Document Detail

Combination therapy with warfarin plus clopidogrel improves outcomes in femoropopliteal bypass surgery patients.
MedLine Citation:
PMID:  22551909     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Patients having undergone femoropopliteal bypass surgery remain at significant risk of graft failure. Although antithrombotic therapy is of paramount importance in these patients, the effect of oral anticoagulation therapy (OAT) on outcomes remains unresolved. We performed a randomized, prospective study to assess the impact of OAT plus clopidogrel vs dual antiplatelet therapy on peripheral vascular and systemic cardiovascular outcomes in patients who had undergone femoropopliteal bypass surgery.
METHODS: Three hundred forty-one patients who had undergone femoropopliteal surgery were enrolled and randomized: 173 patients received clopidogrel 75 mg/d plus OAT with warfarin (C + OAT), and 168 patients received dual antiplatelet therapy with clopidogrel 75 mg/d plus aspirin 100 mg/d (C + acetylsalicylic acid [ASA]). Study end points were graft patency and the occurrence of severe peripheral arterial ischemia, and the incidence of bleeding episodes.
RESULTS: Follow-up ranged from 4 to 9 years. The graft patency rate and the freedom from severe peripheral arterial ischemia was significantly higher in C + OAT group than in C + ASA group (P = .026 and .044, respectively, Cox-Mantel test). The linearized incidence of minor bleeding complications was significantly higher in C + OAT group than in C + ASA group (2.85% patient-years vs 1.37% patient-years; P = .03). The incidence of major adverse cardiovascular events, including mortality, was found to be similar (P = .34) for both study groups.
CONCLUSIONS: In patients who have undergone femoropopliteal vascular surgery, combination therapy with clopidogrel plus warfarin is more effective than dual antiplatelet therapy in increasing graft patency and in reducing severe peripheral ischemia. These improvements are obtained at the expenses of an increase in the rate of minor anticoagulation-related complications.
Mario Monaco; Luigi Di Tommaso; Giovanni Battista Pinna; Stefano Lillo; Vincenzo Schiavone; Paolo Stassano
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial     Date:  2012-05-01
Journal Detail:
Title:  Journal of vascular surgery     Volume:  56     ISSN:  1097-6809     ISO Abbreviation:  J. Vasc. Surg.     Publication Date:  2012 Jul 
Date Detail:
Created Date:  2012-07-03     Completed Date:  2012-09-20     Revised Date:  2012-10-03    
Medline Journal Info:
Nlm Unique ID:  8407742     Medline TA:  J Vasc Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  96-105     Citation Subset:  IM    
Copyright Information:
Copyright © 2012 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.
Departments of Cardiovascular Surgery and Anesthesiology, Istituto Clinico Pineta Grande, Castel Volturno (CE), Italy.
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MeSH Terms
Administration, Oral
Aspirin / administration & dosage,  therapeutic use
Cardiovascular Diseases / prevention & control*
Chi-Square Distribution
Drug Therapy, Combination
Femoral Artery / surgery*
Graft Occlusion, Vascular / prevention & control*
Logistic Models
Peripheral Vascular Diseases / prevention & control
Platelet Aggregation Inhibitors / administration & dosage,  therapeutic use*
Popliteal Artery / surgery*
Proportional Hazards Models
Prospective Studies
Ticlopidine / administration & dosage,  analogs & derivatives*,  therapeutic use
Treatment Outcome
Vascular Patency
Warfarin / administration & dosage,  therapeutic use*
Reg. No./Substance:
0/Platelet Aggregation Inhibitors; 50-78-2/Aspirin; 55142-85-3/Ticlopidine; 81-81-2/Warfarin; 90055-48-4/clopidogrel

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

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