DRA) ocurre con frecuencia tras el implante percutáneo de válvula aórtica (TAVI) y se asocia con una mayor mortalidad. Sin embargo, el impacto del DRA en la evolución a largo plazo continúa siendo controvertida. Por dicho motivo se evalúa el impacto del DRA el resultado a corto y largo plazo tras el TAVI usando los criterios Valve Academic Research Consortium 2. Métodos: Se incluyeron 794 pacientes consecutivos con estenosis aórtica grave en un registro multicéntrico brasileño. Para la identificación de los predictores de DRA se utilizó el análisis de regresión logística. La supervivencia a 4 años se determinó mediante las curvas de Kaplan-Meier y para determinar el impacto del DRA en la mortalidad entre los supervivientes a 12 meses se usó un análisis de punto de referencia ajustado. Resultados: La incidencia de DRA tras el TAVI fue del 18%. Los predictores independientes de DRA fueron: edad, diabetes mellitus, hemorragia mayor o amenazante para la vida y la malaposición valvular. El DRA se asoció independientemente con un riesgo mayor de muerte total (HR ajustada = 2,8; IC95%, 2,0-3,9; p < 0,001) y cardiovascular (HR ajustada = 2,9; IC95%, 1,9-4,4; p < 0,001) durante el periodo de seguimiento completo. Sin embargo, cuando se consideró solo los supervivientes a 12 meses, no hubo diferencias en ambos objetivos clínicos (HR ajustada = 1,2; IC95%, 0,5-2,4; p = 0,71, y HR = 0,7; IC95%, 0,2-2,1; p = 0,57, respectivamente). Conclusiones: El DRA es una complicación frecuente tras el TAVI. La edad avanzada, la diabetes, la hemorragia mayor o amenazante para la vida y la malaposición valvular eran factores predictivos de DRA. El DRA se asoció con el pronóstico a corto y largo plazo, sin embargo, el impacto del DRA sobre la mortalidad se limitó al primer año tras el TAVI
Introduction and objectives: Acute kidney injury (AKI) is frequently observed after transcatheter aortic valve implantation (TAVI) and is associated with higher mortality. However, the impact of AKI on long-term outcomes remains controversial. Therefore, we sought to evaluate the impact of AKI on short- and long-term outcomes following TAVI using the Valve Academic Research Consortium 2 criteria. Methods: Consecutive patients (n = 794) with severe aortic stenosis who underwent TAVI were included in a multicenter Brazilian registry. Logistic regression analysis was used to identify predictors of AKI. Four-year outcomes were determined as Kaplan-Meier survival curves, and an adjusted landmark analysis was used to test the impact of AKI on mortality among survivors at 12 months. Results: The incidence of AKI after TAVI was 18%. Independent predictors of AKI were age, diabetes mellitus, major or life-threatening bleeding and valve malpositioning. Acute kidney injury was independently associated with higher risk of all-cause death (adjusted HR, 2.8; 95%CI, 2.0-3.9; P < .001) and cardiovascular mortality (adjusted HR, 2.9; 95%CI, 1.9-4.4; P < .001) over the entire follow-up period. However, when considering only survivors at 12 months, there was no difference in both clinical endpoints (adjusted HR, 1.2; 95%CI, 0.5-2.4; P = .71, and HR, 0.7; 95%CI, 0.2-2.1; P = .57, respectively). Conclusions: Acute kidney injury is a frequent complication after TAVI. Older age, diabetes, major or life-threatening bleeding, and valve malpositioning were independent predictors of AKI. Acute kidney injury is associated with worse short- and long-term outcomes. However, the major impact of AKI on mortality is limited to the first year after TAVI
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Humanos , Masculino , Femenino , Anciano , Anciano de 80 o más Años , Lesión Renal Aguda/epidemiología , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/complicaciones , Factores de Riesgo , Complicaciones PosoperatoriasRESUMEN
BACKGROUND: Few studies have examined the very long-term outcomes after implantation of drug-eluting stents (DES) coated with biodegradable polymers (BP). This report presents the 5-year clinical follow-up of patients treated with BP-DES in the randomized PAINT trial. METHODS: The PAINT study is a prospective, multicenter randomized controlled trial that allocated 274 patients for treatment with two BP-DES formulations [paclitaxel-eluting stents (PES) or sirolimus-eluting stents (SES)] or bare metal stents (BMS) in a 1:2:2 ratio, respectively. The primary end-point of this sub-study was defined as the composite of the major cardiac adverse events (MACE) cardiac death, myocardial infarction (MI) or ischemia-driven target vessel revascularization (TVR) at 5 years. RESULTS: The 5-year MACE rates were different among the groups: 35.3%, 22.5% and 16.9% for BMS, PES and SES, respectively (P<0.05 for both DES vs. bare stent comparisons). The primary end-point was mainly driven by TVR: 31.8%, 14.1% and 12.2% for bare stents, PES and SES, respectively (P<0.05 for both DES vs. bare stent comparisons). The incidence of stent thrombosis (ST) was null for BMS during the entire follow-up. There was no definite or probable ST in the SES group after the second year, while one patient (1.0%) presented with a definite ST episode in the PES group between 4 and 5 years. CONCLUSIONS: The tested biodegradable-polymer coated stents releasing either paclitaxel or sirolimus, compared with same bare metal platform, sustained their effectiveness in reducing combined major adverse cardiac events and re-intervention without an increase in ST during 5 years of follow-up.
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AIMS: The long-term clinical performance of drug-eluting stents (DES) coated with biodegradable polymers is poorly known. METHODS AND RESULTS: A total of 274 coronary patients were randomly allocated to paclitaxel-eluting stents, sirolimus-eluting stents, or bare metal stents (2:2:1 ratio). The two DES used the same biodegradable polymers and were identical except for the drug. At three years, the pooled DES population had similar rates of cardiac death or myocardial infarction (9.0% vs. 7.1; p=0.6), but lower risk of repeat interventions (10.0% vs. 29.9%; p<0.01) than controls with bare stents. The cumulative 3-year incidence of definite or probable stent thrombosis in the pooled DES group was 2.3% (first year: 1.8%; second year: 0.4%; third year: zero). There were no significant differences in outcomes between paclitaxel- and sirolimus-eluting stents. CONCLUSIONS: The biodegradable-polymer coated DES releasing either paclitaxel or sirolimus were effective in reducing the 3-year rate of re-interventions.