Panorama das Intervenções Coronárias Percutâneas em Oclusões Totais Crônicas em Centros Participantes do LATAM CTO Registry no Brasil / Overview of Percutaneous Coronary Interventions for Chronic Total Occlusions Treated at Brazilian Centers Participating in the LATAM CTO Registry

Resumo Fundamento Tem sido observado um grande avanço nas técnicas e nos dispositivos para a realização de intervenções coronárias percutâneas (ICP) em oclusões totais coronarianas crônicas (OTC), mas existem poucos dados da prática do mundo real em países em desenvolvimento. Objetivos Relatar as características clínicas e angiográficas, os aspectos dos procedimentos e os resultados clínicos da ICP de OTC em centros dedicados a esse procedimento no Brasil. Métodos Os pacientes incluídos foram submetidos à ICP de OTC em centros participantes do LATAM CTO Registry, um registro multicêntrico latino-americano dedicado à coleta prospectiva desses dados. Os critérios de inclusão foram procedimentos realizados no Brasil, idade acima de 18 anos e presença de OTC com tentativa de ICP. A definição de OTC foi lesão de 100% em uma artéria coronária epicárdica, conhecida ou estimada como tendo pelo menos 3 meses de evolução. Resultados Foram incluídos dados de 1.196 ICPs de OTC. Os procedimentos foram realizados principalmente para controle da angina (85%) e/ou tratamento de uma grande área isquêmica (24%). A taxa de sucesso técnico foi de 84% e foi alcançada com técnicas de fios anterógrados em 81%, dissecção/reentrada anterógrada em 9% e retrógrada em 10% dos procedimentos. Os eventos cardiovasculares adversos intra-hospitalares ocorreram em 2,3% dos casos, sendo a mortalidade de 0,75%. Conclusões As OTC podem ser tratadas no Brasil por intervenção coronária percutânea de forma efetiva e com baixas taxas de complicações. O desenvolvimento científico e tecnológico observado nessa área na última década reflete-se na prática clínica de centros brasileiros dedicados a essa técnica.

Abstract Background Major advances have been seen in techniques and devices for performing percutaneous coronary interventions (PCIs) for chronic total occlusions (CTOs), but there are limited real-world practice data from developing countries. Objectives To report clinical and angiographic characteristics, procedural aspects, and clinical outcomes of CTO PCI performed at dedicated centers in Brazil. Methods Included patients underwent CTO PCI at centers participating in the LATAM CTO Registry, a Latin American multicenter registry dedicated to prospective collection of these data. Inclusion criteria were procedures performed in Brazil, age 18 years or over, and presence of CTO with PCI attempt. CTO was defined as a 100% lesion in an epicardial coronary artery, known or estimated to have lasted at least 3 months. Results Data on 1196 CTO PCIs were included. Procedures were performed primarily for angina control (85%) and/or treatment of moderate/severe ischemia (24%). Technical success rate was 84%, being achieved with antegrade wire approaches in 81% of procedures, antegrade dissection and re-entry in 9%, and retrograde approaches in 10%. In-hospital adverse cardiovascular events occurred in 2.3% of cases, with a mortality rate of 0.75%. Conclusions CTOs can be treated effectively in Brazil by using PCI, with low complication rates. The scientific and technological development observed in this area in the past decade is reflected in the clinical practice of dedicated Brazilian centers.

