Artéria femoral profunda: uma opção como origem de fluxo para derivações infrageniculares Deep femoral artery: an option as inflow site in infragenicular bypasses

CONTEXTO: Na isquemia crítica, a artéria femoral profunda pode tornar-se a opção mais distal como origem de fluxo para derivações distais em casos de oclusão da origem da artéria femoral superficial associada a prega inguinal hostil. OBJETIVO:Avaliar, retrospectivamente, a artéria femoral profunda como doadora de fluxo para derivações infrageniculares. MÉTODOS: De 2000 a 2005, 129 derivações infrageniculares apresentaram anastomose proximal nas artérias femorais, comum (40), superficial (72) e profunda (17). O presente estudo teve como foco a artéria femoral profunda, e suas indicações foram: prega inguinal hostil (seis casos), limite da extensão do substituto (seis casos) e ambos os fatores (outros cinco casos). Foram abordadas a primeira e a segunda porção em 12 casos e a terceira porção em cinco casos. As cirurgias foram secundárias em 47% dos casos, e os substitutos utilizados foram veias do membro superior em 11 casos, safena interna em cinco e safena externa em um caso. RESULTADOS: No total dos enxertos (129), as estimativas de perviedade primária e salvamento do membro foram: 68,0% e 84,7%, respectivamente, com erro padrão (EP) aceitável (0,1) em 36 meses. Quando o grupo foi estratificado, as artérias femorais comum, superficial e profunda apresentaram resultados comparáveis de perviedade primária (63,3, 70,2 e 64,7%; p = 0,63) e salvamento do membro (83,1, 82,4 e 92,3%; p = 0,78). A perviedade dos enxertos com origem nas porções proximal e distal da artéria femoral profunda, bem como das cirurgias primárias e secundárias, foram comparáveis, sem diferença estatística significante (p = 0,89 e p = 0,77, respectivamente). CONCLUSÃO: A artéria femoral profunda mostrou ser acessível e efetiva como origem de fluxo de enxertos infrageniculares, com resultados satisfatórios de perviedade e salvamento do membro.<br>BACKGROUND: Deep femoral artery can be the most distal technical option as donor site in patients with critical limb ischemia presenting superficial artery occlusion and hostile groins. OBJECTIVE: To retrospectively assess the deep femoral artery as an inflow site for infragenicular bypass grafts. METHODS: From 2000 to 2005, 129 infragenicular bypass grafts with proximal anastomosis located in femoral arteries were performed. Forty were located in the common femoral artery (CFA), 72 in the superficial femoral artery (SFA) and 17 in the deep femoral artery (DFA). Indications for using the DFA as inflow were hostile groin (six cases), limited arterial substitute length (six cases) or both (five cases). Anastomosis site was located in the first or second portion in 12 cases, and in the third in five cases. The surgery was secondary in 47% of the cases, and the arterial substitutes used were arm veins (11), greater saphenous vein (five) and lesser saphenous vein (one). RESULTS: Primary patency and limb salvage rates were 68.0 and 84.7%, respectively, with acceptable standard error (0.1) in 36 months. The results of patency divided by inflow artery were similar (CFA, 63.3%; SFA, 70.2%; DFA 64.7%; p = 0.63), as well as limb salvage rates (CFA, 83.1%; SFA, 82.4%; DFA 92.3%; p = 0.78). Analyzing the deep femoral group, no difference of patency rates was observed when the anastomotic site was compared (proximal vs. distal portions of the DFA) or between patients with or without previous grafts. (p = 0.89 and 0.77, respectively). CONCLUSION: Deep femoral artery is a feasible and effective option as donor site for infragenicular bypass grafts, with satisfactory patency and limb salvage rates

Terutroban versus aspirin in patients with cerebral ischaemic events (PERFORM): a randomised, double-blind, parallel-group trial

Background: Patients with ischaemic stroke or transient ischaemic attack (TIA) are at high risk of recurrent stroke or other cardiovascular events. We compared the selective thromboxane-prostaglandin receptor antagonist terutroban with aspirin in the prevention of cerebral and cardiovascular ischaemic events in patients with a recent non-cardioembolic cerebral ischaemic event. &lt;p/&gt;Methods: This randomised, double-blind, parallel-group trial was undertaken in 802 centres in 46 countries. Patients who had an ischaemic stroke in the previous 3 months or a TIA in the previous 8 days were randomly allocated with a central interactive response system to 30 mg per day terutroban or 100 mg per day aspirin. Patients and investigators were masked to treatment allocation. The primary efficacy endpoint was a composite of fatal or non-fatal ischaemic stroke, fatal or non-fatal myocardial infarction, or other vascular death (excluding haemorrhagic death). We planned a sequential statistical analysis of non-inferiority (margin 1·05) followed by analysis of superiority. Analysis was by intention to treat. The study was stopped prematurely for futility on the basis of the recommendation of the Data Monitoring Committee. This study is registered, number ISRCTN66157730. &lt;p/&gt;Findings: 9562 patients were assigned to terutroban (9556 analysed) and 9558 to aspirin (9544 analysed); mean follow-up was 28·3 months (SD 7·7). The primary endpoint occurred in 1091 (11%) patients receiving terutroban and 1062 (11%) receiving aspirin (hazard ratio [HR] 1·02, 95% CI 0·94–1·12). There was no evidence of a difference between terutroban and aspirin for the secondary or tertiary endpoints. We recorded some increase in minor bleedings with terutroban compared with aspirin (1147 [12%] vs 1045 [11%]; HR 1·11, 95% CI 1·02–1·21), but no significant differences in other safety endpoints. &lt;p/&gt;Interpretation: The trial did not meet the predefined criteria for non-inferiority, but showed similar rates of the primary endpoint with terutroban and aspirin, without safety advantages for terutroban. In a worldwide perspective, aspirin remains the gold standard antiplatelet drug for secondary stroke prevention in view of its efficacy, tolerance, and cost

