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BACKGROUND. Despite the potential benefits of percutaneous procedures for the assessment and treatment of coronary artery disease, these interventions require the use of iodine contrast, which might lead to contrast-induced nephropathy (CIN) and increased risk of dialysis and major adverse cardiac events (MACE). Aims. We sought to compare two different iodine contrasts (low vs. iso-osmolar) for the prevention of CIN among high-risk patients. METHODS. This is a single-center, randomized (1:1) trial comparing consecutive patients at high risk for CIN referred to percutaneous coronary diagnostic and/or therapeutic procedures with low (ioxaglate) vs iso-osmolarity (iodixanol) iodine contrast. High risk was defined by the presence of at least one of the following conditions: age >70 years, diabetes mellitus, non-dialytic chronic kidney disease, chronic heart failure, cardiogenic shock, and acute coronary syndrome (ACS). The primary endpoint was the occurrence of CIN, defined as a >25% relative increase and/or >0.5 mg/dL absolute increase in creatinine (Cr) levels compared with baseline between the 2nd and 5th day after contrast media administration. RESULTS. A total of 2268 patients were enrolled. Mean age was 67 years. Diabetes mellitus (53%), non-dialytic chronic kidney disease (31%), and ACS (39%) were highly prevalent. The mean volume of contrast media was 89 ml ± 48.6. CIN occurred in 15% of all patients, with no significant difference regarding the type of contrast used (iso = 15.2% vs low = 15.1%, P>.99). Differences were not observed in specific subgroups such as diabetics, elderly, and ACS patients. At 30-day follow-up, 13 patients in the iso-osmolarity group and 11 in low-osmolarity group required dialysis (P=.8). There were 37 (3.3%) deaths in the iso-osmolarity cohort vs 29 (2.6%) in the low-osmolarity group (P=.4). CONCLUSION. Among patients at high risk for CIN, the incidence of this complication was 15%, and independent of the use of low- or iso-osmolar contrast.

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FUNDAMENTOS: Estudos prévios demonstram que o principal determinante de vulnerabilidade da placa aterosclerótica é a sua composição. Recentemente, diversos métodos de imagens e marcadores laboratoriais têm sido investigados visando identificar lesões vulneráveis. O ultrassom com Histologia Virtual® (HV) permite a diferenciação e quantificação dos componentes da placa. Por sua vez, a proteína C-reativa (PCR) é apontada como importante preditor de eventos adversos. A correlação entre este marcador e as características da placa não é bem estabelecida. OBJETIVOS: Avaliar a constituição da lesão culpada em pacientes com síndrome coronária aguda (SCA) - conforme caracterizada pela HV - e investigar a relação dos componentes da placa com o marcador inflamatório PCR. MÉTODOS: Cinquenta e dois pacientes com SCA e com indicação de intervenção coronária percutânea foram submetidos a dosagens de PCR de alta sensibilidade antes e 24 horas após a ICP. Análise por ultrassom HV da lesão-alvo foi realizada antes da ICP. RESULTADOS: A média de idade foi de 55,3 ± 4,9 anos, sendo 76,9% homens, 67,3% hipertensos e 30,8% diabéticos. A área luminal mínima foi de 3,9 ± 1,3 mm², e a carga de placa de 69 ± 11,3%. Os componentes da placa foram assim identificados: fibrótico (59,6 ± 15,8%), fibrolipídico (7,6 ± 8,2%), cálcio (12,1 ± 9,2%), necrótico (20,7 ± 12,7%). Não observamos correlação entre os níveis basais de PCR ou a variação dentre os valores pré e pós-ICP com os componentes da placa. CONCLUSÃO: Neste estudo, a composição das placas pela HV foi predominantemente fibrótica, com alto conteúdo necrótico. Não foi encontrada correlação entre a PCR e os componentes da lesão culpada em pacientes com SCA.

