RESUMO

Background: Drug-eluting stents (DESs) based on biodegradable polymers (BPs) have been introduced to reduce the risk for late and very late stent thrombosis (ST), which were frequently observed with earlier generations of DES designs based on durable polymers (DPs); however, randomized controlled trials on these DES designs are scarce. The meriT-V trial is a randomized, active-controlled, non-inferiority trial with a prospective, multicenter design that evaluated the 2-year efficacy of a novel third-generation, ultra-thin strut, BP-based BioMime sirolimus-eluting stent (SES) versus the DP-based XIENCE everolimus-eluting stent (EES) for the treatment of de novo lesions. Methods: The meriT-V is a randomized trial that enrolled 256 patients at 15 centers across Europe and Brazil. Here, we report the outcomes of the extended follow-up period of 2 years. The randomization of enrolled patients was in a 2:1 ratio; the enrolled patients received either the BioMime SES (n = 170) or the XIENCE EES (n = 86). The three-point major adverse cardiac event (MACE), defined as a composite of cardiac death, myocardial infarction (MI), or ischemia-driven target vessel revascularization (ID-TVR), was considered as the composite safety and efficacy endpoint. Ischemia-driven target lesion revascularization (ID-TLR) was evaluated as well as the frequency of definite/probable ST, based on the first Academic Research Consortium definitions. Results: The trial had a 2-year follow-up completion rate of 98.44% (n = 252/256 patients), and the clinical outcomes assessment showed a nonsignificant difference in the cumulative rate of three-point MACE between both arms (BioMime vs. XIENCE: 7.74% vs. 9.52%, P = 0.62). Even the MI incidences in the BioMime arm were insignificantly lower than those of the XIENCE arm (1.79% vs. 5.95%, P = 0.17). Late ST was observed in 1.19% cases of the XIENCE arm, while there were no such cases in the BioMime arm (P = 0.16). Conclusions: The objective comparisons between the novel BP-based BioMime SES and the well-established DP-based XIENCE EES in this randomized controlled trial show acceptable outcomes of both the devices in the cardiac deaths, MI, ID-TVR, and ST. Moreover, since there were no incidences of cardiac death in the entire study sample over the course of 2 years, we contend that the findings of the study are highly significant for both these DES designs. In this preliminary comparative trial, the device safety of BioMime SES can be affirmed to be acceptable, considering the lower three-point MACE rate and absence of late ST in the BioMime arm over the 2-year period.

RESUMO

Por várias décadas, a revascularização do miocárdio foi considerada o tratamento padrão-ouro de lesões não protegidas do tronco da coronária esquerda. No entanto, a acessibilidade anatômica e o grande calibre dos vasos tornam as lesões de tronco uma opção atraente para a intervenção coronária percutânea. A aplicação dessa intervenção nesse cenário foi expandida ainda mais como resultado da introdução de novos stents farmacológicos, com rápidos avanços em técnicas, dispositivos e farmacoterapias adjuvantes. As evidências atuais têm demonstrado que pacientes com complexidade coronariana baixa ou intermediária têm desfechos similares com a intervenção coronária percutânea ou a revascularização cirúrgica do miocárdio por até 10 anos. O tratamento das lesões da bifurcação do tronco da coronária esquerda continua tecnicamente complexo, apesar dos recentes avanços. A abordagem provisional é a estratégia padrão na maioria dos tipos de lesões da bifurcação do tronco da coronária esquerda. No entanto, algumas lesões complexas da bifurcação do tronco da coronária esquerda justificariam uma técnica eletiva com implante de dois stents. A abordagem integrada, que incorpora técnicas dedicadas, uma avaliação fisiológica e anatômica adjuvante e agentes farmacológicos, é fundamental para abordar com sucesso esse desafio ímpar e melhorar os desfechos clínicos.

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For several decades coronary bypass grafting has been considered the gold standard treatment for unprotected left main coronary artery lesions. However, the anatomic accessibility and the large caliber of the vessel render the percutaneous coronary intervention a very attractive treatment option for left main coronary artery lesions. The use of percutaneous coronary intervention in this subset of lesions has been further expanded as a result of the introduction of newer drug-eluting stents along with rapid advancements in techniques, devices, and adjunctive pharmacotherapies. The current evidence has demonstrated that patients with low or intermediate coronary complexity treated with percutaneous coronary intervention or coronary bypass grafting have comparable outcomes, for up to 10 years. Treatment of left main bifurcation lesions remains technically demanding despite recent developments. The provisional approach is the default strategy in most types of left main bifurcation lesions. However, a few complex left main bifurcation lesions would warrant an elective two-stent technique. An integrated approach incorporating custom- tailored techniques, adjunctive physiological and morphologic evaluation, and pharmacologic agents is critical to tackle this unique challenge and improve clinical outcomes.

