The Role of Quantitative Aortographic Assessment of Aortic Regurgitation by Videodensitometry in the Guidance of Transcatheter Aortic Valve Implantation / Papel da Avaliação Aortográfica Quantitativa da Regurgitação Aórtica por Videodensitometria na Orientação do Implante da Valva Aórtica Transcateter

Abstract Background: Balloon post-dilatation (BPD) is often needed for optimizing transcatheter heart valve (THV) implantation, since paravalvular leak (PVL) after transcatheter aortic valve implantation is associated with poor outcome and mortality. Quantitative assessment of PVL severity before and after BPD is mandatory to properly assess PVL, thus improving implantation results and outcomes. Objective: To investigate a quantitative angiographic assessment of aortic regurgitation (AR) by videodensitometry before and after BPD. Methods: Videodensitometric-AR assessments (VD-AR) before and after BPD were analysed in 61 cases. Results: VD-AR decreased significantly from 24.0[18.0-30.5]% to 12.0[5.5-19.0]% (p < 0.001, a two-tailed p < 0.05 defined the statistical significance). The relative delta of VD-AR after BPD ranged from -100% (improvement) to +40% (deterioration) and its median value was -46.2%. The frequency of improvement, no change, and deterioration were 70% (n = 43), 25% (n = 15) and 5% (n = 3), respectively. Significant AR (VD-AR > 17%) was observed in 47 patients (77%) before and in 19 patients (31%) after BPD. Conclusions: VD-AR after THV implantation provides a quantitative assessment of post-TAVI regurgitation and can help in the decision-making process on performing BPD and in determining its efficacy.

Resumo Fundamento: A pós-dilatação com balão (PDB) é normalmente necessária para otimização do implante da válvula cardíaca transcateter (THV), uma vez que o "escape" ou leak paravalvar (PVL) após implante de valva aórtica transcateter está associada com desfecho ruim e mortalidade. A avaliação quantitativa da gravidade do PVL antes e após a PDB é mandatória para se avaliar adequadamente o PVL e, assim, melhorar os resultados e os desfechos do implante. Objetivo: Investigar uma avalição angiográfica quantitativa da regurgitação aórtica (RA) por videodensitometria (VD-RA) antes e após a PDB. Métodos: Resultados da VD-RA antes e após a PDB foram analisados em 61 casos. Resultados Houve diminuição significativa da VD-RA de 24,0(18,0-30,5)% para 12,0(5,5-19,0)% (p < 0,001; p < 0,05 bilateral foi definido como significância estatística). O delta relativo de VD-RA após a PDB variou de -100% (melhora) a +40% (piora) e o valor mediano foi -46,2%. As frequências de melhora, ausência de mudança, e piora foram 70% (n = 43), 25% (n = 15) e 5% (n = 3), respectivamente. Observou-se RA significativo (VD-RA > 17%) em 47 pacientes (77%) antes e em 19 pacientes (31%) após a PDB. Conclusões: A VD-RA após o implante de THV possibilita a avaliação quantitativa da regurgitação pós-TAVI, e pode auxiliar na tomada de decisão quanto à realização ou não da PDB, bem como na avaliação de sua eficácia.

Hemodynamic analysis of a novel bioresorbable scaffold in porcine coronary artery model

