Document Detail

Results of a prospective, randomized trial of surgery versus thrombolysis for occluded lower extremity bypass grafts.
MedLine Citation:
PMID:  8795509     Owner:  NLM     Status:  MEDLINE    
PURPOSE: The purpose of this study was to prospectively evaluate the treatment of patients with occluded lower extremity bypass grafts, comparing surgical revascularization with catheter-directed thrombolysis. MATERIALS AND METHODS: One hundred twenty-four patients (68% male and 32% female) with lower limb bypass graft occlusion (46 autogenous and 78 prosthetic) were prospectively randomized to surgery (n = 46) or intra-arterial catheter-directed thrombolysis (n = 78) with recombinant tissue plasminogen activator (rt-PA) 0.1 mg/kg/h modified to 0.05 mg/kg/h for up to 12 hours, or urokinase (UK) 250,000 U bolus followed by 4,000 U/min for 4 hours, then 2,000 U/min for up to 36 hours. A composite clinical outcome including death, amputation, ongoing/recurrent ischemia, and major morbidity was analyzed on an intent-to-treat basis at 30 days and 1 year. RESULTS: The average duration of graft occlusion was 34.0 days, with 58 (48%) presenting with acute ischemia (0 to 14 days) and 64 (52%) with chronic ischemia (> 14 days). Thirty-nine percent randomized to lysis failed catheter placement and required surgical revascularization. Overall, there was a better composite clinical outcome at 30 days (P = 0.023) and 1 year (P = 0.04) in the surgical group compared with lysis, due predominately to a reduction in ongoing/recurrent ischemia, most notable in autogenous grafts. However, following successful catheter placement, patency was restored by lysis in 84%, and 42% had a major reduction in their planned operation. One-year results of successful lysis compared favorably with the best surgical procedure, which was new graft placement. Acutely ischemic patients (0 to 14 days) randomized to lysis demonstrated a trend toward a lower major amputation rate at 30 days (P = 0.074) and significantly at 1 year (P = 0.026) compared with surgical patients, while those with > 14 days ischemia showed no difference in limb salvage but higher ongoing/recurrent ischemia in lytic patients (P < 0.001). Patients with occluded prosthetic grafts had greater major morbidity than did those with occluded autogenous grafts (P < 0.02). CONCLUSIONS: Proper catheter positioning currently limits the potential of catheter-directed thrombolysis for lower extremity bypass graft occlusion. Patients with graft occlusion > 14 days have a significantly better outcome when treated surgically, with a new bypass being the best surgical option. However, in patients with acute limb ischemia (< 14 days) successful thrombolysis of occluded lower extremity bypass grafts improves limb salvage and reduces the magnitude of the planned surgical procedure. Patients with occluded prosthetic grafts suffer more major morbid events compared with occluded autogenous grafts.
A J Comerota; F A Weaver; J D Hosking; J Froehlich; H Folander; B Sussman; K Rosenfield
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  American journal of surgery     Volume:  172     ISSN:  0002-9610     ISO Abbreviation:  Am. J. Surg.     Publication Date:  1996 Aug 
Date Detail:
Created Date:  1996-10-15     Completed Date:  1996-10-15     Revised Date:  2008-11-21    
Medline Journal Info:
Nlm Unique ID:  0370473     Medline TA:  Am J Surg     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  105-12     Citation Subset:  AIM; IM    
Temple University Hospital, Philadelphia, Pennsylvania 19140, USA.
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MeSH Terms
Graft Occlusion, Vascular / complications,  drug therapy*,  surgery*
Ischemia / drug therapy,  etiology,  surgery
Leg / blood supply*
Plasminogen Activators / therapeutic use*
Prospective Studies
Thrombolytic Therapy*
Time Factors
Tissue Plasminogen Activator / therapeutic use*
Treatment Outcome
Urokinase-Type Plasminogen Activator / therapeutic use*
Reg. No./Substance:
EC 3.4.21.-/Plasminogen Activators; EC Plasminogen Activator; EC Plasminogen Activator

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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