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) formation following implantation of 2 different generations of drug-eluting stents (DES). BACKGROUND: The amount of NIH following DES implantation correlates with the potency of the antiproliferative drug, its kinetic release, as well as some individual characteristics, as the presence of diabetes mellitus (DM). Recently, some publications have suggested a continuous growth of NIH following DES, which in some cases, might result in late "catch-up." METHODS: Twenty-five patients with single, de novo lesions were treated with sirolimus-eluting stents (SES) (n = 12) and biolimus-eluting stents (BES) (n = 13) and underwent intravascular ultrasound evaluation immediately after the procedure and at 9-month and 5-year follow-ups. The primary endpoint was the comparison of the percentage of NIH obstruction between mid- and long-term follow-up. RESULTS: Mean age was 59 years and 28% of patients had DM. Overall, the percentage of NIH obstruction significantly increased from 9 months to 5 years (1.3% at first follow-up vs. 4.8% at second follow-up, p = 0.002). There was no significant difference in the variation of vessel volume (Δ = -0.70 mm(3)/mm BES vs. Δ = 0.18 mm(3)/mm SES, p = 0.56), lumen volume (Δ = 0.40 mm(3)/mm BES vs. Δ = -0.05 mm(3)/mm SES, p = 0.71), and percentage of NIH obstruction (Δ = 3.0% BES vs. Δ = 3.8% SES, p = 0.55) among DES. However, diabetic patients had a marked NIH increase along the years (NIH volume at second follow-up: 10.15 mm(3) DM vs. 5.11 mm(3) non-DM, p = 0.028). CONCLUSIONS: The present serial intravascular ultrasound assessment supports the occurrence of continuous NIH growth following different generations of DES. These findings seem to be particularly more pronounced among patients with DM.

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.

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.