BACKGROUND: Previous studies have shown that coronary plaque composition plays a pivotal role in plaque instability, and imaging modalities and serum biomarkers have been investigated to identify vulnerable plaque. Virtual histology IVUS (VH-IVUS) characterizes plaque components as calcified, fibrotic, fibrofatty, or necrotic core. C-reactive protein (hsCRP) is an independent risk factor and a powerful predictor of future coronary events. However, a relationship between inflammatory response indicated by CRP and plaque characteristics in ACS patients remains not well established. OBJECTIVE: To determine, by using VH-IVUS, the relation between coronary plaque components and plasma high-sensitivity CRP levels in patients with acute coronary syndromes (ACS). METHODS: 52 patients with ACS were enrolled in this prospective study. Electrocardiographically-gated VH-IVUS were performed in the culprit lesion before PCI. Blood sample was drawn from all patients before the procedure and after 24 hours, and hs-CRP levels were determined. RESULTS: Mean age was 55.3±4.9 years, 76.9% were men and 30.9% had diabetes. Mean MLA was 3.9±1.3 mm², and plaque burden was 69±11.3%, as assessed by IVUS. VH-IVUS analysis at the minimum luminal site identified plaque components: fibrotic (59.6±15.8%), fibrofatty (7.6±8.2%), dense calcium (12.1±9.2%) and necrotic core (20.7±12.7%). Plasma hs-CRP (mean 16.02±18.07 mg/L) did not correlate with necrotic core (r=-0.089, p = 0.53) and other plaque components. CONCLUSIONS: In this prospective study with patients with ACS, the predominant components of the culprit plaque were fibrotic and necrotic core. Serum hs C-reactive protein levels did not correlate with plaque composition.

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BACKGROUND: Previous studies have shown that coronary plaque composition plays a pivotal role in plaque instability, and imaging modalities and serum biomarkers have been investigated to identify vulnerable plaque. Virtual histology IVUS (VH-IVUS) characterizes plaque components as calcified, fibrotic, fibrofatty, or necrotic core. C-reactive protein (hsCRP) is an independent risk factor and a powerful predictor of future coronary events. However, a relationship between inflammatory response indicated by CRP and plaque characteristics in ACS patients remains not well established. OBJECTIVE: To determine, by using VH-IVUS, the relation between coronary plaque components and plasma high-sensitivity CRP levels in patients with acute coronary syndromes (ACS). METHODS: 52 patients with ACS were enrolled in this prospective study. Electrocardiographically-gated VH-IVUS were performed in the culprit lesion before PCI. Blood sample was drawn from all patients before the procedure and after 24 hours, and hs-CRP levels were determined. RESULTS: Mean age was 55.3±4.9 years, 76.9% were men and 30.9% had diabetes. Mean MLA was 3.9±1.3 mm², and plaque burden was 69±11.3%, as assessed by IVUS. VH-IVUS analysis at the minimum luminal site identified plaque components: fibrotic (59.6±15.8%), fibrofatty (7.6±8.2%), dense calcium (12.1±9.2%) and necrotic core (20.7±12.7%). Plasma hs-CRP (mean 16.02±18.07 mg/L) did not correlate with necrotic core (r=-0.089, p = 0.53) and other plaque components. CONCLUSIONS: In this prospective study with patients with ACS, the predominant components of the culprit plaque were fibrotic and necrotic core. Serum hs C-reactive protein levels did not correlate with plaque composition.