RESUMO

RESUMEN Introducción: La reestenosis de los stents liberadores de paclitaxel utilizados en Cuba no ha sido estudiada. Objetivo: Evaluar la reestenosis de los stents liberadores de paclitaxel y los convencionales. Métodos: Se incluyeron 64 pacientes con reestenosis de stent, de un estudio prospectivo previo; en 318 pacientes seguidos por 3 años luego de intervención coronaria percutánea; 25 con stent liberador de paclitaxel y 39 stent metálico convencional. Se consideró reestenosis como nueva lesión ≥ 50 % de la luz del vaso con isquemia demostrada. Se describió el tiempo de aparición, patrón angiográfico y alternativa de revascularización. Resultados: La reestenosis en el grupo de stents liberadores de paclitaxel fue 15,7 % con tiempo medio de supervivencia sin reestenosis de 32,4 meses vs. 24,5 % en stents convencionales, con supervivencia sin reestenosis de 29,8 meses, (p= 0,047). En el grupo de stents liberadores de paclitaxel predominó el patrón IB, (30,3 %) y stent convencional el III (28,3 %). En el 28,0 % del grupo de stents liberadores de paclitaxel, se recurrió a la cirugía de revascularización vs. 5,1 % en el grupo de stent convencional. Conclusiones: El stent liberador de paclitaxel logra una supervivencia libre de reestenosis superior y más perdurable que el stent convencional. La reestenosis en los de stents liberadores de paclitaxel es focal, con mayor frecuencia de nueva revascularización por cirugía y en los stents convencionales es mayormente difusa.

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ABSTRACT Introduction: The restenosis of the paclitaxel-eluting stents used in Cuba has not been studied. Objective: To evaluate the restenosis of paclitaxel-eluting stents and conventional stents. Methods: 64 patients with stent restenosis were included, from a previous prospective study; in 318 patients followed up for 3 years after percutaneous coronary intervention; 25 with a paclitaxel-eluting stent and 39 conventional metal stent. Restenosis was considered as a new lesion ≥ 50 % of the vessel lumen with proven ischemia. The time to onset, angiographic pattern and alternative revascularization were described. Results: Restenosis in the group with paclitaxel-eluting stents was 15.7 % with a mean survival time without restenosis of 32.4 months vs. 24.5 % in conventional stents, with restenosis-free survival of 29.8 months, (p = 0.047). In the group with paclitaxel-eluting stents, the IB pattern predominated (30.3 %) and the conventional stent III (28.3 %). In 28.0 % of the paclitaxel-eluting stent group, revascularization surgery was used vs. 5.1 % in the conventional stent group. Conclusions: The paclitaxel-eluting stent achieves a superior and more durable restenosis-free survival than the conventional stent. Restenosis in paclitaxel-eluting stents is focal, with a higher frequency of revascularization by surgery, and in conventional stents it is mostly diffuse.

RESUMO

BACKGROUND: There is little information on the performance of the new generation of stents with bioabsorbable polymers in the Latin American population. This registry aimed to further validate the safety and efficacy of the Orsiro bioresorbable-polymer sirolimus-eluting stent (BPSES) in unselected patients undergoing percutaneous coronary intervention (PCI) in Chilean centers. METHODS: We prospectively enrolled patients undergoing PCI with BPSES in 6 Chilean centers. The primary endpoint was defined as the composite of cardiac death, target vessel-related myocardial infarction (MI), and clinically driven target lesion revascularization at 1-year follow-up. RESULTS: From April 2017 to February 2019, 520 patients were enrolled in the registry, more frequently male (74.6%), with a mean age of 62.7 ± 10.8 years and a high prevalence of diabetes (40.2%). The clinical presentation was stable angina in 41.1% (n = 214), acute MI in 52.5% (n = 167 [32.1%] ST-elevation MI and n = 106 [20.4%] non-ST-elevation MI), and unstable angina in 6.3% (n = 33). Of 610 treated lesions, 425 (69.7%) were American College of Cardiology/American Heart Association type B or C lesions. Device and procedural success were achieved in 99.4% and 98.7% of the patients, respectively. The primary endpoint of the study occurred in 4%, primarily driven by cardiac death. CONCLUSIONS: The results of the ROSES multicenter registry indicated good clinical outcomes of BPSES Orsiro in all-comers Latin Americann patients undergoing PCI, despite the high-risk patients and treated lesions.

Assuntos

Fármacos Cardiovasculares , Doença da Artéria Coronariana , Stents Farmacológicos , Intervenção Coronária Percutânea , Rosa , Implantes Absorvíveis , Idoso , Fármacos Cardiovasculares/efeitos adversos , Chile , Doença da Artéria Coronariana/terapia , Stents Farmacológicos/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Desenho de Prótese , Sistema de Registros , Fatores de Tempo , Resultado do Tratamento

RESUMO

Renal transplant remains the preferred therapy for end-stage renal disease (ESRD). Given the shortage of suitable donor kidneys, use of an expanded criteria donor (ECD) allows marginal kidneys to be transplanted; albeit at risk of increased graft failure due to lower nephron mass. To reduce the risk of graft failure, double kidney transplant (DKT) is advocated, with favorable outcomes. Transplant renal artery stenosis (TRAS) is one of the most common vascular complications following renal transplant. Unlike single kidney transplants, where TRAS usually presents with fluid overload, uncontrolled hypertension, and worsening kidney functions; it may be clinically silent in DKT patients since they have two functional transplanted kidneys. We hereby report a case of TRAS in a DKT patient who had 2 years of favorable clinical outcomes following successful endovascular stenting. He however recently died of COVID-19 associated pneumonitis.

