Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 10 de 10
Filtrar
1.
J Am Coll Cardiol ; 2024 May 06.
Artigo em Inglês | MEDLINE | ID: mdl-38759907

RESUMO

BACKGROUND: ILUMIEN IV was the first large-scale, multicenter, randomized trial comparing optical coherence tomography (OCT)-guided versus angiography-guided stent implantation in patients with high-risk clinical characteristics and/or complex angiographic lesions. OBJECTIVE: Here, we aimed to specifically examine outcomes in the complex angiographic lesions subgroup. METHODS: From the original trial population (n=2487), high-risk patients without complex angiographic lesions were excluded (n=514). Complex angiographic lesion characteristics included 1) long or multiple lesions with intended total stent length ≥28 mm; 2) bifurcation lesion with intended two-stent strategy; 3) severely calcified lesion; 4) chronic total occlusion; or 5) in-stent restenosis. The study endpoints were 1) final minimal stent area (MSA); 2) 2-year composite of serious major adverse cardiovascular events (MACE; cardiac death, target-vessel myocardial infarction (MI), or stent thrombosis); and 3) 2-year effectiveness, defined as target-vessel failure (TVF), a composite of cardiac death, target-vessel MI, or ischemia-driven target-vessel revascularization. RESULTS: The post-PCI MSA was larger in the OCT- (n=992) versus angiography-guided (n=981) group (5.56±1.95 versus 5.26±1.81mm2; difference, 0.30; 95% confidence interval [CI], 0.14-0.47; P<0.001). Compared with angiography-guided PCI, OCT-guided PCI resulted in a lower risk of serious MACE (3.1% versus 4.9%; hazard ratio [HR], 0.63; 95% CI, 0.40-0.99; P=0.04). TVF was not significantly different between groups (7.3% versus 8.8%; HR, 0.82; 95% CI, 0.59-1.12; P=0.20). CONCLUSIONS: In complex angiographic lesions, OCT-guided PCI led to a larger MSA and reduced the serious MACE composite of cardiac death, target-vessel MI, or stent thrombosis compared with angiography-guided PCI at 2 years, but did not significantly improve TVF.

2.
N Engl J Med ; 389(16): 1466-1476, 2023 Oct 19.
Artigo em Inglês | MEDLINE | ID: mdl-37634188

RESUMO

BACKGROUND: Data regarding clinical outcomes after optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) as compared with angiography-guided PCI are limited. METHODS: In this prospective, randomized, single-blind trial, we randomly assigned patients with medication-treated diabetes or complex coronary-artery lesions to undergo OCT-guided PCI or angiography-guided PCI. A final blinded OCT procedure was performed in patients in the angiography group. The two primary efficacy end points were the minimum stent area after PCI as assessed with OCT and target-vessel failure at 2 years, defined as a composite of death from cardiac causes, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization. Safety was also assessed. RESULTS: The trial was conducted at 80 sites in 18 countries. A total of 2487 patients underwent randomization: 1233 patients were assigned to undergo OCT-guided PCI, and 1254 to undergo angiography-guided PCI. The minimum stent area after PCI was 5.72±2.04 mm2 in the OCT group and 5.36±1.87 mm2 in the angiography group (mean difference, 0.36 mm2; 95% confidence interval [CI], 0.21 to 0.51; P<0.001). Target-vessel failure within 2 years occurred in 88 patients in the OCT group and in 99 patients in the angiography group (Kaplan-Meier estimates, 7.4% and 8.2%, respectively; hazard ratio, 0.90; 95% CI, 0.67 to 1.19; P = 0.45). OCT-related adverse events occurred in 1 patient in the OCT group and in 2 patients in the angiography group. Stent thrombosis within 2 years occurred in 6 patients (0.5%) in the OCT group and in 17 patients (1.4%) in the angiography group. CONCLUSIONS: Among patients undergoing PCI, OCT guidance resulted in a larger minimum stent area than angiography guidance, but there was no apparent between-group difference in the percentage of patients with target-vessel failure at 2 years. (Funded by Abbott; ILUMIEN IV: OPTIMAL PCI ClinicalTrials.gov number, NCT03507777.).


