RESUMO
Purpose: To report the 12-month results of a multicenter, prospective, randomized controlled trial to determine if the ZILVER PTX paclitaxel-eluting stent was noninferior in terms of safety and efficacy compared with surgical bypass. Materials and Methods: This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs surgical bypass surgery using a prosthetic graft (ClinicalTrials.gov identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.4%) or the bypass treatment group (107, 48.6%). Most of the lesions were occlusions (208, 94.5%); the mean lesion length was 247.1±69.3 mm. The primary outcome measure was primary patency at 12 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex-derived peak systolic velocity ratio <2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass. Results: The estimated 12-month primary patency rate was 74.5% (95% CI 66.3% to 82.7%) for the ZILVER PTX group vs 72.5% (95% CI 63.7% to 81.3%) for the bypass arm (p=0.998). Freedom from TLR at 12 months was 80.9% (95% CI 73.3% to 88.5%) for the ZILVER PTX group vs 76.2% (95% CI 68.0% to 84.4%) for the bypass group (p=0.471). The 30-day complication rate was significantly lower in the ZILVER PTX group (4.4% vs 11.3%, p=0.004). Also, procedure time and hospital stay were significantly shorter in the ZILVER PTX group (p<0.001 for both). Conclusion: With noninferior patency results, a lower complication rate, and shorter procedures and hospital stays, paclitaxel-eluting stenting might become a recommended treatment for long TASC C and D femoropopliteal lesions.
Assuntos
Implante de Prótese Vascular/instrumentação , Prótese Vascular , Stents Farmacológicos , Procedimentos Endovasculares/instrumentação , Artéria Femoral/cirurgia , Paclitaxel/administração & dosagem , Doença Arterial Periférica/terapia , Artéria Poplítea/cirurgia , Idoso , Idoso de 80 Anos ou mais , Implante de Prótese Vascular/efeitos adversos , Brasil , Fármacos Cardiovasculares/uso terapêutico , Procedimentos Endovasculares/efeitos adversos , Europa (Continente) , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Paclitaxel/efeitos adversos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Estudos Prospectivos , Desenho de Prótese , Recidiva , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução VascularRESUMO
BACKGROUND: The aim of this study was to evaluate the short and mid-term safety and efficacy of the EPIC™ nitinol vascular stent system for the treatment of lesions located in the superficial femoral artery (SFA). METHODS: From October 2010 to June 2012, 83 subjects were enrolled in a prospective, multicenter, non-randomized study designed to demonstrate that the EPIC nitinol vascular stent system for SFA lesions is non-inferior to the published patency rates found in literature. Inclusion criteria were stenosis or occlusion of the SFA or SFA and proximal popliteal artery, with total length from 4 to 11 cm and amenable for treatment with a single stent, in patients with a score from 2 to 5 on Rutherford classification. The primary endpoint was primary patency rate at 12 months as determined by Duplex ultrasound. The secondary endpoints evaluated were: initial arteriographic success, primary patency rate at 6 months, major adverse event rate at one year and technical success. Follow-up with a complete clinical and physical exam, including ABI and Duplex ultrasound was performed at 6 and 12 months. RESULTS: Most patients (56.6%) were men and the mean age was 68.59 (33.1-99.15) years. 25.3% of the total population had intermittent claudication and 73.5% presented with critical limb ischemia. Most lesions were total occlusions (75.9%) and the mean lesion length was 71.16 mm. Contralateral femoral access was performed in 26.5%cases, and ipsilateral femoral approach was used for the remaining 73.5% patients. Technical and arteriographic success was obtained in all 83 (100.00%) patients. Duplex controlled primary patency rate at 6 and 12 months was 95.8% and 76.1%, respectively. The freedom from target lesion revascularization rate was 98.7% and 92.6% at 6 and 12 months, respectively. No stent fractures were observed in this study. Major adverse event rate at 1 year (clinically driven TLR, major amputation, and all-cause mortality) was 15.7%: two target lesion revascularizations (2.4%), one major amputation (1.2%) and ten deaths not related to the procedure (12%). CONCLUSIONS: In conclusion, this study demonstrates the safety and efficacy of the EPIC™ Nitinol Vascular Stent System for the treatment of SFA lesions.