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O transplante renal continua sendo a terapia preferida para doenças renais em fase terminal. Dada a escassez de rins de doadores adequados, o doador com critérios expandidos permite que rins marginais sejam transplantados, embora haja um maior risco de falha do enxerto devido à diminuição da massa nefrótica. Para diminuir o risco de falha do enxerto, recomenda-se o transplante renal duplo (TRD), com resultados favoráveis. A estenose de artéria renal transplantada (EART) é uma das complicações vasculares mais comuns após o transplante renal. Ao contrário dos transplantes de rim simples, nos quais a EART geralmente se manifesta como sobrecarga de fluido, hipertensão descontrolada e piora das funções renais, ela pode ser clinicamente silenciosa em pacientes com TRD, pois eles têm dois rins funcionais transplantados. Relatamos aqui um caso de EART em um paciente com TRD que teve resultados clínicos favoráveis por dois anos após o sucesso do implante de stent endovascular. No entanto, ele morreu recentemente de pneumonite associada à covid-19.

RESUMO

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.

Assuntos

Doença da Artéria Coronariana , Stents Farmacológicos , Implantes Absorvíveis , Doença da Artéria Coronariana/cirurgia , Humanos , Polímeros , Desenho de Prótese , Resultado do Tratamento

RESUMO

Abstract Renal transplant remains the preferred therapy for end-stage renal disease (ESRD). Given the shortage of suitable donor kidneys, use of an expanded criteria donor (ECD) allows marginal kidneys to be transplanted; albeit at risk of increased graft failure due to lower nephron mass. To reduce the risk of graft failure, double kidney transplant (DKT) is advocated, with favorable outcomes. Transplant renal artery stenosis (TRAS) is one of the most common vascular complications following renal transplant. Unlike single kidney transplants, where TRAS usually presents with fluid overload, uncontrolled hypertension, and worsening kidney functions; it may be clinically silent in DKT patients since they have two functional transplanted kidneys. We hereby report a case of TRAS in a DKT patient who had 2 years of favorable clinical outcomes following successful endovascular stenting. He however recently died of COVID-19 associated pneumonitis.

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Resumo O transplante renal continua sendo a terapia preferida para doenças renais em fase terminal. Dada a escassez de rins de doadores adequados, o doador com critérios expandidos permite que rins marginais sejam transplantados, embora haja um maior risco de falha do enxerto devido à diminuição da massa nefrótica. Para diminuir o risco de falha do enxerto, recomenda-se o transplante renal duplo (TRD), com resultados favoráveis. A estenose de artéria renal transplantada (EART) é uma das complicações vasculares mais comuns após o transplante renal. Ao contrário dos transplantes de rim simples, nos quais a EART geralmente se manifesta como sobrecarga de fluido, hipertensão descontrolada e piora das funções renais, ela pode ser clinicamente silenciosa em pacientes com TRD, pois eles têm dois rins funcionais transplantados. Relatamos aqui um caso de EART em um paciente com TRD que teve resultados clínicos favoráveis por dois anos após o sucesso do implante de stent endovascular. No entanto, ele morreu recentemente de pneumonite associada à covid-19.

Assuntos

Humanos , Masculino , Pessoa de Meia-Idade , Obstrução da Artéria Renal/terapia , Trombose , Transplante de Rim/efeitos adversos , Angioplastia , Stents Farmacológicos , Artéria Renal , Transplante de Rim/métodos , Seleção do Doador/métodos , Procedimentos Endovasculares , Transplantados

RESUMO

Purpose: To report the 12-month results of a multicenter, prospective, randomized controlled trial to determine if the ZILVER PTX paclitaxel-eluting stent was noninferior in terms of safety and efficacy compared with surgical bypass. Materials and Methods: This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs surgical bypass surgery using a prosthetic graft (ClinicalTrials.gov identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.4%) or the bypass treatment group (107, 48.6%). Most of the lesions were occlusions (208, 94.5%); the mean lesion length was 247.1±69.3 mm. The primary outcome measure was primary patency at 12 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex-derived peak systolic velocity ratio <2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass. Results: The estimated 12-month primary patency rate was 74.5% (95% CI 66.3% to 82.7%) for the ZILVER PTX group vs 72.5% (95% CI 63.7% to 81.3%) for the bypass arm (p=0.998). Freedom from TLR at 12 months was 80.9% (95% CI 73.3% to 88.5%) for the ZILVER PTX group vs 76.2% (95% CI 68.0% to 84.4%) for the bypass group (p=0.471). The 30-day complication rate was significantly lower in the ZILVER PTX group (4.4% vs 11.3%, p=0.004). Also, procedure time and hospital stay were significantly shorter in the ZILVER PTX group (p<0.001 for both). Conclusion: With noninferior patency results, a lower complication rate, and shorter procedures and hospital stays, paclitaxel-eluting stenting might become a recommended treatment for long TASC C and D femoropopliteal lesions.

