RESUMO
The Sparrow stent system (Biosensors International) consists of a self-expanding, ultra-thin nitinol stent mounted within a 0.014½ guidewire designed for small or tortuous coronary lesions. We compared the intravascular ultrasound (IVUS) findings between the novel self-expanding sirolimus-eluting stent (Sparrow-SES) and a conventional balloon-expandable sirolimus-eluting stent (Cypher-SES) in patients with small coronary disease. Methods. We examined 14 lesions treated with the Sparrow-SES from CARE II, compared with 22 small vessel lesions treated with Cypher-SES. IVUS examination was performed post-procedure and 8 months later. Volumetric data were standardized by length as volume index (VI; mm3/mm). Results. While baseline stent VI trended smaller in Sparrow-SES, follow-up stent VI became similar between the 2 groups due to a significant increase of stent VI in self-expanding Sparrow-SES during the follow-up period. At 8 months, Sparrow-SES showed greater neointima than Cypher-SES (0.8 ± 0.6 mm3/mm vs 0.2 ± 0.2 mm3/mm; P<.001). However, the decrease in lumen VI was only 0.3 ± 0.7 mm3/mm in Sparrow-SES, as compared to 0.1 ± 0.3 mm3/mm in Cypher-SES (P=.259), since the late loss due to neointimal hyperplasia was partly counterbalanced by the chronic stent expansion in Sparrow-SES. Conclusion. While 8-month follow-up of Sparrow-SES revealed greater amounts of neointimal hyperplasia compared with conventional Cypher-SES, chronic stent expansion preserved the lumen by increasing stent volume. This novel, guidewire-based, self-expanding stent system designed to be delivered through complex anatomies may be useful to treat patients with small-caliber coronary lesions by offering sufficient lumen preservation at follow-up.
Assuntos
Doença da Artéria Coronariana , Doença das Coronárias , Stents FarmacológicosRESUMO
BackgroundThe NEVO sirolimus-eluting stent (NEVO SES) is a novel cobalt-chromium stent combining sirolimusrelease from reservoirs with bioabsorbable polymer to reduce spatial and temporal polymer exposure. The aim of thisstudy was to assess the arterial response to the NEVO SES in a randomized, blinded comparison versus thesurface-coated TAXUS Liberte paclitaxel-eluting stent (TAXUS Liberte´ PES) in human native coronary lesions usingintravascular ultrasound (IVUS).Methods and ResultsThe NEVO ResElution-I IVUS substudy enrolled 100 patients (1:1 randomization). In addition tostandard IVUS variables, uniformity of neointimal distribution within stents was evaluated in 3 dimensions bycomputing mean neointimal thickness within 12 equally spaced radial sectors on every 1-mm cross section along thestented segment. The NEVO SES showed significantly less neointimal proliferation (neointimal obstruction: 5.5 11.0%versus 11.5 9.7%, P 0.02), resulting in less late lumen area loss and smaller maximum cross-sectional narrowing at6 months. The absolute variability of neointima distribution, assessed by the standard deviation of neointimal thicknesswithin each stent, was significantly reduced with the NEVO SES compared with the TAXUS Liberte´PES(0.04 0.04 mm versus 0.10 0.07 mm, P 0.0001). TAXUS Liberte´ PES showed significantly greater positivevessel remodeling than the NEVO SES ( vessel volume index: 1.30 1.36 mm3/mm versus 0.36 0.63 mm3/mm,respectively, P 0.003).ConclusionsThe NEVO SES with focal release of sirolimus from reservoirs achieved significantly greater and moreconsistent suppression of neointimal hyperplasia than the surface-coated TAXUS Liberte´ PES. This was associated withless positive remodeling and no increased morphological or morphometric abnormalities surrounding the stent or at thestent margins.
Assuntos
Stents , Stents FarmacológicosRESUMO
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 were included. 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 mm(3)/mm vs. 1.65 +/- 1.02 mm(3)/mm, p = 0.50). However, CMS presented a 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 resulting in significantly lower late loss and percent of IH volumetric obstruction in comparison with the MLP stent.
