Ioxaglate Versus IoDixanol for the Prevention of Contrast-Induced Nephropathy: The IDPC Trial.

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 2,268 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.

Ioxaglate versus IoDixanol for the prevention of contrast-induced nephropathy: the IDPC trial

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.

Correlação da composição de placas à histologia virtual com proteína C-reativa / Correlation between plaque composition as assessed by virtual histology and C-reactive protein

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.

Correlation between plaque composition as assessed by virtual histology and C-reactive protein.

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.

One-year results of the INSPIRE trial with the novel MGuard Stent: serial analysis with QCA and IVUS

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.

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.

Serial angiographic and intravascular ultrasound evaluation to interrogate the presence of late ‘‘catch-up’’ phenomenonafter cypher sirolimus-eluting stent implantation

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.

Serial Angiography and Intravascular Ultrasound: Results of the SISC Registry(Stents In Small Coronaries)

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.

1-year results of the hydroxyapatite polymer-free sirolimus-eluting stent for the treatment of single de novo coronary lesions

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...

EXCELLA First-in-Man (FIM) study: safety and efficacy of novolimus-eluting stent in de novo coronary lesions.

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.

Preliminary results of the hydroxyapatite nonpolymer-based sirolimus-eluting stent for the treatment of single de novo coronary lesions

Objectives We sought to investigate the performance and efficacy of the third-generation polymerfree Vestasync-eluting stent (VES). Background Recent concerns regarding the long-term safety of drug-eluting stents have been raised. Synthetic polymers have been associated with intensive inflammatory response and late stent thrombosis. Newly developed, the VES combines a stainless steel platform with a nanothinmicroporous hydroxyapatite surface coating impregnated with a polymer-free sirolimus formulation (55 m). Methods In May 2007, 15 patients with single de novo lesion located in native coronary arteries 3.0 to 3.5 mm in diameter and 14 mm in length were consecutively enrolled. Primary end points included in-stent late lumen loss and in-stent percent of obstruction at 4 months. Serial angiography and intravascular ultrasound were obtained at the index procedure and repeated at 4-month follow-up. Results Mean population age was 63.8 years; 33% of patients were diabetic. The left anterior descending artery was the prevalent target vessel (47%). Reference vessel diameter and lesion length were 2.67 0.32 mm and 9.98 1.98 mm, respectively. The VES was successfully implanted in all cases, and there were no procedure and in-hospital complications. Life-long aspirin and 6-month clopidogrel therapy were prescribed for all patients. At 4 months, in-stent late lumen loss was 0.30 0.25 mm and percent of stent obstruction was 2.8 2.2%. After up to 6 months of clinical follow-up, no major adverse cardiac event was registered. Conclusions The third-generation VES demonstrated excellent acute results in the treatment of de novo coronary lesions. Longer follow-up with a more complex subset of patients and lesions is required to confirm these preliminary results. (J Am Coll Cardiol Intv 2008;1:545–51) © 2008 by the American College of Cardiology Foundation

Segurança e eficácia de um novo sistema de stent com rede de proteção para prevenção de embolização distal: resultados preliminares do estudo INSPIRE / Safety and efficacy of a novel stent system with a protection net to prevent distal embolization: preliminary results of the INSPIRE trial

Fundamentos: Distúrbios de fluxo coronário decorrentes de embolização de fragmentos de ateroma/trombo estão associados a pior prognóstico após intervenção coronária percutânea (ICP). A abordagem de lesões em pontes de safena (PS) e no cenário de síndromes coronárias agudas (SCA) está frequentemente associadda a essas complicações. Apesar de dispositivos de proteção embólica terem demonstrado seu valor na prevenção desses eventos, estes adicionam tempo e custo à ICP, além de terem seu uso limitado às PS. Recém-desenvolvido, o stent MGuard combina uma malha microscóspica presa às hastes de um stent não-farmacológico, conferindo baixo perfil a esse dispositivo. Objetivos: Avaliar a eficácia e a segurança do stent MGuard por meio de desfechos clínicos e angiográficos. Método: Estudo unicêntrico com 19 pacientes portadores de lesões de novo em PS ou lesões com características angiográficas de instabilidade em coronárias nativas. O desfecho primário inclui a taxa de eventos cardíacos adversos maiores (ECAM) em trinta dias. Resultados: A apresentação clínica em 60 por cento dos casos era de SCA e em 55 por cento dos pacientes a lesão encontrava-se em PS. O stent MGuard foi implantado com sucesso em todos os casos, alcançando fluxo TIMI 3/blush 3 ao final de todas as ICPs, não sendo observadas complicações angiográficas. Não registradas elevações de CK-MB maiores de três vezes o valor de rferência pós-ICP ou ECAM...