Assuntos

Implante de Prótese Vascular/instrumentação , Prótese Vascular , Stents Farmacológicos , Procedimentos Endovasculares/instrumentação , Artéria Femoral/cirurgia , Paclitaxel/administração & dosagem , Doença Arterial Periférica/terapia , Artéria Poplítea/cirurgia , Idoso , Idoso de 80 Anos ou mais , Implante de Prótese Vascular/efeitos adversos , Brasil , Fármacos Cardiovasculares/uso terapêutico , Procedimentos Endovasculares/efeitos adversos , Europa (Continente) , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Paclitaxel/efeitos adversos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Estudos Prospectivos , Desenho de Prótese , Recidiva , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular

RESUMO

The incidence of coronary artery aneurysms ranges from 0.2% to 10.5%. Aneurysms have been described after percutaneous coronary interventions (PCIs) and hypersensitivity to polymers, nickel, cobalt, inflammatory reaction rich in eosinophils, drug released by the stent, fracture and malapposition of the stent, stent endothelialization delay, high pressures used in the procedures, oversizing of balloons and stents, unhealed dissections, atheroablative techniques, and trauma of the arterial wall are related to appearance of coronary artery aneurysms. In this case report, we described a patient with human immunodeficiency virus and thrombophilia who underwent primary PCI and at the end of the procedure had thrombi in the coronary artery. It was decided by triple therapy and new angiographic study 2 days later. This new angiography revealed thrombi resolution but the appearance of an aneurysm in the middle portion of the drug-eluting stent. The anticoagulant was stopped and we performed watchful waiting strategy with new serial angiograms that revealed progressive reduction and disappearance of the aneurysm. Subsequently triple therapy with warfarin, aspirin and clopidogrel was restarted and the patient progressed asymptomatic and performed his daily activities normally. At 6 months of clinical follow-up, we advised the patient to suspend aspirin and to continue secondary prevention of cardiovascular events.

RESUMO

The field of interventional cardiology has significantly evolved over 40 years by overcoming several challenges. The introduction of first-generation drug-eluting stents significantly reduced the rates of restenosis, but at the expense of an increase of late stent thrombosis. Prolonged antithrombotic therapy reduced rates of stent thrombosis, but at the cost of increased bleeding. Although the advent of second-generation drug-eluting stents subsequently reduced the incidence of late stent thrombosis, its permanent nature prevents full recovery of vascular structure and function with accordant risk of very late stent failure. In the present era of interventional cardiology, the tradeoff between stent thrombosis, restenosis, and bleeding presents as a particularly complex challenge. In this review, the authors highlight major contributors of late/very late stent thrombosis while targeting stent restenosis, and they discuss evolutionary advances in stent technology and antiplatelet therapy, to further improve upon the care of patients with coronary artery disease.

Assuntos

Reestenose Coronária/prevenção & controle , Trombose Coronária/etiologia , Stents Farmacológicos/efeitos adversos , Neointima/prevenção & controle , Antineoplásicos/efeitos adversos , Endotélio Vascular/efeitos dos fármacos , Humanos , Hipersensibilidade/etiologia

RESUMO

Abstract: Introduction: Internationally, the Titan bioactive stent efficacy and safety have been evaluated against second-generation drug-eluting stents (DES) in patients with acute coronary syndrome. In our field, however, there is not enough information about its short-term or one-year follow-up outcomes when compared with a second-generation drug-eluting stent in ST-segment elevation myocardial infarction (STEMI). Objective: To evaluate and compare immediate, in-hospital and one-year use clinical outcomes of the Titan stent versus Endeavor stent in patients with ST-segment elevation myocardial infarction. Material and methods: A descriptive, comparative, longitudinal, retrospective, observational study was performed in patients with ST-segment elevation myocardial infarction type acute coronary syndrome who were subjected to primary, pharmacoinvasive and rescue angioplasties, using a Titan stent against Endeavor stent. Primary points: major adverse cardiac events (MACEs), death, myocardial infarction, need for target lesion revascularization (TLR), target vessel revascularization (TVR), cerebrovascular event (CVE) and stent thrombosis. Secondary points: Dual antiplatelet therapy (DAPT) usage time. Results: 256 patients with ST-segment elevation myocardial infarction were examined from January 2011 to December 2014. They were treated with a Titan bioactive stent (135 patients) or Endeavor stent (121 patients). There were no significant differences related to major adverse cardiac events, death, myocardial infarction, stent thrombosis or cerebrovascular event, either in-hospital or one-year follow-up. More patients were observed in the Killip-Kimball 3-4 classification in Endeavor stent group versus patients in Titan stent group (62.2% versus 42.2%, respectively, p = 0.010). A greater pre-PTCA (Percutaneous Transluminal Coronary Angioplasty) TIMI (Thrombolysis in Myocardial Infarction) 0-1 flow rate was also observed (90.9% in Endeavor stent group versus 79.3% in Titan stent group, p = 0.010). However, the Titan stent was considerably more used in elderly patients (62.36 ± 12.95 years old versus 57.59 ± 10.42 years old in Endeavor stent group, p = 0.001); in more complex type C lesions (62.4% in Titan stent group versus 40.5% in Endeavor stent group, p = 0.010); and small vessels (28.9% in Titan stent group versus 18.2% in Endeavor stent group, p = 0.045). Target lesion revascularization and target vessel revascularization rates were similar: 0% versus 2.5%, p = 0.066 and 0% versus 0.8%, p = 0.290, in Titan stent and Endeavor stent groups, respectively. There were no significant differences on the major adverse cardiac events-free survival analysis (Log-rank Mantel-Cox 0.764 test). There were significant differences on dual antiplatelet therapy usage time (6.46 ± 4.11 months in Titan stent group versus 10.98 ± 2.51 months in Endeavor stent group, p ≤ 0.0001). Conclusions: There was no superiority registered in use of a second-generation drug-eluting stent such as the Endeavor stent versus Titan bioactive stent (titanium-nitride-oxide-coated stent) in patients with ST-segment elevation myocardial infarction regarding immediate, in-hospital and one-year follow-up clinical outcomes. The Titan stent seems to be a good choice for this kind of ST-segment elevation acute coronary syndrome in both efficacy and safety against new drug-eluting stents, and it could be used in elderly patients and/or patients with high bleeding risk requiring less time of dual antiplatelet therapy.(AU)