BACKGROUND: The shear stress distribution assessment can provide useful insights for the hemodynamic performance of the implanted stent/scaffold. Our aim was to investigate the effect of a novel bioresorbable scaffold, Mirage on local hemodynamics in animal models. METHOD: The main epicardial coronary arteries of 7 healthy mini-pigs were implanted with 11 Mirage Microfiber sirolimus-eluting Bioresorbable Scaffolds (MMSES). Optical coherence tomography (OCT) was performed post scaffold implantation and the obtained images were fused with angiographic data to reconstruct the coronary artery anatomy. Blood flow simulation was performed and Endothelial Shear Stress (ESS) distribution was estimated for each of the 11 scaffolds. ESS data were extracted in each circumferential 5-degree subunit of each cross-section in the scaffolded segment. The generalized linear mixed-effect analysis was implemented for the comparison of ESS in two scaffold groups; 150-mm strut thickness MMSES and 125-mm strut thickness MMSES. RESULTS: ESS was significantly higher in MMSES (150 mm) [0.85(0.49­1.40) Pa], compared to MMSES (125 mm) [0.68(0.35­1.18) Pa]. Both MMSES (150 mm) and MMSES (125 mm) revealed low recirculation zone percentages per luminal surface area [3.17% 6 1.97% in MMSES (150 mm), 2.71% 6 1.32% in MMSES (125 mm)]. CONCLUSION: Thinner strut Mirage scaffolds induced lower shear stress due to the small size vessels treated as compared to the thick strut version of the Mirage which was implanted in relatively bigger size vessels. Vessel size should be taken into account in planning BRS implantation. Small vessels may not get benefit from BRS implantation even with a streamlined strut profile. This pilot study warrants comparative assessment with commercially available bioresorbable scaffolds.

Pressure-mediated versus pharmacologic treatment of radial artery spasm during cardiac catheterisation: a randomised pilot study

AIMS: The aim of the study was to determine the effectiveness of a novel strategy to treat radial artery spasm (RAS). METHODS AND RESULTS: We conducted a prospective, randomised, single-centre, open-label trial comparing a novel strategy of pressure-mediated dilatation versus intra-arterial administration of a combination of nitroglycerine plus verapamil for the treatment of RAS. The primary endpoint was radial artery intraluminal diameter acute gain assessed by quantitative radial angiography. After screening two hundred and twenty consecutive cases, twenty patients presented with RAS and were randomised 1:1 to either strategy. Overall the mean age was 60.8±11.5 years and 53% were females. Pre-treatment angiographic characteristics were similar between the groups. The primary endpoint of radial artery acute gain was significantly greater in the pressure-mediated dilatation group (0.85±0.46 mm vs. 0.03±0.24 mm, p<0.001). Blood pressure drop was significantly lower in the pressure-mediated dilatation group (ΔBP -3.8±24 vs. -31.6±19 mmHg, p<0.001). There was one case of radial artery occlusion in the pressure-mediated dilatation group at follow-up. Short-duration pain was observed during the application of pressure. CONCLUSIONS: Pressure-mediated dilatation for the treatment of RAS was feasible, with superior angiographic results compared to a pharmacologic vasodilator strategy, with no impact on blood pressure. This novel approach proved to be safe and effective and should be tested in a large randomised trial...

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...

Relação Balão/Artéria e Volume de Obstrução Neontimal Após Implante de Stent Eluidor de Zotarolimus / Balloon/Artery Ratio and Neointimal Hyperplasia Volume Obstruction After Zotarolimus-Eluting Stent Implantation

Introdução: O volume de hiperplasia intimal correlaciona-se com a injúria arterial após implante de stents não farmacológicos. No entanto, pouco se sabe a respeito do impacto da injúria arterial na resposta inflamatória/proliferativa com os stents farmacológicos. Investigamos o impacto da injúria arterial, avaliada pela relação balão/artéria, no volume de obstrução neontimal, avaliado pelo ultrassom intracoronário 12 meses após o implante de stents farmacológicos com eluição de zotarolimus. Métodos: A relação balão/artéria foi definida como a razão do diâmetro máximo do balão, obtido no implante ou na pós-dilatação, e o diâmetro de referência do vaso pré-procedimento. Os pacientes foram categorizados em dois grupos: relação balão/artéria alta (≥ 1,15) e relação balão/artéria baixa (< 1,15). Resultados: Foram incluídos 86 pacientes, nos grupos relação balão/artéria baixa (n = 47/48 lesões) ou relação balão/artéria alta (n = 39/48 lesões). As características clínicas, angiográficas e do procedimento não diferiram entre os grupos, à exceção do diâmetro de referência dos vasos (2,73 ± 0,45 mm vs. 2,97 ± 0,40 mm; p = 0,01). Aos 12 meses, observou-se semelhante perda tardia intra-stent (0,59 ± 0,32 mm vs. 0,62 ± ...