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The newly developed balloon-expandable Mguard stent system, a combination of an ultra-thin polymer mesh sleeve attached to the external surface of a BMS, was conceived to provide embolic protection during PCI of SVG and thrombus-containig lesions. Although the acute results (<30 days) have pointed to the efficacy of this noveldevice, few is known about its long-term performance. Methods: The present article address the 1-year clinical results of a cohort of 30 patients enrolled in the INSPIRE trial. Inclusion critiria was de novo lesions in SVG or native vessels with angiographic evidence of instability with potential to provoke flow disturbances and/or distal embolization. The primary endpoint (incidence of MACE-composite of cardiac death, nonfatal MI, and TLR) up to 30 days of the procedure has already been published. Secondary endpoints here presented included in-stent late lumen loss (QCA), % of stent obstruction(IVUS) at 6 months and combined MACE at 1 year. QCA and IVUS were performed by independent corelabs. Results: Mean population age was 63 years with 38% of diabetics. Overall, 55% presented with ACS and 57% of lesions were located in SVG. Most lesionshad complex morphology including the presence of thrombus (26%) and ulceration (20%). Distal/proximal protection devices were not used. Preprocedural QCA data showed lesion length and reference vessel diameter of 12.0 6 4.5 mm and 3.0 6 0.5 mm.The MGuard stent was successfully delivered in all cases and final TIMI-3 was achieved in 100% with no MACE up to 30 days. At 6 months, in-stent late loss and % of stent obstruction were 1.0 6 0.4 mm and 28.5 6 15.6%. Up to 1 year there was no case of cardiacdeath, two MI (one Q-wave and one non-Q-wave) and six cases of ischemia-driven TLR. Of note, there was no case of definite/probable stent thorombosis. Conclusions: In this series of patients treated with MGuard stent, the novel device showed no midterm efficacy and safety concerns.

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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.

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Despite the expressive reduction in theintimal hyperplasia (IH) formation after DES implantation at the mid-term, late restenosis has been recently noticed. Our objective was to determine, by means of serial angiography (QCA) and intravascular ultrasound (IVUS) at two different time points, whether theoccurrence of the ‘‘late catch-up’’ phenomenon occurs after sirolimus-eluting stent (SES) implantation. Thirtyeight non-complex patients treated with a single 18-mm SES who had systematic serialQCAand IVUSanalyses at mean 8 and 20 months were enrolled. Primary endpoint is to evaluate the temporal course of IHformation after SES implantation, by comparing QCA in-stent late loss and IVUS percent IH obstruction between the invasive follow-ups. Mean cohort age was 59.3 years and 31.6% were diabetics. Baseline reference vessel diameter was 2.8 ± 0.4 mm and lesionlength was 11.5 ± 3.5 mm. Left anterior descending artery was the most frequent target vessel (55.3%). Between 8 and 20 months, a non-significant increase in in-stent late loss from 0.10 ± 0.18 to 0.15 ± 0.30 mm(P = 0.38) was observed. By IVUS, a slight increase in the percent IH obstruction (1.03±2.13 to 1.76±1.87%,P = 0.12) was detected between the two evaluations. Interestingly, all the neoformed tissue accrued from 8 to20 months accumulated in the distal portion of the stent. In the non-complex scenario, SES implantation wasassociated with a minimal, non-significant increase in the IH volume between 8 and 20 months.

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Objectives The aim of this study was to evaluate the novel CardioMind Sparrow (CMS) stent (CardioMind, Inc., Sunnyvale, California) against the Multi-Link Pixel (MLP) stent (Guidant Corp., Santa Clara, California) for small vessel percutaneous coronary intervention (PCI). Background The CMS consists of a guidewire-based, self-expandable, ultra-thin nitinol stent with smaller profile and improved flexibility and deliverability. The performance of this novel device against a standard balloon-expandable stent for small vessel PCI has not been determined. Methods Twenty-one patients were treated with the CMS and compared with 30 patients treated with MLP. Only single de novo lesions 14 mm in length, in native vessels of 2.0 to 2.5 mm wereincluded. The primary goal was the comparison of quantitative coronary angiography lumen loss and intravascular ultrasound intimal hyperplasia (IH) formation between groups at 6 months. Results Clinical characteristics were similar between groups. The CMS cohort had smaller vessels (2.20 0.20 mm vs. 2.43 0.16 mm, p 0.0001) and shorter lesions (10.86 3.19 mm vs. 13.12 2.79 mm, p 0.0091). Six-month late loss was significantly lower among CMS cohort (0.73 0.57 mm vs. 1.11 0.72 mm, p 0.038). By intravascular ultrasound, 6-month IH volume was similar between groups (1.45 0.46 mm3/mm vs. 1.65 1.02 mm3/mm, p 0.50). However, CMS presenteda mean 13.39% expansion of its volumes, resulting in a significantly lower percentage of IH volumetric obstruction (31.94 8.19% vs. 39.90 4.72%, p 0.0005). Conclusions Despite producing similar amounts of IH volume, the self-expanding CMS stent presented chronic expansion of its volumes, better accommodating the neoformed tissue and resultingin significantly lower late loss and percent of IH volumetric obstruction in comparison with the MLPstent.

