Surgical or endovascular revascularization in patients with critical limb ischemia: Influence of diabetes mellitus on clinical outcome

Dick, Florian; Diehm, Nicolas; Galimanis, Aekaterini; Husmann, Marc; Schmidli, Juerg; Baumgartner, Iris

doi:10.1016/j.jvs.2006.12.022

Cited by 190 publications

(170 citation statements)

References 35 publications

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“…18,19 The majority of clinical failure in patients having claudication and treated by angioplasty of the SFA is because of reocclusion. 19 In patients with critical limb ischemia repeated reintervention is required to maintain good outcome.…”

Section: Discussionmentioning

confidence: 99%

“…19 In patients with critical limb ischemia repeated reintervention is required to maintain good outcome. 18 Unfortunately, reintervention after the loss of patency in the SFA has limited success and exposes the patient to repeat hospitalization and clinical risk. 20 In addition, the rate of reintervention is a major driver of the difference in costs between competing interventions and therefore of cost-effectiveness.…”

Section: Discussionmentioning

confidence: 99%

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Helical Centerline Stent Improves Patency

Zeller

Gaines

Ansel

et al. 2016

Circ: Cardiovascular Interventions

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The self-expanding stent is laser cut from a nitinol tube and has a 3D helical centerline geometry set into the nitinol shape memory (Figure 1). The stent is an advanced design with repeating 2 crown units and specific connectors that allow both flexibility and helical geometry. The end 3 crowns have gradually reducing radial force to improve the transition in profile from artery to stent. It is Background-Reintervention in the femoropopliteal artery is frequent and a major driver of cost-effectiveness. High wall shear generated by swirling blood flow is associated with reduced occurrence of atherosclerosis and restenosis. This trial investigated the clinical and hemodynamic outcomes of the BioMimics 3D self-expanding tubular nitinol stent with helical centerline geometry compared with a straight stent in the femoropopliteal artery. Methods and Results-In a prospective, multicenter, randomized controlled trial, 76 patients with symptomatic peripheral arterial disease were randomized 2:1 to receive a helical or a straight stent. An independent core laboratory adjudicated angiographic and ultrasound parameters. The primary safety end point was freedom from a composite of all death, target limb amputation, and target lesion revascularization at 30 days. The primary effectiveness end point was freedom from clinically driven target lesion revascularization at 6 months. Patency was a secondary end point. Subjects were followed up for 2 years from intervention. The primary safety (1-sided P<0.01) and efficacy (1-sided P<0.001) end points for the helical stent were met. The proportion of patients treated with the helical stent who maintained patency at 12 and 24 months was 80% and 72%, respectively, compared with 71% and 55% for the control group. The difference was significant through 24 months (P=0.05). Freedom from clinically driven target lesion revascularization for the helical compared with straight stent was 91% versus 92% at 12 months and 91% versus 76% at 24 months. Conclusions-Both groups had similar safety outcomes and clinically driven target lesion revascularization to 2 years.However, after placement of a BioMimics 3D helical stent, there was improved patency to 2 years. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT02163863.(Circ Cardiovasc Interv. 2016;9:e002930.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Helical Centerline Stent Improves Patency

Zeller

Gaines

Ansel

et al. 2016

Circ: Cardiovascular Interventions

View full text Add to dashboard Cite

show abstract

“…A presença de diabetes melito, leito distal ruim, insuficiência renal, longas lesões oclusivas e isquemia crítica é citada, na literatura, como relacionada à diminuição da perviedade a médio e longo prazo 1,2,6,[20][21][22][23] , enquanto outros não encontraram uma relação precisa 19 . Nossos achados mostraram que somente o diabetes melito e um leito distal pobre (ausên-cia de artéria infrapoplítea pérvia) influenciaram no resultado em 1 ano de acompanhamento.…”

Section: Discussionunclassified

Revascularização endovascular infrainguinal: fatores determinantes para a perviedade

Nasser

Jesus-Silva²,

Biagioni³

et al. 2009

J. vasc. bras.

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ResumoContexto: A terapia endovascular tem avançado muito como tratamento para a doença arterial oclusiva infrainguinal, principalmente com o desenvolvimento dos materiais e dos stents autoexpansíveis de nitinol.Objetivo: Avaliar os resultados e os fatores determinantes da angioplastia fêmoro-poplítea em pacientes portadores de isquemia de membros inferiores. Métodos:Foram tratados, através de angioplastia com ou sem stent, 114 pacientes, e acompanhados por um período médio de 12 meses. A média de idade foi de 66 anos; 53% eram do sexo feminino; 23,7% eram portadores de claudicação incapacitante; 8,8%, de dor isquêmica de repouso; e 67,5%, de lesão trófica. As lesões foram classificadas segundo o TransAtlantic Inter-Society Consensus II em A (53%), B (34%), C (5%) e D (9%).Resultados: A análise angiográfica do leito distal mostrou uma média de 1,4±1,0 artérias infrapoplíteas pérvias. O sucesso inicial foi de 97%. No seguimento de 1, 6, 12 e 24 meses, a perviedade primária foi de 94, 78, 48 e 31%, e a primária assistida, de 94, 84, 73 e 61%, respectivamente (p = 0,005). O leito distal pobre e a presença de diabetes melito foram associados a uma menor perviedade primária (p = 0,01), enquanto a extensão da lesão não influenciou os resultados. As taxas de salvamento de membro em 6, 12 e 24 meses foram de 95, 90 e 90%, respectivamente. Conclusões:A extensão das lesões tratadas não foi um fator determinante em nossa casuística para o menor sucesso da angioplastia, o que pode sugerir que as indicações para o tratamento endovascular possam ser ampliadas para pacientes com lesões TransAtlantic Inter-Society Consensus II C/D. Palavras-chave: Artéria femoral, artéria poplítea, angioplastia com balão, arteriosclerose obliterante. AbstractBackground: Endovascular techniques have undergone major advances with regard to the treatment of infrainguinal arterial occlusive disease, mainly as a result of the improvement of new devices and self-expanding nitinol stents.

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“…Данный феномен у больных СД и КИНК может объясняться развитием не-удовлетворительного коллатерального кровотока на стопе вследствие подавленного артериогенеза и процесса но-вообразования коллатеральных сосудов в ответ на ише-мию [32]. Эти же патогенетические механизмы дефицита коллатерального кровообращения, предположительно, лежат в основе менее долгосрочного клинического успеха реваскуляризации у больных СД в сравнении с лицами без СД [33,34]. Также было отмечено, что изолированная окклюзия хотя бы одной артерии голени у пациентов с СД в условиях недостаточного коллатерального кровотока может приводить к локальной ишемии соответствующего ангиосома и развитию трофических изменений мягких тканей стопы [23].…”

Section: особенности эндоваскулярного лечения больных сд и кинкunclassified

The clinical course of critical limb ischaemia and the role of endovascular revascularisation in patients with diabetes

Бондаренко¹,

Galstyan²,

Dedov³

2015

Diabetes mellitus

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Surgical or endovascular revascularization in patients with critical limb ischemia: Influence of diabetes mellitus on clinical outcome

Abstract: Diabetic patients with chronic CLI benefit from early revascularization. To achieve this benefit, multiple revascularization procedures may be required, and close surveillance is therefore mandatory. Choice of initial revascularization modality seems not to influence clinical success.

Cited by 190 publications

References 35 publications

Helical Centerline Stent Improves Patency

Helical Centerline Stent Improves Patency

Revascularização endovascular infrainguinal: fatores determinantes para a perviedade

The clinical course of critical limb ischaemia and the role of endovascular revascularisation in patients with diabetes

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