Aterectomia coronária com Excimer Laser como tratamento adjuvante da subexpansão grave do stent com calcificação volumosa / Excimer Laser coronary atherectomy as adjunctive treatment of severe stent underexpansion with bulky calcification

A aterectomia coronária com Excimer Laser melhorou significativamente nos últimos anos, utilizando emissão ultravioleta de alta energia e comprimento de onda curto, com menor penetração e menor emissão de calor, resultando em menos danos aos tecidos e menos complicações. Descrevemos o caso de um paciente do sexo masculino, 66 anos, ex-tabagista, hipertenso, diabético, dislipidêmico. Foi submetido a múltiplas intervenções coronárias percutâneas na artéria descendente anterior com stents não farmacológicos e farmacológicos. Na última intervenção coronária percutânea, o stent foi subexpandido, e o paciente apresentou trombose aguda do stent e reestenose recorrente do stent. Foram realizadas novas intervenções coronárias percutâneas com aterectomia coronária com Excimer Laser adjuvante, devido à angina refratária, com uso de carga progressiva e injeção de soro fisiológico, seguidas de posterior insuflação de balão de alta pressão e implante de stent farmacológico, com resultado excelente. No acompanhamento de 8 meses, o paciente se manteve assintomático.

Excimer Laser coronary atherectomy has improved significantly in recent years, emitting high-energy ultraviolet and short wavelength with less penetration and heat emission, ultimately leading to less tissue damage and fewer complications. We described a case of a 66-year-old male patient, former smoker and suffering from hypertension, diabetes mellitus, and dyslipidemia. He underwent multiple percutaneous coronary interventions in the left anterior descending artery with bare metal and drug-eluting stents. In the last percutaneous coronary intervention, the stent was underexpanded and the patient presented acute stent thrombosis and recurrent stent restenosis. New percutaneous coronary interventions with adjunctive Excimer Laser coronary atherectomy were undertaken due to refractory angina, using progressive load and saline injection, followed by subsequent high-pressure balloon inflation and drug-eluting stent implantation with an excellent result. At 8-month follow-up, the patient was asymptomatic.

Patients with COVID-19 who experience a myocardial infarction have complex coronary morphology and high in-hospital mortality: Primary results of a nationwide angiographic study

OBJECTIVES: We aimed to explore angiographic patterns and in-hospital outcomes of patients with concomitant coronavirus disease-19 (COVID-19) and myocardial infarction (MI). BACKGROUND: Patients with COVID-19 may experience MI during the course of the viral infection. However, this association is currently poorly understood. METHODS: This is a multicenter prospective study of consecutive patients with concomitant COVID-19 and MI who underwent coronary angiography. Quantitative and qualitative coronary angiography were analyzed by two observers in an independent core lab. RESULTS: A total of 152 patients were included, of whom 142 (93.4%) had COVID-19 diagnosis confirmation. The median time between symptom onset and hospital admission was 5 (1­10) days. A total of 83 (54.6%) patients presented with ST elevation MI. The median angiographic Syntax score was 16 (9.0­25.3) and 69.0% had multi-vessel disease. At least one complex lesion was found in 73.0% of patients, 51.3% had a thrombus containing lesion, and 57.9% had myocardial blush grades 0/1. The overall in-hospital mortality was 23.7%. ST-segment elevation MI presentation and baseline myocardial blush grades 0 or 1 were independently associated with a higher risk of death (HR 2.75, 95%CI 1.30­5.80 and HR 3.73, 95%CI 1.61­8.61, respectively). CONCLUSIONS: Patients who have a MI in the context of ongoing COVID-19 mostly present complex coronary morphologies, implying a background of prior atherosclerotic disease superimposed on a thrombotic milieu. The in-hospital prognosis is poor with a markedly high mortality, prompting further investigation to better clarify this newly described condition.

Comparative clinical performance of two types of drug-eluting stents with abluminal biodegradable polymer coating: Five-year results of the DESTINY randomized trial

