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Thrombolysis for acute lower limb ischaemia - a prospective, randomised, multicentre study comparing two strategies
Central Hospital, Helsingborg.
Central Hospital, Eskilstuna.
Central Hospital, Västerås.
Central Hospital, Växjö.
Vise andre og tillknytning
2006 (engelsk)Inngår i: European Journal of Vascular and Endovascular Surgery, ISSN 1078-5884, E-ISSN 1532-2165, Vol. 31, s. 651-660Artikkel i tidsskrift (Fagfellevurdert) Published
Abstract [en]

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.

sted, utgiver, år, opplag, sider
2006. Vol. 31, s. 651-660
HSV kategori
Identifikatorer
URN: urn:nbn:se:liu:diva-37846DOI: 10.1016/j.ejvs.2005.11.017Lokal ID: 39630OAI: oai:DiVA.org:liu-37846DiVA, id: diva2:258695
Tilgjengelig fra: 2009-10-10 Laget: 2009-10-10 Sist oppdatert: 2017-12-13

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