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PTFE bypass or thru...
PTFE bypass or thrupass for superficial femoral artery occlusion? : A randomised controlled trial
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Lepäntalo, M. (author)
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Laurila, K. (author)
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Roth, W-D. (author)
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Rossi, P. (author)
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Lavonen, J. (author)
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Mäkinen, K. (author)
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Manninen, H. (author)
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Romsi, P. (author)
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Perälä, J. (author)
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- Bergqvist, David (author)
- Uppsala universitet,Kärlkirurgi
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(creator_code:org_t)
- Elsevier BV, 2009
- 2009
- English.
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In: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1078-5884 .- 1532-2165. ; 37:5, s. 578-584
- Related links:
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http://www.ejves.com...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
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- Early results of a thrupass endograft in the treatment of femoral lesions are promising. Less morbidity and better cost-effectiveness are suggested to be achieved in the treatment of chronic lower limb ischaemia with endovascular treatment compared to surgical treatment. PATIENTS AND METHODS: This randomised multicentre trial aimed to enroll a group of 60+60 patients for the treatment of 5-25-cm occlusions of superficial femoral artery (SFA) to be followed up for 3 years. Patients were treated either with endoluminal PTFE thrupass (WL Gore & Ass) or with surgical polytetrafluoroethylene (PTFE) bypass to proximal popliteal artery. Primary patency at 3 years was scheduled to be the primary end-point and secondary patency, functional success, costs and quality of life the secondary end-points. RESULTS: A sample of 100 consecutive SFA occlusions in one of the centres revealed that only 4% of the lesions were amenable for the study. The trial was prematurely terminated due to the results of an interim analysis at the time when 44 patients were recruited: the 1-year primary patency (excluding technical failures) was 48% for thrupass and 95% for bypass (p=0.02). The patency difference in favour of surgical bypass over endovascular thrupass was also sustained after completion of 1-year follow-up, the primary patencies being 46% and 84% at 1 year with grossly equilinear life-table curves thereafter (p=0.18), respectively. The corresponding secondary patencies were 63% and 100% (p=0.05) when excluding technical failures and 58% and 100% (p=0.02) according to intention-to-treat analysis. Secondary outcomes were thus not analysed. CONCLUSION: Treatment of SFA occlusions (TASC IIB and C or Imelda Ia and II) should be done by PTFE bypass rather than by PTFE thrupass, as thrupass is connected with worse early outcome. These results represent only a small category of femoral disease.
Keyword
- MEDICINE
- MEDICIN
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Lepäntalo, M.
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Laurila, K.
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Roth, W-D.
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Rossi, P.
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Lavonen, J.
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Mäkinen, K.
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show more...
-
Manninen, H.
-
Romsi, P.
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Perälä, J.
-
Bergqvist, David
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show less...
- Articles in the publication
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European Journal ...
- By the university
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Uppsala University