Assuntos
Angiografia Coronária , Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Tomografia de Coerência Óptica , Humanos , Angiografia Coronária/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Doença da Artéria Coronariana/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Estudos Prospectivos , Método Simples-Cego , Tomografia de Coerência Óptica/métodos , Resultado do Tratamento , Diabetes Mellitus , Implante de Prótese Vascular/métodos , Stents
3.
EuroIntervention ; 16(13): 1092-1099, 2021 Jan 20.
Artigo em Inglês | MEDLINE | ID: mdl-32863246

RESUMO

AIMS: Randomised trials have demonstrated improvement in clinical outcomes with intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) compared with angiography-guided PCI. The ILUMIEN III trial demonstrated non-inferiority of an optical coherence tomography (OCT)- versus IVUS-guided PCI strategy in achieving similar post-PCI lumen dimensions. ILUMIEN IV is a large-scale, multicentre, randomised trial designed to demonstrate the superiority of OCT- versus angiography-guided stent implantation in patients with high-risk clinical characteristics (diabetes) and/or complex angiographic lesions in achieving larger post-PCI lumen dimensions and improving clinical outcomes. METHODS AND RESULTS: ILUMIEN IV is a prospective, single-blind clinical investigation that will randomise between 2,490 and 3,656 patients using an adaptive design to OCT-guided versus angiography-guided coronary stent implantation in a 1:1 ratio. The primary endpoints are: (1) post-PCI minimal stent area assessed by OCT in each randomised arm, and (2) target vessel failure, the composite of cardiac death, target vessel myocardial infarction, or ischaemia-driven target vessel revascularisation. Clinical follow-up will continue for up to two years. The trial is currently enrolling, and the principal results are expected in 2022. CONCLUSIONS: The large-scale ILUMIEN IV randomised controlled trial will evaluate the effectiveness of OCT-guided versus angiography-guided PCI in improving post-PCI lumen dimensions and clinical outcomes in patients with diabetes and/or with complex coronary lesions. TRIAL REGISTRATION: NCT03507777.


Assuntos
Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Humanos , Estudos Prospectivos , Método Simples-Cego , Stents , Tomografia de Coerência Óptica , Resultado do Tratamento , Ultrassonografia de Intervenção
4.
Catheter Cardiovasc Interv ; 94(4): 509-515, 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31444897

RESUMO

BACKGROUND: Limited study has detailed the late-term safety and efficacy of chronic total coronary occlusion (CTO) revascularization among multiple centers applying modern techniques and with newer-generation drug-eluting stents. METHODS: Among 20 centers, 222 patients enrolled in the XIENCE coronary stent, performance, and technique (EXPERT) CTO trial underwent CTO percutaneous coronary intervention (PCI) with everolimus-eluting stents (EES). Through planned 4-year follow-up, the primary composite endpoint of major adverse cardiac events (MACE; death, myocardial infarction [MI] and target lesion revascularization) and rates of individual component endpoints and stent thrombosis were determined. RESULTS: Demographic, lesion, and procedural characteristics included prior bypass surgery, 9.9%; diabetes, 40.1%; lesion length, 36.1 ± 18.5 mm; and stent length, 51.7 ± 27.2 mm. By 4 years, MACE rates were 31.6 and 22.4% by the pre-specified ARC and per-protocol definitions, respectively. Clinically-indicated target lesion revascularization at 4 years was 11.3%. In landmark analyses of events beyond the first year of revascularization, the annualized rates of target vessel-related MI and clinically-indicated target lesion revascularization were 0.53 and 1.3%, respectively. Through 4 years, the cumulative definite/probable stent thrombosis rate was 1.7% with no events occurring beyond the initial year of index revascularization. CONCLUSIONS: In a multicenter registration trial representing contemporary technique and EES, these results demonstrate sustained long-term safety and effectiveness of EES in CTO percutaneous revascularization and can be used to inform shared decision making with patients being considered for CTO PCI relative to late safety and vessel patency.


