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    Efficacy summary

    Limb salvage

    In a cohort study of 60 patients with CLTI who had superficial venous arterialisation or antiplatelet therapy (100 mg aspirin per day), the rate of limb salvage was statistically significantly higher in the superficial venous arterialisation group than the antiaggregation therapy group after a mean follow up of 6 months (83% compared with 13%, p<0.001; Djoric 2012).

    In a cohort study of 36 patients with CLTI who had superficial venous arterialisation or conversative treatment (antiplatelet drugs), limb salvage was reported in 92% (11/12) of patients who had superficial venous arterialisation and 13% (3/24) of patients who had conservative treatment at a mean follow up of 5 months (p<0.001; Djoric 2011).

    In a cohort study of 28 patients with CLTI who had superficial venous arterialisation or conservative treatment, the rates of limb salvage at 1, 3, 6 and 12 months were 86%, 64%, 57% and 57% in the venous arterialisation group and 71%, 71%, 54% and 54% in the conservative treatment group (Matzke 1999).

    In a case series of 18 patients with CLTI, limb salvage was reported in 56% (10/18) of patients who had superficial venous arterialisations at a mean follow up of 23 months (Busato 2010).

    Survival

    In the cohort study of 60 patients, the survival rate was statistically significantly higher in the superficial venous arterialisation group than the antiplatelet therapy group after a mean follow up of 6 months (97% compared with 67%, p<0.01; Djoric 2012).

    In the cohort study of 36 patients, the survival rate was statistically significantly higher in patients who had superficial venous arterialisation than patients who had conservative treatment at a mean follow up of 5 months (100% compared with 67%, p=0.024; Djoric 2011).

    In the cohort study of 28 patients, the survival rates at 1, 3, 6 and 12 months were 100%, 92%, 92% and 92% in the superficial venous arterialisation group and 100%, 79%, 64% and 64% in the conservative treatment group (Matzke 1999).

    In the case series of 18 patients, the survival rate was 83% at a mean follow up of 23 months, with an overall mortality rate of 17% (Busato 2010).

    Pain relief

    In the cohort study of 60 patients, pain relief was achieved in 83% of patients in the superficial venous arterialisation group and 7% of patients in the antiaggregation therapy group after a mean follow up of 6 months (p<0.001; Djoric 2012).

    In the cohort study of 36 patients, pain relief was reported in 75% (9/12) of patients who had superficial venous arterialisation compared with 8% (2/24) of patients who had conservative treatment at a mean follow up of 5 months (p<0.001; Djoric 2011).

    Would or minor amputation healing

    In the cohort study of 60 patients, would healing was reported in 88% of patients in the superficial venous arterialisation group compared with 0% in the antiaggregation therapy group after a mean follow up of 6 months (p<0.001; Djoric 2012).

    In the cohort study of 36 patients, there was a statistically significant difference in wound healing between the superficial venous arterialisation group and the conservative treatment group at a mean follow up of 5 months (78% compared with 0%, p<0.001; Djoric 2011)

    In the case series of 18 patients, healing of minor amputations was reported in 33% (6/18) of patients at a mean follow up of 23 months after superficial venous arterialisation (Busato 2010).

    Major amputations

    Major amputations were done in 39% (7/18) of patients at a mean follow up of 23 months after superficial venous arterialisation in the case series of 18 patients (Busato 2010). Of these 7 patients, 1 patient with diabetes and chronic renal failure died after developing septicaemia by ascending infection.