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Resumen: Introducción: A nivel internacional, la eficacia y la seguridad de los stents bioactivos Titan se han evaluado en comparación con los stents liberadores de fármacos (su sigla en inglés es DES) de segunda generación en pacientes con síndrome coronario agudo. Sin embargo, en nuestro campo, no hay suficiente información acerca de sus resultados de seguimiento a corto plazo o de un año cuando se compara con una endoprótesis liberadora de fármacos de segunda generación en el infarto de miocardio por elevación del segmento ST (STEMI). Objetivo: Evaluar y comparar los resultados clínicos inmediatos, en el hospital y a un año de uso del stent Titan frente a stent Endeavor en pacientes con infarto de miocardio por elevación del segmento ST. Material y métodos: Se realizó un estudio observacional descriptivo, comparativo, longitudinal, retrospectivo y observacional en pacientes con el síndrome coronario agudo de infarto de miocardio por elevación del segmento ST que fueron sometidos a angioplastias primarias, farmacoinvasivas y de rescate, utilizando un stent Titan contra el stent Endeavor. Puntos primarios: eventos cardiacos adversos mayores (MACE), muerte, infarto de miocardio, necesidad de revascularización de la lesión objetivo (TLR). Revascularización del vaso objetivo (TVR), evento cerebrovascular (CVE) y trombosis del stent. Puntos secundarios: Tiempo de uso de la terapia antiplaquetaria dual (DAPT). Resultados: De enero de 2011 a diciembre de 2014 se examinaron 256 pacientes con infarto de miocardio por elevación del segmento ST. Fueron tratados con un stent bioactivo de Titan (135 pacientes) o un stent de Endeavor (121 pacientes). No hubo diferencias significativas relacionadas con los eventos cardiacos adversos mayores, muerte, infarto de miocardio, trombosis de stent o evento cerebrovascular, ni en el hospital ni en el seguimiento de un año. Se observaron más pacientes en la clasificación Killip-Kimball 3-4 en el grupo de stent Endeavor versus pacientes en el grupo de stent Titan (62.2% versus 42.2%, respectivamente, p = 0.010). También se observó una mayor tasa de flujo 0-1 antes de la PTCA (angioplastia coronaria transluminal percutánea) TIMI (trombólisis en el infarto de miocardio) (90.9% en el grupo de stent Endeavor frente a 79.3% en el grupo de stent Titan, p = 0.010). Sin embargo, la endoprótesis Titan se utilizó considerablemente más en pacientes de edad avanzada (62.36 ± 12.95 años frente a 57.59 ± 10.42 años en el grupo de endoprótesis Endeavor, p = 0.001); en las lesiones tipo C más complejas (62.4% en el grupo de stent Titan versus 40.5% en el grupo de stent Endeavor, p = 0.010); y en pequeños vasos (28.9% en el grupo de stent Titan versus 18.2% en el grupo de stent Endeavor, p = 0.045). La revascularización de las lesiones objetivo y las tasas de revascularización de los vasos objetivo fueron similares: 0% versus 2.5%, p = 0.066 y 0% versus 0.8%, p = 0.290, en los grupos de stent Titan y stent Endeavor, respectivamente. No hubo diferencias significativas en el análisis de supervivencia sin eventos cardiacos adversos mayores (ensayo de Mantel-Cox 0.764 del rango de logos). Hubo diferencias significativas en el tiempo de uso del tratamiento antiplaquetario dual (6.46 ± 4.11 meses en el grupo con stent Titan versus 10.98 ± 2.51 meses en el grupo con stent Endeavor, p ≤ 0.0001). Conclusiones: No se registró una superioridad en el uso de un stent liberador de fármacos de segunda generación como el stent Endeavor versus el stent bioactivo Titan (stent recubierto de titanio-nitrurado) en pacientes con infarto de miocardio por elevación del segmento ST con respecto a los resultados clínicos de seguimiento inmediato, hospitalario y de un año. El stent Titan parece ser una buena opción para este tipo de síndrome coronario agudo por elevación del segmento ST, tanto en eficacia como en seguridad frente a nuevos stents liberadores de fármacos, y podría utilizarse en pacientes ancianos y/o pacientes con alto riesgo de hemorragia que requieran menos tiempo de tratamiento antiplaquetario dual.(AU)

Assuntos

Humanos , Angioplastia/instrumentação , Stents Farmacológicos , Infarto do Miocárdio/cirurgia , Estudos Epidemiológicos , Estudos Retrospectivos , Estudos Longitudinais , México