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Objectives We sought to assess the safety and efficacy of the novel VESTAsync-eluting stent (MIVTherapeutics, Atlanta, Georgia) combining a stainless steel platform with a nanothin-microporoushydroxyapatite surface coating impregnated with a polymer-free low-dose of sirolimus (55 g). Background Durable polymers in first-generation drug-eluting stents (DES) have been linked to local inflammatory reaction leading to a positive vessel remodeling, late incomplete stent apposition,and in some cases, stent thrombosis. The removal of the polymer from the DES system could increase the safety profile of this novel technology.Methods A total of 15 patients with single de novo lesions in native coronary arteries with 3.0- to 3.5-mm diameter and 14-mm length were enrolled in this first-in-man study. Primary end pointwas in-stent late lumen loss (LL) at 4 and 9 months. Results Baseline characteristics included mean age of 63 years and 33% of diabetics. Reference vessel diameter and lesion length were 2.7 0.3 mm and 10 2.0 mm, respectively. Procedure successwas obtained in all cases. Lifelong aspirin and 5-month clopidogrel treatment were prescribed to all patients. At 4 months, in-stent LL and percentage of neointimal hyperplasia were 0.3 0.25 mm and 2.6 2.2%, respectively, with a nonsignificant increase at 9 months (0.36 0.23 mm and 4.0 2.2%, respectively). Serial intravascular ultrasound did not show late incomplete stent apposition.There were no major adverse cardiac events within 1 year of follow-up.Conclusions The novel VESTAsync-eluting stent was effective in reducing LL and neointimal hyperplasia at 4 and 9 months, with no evidence of late catch-up by quantitative coronary angiographyor intravascular ultrasound. (J Am Coll Cardiol Intv 2009;2:422–7) © 2009 by the American College of Cardiology Foundation From...

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AIMS: First generation DES have markedly reduced restenosis. However, there is a major interest in developing new DES with greater flexibility, radiopacity and safety profile. The Elixir Medical drug eluting stent is a novel DES that combines a chromium-cobalt platform with novolimus (an antiproliferative sirolimus-analogue drug) and a polymer from the methacrylate family. As potential advantages, it provides a lower drug dose as compared to Cypher (85 microg of novolimus vs. 140 microg of sirolimus) and therefore has a lower polymer load. We sought to evaluate the safety and efficacy of this novel device in reducing neointimal hyperplasia as assessed by QCA and IVUS. METHODS AND RESULTS: In April 2007 a consecutive cohort of patients with de novo lesions < or = 14 mm in length, located in native coronaries of diameter from 3.0 to 3.5 mm were consecutively enrolled in this First-in-Man study (FIM). By protocol, angiography and IVUS would be done at baseline and repeated at four and eight months. Dual anti-platelet therapy was maintained for a minimum of 12 months. The primary endpoint was QCA lumen loss at 4-month follow-up. Secondary endpoints included MACE, in-stent neointimal obstruction by IVUS and device success. A total of 15 patients were included with 67% female patients and diabetes was detected in 47% of the cohort. Angiographic and procedural success was achieved in all patients. At 4-month angiographic follow-up there was in-stent late lumen loss (0.15 +/- 0.29 mm) by QCA and % volume obstruction (2.6 +/- 2.6) by IVUS. The angiographic in-stent late lumen loss results at eight months were 0.31 +/- 0.25 mm and % volume obstruction by IVUS was 6.0 +/- 4.4%. Late incomplete stent apposition (ISA) were not observed among these patients and no MACE was evidenced through nine month clinical follow-up. CONCLUSIONS: In this FIM study, implantation of the novolimus-eluting stent was proven to be feasible, safe and elicited minimum neointimal proliferation. Additional large clinical trials should be considered to confirm these promising results.

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