Assuntos
Fármacos Cardiovasculares/administração & dosagem , Oclusão Coronária/terapia , Stents Farmacológicos , Everolimo/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Idoso , Fármacos Cardiovasculares/efeitos adversos , Doença Crônica , Oclusão Coronária/diagnóstico por imagem , Oclusão Coronária/mortalidade , Oclusão Coronária/fisiopatologia , Trombose Coronária/etiologia , Trombose Coronária/mortalidade , Everolimo/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Infarto do Miocárdio/mortalidade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Estudos Prospectivos , Desenho de Prótese , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Grau de Desobstrução Vascular
5.
J Am Coll Cardiol ; 70(23): 2852-2862, 2017 Dec 12.
Artigo em Inglês | MEDLINE | ID: mdl-29100702

RESUMO

BACKGROUND: The Absorb everolimus-eluting poly-L-lactic acid-based bioresorbable vascular scaffold (BVS) provides early drug delivery and mechanical support functions similar to metallic drug-eluting stents (DES), followed by complete bioresorption in approximately 3 years with recovery of vascular structure and function. The ABSORB III trial demonstrated noninferior rates of target lesion failure (cardiac death, target vessel myocardial infarction [TVMI], or ischemia-driven target lesion revascularization) at 1 year in 2,008 patients with coronary artery disease randomized to BVS versus cobalt-chromium everolimus-eluting stents (EES). OBJECTIVES: This study sought to assess clinical outcomes through 3 years following BVS implantation. METHODS: Clinical outcomes from the ABSORB III trial were analyzed by randomized treatment assignment cumulative through 3 years, and between 1 and 3 years. RESULTS: The primary composite endpoint of target lesion failure through 3 years occurred in 13.4% of BVS patients and 10.4% of EES patients (p = 0.06), and between 1 and 3 years in 7.0% versus 6.0% of patients, respectively (p = 0.39). TVMI through 3 years was increased with BVS (8.6% vs. 5.9%; p = 0.03), as was device thrombosis (2.3% vs. 0.7%; p = 0.01). In BVS-assigned patients, treatment of very small vessels (those with quantitatively determined reference vessel diameter <2.25 mm) was an independent predictor of 3-year TLF and scaffold thrombosis. CONCLUSIONS: In the ABSORB III trial, 3-year adverse event rates were higher with BVS than EES, particularly TVMI and device thrombosis. Longer-term clinical follow-up is required to determine whether bioresorption of the polymeric scaffold will influence patient prognosis. (ABSORB III Randomized Controlled Trial [RCT] [ABSORB-III]; NCT01751906).


Assuntos
Implantes Absorvíveis , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Everolimo/administração & dosagem , Imunossupressores/administração & dosagem , Intervenção Coronária Percutânea , Alicerces Teciduais , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Poliésteres , Desenho de Prótese , Método Simples-Cego , Fatores de Tempo , Resultado do Tratamento
6.
JACC Cardiovasc Interv ; 9(11): 1178-87, 2016 06 13.
Artigo em Inglês | MEDLINE | ID: mdl-27282601

RESUMO

OBJECTIVES: This is the first-in-human study of a drug-eluting bioresorbable vascular scaffold (BVS) for treatment of peripheral artery disease (PAD) involving the external iliac artery (EIA) and superficial femoral artery (SFA). BACKGROUND: Drug-eluting BVS has shown promise in coronary arteries. METHODS: The ESPRIT BVS system is a device-drug combination consisting of an everolimus-eluting poly-l-lactide scaffold. Safety and performance were evaluated in 35 subjects with symptomatic claudication. RESULTS: Lesions were located in the SFA (88.6%) and EIA (11.4%). Mean lesion length was 35.7 ± 16.0 mm. The study device was successfully deployed in 100% of cases, without recoil. Procedure-related minor complications were observed in 3 patients (groin hematoma, dissection). Within 2 years there was 1 unrelated death, but no patients in this cohort had an amputation. At 1 and 2 years, the binary restenosis rates were 12.1% and 16.1%, respectively, and target lesion revascularization was performed in 3 of 34 patients (8.8%) and 4 of 32 patients (11.8%), respectively. The ankle brachial index 0.75 ± 0.14 improved from pre-procedure to 0.96 ± 0.16 at 2 years' follow-up. At 2 years, 71.0% of the patients were Rutherford-Becker 0, and 93.5% achieved a maximum walking distance of 1,500 feet. CONCLUSIONS: The safety of the ESPRIT BVS was demonstrated with no procedure or device-related deaths or amputations within 2 years. The low occurrence of revascularizations was consistent with duplex-ultrasonography showing sustained patency at 2-years. (A Clinical Evaluation of the Abbott Vascular ESPRIT BVS [Bioresorbable Vascular Scaffold] System [ESPRIT I]; NCT01468974).