Assuntos
Ligas , Procedimentos Endovasculares/instrumentação , Artéria Femoral , Doença Arterial Periférica/terapia , Stents , Adulto , Idoso , Idoso de 80 Anos ou mais , Angiografia , Índice Tornozelo-Braço , Brasil , Intervalo Livre de Doença , Procedimentos Endovasculares/efeitos adversos , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Estudos Prospectivos , Desenho de Prótese , Fatores de Tempo , Resultado do Tratamento , Ultrassonografia Doppler Dupla , Grau de Desobstrução VascularRESUMO
BACKGROUND: The aim of this study was to evaluate the short and mid-term safety and efficacy of the EPIC nitinol vascular stent system for the treatment of lesions located in the superficial femoral artery (SFA).METHODS: From October 2010 to June 2012, 83 subjects were enrolled in a prospective, multicenter, non-randomized study designed to demonstrate that the EPIC nitinol vascular stent system for SFA lesions is non-inferior to the published patency rates found in literature. Inclusion criteria were stenosis or occlusion of the SFA or SFA and proximal popliteal artery, with total length from 4 to 11 cm and amenable for treatment with a single stent, in patients with a score from 2 to 5 on Rutherford classification. The primary endpoint was primary patency rate at 12 months as determined by Duplex ultrasound. The secondary endpoints evaluated were: initial arteriographic success, primary patency rate at 6 months, major adverse event rate at one year and technical success. Follow-up with a complete clinical and physical exam, including ABI and Duplex ultrasound was performed at 6 and 12 months.
Assuntos
Humanos , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Idoso , Angiografia , Grau de Desobstrução Vascular , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/instrumentação , StentsRESUMO
We describe the case of a 63-year-old woman with chronic mesenteric ischemia, persistent postprandial upper abdominal pain and progressive weight loss. Retrograde recanalization was performed via the superior mesenteric artery in order to achieve the goal of crossing the near-occlusion, showing that retrograde catheterization of the celiac trunk can be a feasible approach in challenging cases in which an antegrade approach fails as a single maneuver.
Descrevemos o caso de uma mulher de 63 anos de idade, com isquemia mesentérica crônica, dor abdominal pós-prandial e emagrecimento progressivo. A recanalização retrógrada foi realizada através da artéria mesentérica superior para transpassar a estenose crítica. Demonstra-se assim que o cateterismo retrógrado do tronco celíaco pode ser uma abordagem viável em casos difíceis, em que a abordagem anterógrada falha como manobra única.
Assuntos
Humanos , Feminino , Idoso , Aterosclerose , Aterosclerose/complicações , Isquemia Mesentérica/diagnóstico , Isquemia Mesentérica/etiologia , Isquemia Mesentérica/fisiopatologia , Fatores de Tempo , Cateterismo/métodos , SeguimentosRESUMO
In this study we performed 548 carotid revascularizations between 2006 and 2008 at the Department of Vascular Surgery of the A.Z. Sint-Blasius, Dendermonde, Belgium - a high-volume experienced center for carotid artery stenting (CAS). In 2006, our 30-day complication rates were 3.21 and 1.51 percent for symptomatic and asymptomatic patients, respectively. At that time, CAS represented approximately 86 percent of all cases we performed. However, the publication of the results of EVA-3S and SPACE studies drove us to reconsider our treatment allocation algorithm. In 2007 and 2008, CAS procedures only accounted for 43 percent of all carotid procedures, which was a result of strict patient selection with comorbidities and high-risk lesions assessment, especially in symptomatic patients. Our current 30-day stroke/death rates are 1.24 percent for symptomatic patients and 0.53 percent for asymptomatic ones, which reflects that correct patient selection is the key to maintain CAS as a valuable alternative to carotid endarterectomy.