Assuntos
Ligas/uso terapêutico , Angioplastia Coronária com Balão , Angiografia Coronária , Doença da Artéria Coronariana/terapia , Vasos Coronários/patologia , Stents , Ultrassonografia de Intervenção , Ligas/administração & dosagem , Angioplastia com Balão , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Vasos Coronários/diagnóstico por imagem , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Sistema de RegistrosRESUMO
BackgroundDrug-eluting stents reduce restenosis and reintervention rates but are complicated by stent thrombosis,which may be related to polymer coating. The NEVO sirolimus-eluting coronary stent (NEVO SES) is designed to improve long-term percutaneous coronary intervention safety by combining sirolimus release from reservoirs withbioabsorbable polymer to reduce spatial and temporal polymer exposure.Methods and ResultsNEVO ResElution-I was a prospective randomized study in 394 patients with coronary arterydisease comparing the NEVO SES with the TAXUS Liberte´ paclitaxel-eluting coronary stent (TAXUS Liberte´ PES)stent. The primary end point was in-stent angiographic late loss at 6 months. Six months after percutaneous coronaryintervention (PCI), the primary end point favored NEVO SES (0.13 0.31 mm versus 0.36 0.48 mm, P 0.001 fornoninferiority and superiority). The study was not powered for clinical end points and showed no significant differencefor NEVO SES versus TAXUS Liberte´ PES: death: 0.5 versus 1.6%, P 0.36; myocardial infarction: 2.0 versus 2.6%,P 0.75; target lesion revascularization: 1.5 versus 3.2%, P 0.33; major adverse cardiac events: 4.0 versus 7.4%, P 0.19.No stent thrombosis was observed with NEVO SES, whereas 2 cases occurred in TAXUS Liberte´ PES. Intravascularultrasound showed lower percent volume obstruction for NEVO SES (5.5 11% versus 11.5 9.7%, P 0.016).ConclusionsThis trial proved the superiority of NEVO SES over TAXUS Liberte´ PES for the primary angiographic endpoint of in-stent late loss. No stent thrombosis occurred in the NEVO SES group.
Assuntos
Angioplastia , Reestenose Coronária , StentsRESUMO
Introdução: Intervenção coronária pecutânea em vasos de fino calibre (VF) está associada a piores resultados imediatos e tardios, com elevadas taxas de reestenose. Estudos prévios têm sugerido que stents auto-expansíveis causam menos injúria vascular no momento do implante, com expansão de seus volumes com o tempo, gerando maiores áreas luminais que stents balão-expansíveis. A influência desses fenômenos em VF ainda é desconhecida. Objetivos: Avaliar as propriedades mecânicas e a eficácia do novo stent CardioMind no tratamento de lesões em VF em comparação ao stent balão-expansível Multi-link Pixel (Pixel). Método: Treze pacientes portadores de lesões únicas primárias < 14 mm de extensão, em artérias coronárias nativas < 2,5 mm de diâmetro, foram tratados com o stent CardioMind e comparados a uma corte histórica de 25 pacientes, com os mesmos critérios de inclusão, tratados com o stent Pixel. Ultrasom intracoronário (USIC) seriado foi realizado pós-procedimento e aos 7,3 +/- 1,0 meses. Resultados: A média das idades foi de 58,1 +/- 9,9 anos, com 60,5 por cento do sexo masculino e 39,4 por cento diabéticos. Ambos os stents produziram volumes de hiperplasia neo-intimal (HNI) smelhantes...
Background: Percutaneous coronary intervention in small vessels (SV) is associated with poor short- and long-term outcomes, with high rates of restenosis. Previous studies have suggested that self-expanding stents can cause less vessel injury at implantation, expanding their volumes over time, and leading to larger luminal areas than those of balloon-expandable stents. The influence of these phenomena on SV remains unknown. Objectives: To assess the mechanical properties and efficacy of the novel CardioMind™ stent in comparison with the balloon-expandable Multi-Link Pixel™ (Pixel) stent in the treatment of SV. Methods: Thirteen patients with single, de novo, < 14 mm length lesions in native coronary arteries < 2.5 mm in diameter were treated with the CardioMind™ stent and compared with a historical cohort of 25 patients, with the same inclusion criteria, treated with the Pixel™ stent. Intravascular ultrasound (IVUS) was performed serially after the procedure and at 7.3 ± 1.0 months of follow-up. Results: Mean age was 58.1 ± 9.9 years; 60.5% were male and 39.4% were diabetic. Both stents produced similar neointimal hyperplasia (NIH) volumes (indexed NIH volume: 1.45 ± 0.46 mm³/mm for CardioMind™ versus 1.66 ± 1.02 mm³/mm for Pixel™; p = 0.48). However, the CardioMind™ stentpresented a 12% expansion of its volume, leading to a...
Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Stents , Angioplastia Coronária com Balão/métodos , Aspirina/administração & dosagem , Estudo Comparativo , Ticlopidina/administração & dosagem , Vasos Coronários/anatomia & histologiaRESUMO
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.
Assuntos
Angioplastia Coronária com Balão/instrumentação , Fármacos Cardiovasculares/uso terapêutico , Estenose Coronária/terapia , Fosforilcolina/uso terapêutico , Sirolimo/análogos & derivados , Stents , Idoso , Implante de Prótese Vascular , Angiografia Coronária , Circulação Coronária , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/etiologia , Estenose Coronária/diagnóstico por imagem , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Desenho de Prótese , Projetos de Pesquisa , Sirolimo/química , Sirolimo/farmacologia , Sirolimo/uso terapêutico , Resultado do Tratamento , Túnica Íntima/diagnóstico por imagem , Túnica Íntima/fisiopatologia , Ultrassonografia de IntervençãoRESUMO
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.
