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BACKGROUND: Robotic-assisted percutaneous coronary intervention (PCI) is a novel technology that permits remote operation of interventional devices. However, little is known about the safety and effectiveness of introducing a robotic PCI program in a hospital already experienced in traditional coronary angioplasty. METHODS: Prospective single-arm survey to assess the safety and effectiveness of robotic-assisted PCI in comparison to pre-defined performance goals. The study cohort comprised all consecutive cases treated with robotic PCI since its introduction. The safety primary endpoint was a composite of (I) overall death or (II) non-fatal adverse events related to target vessel complications (stent thrombosis, myocardial infarction, vessel perforation or cardiac tamponade, or repeat invasive treatment) during the index hospitalization. The efficacy primary endpoint was robotic-assisted procedural success, a composite of (I) successful dilatation of the target lesion and (II) successful robotic assistance, defined as absent non-planned manual conversion. RESULTS: A total of 83 patients and 112 lesions were prospectively enrolled. The rate of angiographic success was 99.1%. From these, 97 lesions (86.6%) were treated with only robotic PCI or with hybrid according to the pre-interventional plan. The rates of efficacy and safety primary endpoints were 85.7% and 2.4% respectively (P

Resumo Fundamento A estenose coronária pode ser causada por de novo aterosclerose, reestenose intra-stent e neoaterosclerose intra-stent, três entidades que se desenvolvem a partir de diversos meios fisiopatológicos. Objetivos Este estudo tem como objetivo investigar, por meio da tomografia de coerência óptica (OCT), se as lesões coronarianas relacionadas a esses processos diferem em seu perfil inflamatório local. Métodos Análise retrospectiva de pacientes com lesões coronárias diagnosticadas ou suspeitas que realizaram exames de OCT por motivos clínicos. Macrófagos e neovascularização intraplaca foram avaliados por OCT e utilizados como marcadores de inflamação local. O nível de significância < 0,05 foi adotado como estatisticamente significante. Resultados Das 121 lesões, 74 eram de novo , 29 eram reestenose e 18 eram neoaterosclerose. Neovascularização foi encontrada em 65,8% das de novo , 10,3% na reestenose e 94,4% na neoaterosclerose (p

Coronary stenosis can be caused de novo atherosclerosis, in-stent restenosis, and in-stent neoatherosclerosis, three entities that develop from a diverse pathophysiological milieu.This study aims to investigate, using optical coherence tomography (OCT), whether or not coronary lesions related to these processes differ in their local inflammatory profile.Retrospective analysis of patients with diagnosed or suspected coronary lesions who had undergone OCT imaging for clinical reasons. Macrophage and intra-plaque neovascularization were assessed by OCT and used as surrogates of local inflammation. A significance level of0.05 was adopted as statistically significant.From the 121 lesions, 74 were de novo, 29 were restenosis, and 18 were neoatherosclerosis. Neovascularization was found in 65.8% of de novo, 10.3% in restenosis, and 94.4% in neoatherosclerosis (p0.01 for all). The volume of neovascularization was different among lesion types (950 vs. 0 vs. 6220, respectively [median values in 1000 x µm3/mm]; p0.01 for all), which were significantly higher in neoatherosclerosis and lower in restenosis. The presence of macrophages differed among the lesions (95.9% in de novo vs. 6.9% in restenosis vs. 100% in neoatherosclerosis [p0.01 for all]). Moreover, the intensity of macrophagic infiltration was different among lesion types (2.5 vs. 0.0 vs. 4.5, respectively [median values of macrophage score]; p0.01 for all), significantly higher in neoatheroscleosis and lower in restenosis.When compared using coronary OCT, de novo atherosclerosis, in-stent restenosis, and neoatherosclerosis presented markedly different inflammatory phenotypes.A estenose coronária pode ser causada por de novo aterosclerose, reestenose intra-stent e neoaterosclerose intra-stent, três entidades que se desenvolvem a partir de diversos meios fisiopatológicos.Este estudo tem como objetivo investigar, por meio da tomografia de coerência óptica (OCT), se as lesões coronarianas relacionadas a esses processos diferem em seu perfil inflamatório local.Análise retrospectiva de pacientes com lesões coronárias diagnosticadas ou suspeitas que realizaram exames de OCT por motivos clínicos. Macrófagos e neovascularização intraplaca foram avaliados por OCT e utilizados como marcadores de inflamação local. O nível de significância0,05 foi adotado como estatisticamente significante.Das 121 lesões, 74 eram de novo , 29 eram reestenose e 18 eram neoaterosclerose. Neovascularização foi encontrada em 65,8% das de novo , 10,3% na reestenose e 94,4% na neoaterosclerose (p0,01 para todos). O volume de neovascularização foi diferente entre os tipos de lesão (950 vs. 0 vs. 6.220, respectivamente [valores medianos em 1000 x µm 3 /mm]; p0,01 para todos), sendo significativamente maior na neoaterosclerose e menor na reestenose. A presença de macrófagos diferiu entre as lesões (95,9% em de novo vs. 6,9% em reestenose vs. 100% em neoaterosclerose [p0,01 para todos]). Além disso, a intensidade da infiltração macrofágica foi diferente entre os tipos de lesão (2,5 vs. 0,0 vs. 4,5, respectivamente [valores medianos do escore de macrófagos]; p0,01 para todos), significativamente maior na neoaterosclerose e menor na reestenose.Quando comparados pela OCT coronariana, de novo , reestenose intra-stent e neoaterosclerose apresentaram fenótipos inflamatórios marcadamente diferentes.

