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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.
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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.
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.
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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.
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.
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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.
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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 TratamentoRESUMO
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.
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.
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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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Doença da Artéria Coronariana , Stents Farmacológicos , Implantes Absorvíveis , Doença da Artéria Coronariana/cirurgia , Humanos , Polímeros , Desenho de Prótese , Resultado do TratamentoRESUMO
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.
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.
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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 , TransplantadosRESUMO
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.
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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 VascularRESUMO
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.
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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.