Resumo Introdução e objetivos: 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) é um estudo randomizado de não inferioridade que comparou o stent farmacológico eluído com Sirolimus Inspiron® (SES) ao controle o stent Biomatrix® Flex eluído com biolimus (BES). Relatórios dentro do primeiro ano mostraram resultados semelhantes para ambos os stents, em seguimento clínico, angiográfico e também em análise de tomografia de coerência ótica e ultrassom intracoronário. A presente análise tem como objetivo comparar o desempenho clínico desses dois stents farmacológicos com polímeros biodegradáveis após cinco anos do procedimento índice. Métodos: Foram randomizados 170 pacientes (194 lesões) em uma proporção de 2:1 para trata mento com SES ou BES, respetivamente. O desfecho primário para o presente estudo foi a taxa em cinco anos de eventos cardíacos adversos maiores combinados, definida como morte cardíaca, infarto do miocárdio ou revascularização da lesão-alvo. Resultados: Em cinco anos, o desfecho primário ocorreu em 12,5% e 17,9% para o grupo SES e BES, respectivamente (p=0,4). Não houve trombose de stent definitiva ou provável entre os pacientes tratados com o novo SES durante os cinco anos de seguimento e ausência de trombose de stent após o primeiro ano no grupo BES. Conclusões: O novo stent Inspiron® apresentou uma boa e semelhante performance clínica no seguimento em longo prazo, quando comparado com o controle o stent de última geração Biomatrix® Flex.

Imagem Cardiovascular e Procedimentos Intervencionistas em Pacientes com Infecção pelo Novo Coronavírus / Cardiovascular Imaging and Interventional Procedures in Patients with Novel Coronavirus Infection

Resumo A pandemia da doença causada pelo novo coronavírus (COVID-19) trouxe grandes desafios para o sistema de saúde devido ao aumento exponencial do número de pacientes acometidos. A racionalização de recursos e a indicação correta e criteriosa de exames de imagem e procedimentos intervencionistas tornaram-se necessárias, priorizando a segurança do paciente, do ambiente e dos profissionais da saúde. Esta revisão visa auxiliar e orientar os profissionais envolvidos na realização desses exames e procedimentos a fazê-los de forma eficaz e segura.

Abstract The coronavirus disease 2019 (COVID-19) pandemic is a huge challenge to the health system because of the exponential increase in the number of individuals affected. The rational use of resources and correct and judicious indication for imaging exams and interventional procedures are necessary, prioritizing patient, healthcare personnel, and environmental safety. This review was aimed at guiding health professionals in safely and effectively performing imaging exams and interventional procedures.

Impact of acute kidney Injury on short-and long-term outcomes after transcatheter aortic valve implantation

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. Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved. KEYWORDS: Acute kidney injury; Aortic stenosis; Daño renal agudo; Edad avanzada; Elderly; Estenosis aórtica; Implante percutáneo de válvula aórtica; Mortalidad; Mortality; Transcatheter aortic valve implantation; Valve Academic Research Consortium.

Risk and timing of clinical events according to diabetic status of patients treated with everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting stent: 2-year results from a propensity score matched comparison of ABSORB EXTEND and SPIRIT trials

OBJECTIVES: to compare the occurrence of clinical events in diabetics treated with the Absorb bioresorbable vascular scaffold (Absorb BVS; Abbott Vascular, Santa Clara, CA) versus everolimus-eluting metal stents (EES; XIENCE V; Abbott Vascular, Santa Clara, CA) BACKGROUND: There are limited data dedicated to clinical outcomes of diabetic patients treated with bioresorbable scaffolds (BRS) at 2-year horizon. METHODS:The present study included 812 patients in the ABSORB EXTEND study in which a total of 215 diabetic patients were treated with Absorb BVS. In addition, 882 diabetic patients treated with EES in pooled data from the SPIRIT clinical program (SPIRIT II, SPIRIT III and SPIRIT IV trials) were used for comparison by applying propensity score matching using 29 different variables. The primary endpoint was ischemia driven major adverse cardiac events (ID-MACE), including cardiac death, myocardial infarction (MI), and ischemia driven target lesion revascularization (ID-TLR). RESULTS: After 2 years, the ID-MACE rate was 6.5% in the Absorb BVS vs. 8.9% in the Xience group (P = 0.40). There was no difference for MACE components or definite/probable device thrombosis (HR: 1.43 [0.24,8.58]; P = 0.69). The occurrence of MACE was not different for both diabetic status (insulin- and non-insulin-requiring diabetes) in all time points up to the 2-year follow-up for the Absorb and Xience groups...