RESUMO

OBJECTIVES: The authors evaluated the 5-year cumulative incidence of cardiovascular events following Resolute zotarolimus-eluting stent (R-ZES) implantation. BACKGROUND: Individual trials are often underpowered to show differences for low-frequency adverse events. The R-ZES was studied in 10 prospective clinical trials, designed with identical adverse event definitions, ascertainment, and adjudication. METHODS: The RESOLUTE Global Clinical Trial Program includes 7,618 patients treated with R-ZES: RESOLUTE first-in-human study (N = 139), RESOLUTE All Comers (N = 1,140), RESOLUTE International (N = 2,349), RESOLUTE US (N = 1,402), RESOLUTE US 38 mm (N = 114), RESOLUTE Japan (N = 100), RESOLUTE Japan Small Vessel Study (N = 65), RESOLUTE Asia (N = 311), RESOLUTE China Randomized Controlled Trial (N = 198), and RESOLUTE China Registry (N = 1,800). The 5-year cumulative incidence of events was calculated. RESULTS: The 5-year cumulative incidence of cardiac events was 13.4% for target lesion failure and included 5.0% cardiac death, 4.4% target vessel myocardial infarction, and 6.3% clinically driven target lesion revascularization. Dual-antiplatelet therapy at 1, 3, and 5 years was 91%, 37%, and 32%, respectively. The 5-year cumulative incidence of definite or probable stent thrombosis was 1.2%, which comprised 0.7% at 1 year and an annualized rate of 0.1% thereafter. Five-year use of dual-antiplatelet therapy varied geographically from 63% in Japan to 11% in Europe. CONCLUSIONS: In the largest group of R-ZES patients examined to date, the majority of stent-related events, including target vessel myocardial infarction and stent thrombosis, occurred within the first year of implantation with much lower risks of these events out to 5 years.

Assuntos

Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea/instrumentação , Sirolimo/análogos & derivados , Idoso , Ásia/epidemiologia , Austrália , Fármacos Cardiovasculares/efeitos adversos , Ensaios Clínicos como Assunto , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Trombose Coronária/epidemiologia , Quimioterapia Combinada , Europa (Continente)/epidemiologia , Medicina Baseada em Evidências , Feminino , Humanos , Incidência , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , América do Norte/epidemiologia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Inibidores da Agregação Plaquetária/administração & dosagem , Desenho de Prótese , Fatores de Risco , Sirolimo/administração & dosagem , Sirolimo/efeitos adversos , América do Sul/epidemiologia , Fatores de Tempo , Resultado do Tratamento

RESUMO

AIM: We sought to determine whether the optimal dual antiplatelet therapy (DAPT) duration after drug-eluting stent (DES) placement varies according to clinical presentation.METHODS AND RESULTS:We performed an individual patient data pairwise and network meta-analysis comparing short-term (≤6-months) versus long-term (1-year) DAPT as well as 3-month vs. 6-month vs 1-year DAPT. The primary study outcome was the 1-year composite risk of myocardial infarction (MI) or definite/probable stent thrombosis (ST). Six trials were included in which DAPT after DES consisted of aspirin and clopidogrel. Among 11 473 randomized patients 6714 (58.5%) had stable CAD and 4758 (41.5%) presented with acute coronary syndrome (ACS), the majority of whom (67.0%) had unstable angina. In ACS patients, ≤6-month DAPT was associated with non-significantly higher 1-year rates of MI or ST compared with 1-year DAPT (Hazard Ratio (HR) 1.48, 95% Confidence interval (CI) 0.98-2.22; P = 0.059), whereas in stable patients rates of MI and ST were similar between the two DAPT strategies (HR 0.93, 95%CI 0.65-1.35; P = 0.71; Pinteraction = 0.09). By network meta-analysis, 3-month DAPT, but not 6-month DAPT, was associated with higher rates of MI or ST in ACS, whereas no significant differences were apparent in stable patients. Short DAPT was associated with lower rates of major bleeding compared with 1-year DAPT, irrespective of clinical presentation. All-cause mortality was not significantly different with short vs. long DAPT in both patients with stable CAD and ACS.

Assuntos

Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Hemorragia/induzido quimicamente , Infarto do Miocárdio , Morte Súbita/epidemiologia

RESUMO

BACKGROUND:Although some randomized controlled trials (RCTs) and meta-analyses have suggested that prolonged dual-antiplatelet therapy (DAPT) may be associated with increased mortality, the mechanistic underpinnings of this association remain unclear.OBJECTIVES:The aim of this study was to analyze the associations among bleeding, mortality, and DAPT duration after drug-eluting stent implantation in a meta-analysis of RCTs.METHODS:RCTs comparing different DAPT durations after drug-eluting stent placement were sought through the MEDLINE, Embase, and Cochrane databases and the proceedings of international meetings. Deaths were considered possibly bleeding related if occurring within 1 year of the episodes of bleeding. Primary analysis was by intention-to-treat. Secondary analysis was performed in a modified intention-to-treat population in which events occurring when all patients were on DAPT were excluded.

Assuntos

Humanos , Hemorragia/induzido quimicamente , Hemorragia/mortalidade , Inibidores da Agregação Plaquetária/administração & dosagem , Inibidores da Agregação Plaquetária/efeitos adversos , Stents Farmacológicos

RESUMO

La fractura del stent es una complicación potencial de estos dispositivos. Su incidencia varía notablemente en los informes publicados (< 1% a 16%), pero la cifra exacta es desconocida debido a la dificultad en el diagnóstico y la falta de definiciones estandarizadas. Se describe un caso donde el mecanismo probable por el cual se genera la fractura se debe a la presencia de un gran quiste pericárdico.

