[PMID]: | 28826727 |
[Au] Autor: | Jongsma H; van Mierlo-van den Broek P; Imani F; van den Heuvel D; de Vries JPM; Fioole B |
[Ad] Endereço: | Department of Vascular Surgery, Maasstad Hospital, Rotterdam, The Netherlands. Electronic address: jongsmah@maasstadziekenhuis.nl. |
[Ti] Título: | Randomized comparison of femoropopliteal artery drug-eluting balloons and drug-eluting stents (FOREST trial): Study protocol for a randomized controlled trial. |
[So] Source: | J Vasc Surg;66(4):1293-1298, 2017 Oct. |
[Is] ISSN: | 1097-6809 |
[Cp] País de publicação: | United States |
[La] Idioma: | eng |
[Ab] Resumo: | The optimal endovascular treatment for femoropopliteal arterial occlusive disease has yet to be assessed. Patency rates after uncoated balloon angioplasty are disappointing. Although stents have better outcomes, they also have limitations. Intra-arterial stenting may lead to stent thrombosis and flow pattern disruption, which may result in stent fracture or in-stent restenosis. In the past decade, drug-eluting balloons (DEBs) and drug-eluting stents (DESs) have been introduced, and both have been proven to possess antirestenotic features compared with conventional techniques. The objective of this study is to perform a noninferiority analysis of DEBs with provisional bare-metal stenting and primary stenting with DESs in the treatment of femoropopliteal arterial occlusive disease. If DEB with provisional bare-metal stenting proves to be noninferior to primary stenting with DESs, DEBs may be the favorable technique because the postoperative long-term limitations of stents will be restricted. This is a prospective, randomized, controlled, single-blind, multicenter trial. The study population consists of volunteers aged ≥18 years, with chronic, symptomatic peripheral arterial occlusive disease (Rutherford-Baker classification 2 to 5) caused by de novo stenotic or occlusive atherosclerotic lesions of the superficial femoral artery or of the popliteal artery (only segment P1). Subjects will be treated with a DEB and provisional bare-metal stenting (if a stenosis >30% or a flow-limiting dissection persists after prolonged inflation with an uncoated balloon) or with primary stenting with a DES. The study will include 254 patients (ratio 1:1). The primary end point is 2-year freedom from binary restenosis, defined as a lumen diameter reduction of <50% assessed by duplex ultrasound imaging (peak systolic velocity ratio <2.5). Secondary end points are technical success, target lesion revascularization, target vessel revascularization, improvement in ankle-brachial index, improvement in Rutherford classification, amputation rate, and mortality rate. |
[Mh] Termos MeSH primário: |
Angioplastia com Balão/instrumentação Fármacos Cardiovasculares/administração & dosagem Materiais Revestidos Biocompatíveis Stents Farmacológicos Artéria Femoral Doença Arterial Periférica/terapia Dispositivos de Acesso Vascular
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[Mh] Termos MeSH secundário: |
Angioplastia com Balão/efeitos adversos Índice Tornozelo-Braço Protocolos Clínicos Constrição Patológica Intervalo Livre de Doença Artéria Femoral/diagnóstico por imagem Artéria Femoral/fisiopatologia Seres Humanos Doença Arterial Periférica/diagnóstico Doença Arterial Periférica/fisiopatologia Desenho de Prótese Recuperação de Função Fisiológica Recidiva Projetos de Pesquisa Fatores de Tempo Resultado do Tratamento Ultrassonografia Doppler Dupla
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[Pt] Tipo de publicação: | COMPARATIVE STUDY; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL |
[Nm] Nome de substância:
| 0 (Cardiovascular Agents); 0 (Coated Materials, Biocompatible) |
[Em] Mês de entrada: | 1710 |
[Cu] Atualização por classe: | 171002 |
[Lr] Data última revisão:
| 171002 |
[Sb] Subgrupo de revista: | IM |
[Da] Data de entrada para processamento: | 170823 |
[St] Status: | MEDLINE |
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