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- Plate, G., et al.
(författare)
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Thrombolysis for acute lower limb ischaemia - a prospective, randomised, multicentre study comparing two strategies
- 2006
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Ingår i: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1078-5884 .- 1532-2165. ; 31, s. 651-660
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Tidskriftsartikel (refereegranskat)abstract
- Objectives To test if initial high-dose, pulse-spray thrombolysis improves the early and late outcome of lower limb ischaemia as compared with low-dose infusion alone. Design Prospective randomised multicentre study. Material and methods Patients with acute and sub-acute (<30 days) lower limb ischaemia were randomised following angiography. Group 1 (n=58) received pulse-spray infusion of recombinant plasminogen activator (rt-PA, 15 mg/h) for 2 h followed by low-dose infusion if needed. Group 2 (n=63) were only treated with low-dose infusion (0.5 mg/h) of rt-PA for 48 h. Underlying lesions were corrected if required. Results The study was stopped prematurely. Complications were equally frequent in both groups. More than 75% lysis was accomplished in 78 versus 67% of the patients (p=0.21). Primary endpoints (re-occlusion, incomplete lysis, life-threatening complication, amputation, or death) were reached in 24 versus 32% of the patients (p=0.35). Neither vascular patency nor clinical parameters differed during the first year, but re-interventions tended to be more frequent (p=0.040 at 1 month; p=0.090 at 1 year) and of a greater magnitude (p=0.028) in group 2. Conclusions There was no obvious advantage with initial high-dose thrombolysis, which may be a type-2 error. A reduction of major re-interventions was recorded. Objectives To test if initial high-dose, pulse-spray thrombolysis improves the early and late outcome of lower limb ischaemia as compared with low-dose infusion alone. Design Prospective randomised multicentre study. Material and methods Patients with acute and sub-acute (<30 days) lower limb ischaemia were randomised following angiography. Group 1 (n=58) received pulse-spray infusion of recombinant plasminogen activator (rt-PA, 15 mg/h) for 2 h followed by low-dose infusion if needed. Group 2 (n=63) were only treated with low-dose infusion (0.5 mg/h) of rt-PA for 48 h. Underlying lesions were corrected if required. Results The study was stopped prematurely. Complications were equally frequent in both groups. More than 75% lysis was accomplished in 78 versus 67% of the patients (p=0.21). Primary endpoints (re-occlusion, incomplete lysis, life-threatening complication, amputation, or death) were reached in 24 versus 32% of the patients (p=0.35). Neither vascular patency nor clinical parameters differed during the first year, but re-interventions tended to be more frequent (p=0.040 at 1 month; p=0.090 at 1 year) and of a greater magnitude (p=0.028) in group 2. Conclusions There was no obvious advantage with initial high-dose thrombolysis, which may be a type-2 error. A reduction of major re-interventions was recorded.
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| 2. |
- Plate, G., et al.
(författare)
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When is Thrombolysis for Acute Lower Limb Ischemia Worthwhile?
- 2009
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Ingår i: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1532-2165 .- 1078-5884. ; 37:2, s. 206-212
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: To find variables associated with outcome following thrombolytic treatment for acute lower limb ischemia. Design: Re-analysis of a prospective multicentre study. Material and methods: One hundred and twenty-one patients with acute lower limb ischemia previously included in a randomised study comparing high- with low-dose thrombolysis were re-analysed ignoring the mode of lytic treatment. All possibly predictive variables were subjected to multivariate analyses to find associations with outcome. Results: Previous successful thrombolysis, ankle-brachial index over 0.33, absence of motor dysfunction, presence of cardiac arrhythmia, and lysis of a vascular graft were all associated with successful thrombolysis (p = 0.003). Previous thrombolysis, age less than 70 years, and ankle-brachial index over 0.33 were all perfect predictors of absence of life-threatening complications or death. Successful lysis, age < 70, and lysis of a native artery as opposed to a vascular graft were all associated with clinical success (preserved patency, limb, and life) after one year (p = 0.002). Conclusions: Previous thrombolysis, age under 70 years, and non-severe ischemia predict successful thrombolysis free from severe complications. Successful thrombolysis is strongly predictive of amputation-free survival with vascular patency for at least one year. Occluded grafts could often be reopened, but long-term outcome is better after thrombolysis of native arteries. (C) 2008 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.
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