Assuntos
Angiografia Coronária , Angioplastia Coronária com Balão/instrumentação , Cardiotônicos/uso terapêutico , Circulação Coronária , Desenho de Prótese , Fosforilcolina/uso terapêutico , Implante de Prótese Vascular , Projetos de Pesquisa Epidemiológica , Reestenose Coronária , Reestenose Coronária/etiologia , Sirolimo/análogos & derivados , Sirolimo/farmacologia , Sirolimo/química , Sirolimo/uso terapêutico , Stents , Túnica Íntima , Túnica Íntima/fisiopatologiaRESUMO
Background: Even though sirolimus-eluting stents (SES) have been shown to significantly improve binaryrestenosis and target lesion revascularisation rates (TLR) compared to bare metal stents in diabeticpatients, the revascularisation rate is still higher than those of non-diabetics. Whether a double dose (DD)of sirolimus on a stent would provide a greater reduction in neointimal hyperplasia compared to single dose(SD) SES in de novo coronary lesion of diabetic patients is unknown.Methods and results: A total of 56 patients (58 lesions) were prospectively randomised in a double blindfashion in a 1:1 ratio to SD (30 lesions) versus DD (28 lesions). Procedure success was achieved in allpatients. QCA results at 6 months were comparable between groups, including the primary endpoint of instentlate lumen loss (0.19±0.29 mm in SD versus 0.18±0.33 mm in DD, p=0.96). Furthermore, restenosiswas not found inside the stent in either group. By IVUS, there was no late/acquired incomplete stentapposition at follow-up, and% neointimal volume was 2.2±1.8% in SD versus 1.7±2.0% in DD, p=0.44. At1-year clinical follow-up, there was no significant difference between groups for major events, includingTLR which occurred in 1 patient in SD versus 3 patients in DD, p=0.61. Overall, there was only 1 subacutestent thrombosis (DD arm), and no late thromboses.Conclusions: Double dose SES did not improve the prevention of neointimal proliferation in diabetic patientswith de novo coronary lesion compare to single dose SES.
Assuntos
Diabetes Mellitus , Reestenose Coronária , Sirolimo , StentsRESUMO
The helixcision system is a novel 6 Fr-compatible catheter designed to debulk tissue for in stent restenosis lesions. The purpose of this study was to determine the efficacy and feasibility of this new system for removing neointimal hyperplasia. A total of 32 in-stent restenosis lesions in 32 patients were treated with helixcision followed ballon angioplasty. Debulking efficacy was assessed with serial baseline intravascular ultrasound (IVUS) in a subset of 18 lesions. To investigate longitudnal efficacy, 3D analyisis was also performed in 12 lesions with automated pullback to calculate average cross-sectional areas across the stent...
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Doença da Artéria Coronariana , Stents/efeitos adversos , Ultrassonografia de IntervençãoRESUMO
Fractional flow reserve (FFR) is a measure of coronary stenosis severity that is based on pressure measurements obtained at maximal hyperemia. The most widely used pharmacologic stimulus for maximal coronary hyperemia is adenosine, administered either as a continuous intravenous (IV) infusion or intracoronary (IC) bolus. IV adenosine has more side effects and is more costly than IC adenosine but has a more stable and prolonged hyperemic effect.Methods We compared the efficacy of IC and IV adenosine administration for the measurement of FFR in a multicentertrial. Fifty-two patients with 60 lesions underwent determination of FFR with both IV and IC adenosine. IV adenosine was administered as a continuous infusion at a rate of 140 μg/kg per minute until a steady state hyperemia was achieved. IC adenosine boluses were administered at a dose of 15 to 20 μg in the right and 18 to 24 μg in the left coronary artery. FFR was calculated as the ratio of the distal coronary pressure (from pressure guide wire) to the aortic pressure (guide catheter)at maximal hyperemia.Results A total of 26 left anterior descending, 23 right, 9 left circumflex, and 3 left main coronary arteries were evaluated. Mean percent stenosis for both groups was 55.8% ± 23.6% (range 0% to 95%), and mean FFR was 0.78 ± 0.15 (range 0.41 to 0.98). There was a strong and linear correlation between FFR measurements with IV and IC adenosine (R =0.978, y = 0.032 + 0.964x, P < .001). The agreement between the 2 sets of measurements was also high, with a mean differencein FFR of 0.004 ± 0.03. However, a small random scatter in both directions of FFR measurements was noted with5 lesions (8.3%) where FFR with IC adenosine was higher by 0.05 or more compared with IV infusions, suggesting a suboptimal hyperemic response in these patients...