Background: Intimal hyperplasia volume is correlated to arterial injury after bare-metal stenting. However, little is known about the impact of arterial injury on the inflammatory/ proliferative response with drug-eluting stents. We investigated the impact of arterial injury, evaluated by the balloon/artery ratio, on neointimal hyperplasia volume obstruction, evaluated by intravascular ultrasound, 12 months after zotarolimus-eluting stent implantation. Methods: Balloon/ artery ratio was defined as the ratio of the maximum balloon diameter, using the maximal implantation or post-dilatation pressure, and the reference diameter of the vessel obtained before the procedure. Patients were divided into two groups: high balloon/artery ratio (≥ 1.15) and low balloon/artery ratio (< 1.15). Results: A total of 86 patients were included in the low balloon/artery ratio group (n = 47/48 lesions) or high balloon/artery ratio (n = 39/48 lesions). The clinical, angiographic and procedurerelated characteristics were not different between groups, except for the vessel reference diameter (2.73 ± 0.45 mm vs. 2.97 ± 0.40 mm; p = 0.01). At 12 months, similar in-stent late loss was observed (0.59 ± 0.32 mm vs. 0.62 ± 0.42 mm; p = 0.92), as well as binary restenosis (4.2% in both cohorts; p > 0.99). Instent neointimal hyperplasia volume obstruction (15.2 ± 14.3% vs. 12.5 ± 10.1%; p = 0.62) showed no difference between groups. No correlation was observed between balloon/artery ratio ...

Denervação simpática renal para o controle da hipertensão arterial resistente / Renal sympathetic denervation for treatment of resistant hypertension

INTRODUÇÃO: A hipertensão arterial sistêmica afeta mais de 1,2 milhão de pessoas no mundo. Apenas 35% dos pacientes hipertensos têm valores de pressão arterial controlados. Recentemente a denervação simpática renal (DSR) tem demonstrado diminuir significativamente os valores de pressão arterial nos pacientes com hipertensão arterial sistêmica resistente. MÉTODOS: Estudo prospectivo, de braço único, observacional, multicêntrico, incluindo pacientes consecutivos submetidos a DSR. O objetivo primário foi avaliar os níveis da pressão arterial sistólica aos 30 dias de seguimento. O objetivo secundário foi determinar a ocorrência de qualquer evento adverso relacionado com o procedimento. RESULTADOS: Foram incluídos os primeiros 20 pacientes submetidos a DSR. A média de pressão arterial antes do procedimento foi de 171,6/93,2 ± 15,5/11,3 mmHg, com média de uso de 4,1 ± 1,5 fármacos anti-hipertensivos por paciente. A taxa de sucesso foi de 95%, tendo sido aplicadas 11,1 ± 1,9 ablações por paciente. Foi observada diminuição média de 29 ± 21 mmHg (P = 0,009) na pressão arterial sistólica 30 dias após o procedimento. Não houve complicação associada ao procedimento. CONCLUSÕES: A DSR por cateter em pacientes da prática clínica diária diminuiu significativamente os valores de pressão arterial. Em nossa experiência, a DSR demonstrou ser factível e segura.

BACKGROUND: Systemic arterial hypertension affects over 1.2 million people worldwide. Only 35% of hypertensive patients have controlled blood pressure levels. Renal sympathetic denervation (RSD) has shown to significantly decrease blood pressure levels in patients with resistant systemic hypertension. METHODS: Prospective, single arm, observational, multicenter study including consecutive patients undergoing RSD. The primary endpoint was to assess systolic blood pressure levels at the 30-day follow-up. The secondary endpoint was to determine the presence of procedure-related adverse events. RESULTS: The first 20 patients undergoing RSD were included. The average blood pressure prior the procedure was 171.6/93.2 ± 15.5/ 11.3 mmHg, with the use of 4.1 ± 1.5 antihypertensive drugs per patient. Success rate was 95%, and 11.1 ± 1.9 ablations were performed per patient. A systolic blood pressure decrease of 29 ± 21 mmHg (P = 0.009) was observed 30 days after the procedure. There were no procedure-related complications. CONCLUSIONS: Catheter-based RSD in daily clinical practice patients significantly decreased blood pressure levels. In our experience, RSD proved to be feasible and safe.