Introduction Owing to the ageing of the population, nonagenarian patients are increasingly present in catheterization laboratories, part of them with ST-segment elevation myocardial infarction (STEMI). Primary percutaneous coronary intervention (PCI) is the recommended reperfusion therapy in patients with STEMI, provided it can be performed promptly. However, elderly patients are usually excluded from clinical trials and few data are available about nonagenarians referred for primary PCI. Purpose The aim of the present study was to evaluate clinical characteristics and in-hospital outcomes of nonagenarians STEMI patients undergoing primary PCI. Methods We retrospectively analyzed clinical, angiographic and in-hospital outcomes of death, re-infarction and stroke of primary PCI in nonagenarian STEMI patients, included in the Brazilian PCI Registry (CENIC) between June 2006 and March 2016. Predictors of in-hospital mortality of this population were determined through multivariate analysis. Results Over a period of 10 years, 847 nonagenarians were enrolled in the CENIC Registry, and 252 presented with STEMI and underwent a primary PCI. The population was predominantly female (55.2%), with a median age of 92 years (interquartile range 4 years, maximum of 105 years) and 63.9% in Killip class I at admission. Median door-to-balloon time was 90±60 minutes. Double or triple-vessel disease was found in 63%. It was used 1.3 stent per patient, 8.9% drug-eluting stents. The femoral access route was preferred in 82.1% of patients and glycoprotein IIb/IIIa inhibitors was given to 9.9%. In-hospital mortality in the period was 10.7% and re-infarction occurred in 0.5%. No cases of stroke have been reported. The only predictor of hospital mortality was Killip class (OR 7.1, 95% CI 2.7–18.5, p Conclusion In a real-world setting, primary PCI in nonagenarian STEMI patients can be performed with good clinical outcomes and acceptable in-hospital mortality rate and must be recommended even in oldest-old age patients. Killip class was the only predictor of in-hospital mortality in this population. Funding Acknowledgement Type of funding source: None

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. 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 tratamento 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.

Percutaneous coronary intervention with drug-eluting balloons has emerged as an adjunctive strategy in the setting of Interventional Cardiology. When compared to drug-eluting stents, drug-eluting balloons offer advantages such as immediate and homogeneous drug release in the arterial wall, absence of polymers that can induce chronic inflammatory reactions, and the potential for using dual antiplatelet therapy for a shorter period of time. Furthermore, in some situations, additional stenting is not desirable, which turns this modality into an interesting option. We report the case of a patient with acute coronary syndrome in whom this intervention was chosen to treat an ostial left anterior descending artery in-stent restenosis.DESCRIPTORS: Coronary restenosis. Percutaneous coronary intervention. Angioplasty, balloon. Paclitaxel.RESUMOEficácia do Balao Farmacológico no Tratamento de Reestenose Intra-Stent em Óstio da Arteria Descendente AnteriorA intervengao coronariana percutanea com balao farmacológico surgiu como estrategia adjunta no cenário da Cardiologia Intervencionista. Em comparagao com o stent farmacológico, o balao farmacológico oferece vantagens, como a liberagao imediata e homogénea do fármaco na parede arterial, a ausencia de polímeros que podem induzir a reagoes inflamatórias crónicas e o potencial de utilizar a dupla anti-agregagao plaquetária por menor tempo. Além disso, em algumas situagoes, nao sao desejáveis implantes adicionais de stents, o que torna essa modalidade uma opgao interessante. Relatamos aqui o caso de uma paciente em síndrome coronariana aguda, em que foi feita a opgao por esse tipo de intervengao em uma reestenose de stent nao farmacológico em óstio de arteria descendente anterior.DESCRITORES: Reestenose coronária. Intervengao coronária percutanea. Angioplastia com balao. Paclitaxel.