Assuntos
Implantes Absorvíveis , Angioplastia com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Everolimo/administração & dosagem , Artéria Femoral , Artéria Ilíaca , Claudicação Intermitente/terapia , Doença Arterial Periférica/terapia , Idoso , Angiografia , Angioplastia com Balão/efeitos adversos , Índice Tornozelo-Braço , Fármacos Cardiovasculares/efeitos adversos , Everolimo/efeitos adversos , Tolerância ao Exercício , Estudos de Viabilidade , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Humanos , Artéria Ilíaca/diagnóstico por imagem , Artéria Ilíaca/fisiopatologia , Claudicação Intermitente/diagnóstico por imagem , Claudicação Intermitente/fisiopatologia , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Estudos Prospectivos , Desenho de Prótese , Recuperação de Função Fisiológica , Recidiva , Retratamento , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Ultrassonografia Doppler Dupla , Grau de Desobstrução Vascular
7.
N Engl J Med ; 373(20): 1905-15, 2015 Nov 12.
Artigo em Inglês | MEDLINE | ID: mdl-26457558

RESUMO

BACKGROUND: In patients with coronary artery disease who receive metallic drug-eluting coronary stents, adverse events such as late target-lesion failure may be related in part to the persistent presence of the metallic stent frame in the coronary-vessel wall. Bioresorbable vascular scaffolds have been developed to attempt to improve long-term outcomes. METHODS: In this large, multicenter, randomized trial, 2008 patients with stable or unstable angina were randomly assigned in a 2:1 ratio to receive an everolimus-eluting bioresorbable vascular (Absorb) scaffold (1322 patients) or an everolimus-eluting cobalt-chromium (Xience) stent (686 patients). The primary end point, which was tested for both noninferiority (margin, 4.5 percentage points for the risk difference) and superiority, was target-lesion failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization) at 1 year. RESULTS: Target-lesion failure at 1 year occurred in 7.8% of patients in the Absorb group and in 6.1% of patients in the Xience group (difference, 1.7 percentage points; 95% confidence interval, -0.5 to 3.9; P=0.007 for noninferiority and P=0.16 for superiority). There was no significant difference between the Absorb group and the Xience group in rates of cardiac death (0.6% and 0.1%, respectively; P=0.29), target-vessel myocardial infarction (6.0% and 4.6%, respectively; P=0.18), or ischemia-driven target-lesion revascularization (3.0% and 2.5%, respectively; P=0.50). Device thrombosis within 1 year occurred in 1.5% of patients in the Absorb group and in 0.7% of patients in the Xience group (P=0.13). CONCLUSIONS: In this large-scale, randomized trial, treatment of noncomplex obstructive coronary artery disease with an everolimus-eluting bioresorbable vascular scaffold, as compared with an everolimus-eluting cobalt-chromium stent, was within the prespecified margin for noninferiority with respect to target-lesion failure at 1 year. (Funded by Abbott Vascular; ABSORB III ClinicalTrials.gov number, NCT01751906.).


Assuntos
Implantes Absorvíveis , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Everolimo/administração & dosagem , Imunossupressores/administração & dosagem , Idoso , Angina Pectoris/terapia , Angiografia Coronária , Doença da Artéria Coronariana/mortalidade , Reestenose Coronária , Stents Farmacológicos/efeitos adversos , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Metais , Pessoa de Meia-Idade , Desenho de Prótese
8.
J Phys Condens Matter ; 22(40): 404204, 2010 Oct 13.
Artigo em Inglês | MEDLINE | ID: mdl-21386565

RESUMO

The structures of phase-change In(0.21)Sb(0.79) thin film in the amorphous phase were modeled using the reverse Monte Carlo (RMC) method, making simultaneous use of measured x-ray diffraction and x-ray absorption fine structure data. The experimental data that we used do not contain the crystalline phase, which can be observed in the diffraction pattern. Three kinds of initial configurations--a simple cubic lattice, a rhombohedral A7 structure and a dense randomly packed hard sphere form--were used in attempts to reproduce the measured data. The former configuration is thought to be the most probable structure for the crystalline In(0.21)Sb(0.79) thin film. For the latter configuration we could not reproduce the structure of the amorphous In(0.21)Sb(0.79) thin film under the present RMC conditions. We obtained probable structure models for the amorphous In(0.21)Sb(0.79) thin film. We found that the models obtained possess some traces of crystallinity.


