Thrombolysis for Acute Lower Limb Ischaemia—A Prospective, Randomised, Multicentre Study Comparing Two Strategies

Pláte, Gunnar; Jansson, I; Forssell, Claes; Weber, P; Oredsson, Sven

doi:10.1016/j.ejvs.2005.11.017

Cited by 38 publications

(34 citation statements)

References 35 publications

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“…Risk factor analysis is very seldom matched against a follow-up period longer than 1 year, and, in particular, long-term data on leg salvage are scarce. The reported limb salvage rate of 82% in one study 15 and up to 88% in other studies 9,16 at 1 year is within the range of our results, whereas the Kaplan-Meier curve in the present study shows a continuous decline towards a limb salvage rate of only 60% at 5 years. Motor deficit and presence of foot ulcer at admission, as well as degree of lysis, were independent factors associated with amputation, which is in accordance with the findings by Earnshaw et al 9 The amputation rate among patients with diabetes mellitus receiving thrombolysis was as high as 47%, which seems to be highly associated with a lesser degree of lysis and the high prevalence of foot ulcers among diabetic patients.…”

Section: Discussionsupporting

confidence: 75%

Long-term prognostic factors after thrombolysis for lower limb ischemia

Kuoppala

Franzén

Lindblad

et al. 2008

Journal of Vascular Surgery

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Thrombolysis is successful, with few major complications in most patients with lower limb ischemia. Patients with ischemic heart disease and foot ulcers are at higher long-term risk for both amputation and death. A lesser degree of lysis and motor deficit were associated with higher amputation rates. The presence of such negative prognostic factors may help clinicians to deny further invasive vascular treatment. Renal insufficiency, cerebrovascular disease, and acute lower limb ischemia were associated with increased mortality.

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Section: Discussionsupporting

confidence: 75%

Long-term prognostic factors after thrombolysis for lower limb ischemia

Kuoppala

Franzén

Lindblad

et al. 2008

Journal of Vascular Surgery

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“…The success rates for the two hospitals with two different treatment strategies were similar at 30 days in terms of limb salvage and survival. The reported amputation-free survival rate of 83·6 per cent in this study is similar to that in previous reports14,23,24.…”

Section: Discussionsupporting

confidence: 92%

“…A higher dose of rtPA can accelerate the thrombolysis and achieve faster restoration of blood flow, a potential advantage to patients with acute ischaemia14,25,26. Faster thrombolysis with a higher dose of rtPA is counterbalanced by a higher rate of bleeding complications16,25; the risk of bleeding must be weighed against the risk of surgery or amputation for each patient27.…”

Section: Discussionmentioning

confidence: 99%

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Outcome and complications after intra-arterial thrombolysis for lower limb ischaemia with or without continuous heparin infusion

Grip

Kuoppala

Acosta

et al. 2014

British Journal of Surgery

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BackgroundThrombolysis is a common treatment for acute leg ischaemia. The purpose of this study was to evaluate different thrombolytic treatment strategies, and risk factors for complications.MethodsThis was a retrospective analysis of prospective databases from two vascular centres. One centre used a higher dose of heparin and recombinant tissue plasminogen activator (rtPA).ResultsSome 749 procedures in 644 patients of median age 73 years were studied; 353 (47·1 per cent) of the procedures were done in women. The aetiology of ischaemia was graft occlusion in 38·8 per cent, acute arterial thrombosis in 32·2 per cent, embolus in 22·3 per cent and popliteal aneurysm in 6·7 per cent. Concomitant heparin infusion was used in 63·2 per cent. The mean dose of rtPA administered was 21·0 mg, with a mean duration of 25·2 h. Technical success was achieved in 80·2 per cent. Major amputation and death within 30 days occurred in 13·1 and 4·4 per cent respectively. Bleeding complications occurred in 227 treatments (30·3 per cent). Blood transfusion was needed in 104 (13·9 per cent). Three patients (0·4 per cent of procedures) had intracranial bleeding; all were fatal. Amputation-free survival was 83·6 per cent at 30 days at both centres. In multivariable analysis, preoperative severe ischaemia with motor deficit was the only independent risk factor for major bleeding (odds ratio (OR) 2·98; P <0·001). Independent risk factors for fasciotomy were severe ischaemia (OR 2·94) and centre (OR 6·50). Embolic occlusion was protective for major amputation at less than 30 days (OR 0·30; P = 0·003). Independent risk factors for death within 30 days were cerebrovascular disease (OR 3·82) and renal insufficiency (OR 3·86).ConclusionBoth treatment strategies were successful in achieving revascularization with acceptable complication rates. Continuous heparin infusion during intra-arterial thrombolysis appeared to offer no advantage.