The benefit of radial access (RA) compared with femoral access (FA) in reducing vascular complications, access-site, bleeding and adverse cardiac events is already well established, especially in the setting of acute coronary syndromes, and has become recommended access route in this context by

Aneurysms of the sinus of Valsalva are very rare and mostly located in the right coronary sinus. They might course with dyspnea, fatigue, and acute coronary syndromes. We present herein an extremely rare case report of a 61-year-old woman diagnosed with external left main coronary compression by a giant aneurysm of the left sinus of Valsalva, which was successfully managed with percutaneous coronary intervention.

Percutaneous coronary intervention (PCI) treatment is closely related to worse clinical events in diabetic patients. This study aims to evaluate the safety and efficacy clinical performance of a new drug-eluting stent (DES) in this population. Long-term evaluation of comparative results between

Introdução: Avaliamos a segurança e eficácia do uso de protamina, guiada pelo tempo de coagulação ativado, para a remoção imediata do introdutor arterial femoral em pacientes submetidos à intervenção coronária percutânea com heparina não fracionada, com o objetivo de propor um algoritmo para a prática clínica. Métodos: Estudo prospectivo, com pacientes consecutivos, com angina estável ou com síndrome coronariana aguda de baixo ou moderado risco. Comparamos os pacientes com a retirada precoce do introdutor arterial àqueles nos quais o introdutor foi retirado de acordo com o protocolo convencional. A decisão pela remoção precoce ou convencional do introdutor foi deixada a critério do operador. Resultados: O grupo de remoção precoce (n = 149) apresentou menor tempo de manuseio do sítio de punção que o grupo de remoção convencional (58,3 ± 21,4 minutos vs. 355 ± 62,9 minutos; p < 0,01), principalmente devido à redução do tempo até a retirada do introdutor (42,3 ± 21,1 minutos vs. 338,6 ± 61,5 minutos; p < 0,01), sem impacto sobre a duração da compressão femoral (16,0 ± 3,6 minutos vs. 16,4 ± 5,1 minutos; p = 0,49). Não houve trombose hospitalar de stent e nem diferença significativa na incidência de eventos vasculares ou hemorrágicos. A incidência de outras hemorragias, que levaram à hospitalização prolongada, foi menor no grupo de remoção precoce (1,3% vs. 5,1%; p = 0,05). Conclusões: O uso seletivo de uma abordagem, para a remoção imediata do introdutor femoral guiada pelo tempo de coagulação ativado e a administração de protamina, é seguro e eficaz em pacientes submetidos à intervenção coronária percutânea pela via femoral. Introduction: We evaluated the safety and efficacy of protamine administration, guided by activated clotting time, for the immediate femoral arterial sheath removal in patients undergoing percutaneous coronary intervention with unfractionated heparin in order to propose an algorithm for clinical practice. Methods: Prospective study with consecutive patients with stable angina or low-to-moderate risk acute coronary syndrome. We compared patients with an early removal of the arterial sheath to those whose sheath removal was based on a standard protocol. Results: The early removal group (n = 149) had lower access manipulation time than the conventional group (58.3 ± 21.4 minutes vs. 355.0 ± 62.9 minutes; p < 0.01), mainly due to a reduced time to sheath removal (42.3 ± 21.1 minutes vs. 338.6 ± 61.5 minutes; p < 0.01), with no impact on the duration of femoral compression (16.0 ± 3.6 minutes vs. 16.4 ± 5.1 minutes; p = 0.49). There was no stent thrombosis during hospitalization and no significant differences in the incidence of major vascular or bleeding events. The incidence of other bleeding events leading to a prolonged in-hospital length of stay was lower in the early removal group (1.3% vs. 5.1%; p = 0.05). Conclusions: The selective use of an approach for immediate femoral sheath removal, based on activated clotting time guidance and protamine administration, is a safe and effective option in patients undergoing percutaneous coronary intervention by femoral access.

The new Inspiron™ (Scitech, Brazil) is a thin-strut (75 μm) cobalt-chromium stent, abluminally coated with a thin (4.4 μg) PLA-PLGA polymeric layer, eluted with low-dose sirolimus. The present study aims to evaluate the safety and efficacy profile of the novel drug-eluting-stent in a very high