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A stent fracture (SF) is a potential complication of these devices. Their incidence varies considerably in published reports (<1% to 16%), but the exact figure remains unknown due to the difficulty of diagnosis and the lack of standardised definitions. A case is presented where the probable mechanism that originated the fracture was the presence of a large pericardial cyst.

Assuntos

Humanos , Stents Farmacológicos , Reestenose Coronária , Pericárdio

RESUMO

BACKGROUND: Although drug-eluting stents (DES) have been widely incorporated into clinical practice in developed countries, several countries restrict their use mainly because of their high cost and unfavorable incremental cost-effectiveness ratios (ICER). OBJECTIVE: To evaluate the cost-effectiveness of DES in comparison with bare-metal stents (BMS) for treatment of coronary artery disease (CAD). DESIGN: Markov model. DATA SOURCES: Published literature, government database, and CAD patient cohort. TARGET POPULATION: Single-vessel CAD patients. TIME HORIZON: One year and lifetime. PERSPECTIVE: Brazilian Public Health System (SUS). INTERVENTION: Six strategies composed of percutaneous intervention with a BMS or 1 of 5 DES (paclitaxel, sirolimus, everolimus, zotarolimus, and zotarolimus resolute). OUTCOME MEASURES: Cost for target vessel revascularization avoided and cost for quality-adjusted life year gained. BASE CASE ANALYSIS: In the short-term analysis, sirolimus was the most effective and least costly among DES (ICER of I$20,642 per target vessel revascularization avoided), with all others DES dominated by sirolimus. Lifetime cumulative costs ranged from I$18,765 to I$21,400. In the base case analysis, zotarolimus resolute had the most favorable ICER among the DES (ICER I$62,761), with sirolimus, paclitaxel, and zotarolimus being absolute dominated and everolimus extended dominated by zotarolimus resolute, although all the results were above the willingness-to-pay threshold of 3 times the gross domestic product per capita (I$35,307). SENSITIVITY ANALYSIS: In deterministic sensitivity analysis, results were sensitive to cost of DES, number of stents used per patient, baseline probability, and duration of stent thrombosis risk. The probabilistic sensitivity analysis demonstrated a probability of 81% for BMS being the strategy of choice, with 9% for everolimus and 9% zotarolimus resolute, at the willingness-to-pay threshold. CONCLUSION: DES is not a good value for money in SUS perspective, despite its benefit in reducing target vessel revascularization. Since the cost-effectiveness of DES is mainly driven by the stents' cost difference, they should cost less than twice the BMS price to become a cost-effective alternative.

Assuntos

Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos/economia , Brasil , Análise Custo-Benefício , Técnicas de Apoio para a Decisão , Humanos , Imunossupressores/economia , Imunossupressores/uso terapêutico , Cadeias de Markov , Modelos Econométricos , Modelos Estatísticos , Anos de Vida Ajustados por Qualidade de Vida , Fatores de Risco , Stents/economia

RESUMO

UNLABELLED: The use of coronary stents in coronary angioplasty has evolved dramatically in its design, type materials, polymers, and a variety of drugs, the use of coronary stents covered nitric oxide have shown satisfactory results in practice, however compared to the results reported drug-eluting stents, there is little information. OBJECTIVES: The aim of this study was to compare clinical outcomes of a stainless steel stent Bioactive nitric oxide coated titanium (BAS) and a drug-eluting stent zotarolimus (DES) in daily clinical practice. METHODS: A retrospective, analytical, descriptive and comparative study aimed at evaluating the safety and efficacy of two devices with different characteristics in our population. The primary endpoints were: death, acute infarction (AMI), and re intervention injury Treated (RLT). RESULTS: A total of 759 patients were included in the study which was performed angioplasty to a single vessel. Were divided into two arms 382 with DES and 377 patients with BAS, the one year follow up was carried in 95%. After this follow-up period, primary points (cardiovascular death, myocardial infarction, TLR and stent thrombosis) for arm DES vs BAS; 9.5% vs 8.5% P=NS but with shorter periods of dual antiplatelet therapy for arm BAS 6.9±4.1 vs 11.1±2.5 months DES P=.0001. The results were independent of the clinical syndrome of presentation. CONCLUSIONS: After one year of follow no statistically significant difference in major clinical events, there was a trend in favour of BAS vs SM with respect to revascularization of the target lesion without reaching statistical significance.

Assuntos

Stents Farmacológicos , Isquemia Miocárdica/cirurgia , Revascularização Miocárdica/métodos , Óxido Nítrico/administração & dosagem , Sirolimo/análogos & derivados , Titânio/administração & dosagem , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Desenho de Prótese , Estudos Retrospectivos , Sirolimo/administração & dosagem , Resultado do Tratamento

RESUMO

BACKGROUND: The present study aimed to evaluate the clinical performance, in the daily practice of a busy catheterization laboratory, of a novel drug-eluting stent (DES) built with an ultra-thin-strut metallic platform, eluting sirolimus at low doses, abluminal coated with biodegradable polymers, and mounted in a low-compliant delivery system. METHODS: Prospective, single-arm study, comprising all consecutive patients undergoing percutaneous coronary intervention (PCI) with the Inspiron™ sirolimus-eluting stent (SES) (Scitech, Aparecida de Goiania, Brazil). The primary endpoint was the occurrence of major adverse cardiac events (MACE) [cardiac death, non-PCI related myocardial infarction (MI), or target vessel revascularization (TVR)]. RESULTS: A total of 470 patients were included, from which 51.3% were diabetics, 33.8% had triple-vessel disease, 15.3% had heart failure, 38.9% had at least one bifurcation treated, 19.8% were treated for a bare metal stent restenosis, and 61.9% had at least one type C lesion; one or more of these features were found in 96.0%. At 300 days, the rate target lesion revascularization was 5.4% and the rate of MACE was 8.1%. The incidence of definite or probable stent thrombosis was 0.4%, with no cases between 30 and 300 days. CONCLUSIONS: The novel stent is associated with excellent short and mid-term clinical outcomes in patients treated with PCI in the daily practice.