Background: Disturbances in coronary flow due to embolization of thrombus/atheroma fragments are associated with poor prognosis after percutaneous coronary intervention (PCI). Lesions in saphenous vein grafts (SVG) and acute coronary syndromes (ACS) are typically associated with these complications. Although embolic protection devices have shown to reduce the incidence of such complications, they add time and costs to the procedure, and their use is limited to SVG. The newly developed MGuard™ stent combines a microscopic net connected to the struts of a bare metal stent, characterizing this new low-profile device. Objective: To evaluate safety and efficacy of the novel MGuard™ stent system through clinical and angiographic outcomes. Methods: Single-center study including 19 patients with de novo lesions in SVG or with unstable lesions in native vessels as evidenced by angiography. Primary end point included 30-day incidence of major adverse cardiac events (MACE). Results: ACS was the clinical presentation in 60% of cases, and in 55% of the patients the lesion was in a SVG. The MGuard™ stent was successfully delivered in all cases, reaching TIMI 3/blush 3 flow at the end of all procedures. There were no cases of angiographic complications, CK-MB elevations > 3x the reference values after PCI, or MACE at 30 day-follow-up. Conclusion: In this preliminary evaluation, the MGuard™ stent showed high efficacy in a group of patients with highly complex angiographic profile (without the use of adjunctive embolic protection devices). Six-month angiographic follow-up and a larger cohort of patients are necessary to corroborate these results.

Preliminary results of the hydroxyapatite nonpolymer-based sirolimus-eluting stent for the treatment of single de novo coronary lesions a first-in-human analysis of a third-generation drug-eluting stent system.

OBJECTIVES: We sought to investigate the performance and efficacy of the third-generation polymer-free Vestasync-eluting stent (VES). BACKGROUND: Recent concerns regarding the long-term safety of drug-eluting stents have been raised. Synthetic polymers have been associated with intensive inflammatory response and late stent thrombosis. Newly developed, the VES combines a stainless steel platform with a nanothin-microporous hydroxyapatite surface coating impregnated with a polymer-free sirolimus formulation (55 mum). METHODS: In May 2007, 15 patients with single de novo lesion located in native coronary arteries 3.0 to 3.5 mm in diameter and < or =14 mm in length were consecutively enrolled. Primary end points included in-stent late lumen loss and in-stent percent of obstruction at 4 months. Serial angiography and intravascular ultrasound were obtained at the index procedure and repeated at 4-month follow-up. RESULTS: Mean population age was 63.8 years; 33% of patients were diabetic. The left anterior descending artery was the prevalent target vessel (47%). Reference vessel diameter and lesion length were 2.67 +/- 0.32 mm and 9.98 +/- 1.98 mm, respectively. The VES was successfully implanted in all cases, and there were no procedure and in-hospital complications. Life-long aspirin and 6-month clopidogrel therapy were prescribed for all patients. At 4 months, in-stent late lumen loss was 0.30 +/- 0.25 mm and percent of stent obstruction was 2.8 +/- 2.2%. After up to 6 months of clinical follow-up, no major adverse cardiac event was registered. CONCLUSIONS: The third-generation VES demonstrated excellent acute results in the treatment of de novo coronary lesions. Longer follow-up with a more complex subset of patients and lesions is required to confirm these preliminary results.

Preliminary results of the hydroxyapatite nonpolymer-based sirolimus-eluting stent for thetreatment of single de novo coronary lesions: a first-in-human analysis of a third-generation drug-eluting stent system

Objectives We sought to investigate the performance and efficacy of the third-generation polymerfree Vestasync-eluting stent (VES). Background Recent concerns regarding the long-term safety of drug-eluting stents have beenraised. Synthetic polymers have been associated with intensive inflammatory response and late stent thrombosis. Newly developed, the VES combines a stainless steel platform with a nanothinmicroporous hydroxyapatite surface coating impregnated with a polymer-free sirolimus formulation(55 m). Methods In May 2007, 15 patients with single de novo lesion located in native coronary arteries3.0 to 3.5 mm in diameter and 14 mm in length were consecutively enrolled. Primary end points included in-stent late lumen loss and in-stent percent of obstruction at 4 months. Serial angiography and intravascular ultrasound were obtained at the index procedure and repeated at 4-month follow-up. Results Mean population age was 63.8 years; 33% of patients were diabetic. The left anterior descendingartery was the prevalent target vessel (47%). Reference vessel diameter and lesion length were 2.67 0.32 mm and 9.98 1.98 mm, respectively. The VES was successfully implanted in allcases, and there were no procedure and in-hospital complications. Life-long aspirin and 6-month clopidogrel therapy were prescribed for all patients. At 4 months, in-stent late lumen loss was0.30 0.25 mm and percent of stent obstruction was 2.8 2.2%. After up to 6 months of clinical follow-up, no major adverse cardiac event was registered.Conclusions The third-generation VES demonstrated excellent acute results in the treatment of de novo coronary lesions. Longer follow-up with a more complex subset of patients and lesions is required to confirm these preliminary results.