Avaliação do recolhimento elástico tardio de stents farmacológicos de primeira e segunda gerações / Evaluation of the late stent recoil of first and second generation drug-eluting stents

Introdução: A expansão radial e a sustentação da parede do vaso pelos stents melhoraram os resultados da angioplastia coronária por balão. Entre as características dos stents mais contemporâneos destacam-se a redução da espessura de suas hastes e plataformas com novos desenhos, mas não está claro se essas modificações podem resultar em próteses de menor força radial e suscetíveis a recolhimento elástico, especialmente em evoluções muito tardias. Este estudo teve como objetivo investigar se ocorre recolhimento elástico tardio em duas gerações de stents farmacológicos (SFs) em avaliação por ultrassom intracoronário (USIC) seriado a longo prazo. Métodos: O estudo avaliou 25 pacientes com lesões coronárias únicas, de novo, tratados com SFs (12 CypherTM e 13 BioMatrixTM) e submetidos a USIC pós-procedimento e 4-6 meses e 4-5 anos após o implante. Foram comparados os volumes dos stents no período compreendido entre o procedimento índice e os reestudos de médio e longo prazos. O recolhimento elástico do stent foi definido como diminuição > 10% do volume índice do stent. Resultados: A maioria dos pacientes era do sexo masculino (52%), com média de idade de 58,8 ± 7,6 anos, e 28% eram diabéticos. O volume do stent índice, objetivo primário deste estudo, foi de 7,7 ± 1,5 mm3/mm no pós-procedimento, de 7,7 ± 2,1 mm3/mm aos 4-6 meses, e de 7,8 ± 1,6 mm3/mm aos 4-5 anos, com variação tardia de -0,02 ± 1,6 mm3/mm (P = 0,97). A variação a longo prazo do volume do stent índice foi de 0,13 ± 1,8 mm3/mm (1,7%) para o stent CypherTM e de -0,05 ± 1,3 mm3/mm (-0,6%) para o stent BioMatrixTM (P = 0,78). Conclusões: A avaliação invasiva seriada por meio do USIC mostrou que SFs de aço inoxidável, de diferentes gerações, não demonstraram evidência de recolhimento elástico a longo prazo.

BACKGROUND: Radial expansion and vessel wall scaffolding properties of stainless steel stents have improved the outcomes of coronary balloon angioplasty. Thinner struts and new platform designs are characteristic of more contemporaneous stents, but it is not clear whether these changes may result in devices with less radial strength, susceptible to elastic recoil, especially in the very late follow-up. This study was aimed at assessing late stent recoil in two generations of drug-eluting stents (DES) using serial intravascular ultrasound (IVUS) analysis. METHODS: Twenty-five patients with single de novo coronary lesions, treated with DES (12 CypherTM and 13 BioMatrixTM), were included and serial IVUS analysis was performed after stent implantation and at 4-6-months and 4-5 years of follow-up. Stent volume index was compared between the procedure and the mid and long-term follow-ups. Stent recoil was defined as a decrease > 10% of the stent volume index. RESULTS: Most of the patients were male (52%), with mean age of 58.8 ± 7.6 years, and 28% were diabetic. Stent volume index, the primary objective of this study, was 7.7 ± 1.5 mm³/mm post-procedure, 7.7 ± 2.1 mm³/mm at 4-6 months and 7.8 ± 1.6 mm³/mm at 4-5 years, with a delta of -0.02 ± 1.6 mm³/mm (P = 0.97). The long-term delta stent volume index was 0.13 ± 1.8 mm³/mm (1.7%) for the CypherTM stent and -0.05 ± 1.3 mm³/mm (-0.6%) for the BioMatrixTM stent (P = 0.78). CONCLUSIONS: Serial IVUS analysis showed that stainless steel DES of different generations did not show evidence of long-term elastic recoil.