Assuntos
Índio/química , Modelos Moleculares , Método de Monte Carlo , Oligoelementos/química , Simulação por Computador , Modelos Biológicos , Modelos Químicos , Transição de Fase , Difração de Raios X
9.
Lancet ; 371(9616): 899-907, 2008 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-18342684

RESUMO

BACKGROUND: A fully bioabsorbable drug-eluting coronary stent that scaffolds the vessel wall when needed and then disappears once the acute recoil and constrictive remodelling processes have subsided has theoretical advantages. The bioasorbable everolimus-eluting stent (BVS) has a backbone of poly-L-lactic acid that provides the support and a coating of poly-D,L-lactic acid that contains and controls the release of the antiproliferative agent everolimus. We assessed the feasibility and safety of this BVS stent. METHODS: In this prospective, open-label study we enrolled 30 patients who had either stable, unstable, or silent ischaemia and a single de-novo lesion that was suitable for treatment with a single 3.0 x 12 mm or 3.0 x 18 mm stent. Patients were enrolled from four academic hospitals in Auckland, Rotterdam, Krakow, and Skejby. The composite endpoint was cardiac death, myocardial infarction, and ischaemia-driven target lesion revascularisation. Angiographic endpoints were available for 26 patients and intravascular-ultrasound endpoints for 24 patients. Clinical endpoints were assessed in all 30 patients at 6 and 12 months. In a subset of 13 patients, optical coherence tomography was undertaken at baseline and follow-up. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00300131. FINDINGS: Procedural success was 100% (30/30 patients), and device success 94% (29/31 attempts at implantation of the stent). At 1 year, the rate of major adverse cardiac events was 3.3%, with only one patient having a non-Q wave myocardial infarction and no target lesion revascularisations. No late stent thromboses were recorded. At 6-month follow-up, the angiographic in-stent late loss was 0.44 (0.35) mm and was mainly due to a mild reduction of the stent area (-11.8%) as measured by intravascular ultrasound. The neointimal area was small (0.30 [SD 0.44] mm2), with a minimal area obstruction of 5.5%. INTERPRETATION: This study shows the feasibility of implantation of the bioabsorbable everolimus-eluting stent, with an acceptable in-stent late loss, minimal intrastent neointimal hyperplasia, and a low stent area obstruction. FUNDING: Abbott Vascular.


Assuntos
Doença das Coronárias/terapia , Stents Farmacológicos , Imunossupressores , Sirolimo/análogos & derivados , Implantes Absorvíveis , Angioplastia Coronária com Balão , Doença das Coronárias/diagnóstico por imagem , Reestenose Coronária , Everolimo , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Segurança , Ultrassonografia
10.
J Chem Phys ; 125(4): 44508, 2006 Jul 28.
Artigo em Inglês | MEDLINE | ID: mdl-16942157

RESUMO

Neutron diffraction measurements on liquid antimony pentachloride and tungsten hexachloride have been carried out using the Studsvik liquids and amorphous diffractometer (SLAD) at the Studsvik Neutron Research Laboratory. The corrected structure factors have been interpreted by means of reverse Monte Carlo modeling which provides large structural models, containing thousands of atoms, that are consistent with the experimental data within their uncertainties. From these models, partial structure factors and pair correlation functions can be calculated. It is demonstrated that the intramolecular structure can be determined on the basis of data extending up to 10 Angstrom (-1). SbCl(5) is found to have a trigonal bipyramidal shape in the liquid, while liquid WCl(6) consists of octahedral molecules. The intermolecular structure of liquid SbCl(5) and WCl(6) seems to be determined largely by steric effects (excluded volume and molecular shape).

SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA
...