Percutaneous coronary revascularization using a trilayer metal phosphorylcholine-coated zotarolimus-eluting stent.

The ZoMaxx Coronary Stent System elutes the antiproliferative agent zotarolimus via a biocompatible phosphorylcholine polymer loaded onto a novel, thin, stainless steel stent platform containing an 0.0007-inch inner layer of tantalum that enhances fluoroscopic radiopacity. The objective of this single-arm prospective clinical trial was to assess the safety and performance of the ZoMaxx stent for the treatment of coronary artery stenosis. Forty consecutive patients with ischemic coronary occlusive disease due to single de novo obstructive lesions of native coronary arteries were treated with 3 x 18 mm ZoMaxx stents at the Dante Pazzanese de Cardiologie in Saõ Paulo, Brazil, between April and July 2005. Independent core laboratories analyzed quantitative coronary angiography and intravascular ultrasound results immediately after stent implantation, and after 4 months. The lesion, procedure, and device-deployment success rates were all 100% (40 of 40). There were no major adverse cardiac events during the study. Follow-up quantitative coronary angiography at 4 months revealed in-stent and in-segment late lumen losses of 0.20 +/- 0.35 and 0.17 +/- 0.35 mm, respectively. Follow-up intravascular ultrasound at 4 months revealed 6.5 +/- 6.2% neointimal volume obstruction. There were no instances of late acquired stent incomplete apposition or stent thrombosis. In conclusion, the ZoMaxx Coronary Stent can be safely implanted for the treatment of de novo coronary artery stenosis. The inhibition of neointima formation as measured by follow-up angiography and IVUS after 4 months suggests therapeutic potential for the reduction of restenosis.

Percutaneous coronary revascularization using a trilayer metal phosphorycholine-coated zotarolimus-eluting stent

The ZoMaxx Coronary Stent System elutes the antiproliferative agent zotarolimus via a biocompatible phosphorylcholine polymer loaded onto a novel, thin, stainless steel stent platform containing an 0.0007-inch inner layer of tantalum that enhances fluoroscopic radiopacity. The objective of this single-arm prospective clinical trial was to assess the safety and performance of the ZoMaxx stent for the treatment of coronary artery stenosis. Forty consecutive patients with ischemic coronary occlusive disease due to single de novo obstructive lesions of native coronary arteries were treated with 3 x 18 mm ZoMaxx stents at the Dante Pazzanese de Cardiologie in Saõ Paulo, Brazil, between April and July 2005. Independent core laboratories analyzed quantitative coronary angiography and intravascular ultrasound results immediately after stent implantation, and after 4 months. The lesion, procedure, and device-deployment success rates were all 100% (40 of 40). There were no major adverse cardiac events during the study. Follow-up quantitative coronary angiography at 4 months revealed in-stent and in-segment late lumen losses of 0.20 +/- 0.35 and 0.17 +/- 0.35 mm, respectively. Follow-up intravascular ultrasound at 4 months revealed 6.5 +/- 6.2% neointimal volume obstruction. There were no instances of late acquired stent incomplete apposition or stent thrombosis. In conclusion, the ZoMaxx Coronary Stent can be safely implanted for the treatment of de novo coronary artery stenosis. The inhibition of neointima formation as measured by follow-up angiography and IVUS after 4 months suggests therapeutic potential for the reduction of restenosis.

Resposta coronária às intervenções intravasculares / Coronary response intravascular interventions

O uso de instrumentais percutâneos par tratamento de obstruções no leito coronariano promove algum grau de dano vascular. A resposta do endotélio a essa agressão possui várias etapas, podendo ocorrer em diferentes proporções, desde o modelo considerado fisiológico de reparo vascular até as formas mais extremas representadas pela resposta neointimal exarcebada ou deficiente que parecem estar relacionadas com duas das principais...

Seguimento tardio de pacientes diabéticos tratados com stents com eluição de sirolimus: um estudo angiográfico e com ultra-som intracoronário tridimensional / Long-term follow up of diabetic patients treated with Sirolimus-eluting stents: angiographic and tridimensional intracoronary ultrasonographic study

Fundmentos: Os stents com eluição de sirolimus (SES) têm demonstrado sua eficácia tardia em suprimir a hiperplasia neointimal em pacientes que não são de alto risco. A evolução tardia de pacientes diabéticos tratados com SES ainda não foi avaliada. Método e Resultados: A comparação dos resultados da angiografia coronária quantativa e do ulta-som intracoronária foi realizada em 35 pacientes diabéticos tratados com o SES entre o 6º (6,0 +- 1,0 meses) e o 18º mês (18,5 +- 4,9 meses). não foram observadas mudanças significativas no diâmetro mínimo da luz (DML) entre o acompanhamento de curto e longo-prazos (2,69 +- 0,46 vs. 2,61 +- 0,4 mm; p=5), bem como no DML intra-stent (2,38 +-0,54 vs. 2,30 +- 0,62mm; p=0,6)...