Stents farmacológicos vs. stents não-farmacológicos no tratamento de enxertos de veia safena / Drug-eluting stents vs. bare-netal stents in saphenous vein graft lesions

Introdução: Embora os stents farmacológicos tenham reduzido acentuadamente a reestenose e a necessidade de novas revascularizações na maioria dos cenários clínicos e angiográficos, o benefício desses dispositivos no tratamento de lesões em enxertos de veia safena (EVS) ainda precisa ser definido. O objetivo deste estudo foi comparar a incidência de eventos cardíacos adversos maiores (ECAM) entre stents farmacológicos e stents não-farmacológicos em lesões em EVS em pacientes não-selecionados. Métodos: Foram incluídos pacientes tratados em dois hospitais terciáriosentre maio de 2006 e janeiro de 2009. O objetivo primário foi comparar a incidência de ECAM entre stents farmacológicos e stents não-farmacológicos durante a hospitalizaçãoe no seguimento a longo prazo. Resultados: No total, foram incluídos, consecutivamente, 308 pacientes, divididos de acordo com o tipo de stent implantado (209 com stents farmacológicos e 99 com stents não-farmacológicos). A média de idade do grupo foi de 68 anos e a dos EVS, de 10,9 anos. Na fase intra-hospitalar, houve tendência para maior incidência de ECAM no grupo que recebeu stents farmacológicos (12% vs. 5,1%; P = 0,06). Até 24 meses, a incidência de ECAM foi equivalente nos dois grupos (17,2% nogrupo stents farmacológicos vs. 18,2% no grupo stents não-farmacológicos; P = 0,87). Trombose do stent definitiva/provável foi semelhante em ambos os grupos (2,3% no grupo stents farmacológicos vs. 2% no grupo stentsnão-farmacológicos; P = 0,94). Conclusões: Nesta série de pacientes complexos do mundo real, não houve preocupação com a segurança a longo prazo relacionada ao uso de stents farmacológicos no tratamento de lesões em EVS, com incidências similares de morte cardíaca/infarto do miocárdio/trombose do stent em ambos os grupos.

Background: Although drug-eluting stents have markedly reduced restenosis and the need for repeat lesion revascularization in the vast majority of clinical and angiographic scenarios, the benefit of these devices for the treatment of saphenous-vein graft (SVG) lesions is yet to be defined. The aim of our study was to compare the rate of major adverse clinical events (MACE) between drug-eluting stentsand bare-metal stents in SVG lesions in non-selected patients. Methods: Patients treated in two tertiary hospitals betweenMay 2006 and January 2009 were included. The primary objective was to compare the incidence of MACE betweendrug-eluting stents and bare-metal stents during hospitalization and in the long-term follow-up. Results: Overall, 308 patients were consecutively enrolled and divided according to the type of stent deployed (209 with drug-eluting stents and 99 with bare-metal stents). Mean age was 68 years and SVG mean age was 10.9 years. In the in-hospital phase there was a trend towards higher MACE in the drug-eluting stents group (12% vs. 5.1%; P = 0.06). The incidence of MACE in up to 24 months was equivalent between groups (17.2%for the drug-eluting stents group vs. 18.2% for the baremetal stents group; P = 0.87). Definite/probable stent thrombosis was similar in both groups (2.3% for the drug-eluting stents group vs. 2% for bare-metal stents group; P = 0.94). Conclusions: In this real world series of complex patients there was no long-term safety concerns related to the use of drug-eluting stents in the treatment of SVG lesions, with similar rates of cardiac death/myocardial infarction/stent thrombosis in both groups.

Dedicated bifurcation analysis: dedicated devices

Percutaneous treatment of bifurcationswith conventional (straight) stents has been associated with complex procedures and poor clinicaloutcomes. Also, several limitations including side branch ostial gap, excessive metal density in theparent vessel, incomplete stent apposition, and stent distortion/disruption have been reported with current techniques. Dedicated bifurcation stents have beendesigned to simplify the procedure, even in complex and challenging anatomies, and to improve acute and late outcomes. The application of conventionalquantitative coronary angiography (QCA) analysis, originally designed for straight vessel analysis, in thebifurcation anatomy has resulted in inconsistent results. Also, the lack of standardized QCA method for reporting has precluded the possibility for accuratecomparison between clinical trials and different techniques and devices. We review QCA results of dedicated bifurcation devices reported according new dedicated QCA segmental analysis.