Rationale and design of a randomized, double-blind, parallel-group study of terutroban 30 mg/day versus aspirin 100 mg/day in stroke patients: the prevention of cerebrovascular and cardiovascular events of ischemic origin with terutroban in patients with a history of ischemic stroke or transient ischemic attack (PERFORM) study.

BACKGROUND: Ischemic stroke is the leading cause of mortality worldwide and a major contributor to neurological disability and dementia. Terutroban is a specific TP receptor antagonist with antithrombotic, antivasoconstrictive, and antiatherosclerotic properties, which may be of interest for the secondary prevention of ischemic stroke. This article describes the rationale and design of the Prevention of cerebrovascular and cardiovascular Events of ischemic origin with teRutroban in patients with a history oF ischemic strOke or tRansient ischeMic Attack (PERFORM) Study, which aims to demonstrate the superiority of the efficacy of terutroban versus aspirin in secondary prevention of cerebrovascular and cardiovascular events. METHODS AND RESULTS: The PERFORM Study is a multicenter, randomized, double-blind, parallel-group study being carried out in 802 centers in 46 countries. The study population includes patients aged > or =55 years, having suffered an ischemic stroke (< or =3 months) or a transient ischemic attack (< or =8 days). Participants are randomly allocated to terutroban (30 mg/day) or aspirin (100 mg/day). The primary efficacy endpoint is a composite of ischemic stroke (fatal or nonfatal), myocardial infarction (fatal or nonfatal), or other vascular death (excluding hemorrhagic death of any origin). Safety is being evaluated by assessing hemorrhagic events. Follow-up is expected to last for 2-4 years. Assuming a relative risk reduction of 13%, the expected number of primary events is 2,340. To obtain statistical power of 90%, this requires inclusion of at least 18,000 patients in this event-driven trial. The first patient was randomized in February 2006. CONCLUSIONS: The PERFORM Study will explore the benefits and safety of terutroban in secondary cardiovascular prevention after a cerebral ischemic event.Journal ArticleMulticenter StudyRandomized Controlled TrialResearch Support, Non-U.S. Gov'tinfo:eu-repo/semantics/publishe

Rationale and design of a randomized, double-blind, parallel-group study of terutroban 30 mg/day versus aspirin 100 mg/day in stroke patients: the prevention of cerebrovascular and cardiovascular events of ischemic origin with terutroban in patients with a history of ischemic stroke or transient ischemic attack (PERFORM) study.

BACKGROUND: Ischemic stroke is the leading cause of mortality worldwide and a major contributor to neurological disability and dementia. Terutroban is a specific TP receptor antagonist with antithrombotic, antivasoconstrictive, and antiatherosclerotic properties, which may be of interest for the secondary prevention of ischemic stroke. This article describes the rationale and design of the Prevention of cerebrovascular and cardiovascular Events of ischemic origin with teRutroban in patients with a history oF ischemic strOke or tRansient ischeMic Attack (PERFORM) Study, which aims to demonstrate the superiority of the efficacy of terutroban versus aspirin in secondary prevention of cerebrovascular and cardiovascular events. METHODS AND RESULTS: The PERFORM Study is a multicenter, randomized, double-blind, parallel-group study being carried out in 802 centers in 46 countries. The study population includes patients aged > or =55 years, having suffered an ischemic stroke (< or =3 months) or a transient ischemic attack (< or =8 days). Participants are randomly allocated to terutroban (30 mg/day) or aspirin (100 mg/day). The primary efficacy endpoint is a composite of ischemic stroke (fatal or nonfatal), myocardial infarction (fatal or nonfatal), or other vascular death (excluding hemorrhagic death of any origin). Safety is being evaluated by assessing hemorrhagic events. Follow-up is expected to last for 2-4 years. Assuming a relative risk reduction of 13%, the expected number of primary events is 2,340. To obtain statistical power of 90%, this requires inclusion of at least 18,000 patients in this event-driven trial. The first patient was randomized in February 2006. CONCLUSIONS: The PERFORM Study will explore the benefits and safety of terutroban in secondary cardiovascular prevention after a cerebral ischemic event