ABSTRACT
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.
Subject(s)
Coronary Artery Disease , Drug-Eluting Stents , Absorbable Implants , Coronary Artery Disease/surgery , Humans , Polymers , Prosthesis Design , Treatment OutcomeABSTRACT
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.
Subject(s)
Humans , Male , Middle Aged , Renal Artery Obstruction/therapy , Thrombosis , Kidney Transplantation/adverse effects , Angioplasty , Drug-Eluting Stents , Renal Artery , Kidney Transplantation/methods , Donor Selection/methods , Endovascular Procedures , Transplant RecipientsABSTRACT
OBJECTIVE: To evaluate and compare the costs and effectiveness of two alternative stent, drug eluting stent (SF) and bare metal stent (SNF). MATERIAL AND METHODS: Cost-utility analysis based on a Markov model using data from a cohort study of Hospital Las Higueras of Talcahuano, Chile. The effectiveness measure was the rate of restenosis and the time of restenosis. The effectiveness outcomes are expressed in quality-adjusted life years (QALY) gained. Costs are expressed in national currency 2011. The evaluation perspective was from the public heath budget. We model a cohort from age 63 to 80 years, life expectancy in Chile. Apply discount rate of 0, 3% and 6% for results and costs. Sensitivity analysis is performed according to the ranges of variability in costs, the utility values of the variables and transition between states. RESULTS: No differences in restenosis rates between the two stents, although there were differences in the time of restenosis. The incremental cost effectiveness ratio (ICER) no discount rate was CH$ 235.749 per QALY gained when using drug-eluting stent, the value below the equivalent of 1 Gross Domestic Product (PIB) per capita for 2011 in Chile. CONCLUSIONS: The drug-eluting stent (SF) is cost effective compared to bare metal stent (SNF). The ICER is not affected by the sensitivity analysis (variability of cost, utility ranges used, probability of restenosis).
ABSTRACT
Objetivo: Demonstrar a segurança dos stents farmacológicos (SF) no IAM em lesões com elevado risco de trombose quando comparados aos stents convencionais. Métodos: Estudo prospectivo não-randomizado em queforam analisados, de forma consecutiva, 86 pacientes submetidos à angioplastia primária, no período de 01/01/2005 a 31/10/2006, que apresentavam lesões tipo B2 ou C e evidência de trombos à angiografia na lesão culpada, definidos como falha de enchimento visualizadaem mais de uma incidência. Foi comparada a ocorrência de trombose subaguda (TSA) e trombose aguda (TA) em um grupo de pacientes que usou SF (Grupo I) com um grupo que usou SC (Grupo II). As características dos dois grupos são: Grupo I: idade média 64,3±12,69 anos; 57,1% hipertensos; 37,1% diabéticos; 25,7% tabagistas; 51,4% dislipidêmicos; 74,2% do sexo masculino; 88,5% fizeram uso de antagonistas do receptor de IIb/IIIa ; nenhum caso de TA e apenas 1 caso de TSA. Grupo II: idade média 66,54±10,81; 57,1% hipertensos (p=0,19); 15,6% diabéticos (p=0,02); 35,2% tabagistas (p=0,35); 62,7% dislipidêmicos (p=0,29); 84,3% fizeram uso de antagonistas do receptorde IIb/IIIa (p=0,36); nenhum caso de TA e TSA. Resultados: Os grupos analisados foram homogêneos,não apresentando significância estatística para os elementos analisados à exceção do maior número de pacientes diabéticos no Grupo I. A diferença entre os grupos de trombose aguda ou subaguda não atingiu relevância estatística. Conclusão: O uso de SF no IAM em lesões com trombos visualizados à angiografia é seguro e não está associado a um aumento da incidência de trombose quandocomparado ao stent convencional.
Objective: To demonstrate the safety of drug eluting stents (DES) in AMI in lesions with high risk of thrombosis when compared to conventionalstents. Methods: Non-randomized prospective study of 86 consecutive patients submitted to primary angioplasty from January 1st 2005 to October 31st 2006 who presented type B2 or C lesions and evidence of thrombus in angioplasty in the affectedlesion, defined as a filling gap visualized in more than one incidence. The occurrence of subacute thrombosis (SAT) and acute thrombosis (AT) werecompared between a group of patients that used DES (Group I) and a group that used CS (Group II). The characteristics of both groups are: Group I: mean age 64.3±12.69 years; 57.1% hypertensive; 37.1% diabetic; 25.7% tobacco users; 51.4%dyslipidemic; 74.2% males; 88.5% used IIb/IIIa receptor antagonists; no cases of AT and only one case of SAT. Group II: mean age of 66.54±10.81years; 57.1% hypertensive (p=0.19); 15.6% diabetic (p=0.02); 35.2% tobacco users (p=0.35); 62.7%dyslipidemic (p=0.29); 84.3% used IIb/IIIa receptor antagonists (p=0.36); no cases of AT or SAT. Conclusion: The use of DES in AMI in lesions withthrombi visualized in angiography is safe and is not associated with an increase in the incidence of thrombosis when compared to conventional stent.