Assessing the temporal course of neointimal hyperplasia formation after different generations of drug-eluting stents

Objectives This study sought to assess the temporal course of neointimal hyperplasia (NIH) formationfollowing implantation of 2 different generations of drug-eluting stents (DES).Background The amount of NIH following DES implantation correlates with the potency of the antiproliferativedrug, its kinetic release, as well as some individual characteristics, as the presence ofdiabetes mellitus (DM). Recently, some publications have suggested a continuous growth of NIH followingDES, which in some cases, might result in late “catch-up.”Methods Twenty-five patients with single, de novo lesions were treated with sirolimus-elutingstents (SES) (n 12) and biolimus-eluting stents (BES) (n 13) and underwent intravascular ultrasoundevaluation immediately after the procedure and at 9-month and 5-year follow-ups. The primaryendpoint was the comparison of the percentage of NIH obstruction between mid- and longtermfollow-up.Results Mean age was 59 years and 28% of patients had DM. Overall, the percentage of NIH obstructionsignificantly increased from 9 months to 5 years (1.3% at first follow-up vs. 4.8% at secondfollow-up, p 0.002). There was no significant difference in the variation of vessel volume (Ä 0.70 mm3/mm BES vs. Ä 0.18 mm3/mm SES, p 0.56), lumen volume (Ä 0.40 mm3/mm BESvs. Ä 0.05 mm3/mm SES, p 0.71), and percentage of NIH obstruction (Ä 3.0% BES vs. Ä 3.8% SES, p 0.55) among DES. However, diabetic patients had a marked NIH increase along theyears (NIH volume at second follow-up: 10.15 mm3 DM vs. 5.11 mm3 non-DM, p 0.028).Conclusions The present serial intravascular ultrasound assessment supports the occurrence of continuousNIH growth following different generations of DES. These findings seem to be particularlymore pronounced among patients with DM.

Tratamento de reestenose intrastent com o novo stent farmacológico firebird TM, limerador de sirolimus - Resultados angiográficos e ultrassonográficos de um ano de evolução / Treatment of in-stent restenosis with the new firebird TM sirolimus eluting stent - One year angiographic and intravascular ultrasound follow-up results

Introdução: A reestenose intrastent (RIS), resultante da excessiva resposta reparadora neointimal após o implante da prótese, é uma das principais limitações da intervenção coronária percutânea. A despeito da eficácia dos stents farmacológicos (SF) de primeira geração no tratamento da RIS, questões relacionadas à segurança e ao perfil de flexibilidade/navegabilidade dessas próteses estimularam o desenvolvimento de novas gerações de SF. O novo SF Firebird TM (Microport Co. Ltd., Xangai, China) combina uma plataforma de aço inoxidável (316 L) de hastes finas (0,0040 polegada), um potente agente antiproliferativo (sirolimus, na dose de 9 ug/mm2) e um revestimento que inclui três camadas de polímero durável, que controla a liberação do fármaco. Apesar de ser um dos SF mais utilizados na China, pouco se conhece sobre seu desempenho, sobretudo em subgrupos de maior complexidade. Método: Entre fevereiro e dezembro de 2009, pacientes portadores de lesão reestenótica única, de stents não-farmacológicos, foram submetidos a intervenão coronária percutânea com implante de stent Firebird TM. Avaliação com angiografia ultrassom intracoronário (USIC) foi programada para todos os pacientes...