Plastia valvar mitral com mitraclip(mr): seleção de pacientes, técnica de implante e resultados clínicos / Mitral valve repair with mitraclip(mr): seletion of patients, implant technique and clinical results

A regurgitação mitral (RM) é a doença valvar mais prevalente nos Estados Unidos e sua prevalência aumenta a cada ano devido ao envelhecimento populacional. Independentemente da etiologia, a RM sintomática grave cursa com prognóstico desfavorável. O procedimento cirúrgico ainda é o tratamento padrão para essa patologia; porém, como vários pacientes não são submetidos à cirurgia devido ao alto risco, o tratamento percutâneo com MitraClip surgiu como opção viável. A segurança, eficácia e durabilidade do reparo valvar percutâneo com MitraClip já foram demonstradas em estudos randomizados e, com isso, sua indicação vem-se expandindo

Mitral regurgitation (MR) is the most prevalent valve disease in the United States and its prevalence is increasing every year due to population aging. Regardless of the etiology, severe symptomatic MR presents with an unfavorable prognosis. The surgical procedure is still the standard treatment for this pathology, however, various patients do not receive this treatment because of a high surgical risk, and percutaneous treatment with MitraClip has emerged as a viable option. The safety, efficacy, and durability of percutaneous valve repair with the MitraClip have already been demonstrated in randomized trials, and as a result, its indication has been expanding

Angiographic assessment of aortic regurgitation by video-densitometry in the setting of TAVI: echocardiographic and clinical correlates

We sought to investigate a new angiographic method for aortic regurgitation (AR) severity assessment in the setting of transcatheter aortic valve implantation (TAVI). AR after TAVI is common but challenging to quantitate, especially in the cath-lab. In 228 patients, AR was quantitated before and after TAVI by echocardiography and by video-densitometric analysis of aortograms. Contrast time– density curves for the aortic root (the reference region) and the left ventricular outflow tract, LVOT were generated. LVOT-AR was calculated as the area under the curve of the LVOT as a fraction of the area under the curve of the reference region. LVOT-AR was 0.10 6 0.08, 0.13 6 0.10 and 0.28 6 0.14 in none-trace, mild and moderate-severe post-TAVI AR as defined by echocardiography (P 0.17 corresponded to moderate-severe AR on echocardiography (area under the curve 5 0.84). At follow-up (median, 496 days), patients with LVOT-AR 0.17 showed a significant reduction of LV mass index (LVMi; 121 [95–148] vs. 140 [112– 169] g/m2 , P 5 0.009) and the prevalence of LV hypertrophy (LVH; 64 vs. 88%, P 5 0.001) compared to baseline. In patients with LVOT-AR > 0.17, LVMi (149 [121–178] vs. 166 [144–188] g/m2 , P 5 0.14) and the prevalence of LVH (74 vs. 87%, P 5 0.23) did not show a significant change. Compared to patients with LVOT-AR 0.17, those with LVOT-AR > 0.17 had an increased 30-day (16.4% vs. 7.1%, P 5 0.035) and one year mortality (32.9 vs. 14.2%, log rank P value 5 0.001; HR: 2.690 [1.461–4.953], P 5 0.001). LVOT-AR > 0.17 corresponds to greater than mild AR as defined by echocardiography and predicts impaired LV reverse remodeling and increased early and midterm mortality after TAVI.