RESUMO

OBJECTIVES: To assess the clinical profile and long-term mortality in SYNTAX score II based strata of patients who received percutaneous coronary interventions (PCI) in contemporary randomized trials. BACKGROUND: The SYNTAX score II was developed in the randomized, all-comers' SYNTAX trial population and is composed by 2 anatomical and 6 clinical variables. The interaction of these variables with the treatment provides individual long-term mortality predictions if a patient undergoes coronary artery bypass grafting (CABG) or PCI. METHODS: Patient-level (n=5433) data from 7 contemporary coronary drug-eluting stent (DES) trials were pooled. The mortality for CABG or PCI was estimated for every patient. The difference in mortality estimates for these two revascularization strategies was used to divide the patients into three groups of theoretical treatment recommendations: PCI, CABG or PCI/CABG (the latter means equipoise between CABG and PCI for long term mortality). RESULTS: The three groups had marked differences in their baseline characteristics. According to the predicted risk differences, 5115 patients could be treated either by PCI or CABG, 271 should be treated only by PCI and, rarely, CABG (n=47) was recommended. At 3-year follow-up, according to the SYNTAX score II recommendations, patients recommended for CABG had higher mortality compared to the PCI and PCI/CABG groups (17.4%; 6.1% and 5.3%, respectively; P<0.01). CONCLUSIONS: The SYNTAX score II demonstrated capability to help in stratifying PCI procedures.

Assuntos

Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos , Intervenção Coronária Percutânea/métodos , Doença da Artéria Coronariana/mortalidade , Feminino , Seguimentos , Saúde Global , Humanos , Masculino , Pessoa de Meia-Idade , Taxa de Sobrevida/tendências , Fatores de Tempo , Resultado do Tratamento

RESUMO

Objetivo: Analizar la costo-efectividad y el valor esperado de la información perfecta del stent medicado con sirolimus comparado con el convencional para pacientes con infarto agudo de miocardio con elevación del ST en Colombia. Métodos: Se construyó un modelo de Markov bajo la perspectiva del pagador y un horizonte temporal de diez años. Las probabilidades de transición se extrajeron de estudios clínicos identificados a partir de revisiones de la literatura. Los costos se estimaron mediante el uso de consenso de expertos y manuales tarifarios colombianos. Se realizó un análisis de sensibilidad determinístico alrededor del horizonte temporal, precio del stent medicado y tasa de descuento. Se construyó un análisis de sensibilidad probabilístico (10.000 simulaciones de Monte Carlo) y el valor esperado de la información perfecta para la decisión global y grupos de parámetros. Resultados: En el caso base, el costo por año de vida ajustado por calidad se ubicó en 53.749.654 $. Los resultados no son sensibles al horizonte temporal ni a la tasa de descuento, pero sí al precio del stent medicado. El valor esperado de la información perfecta fue significativamente mayor para la probabilidad de muerte y de sufrir una trombosis muy tardía del stent. Conclusiones: El stent medicado con sirolimus no es costo-efectivo para pacientes con infarto agudo de miocardio con elevación del ST en Colombia. Se recomienda mayor investigación futura sobre la probabilidad de muerte y trombosis muy tardía del stent, así como en subgrupos específicos de pacientes y stents medicados de segunda generación.

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Objective: To perform a cost-effectiveness and value of perfect information analysis comparing sirolimus-eluting stent with bare metal stent for patients with ST-segment elevation myocardial infarction in Colombia. Methods: We developed a Markov model from the payer perspective and considering a time horizon of 10 years in the base case. Transition probabilities were extracted from clinical studies identified from literature reviews. Costs were estimated using expert consensus and Colombian tariff handbooks. We performed a deterministic analysis around the time horizon, the discount rate and the price of the drug eluting stent. We developed a probabilistic sensitivity analysis (10,000 Monte Carlo simulations) and a value of perfect information analysis for the global decision and parameter groups. Results: In the base case, the cost per quality adjusted life year gained was $ 53,749,654. The results are sensitive to the drug eluting stent price, but not to the time horizon and the discount rate. The expected value of perfect information was significantly higher for the probability of death and very late stent thrombosis. Conclusions: Sirolimus-eluting stent is not cost-effective for patients with an ST segment elevation myocardial infarction. More future research is recommended around the risk of death and very late stent thrombosis, as well as in specific subgroups of patients and second-generation drug-eluting stents.

Assuntos

Avaliação em Saúde , Análise de Custo-Efetividade , Infarto do Miocárdio com Supradesnível do Segmento ST , Stents , Stents Farmacológicos