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“…8 Recent systematic reviews have focused on developing a technique that produces the best immediate or short-term patency, instead of comparing thrombolysis with open surgery. 9 Some studies have investigated the optimal infusion technique 10,11 and others have focused on which fibrinolytic agent to use. 12 Although there has been much focus on the immediate efficacy of intra-arterial thrombolysis compared with surgery and different thrombolytic techniques, the long-term outcomes after thrombolysis are less well documented.…”

Section: Introductionmentioning

confidence: 99%

Long-term Outcome after Thrombolysis for Acute Lower Limb Ischaemia

Grip¹,

Wanhainen²,

Acosta³

et al. 2017

Journal of Vascular Surgery

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WHAT THIS STUDY ADDSReporting on the long-term outcome in a large cohort of patients treated with intra-arterial thrombolysis for acute lower limb ischaemia makes it possible to analyse the four main aetiological subgroups. Patients treated for occluded grafts, stents, or stent grafts had a higher risk of amputation and a lower amputation free survival, indicating the need for better treatment and follow-up. Re-interventions were most common after occluded grafts/stents/stent grafts, followed by occluded popliteal aneurysms, and native artery thrombosis, and least common after embolus. Overall, thrombolytic therapy achieved good medium and long-term clinical outcome and transformed an emergent into an elective situation. Objectives:The purpose was to study long-term outcome after thrombolysis for acute arterial lower limb ischaemia, and to evaluate the results depending on the underlying aetiology of arterial occlusion. Methods: This was a retrospective study of patients entered into a prospective database. Patients were identified in prospective databases from two vascular centres, including a large number of variables. Case records were analysed retrospectively. Through cross linkage with the Population Registry 100% accurate survival data were obtained. Between January 2001 and December 2013, 689 procedures were included. The aetiology of ischaemia was graft/stent/stent graft occlusion in 39.8%, arterial thrombosis in 27.7%, embolus in 25.1% and popliteal aneurysm in 7.4%. Results: The mean follow-up was 59.4 months (95% CI, 56.1e62.7), during which 32.9% needed further reinterventions, 16.4% underwent amputation without re-intervention, and 50.7% had no re-intervention. The need for re-intervention during follow-up was 48.0% in the graft/stent occlusions group, 34.0% of the popliteal aneurysm group, 25.4% in the thrombosis group, and 16.3% in the embolus group (p < .001). The overall primary patency rates were 69.1% and 55.9% at 1 and 5 years, respectively. Primary patency at 5 years was higher for the embolus group (83.3%, p ¼ .002) and lower for the occluded graft/stent group (43.3%, p < .001). Secondary patency rates were 80.1% and 75.2% at 1 and 5 years, respectively, without difference between the subgroups. The amputation rate was lower in the embolic group at 1 and 5 years (8.1% and 11.1%, respectively, p ¼ .001). Survival was higher in the group with occluded popliteal aneurysms at 5 years (83.3%, p ¼ 0.004). Amputation free survival was 72.1% and 45.2% at 1 and 5 years; lower in the occluded graft/stent group at five years (37.9%, p ¼ .007). Conclusion: Intra-arterial thrombolytic therapy achieves good medium and long-term clinical outcome, reducing the need of open surgical treatment in most patients.

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Thrombolysis for Acute Lower Limb Ischaemia—A Prospective, Randomised, Multicentre Study Comparing Two Strategies

Abstract: 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.

Cited by 38 publications

References 35 publications

Long-term prognostic factors after thrombolysis for lower limb ischemia

Long-term prognostic factors after thrombolysis for lower limb ischemia

Outcome and complications after intra-arterial thrombolysis for lower limb ischaemia with or without continuous heparin infusion

Long-term Outcome after Thrombolysis for Acute Lower Limb Ischaemia

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