The interaction of de novo and pre-existing aortic regurgitation after TAVI: insights from a new quantitative aortographic technique

AIMS: The aim of this study was to evaluate the intermediate-term clinical impact of aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) using a novel quantitative angiographic method taking into account the influence of pre-existing AR.METHODS AND RESULTS:AR after TAVI was quantified in 338 patients (age 82 [78-86] years; 55% male) and the influence on intermediate-term all-cause mortality was evaluated. In 228 aortograms, AR was quantitated using a dedicated videodensitometric method focused in the left ventricular outflow tract (LVOT-AR). Patients with LVOT-AR >0.17 had a significantly increased all-cause mortality at three years, compared with patients who had LVOT-AR ≤0.17 (adjusted hazard ratio [HR]: 1.73, 95% confidence interval [CI]: 1.05-2.86, p=0.032). Taking the influence of pre-existing AR into account, patients with post-procedural LVOT-AR >0.17 and ≤mild pre-existing AR had a significantly increased mortality at two years, compared to patients with LVOT-AR >0.17 and >mild pre-existing AR (HR: 2.55, 95% CI: 1.16-5.58, p=0.029). In those with >mild pre-existing AR (n=70), post-TAVI LVOT-AR >0.17 was not associated with increased mortality (HR: 0.77, 95% CI: 0.31-1.91, p=0.578).CONCLUSIONS:AR after TAVI could be quantitated utilising LVOT-AR. The cut-point of >0.17 indicates a significant AR pertaining to increased intermediate-term mortality, especially in those with no significant pre-existing AR...

Assessment of long-term mortality in patients with complex coronary artery disease undergoing percutaneous intervention: comparison of multiple anatomical and clinical prognostic risk scores

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.

Extensa dissecção coronária espontânea com boa evolução clínica mantida sob tratamento conservador / Extensive spontaneous coronary dissection with favorable evolution maintained under conservative treatment

A dissecção coronária espontânea é uma entidade rara e, por conseguinte, de etiologia, fisiopatologia e tratamento ainda não estabelecidos. Acomete, em geral, mulheres jovens, sem os clássicos fatores de risco cardiovascular, comumente ao longo do ciclo gravídico-puerperal. Vários fatores influenciam na estratégia de tratamento, como quadro clínico, status hemodinâmico, topografia da dissecção, número de artérias afetadas e fluxo coronário distal. Como no caso relatado, em pacientes estáveis, com dissecções bem delimitadas e, sobremodo, quando o fluxo coronário é reestabelecido, pode-se optar por uma abordagem conservadora, em razão da alta incidência de resolução espontânea e da baixa incidência de eventos adversos a longo prazo

Spontaneous coronary dissection is a rare entity and, therefore, its etiology, pathophysiology, and treatment are not yet established. It affects mainly young women without the classic cardiovascular risk factors, commonly during the pregnancy-childbirth cycle. Several factors influence the treatment strategy, such as clinical presentation, hemodynamic status, topography, number of affected arteries, and distal coronary flow. As in the reported case, in stable patients with well-defined dissections and mainly when the coronary flow has been re-established, one can choose a conservative approach, due to the high incidence of spontaneous resolution and low incidence of long-term adverse events

Comparison between MDCT and Grayscale IVUS in a Quantitative Analysis of Coronary Lumen in Segments with or without Atherosclerotic Plaques / Comparação da TCMD e da USIV em escala de cinza na Análise Quantitativa da Luz Coronária em Segmentos com ou sem Placas Ateroscleróticas

Background: The diagnostic accuracy of 64-slice MDCT in comparison with IVUS has been poorly described and is mainly restricted to reports analyzing segments with documented atherosclerotic plaques. Objectives: We compared 64-slice multidetector computed tomography (MDCT) with gray scale intravascular ultrasound (IVUS) for the evaluation of coronary lumen dimensions in the context of a comprehensive analysis, including segments with absent or mild disease. Methods: The 64-slice MDCT was performed within 72 h before the IVUS imaging, which was obtained for at least one coronary, regardless of the presence of luminal stenosis at angiography. A total of 21 patients were included, with 70 imaged vessels (total length 114.6 ± 38.3 mm per patient). A coronary plaque was diagnosed in segments with plaque burden > 40%. Results: At patient, vessel, and segment levels, average lumen area, minimal lumen area, and minimal lumen diameter were highly correlated between IVUS and 64-slice MDCT (p < 0.01). However, 64-slice MDCT tended to underestimate the lumen size with a relatively wide dispersion of the differences. The comparison between 64-slice MDCT and IVUS lumen measurements was not substantially affected by the presence or absence of an underlying plaque. In addition, 64-slice MDCT showed good global accuracy for the detection of IVUS parameters associated with flow-limiting lesions. Conclusions: In a comprehensive, multi-territory, and whole-artery analysis, the assessment of coronary lumen by 64-slice MDCT compared with coronary IVUS showed a good overall diagnostic ability, regardless of the presence or absence of underlying atherosclerotic plaques. .