Neste estudo, realizamos 548 revascularizações carotídeas entre 2006 e 2008 no Departamento de Cirurgia Vascular do A.Z. Sint-Blasius, Dendermonde, Bélgica - um centro de grande porte com experiência em angioplastia com stent de carótida (CAS, do inglês carotid artery stenting). Em 2006, nossas taxas de complicação em 30 dias foram de 3,21 e 1,51 por cento para pacientes sintomáticos e assintomáticos, respectivamente. Àquela época, a CAS representava aproximadamente 86 por cento de todos os casos realizados; entretanto, a publicação dos resultados dos estudos EVA-3S e SPACE nos levaram a reconsiderar nosso algoritmo de tratamento. Em 2007 e 2008, os procedimentos de CAS representaram apenas 43 por cento de todos os procedimentos carotídeos, o que foi resultado da seleção rigorosa de pacientes com avaliação de comorbidades e das lesões de alto risco, especialmente em pacientes sintomáticos. Nossas taxas atuais de AVE/óbito em 30 dias são de 1,24 por cento para pacientes sintomáticos e de 0,53 por cento para assintomáticos, refletindo que a seleção correta de pacientes é a chave para manter a CAS como uma alternativa válida à endarterectomia carotídea.
Assuntos
Humanos , Adulto , Endarterectomia das Carótidas , Estenose das Carótidas/terapia , Angioplastia/métodosRESUMO
Due to the fear that early thrombosis and late luminal loss resulting from intimal hyperplasia might impede sustained patency of small-caliber arteries, such as those of the infrapopliteal bed, stent implantation in below-knee vessels remains controversial and is generally reserved for cases with a suboptimal outcome after percutaneous transluminal angioplasty (i.e. > 50% residual stenosis, flow-limiting dissection). Although evidence starts to build, favoring the use of stenting in the tibial area, results of well-conducted randomized controlled trials have to be awaited to change this strategy. Because of diameter similarities with coronary arteries, the first stents applied in the infrapopliteal vessels were all coronary devices. Once the feasibility of the stenting approach with these coronary products was shown, device manufacturers started to develop a dedicated infrapopliteal product range. To date, a broad spectrum of stent types has been used and investigated for the given indication. This article overviews the available literature and results of different balloon-expandable (bare metal, passive coated, drug eluting), self-expanding and absorbable stent types available for below-the-knee application and gives recommendations for future device technology advancements.
Devido ao receio de que a trombose precoce ou a estenose tardia por hiperplasia intimal possam impedir a manutenção da perviedade em vasos de pequeno calibre, o uso de stents pós-angioplastia no leito arterial infrapoplíteo permanece controverso e geralmente é reservado aos casos de resultado subótimo após angioplastia transluminal percutânea (isto é, estenose residual > 50% ou dissecção com limitação do fluxo). Apesar de evidências começarem a favorecer o uso de stents no segmento tibial, é necessário aguardar o resultado de ensaios controlados, randomizados e bem conduzidos para mudar esta estratégia. Sendo estes vasos infrapoplíteos de diâmetro similar às artérias coronárias, os primeiros stents usados neste segmento eram todos stents coronários. Uma vez que se mostrou exeqüível o uso destes stents, a indústria iniciou o desenvolvimento de uma linha de produtos específicos ao segmento infrapoplíteo. Atualmente uma gama de stents tem sido usada e investigada para este fim. Este artigo revê resultados disponíveis na literatura com diferentes stents expansíveis por balão (metal não-recoberto, revestimento passivo, eluição de fármacos), auto-expansíveis e absorvíveis disponíveis para o segmento infrapoplíteo e apresenta recomendações para os futuros avanços tecnológicos dos dispositivos.