BACKGROUND: In-stent restenosis (ISR), resulting from excessive neointimal hyperplasia, is a major limitation of percutaneous coronary intervention. Despite the efficacy of first generation drug-eluting stents (DES) in the treatment of ISR, issues related to the safety and flexibility/navigability profile have encouraged the development of new generations of DES. The new FirebirdTM DES (Microport Co. Ltd., Shanghai, China) combines a stainless steel platform (L316) of fine struts (0,0040'), a powerful anti-proliferative agent (sirolimus, at a dose of 9 µg/mm²) and a coating that includes three layers of a durable polymer, which controls drug release. Though it is a most used DES in China, little is known about its performance, particularly in subgroups of greater complexity. METHOD: Between February and December 2009, patients with single bare metal stent restenotic lesions, were submitted to percutaneous coronary intervention with FirebirdTM stent implantation. Angiography and intravascular ultrasound (IVUS) were scheduled for all patients at 12 months of follow-up. The primary end-point was late loss and the percentage of in-stent volumetric obstruction at 12 months. RESULTS: Twenty-five patients with mean age of 56.8 ± 7.7 years were included, of which 80% were males and 40% diabetics. The anterior descending artery was the most frequently treated vessel (44%) and most lesions had a diffuse/proliferative pattern (64%). At 12 months, late luminal loss was 0.3 ± 0.24 mm, and no case of binary restenosis was identified. IVUS percent volumetric obstruction was 2.6 ± 1.9%. CONCLUSION: In this single center study, the new FirebirdTM DES showed favorable angiographic and IVUS results for the treatment of bare metal ISR at the one year follow-up.

Stent com liberação de everolimus vs. stent com liberação de zotarolimus na prática clínica do mundo real / Everolimus-eluting stents versus zotarolimus-eluting stent in the real word clinical practice

INTRODUÇÃO: Os stents com liberação de fármacos antiproliferativos (SF) têm demonstrado sua eficácia nos mais variados cenários. Entretanto, preocupações recentes com a maior ocorrência de trombose muito tardia com a primeira geração de SF, possivelmente associda a reendotelização retardada ou incompleta, impulsionaram o desenvolvimento de dispositivos mais eficazes e seguros. Método: Estudo retrospectivo, de centro único, incluindo pacientes submetidos a intervenção coronária percutânea entre janeiro de 2006 e dezembro de 2008, tratados com SF com liberação de everolimus (everolimus-eluting stent - EES) (Xience V TM/Promus TM) e com SF com liberação de zotarolimus (zotarolimus-eluting stent - ZES) (Endeavor TM). O objetivo principal foi comparar a taxa de eventos cardíacos maiores no seguimento de 12 meses entre os pacientes dos grupos EES e ZES. Resultados: No total, 198 pacientes com 266 lesões foram incluídos nesta análise. A média de idade foi de 60 + - 10 anos e 39 por cento tinham diabetes melito, sem diferenças entre os grupos. O diâmetro de referência (2,3 + - 0,5 mm vs. 2,38 + - 0,2 mm; P=0,14) e a extensão da lesão (16,3 + - 9,4 mm vs. 16,1 + - 11,3 mm; P = 0,89) também não diferiram entre os grupos. Após 12 meses de seguimento, a taxa de eventos...

BACKGROUND: The use of drug-eluting stents (DES) has proven to be effective in different angiographic scenarios. However, recent concerns with the occurrence of very late stent thrombosis with the first DES generation, probably related to delayed or incomplete endothelization, have led to the development of new safer and more effective devices. METHOD: Retrospective, single center study, including patients undergoing percutaneous coronary intervention between January 2006 and December 2008, treated with everolimuseluting stent (EES) (Xience V TM/PromusTM) and zotarolimuseluting stent (ZES) (EndeavorTM). Our objective was to compare the rates of major adverse cardiac events between EES and ZES patients after 12 months of follow-up. RESULTS: Overall, 198 patients with 266 lesions were included in the study. Mean age was 60 ± 10 years and 39% had diabetes mellitus, without significant differences between groups. The reference diameter (2.3 ± 0.5 mm vs. 2.38 ± 0.2 mm; P = 0.14), as well as lesion length (16.3 ± 9.4 mm vs. 16.1 ± 11.3 mm; P = 0.89), were also not significantly different between groups. After 12 months of follow-up, the rate of major adverse cardiac events was 8.16% in the EES group vs. 8% in the ZES group (P = 0.96), with a global rate of target-lesion revascularization of 2% (1% EES and 3% ZES; P = 0.32). There were no cases of definite stent thrombosis. CONCLUSION: In this study of non-selected patients, the rates of major adverse cardiac events were similar between patients treated in the EES and ZES groups, with low target-lesion revascularization rates and excellent safety profile after 12 months of follow-up.