Fundamento: A comparação do rigor diagnóstico da TCMD e da USIV foi pouco descrita, estando restrita principalmente a estudos que avaliaram segmentos com placas ateroscleróticas já documentadas. Objetivos: Este estudo objetiva avaliar o desempenho diagnóstico da tomografia computadorizada com 64 colunas de detectores (tomografia computadorizada multidetector- TCMD) e da ultrassonografia intravascular (USIV) em escala de cinza na verificação das dimensões da luz coronária, em um contexto mais amplo, incluindo também segmentos coronários sadios e com patologia leve. Métodos: A TCMD foi realizada em todos os pacientes antes da realização da USIV, com um intervalo < 72 horas entre os dois exames. Imagens de USIV foram obtidas de pelo menos uma coronária, independente da presença de estenose luminal durante a angiografia. Um total de 21 pacientes foram incluídos, com imagens de 70 vasos (comprimento total 114,6 ± 38.3 mm por paciente). Placas coronárias foram diagnosticada em segmentos com carga de placas > 40%. Resultados: Uma alta correlação entre as medidas de TCMD e USIV para área luminar média, área luminar mínima e diâmetro luminar mínimo foi encontrada no nível de paciente, vaso e segmento (p-valor < 0,01 para todas as correlações). A TCMD, no entanto, tendeu a subestimar o tamanho luminar com uma dispersão de diferenças relativamente ampla. A comparação entre as medidas da luz por TCMD e USIV não foi substancialmente afetada pela presença ou ausência de placa subjacente. Além disso, a TCMD mostrou boa precisão geral na detecção de parâmetros associados a lesões limitantes de fluxo. Conclusão: Em uma análise compreensiva e multi-focal da luz coronária, demonstramos bom desempenho diagnóstico da TCMD, quando comparada a USIV, independente da presença de placas ateroscleróticas adjacentes. .

Four-year clinical follow-up of the first-in-man randomized comparison of a novel sirolimus eluting stent with abluminal biodegradable polymer and ultra-thin strut cobalt-chromium alloy: the INSPIRON-I trial

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)...

First-in-man randomised comparison of a novel sirolimuselutingstent with abluminal biodegradable polymer and thinstrutcobalt-chromium alloy: INSPIRON-I trial

The INSPIRON-I trial is a first-in-man evaluation of the safety and efficacy of the Inspiron drug-elutingstent, a sirolimus-eluting stent with abluminal biodegradable polymer coating and thin cobalt-chromiumalloy.Methods and results: This is a randomised, multicentre comparison between Inspiron and a stent with thesame metallic structure but without polymer coating or drug elution (Cronus). The primary objective was toevaluate the in-segment late loss (LLL) at six months. Secondary endpoints included percent in-stent obstructionas 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 angiographiccharacteristics of both groups were similar. At six months, the in-segment LLL was reduced in theInspiron group compared to the control group (0.19±0.16 mm vs. 0.58±0.4 mm, respectively; p<0.001), aswell as the percent neointimal obstruction (7.8±7.1% vs. 26.5±11.4%; p<0.001). At two-year follow-up, incidenceof MACE was similar between groups (7.9 vs. 21.1%, respectively; p=0.20), with lower target lesionrevascularisation 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 alloyproved effective in reducing restenosis at six months.