Document Detail


Comparison of bivalirudin monotherapy versus unfractionated heparin plus tirofiban in patients with diabetes mellitus undergoing elective percutaneous coronary intervention.
MedLine Citation:
PMID:  19840566     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Bivalirudin demonstrated similar efficacy but resulted in a lower rate of bleeding compared to unfractionated heparin (UFH) plus platelet glycoprotein IIb/IIIa inhibitors in patients undergoing percutaneous coronary intervention. It has not been clearly evaluated whether this can also be applied to patients with diabetes mellitus. A total of 335 consecutive patients with diabetes mellitus referred for elective percutaneous coronary intervention were randomized in the Novel Approaches for Preventing or Limiting EventS (NAPLES) trial to receive bivalirudin monotherapy or UFH plus routine tirofiban. The primary composite end point (30-day composite incidence of death, urgent repeat revascularization, myocardial infarction, and all bleeding) was lower in the bivalirudin group than in the UFH plus tirofiban group (18.0% vs 31.5%, odds ratio 0.47, 95% confidence interval 0.28 to 0.79, p = 0.004). No death, urgent revascularization, or Q-wave myocardial infarction occurred. The rate of non-Q-wave myocardial infarction was similar in the 2 groups (10.2% in the bivalirudin group vs 12.5% in the UFH plus tirofiban group, p = 0.606). In contrast, fewer patients in the bivalirudin group experienced bleeding (8.4% vs 20.8%, odds ratio 0.34, 95% confidence interval 0.18 to 0.67, p = 0.002). This difference was mainly ascribed to the lower rate of minor bleeding (7.8% in the bivalirudin group vs 18.5% in the UFH plus tirofiban group, odds ratio 0.37, 95% confidence interval 0.19 to 0.74, p = 0.005), although the rate of major bleeding in the 2 groups was comparable (0.6% vs 2.4%, respectively; p = 0.371). In conclusion, in patients with diabetes mellitus undergoing elective percutaneous coronary intervention, the strategy of bivalirudin monotherapy compared to UFH plus routine tirofiban is safe and feasible and associated with a significant reduction of in-hospital bleeding.
Authors:
Davide Tavano; Gabriella Visconti; Davide D'Andrea; Amelia Focaccio; Bruno Golia; Mariateresa Librera; Mario Caccavale; Bruno Ricciarelli; Carlo Briguori
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  The American journal of cardiology     Volume:  104     ISSN:  1879-1913     ISO Abbreviation:  Am. J. Cardiol.     Publication Date:  2009 Nov 
Date Detail:
Created Date:  2009-10-20     Completed Date:  2009-11-24     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0207277     Medline TA:  Am J Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1222-8     Citation Subset:  AIM; IM    
Affiliation:
Clinica Mediterranea, Naples, Italy.
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MeSH Terms
Descriptor/Qualifier:
Aged
Angioplasty, Transluminal, Percutaneous Coronary*
Anticoagulants / therapeutic use*
Coronary Artery Disease / epidemiology,  therapy*
Diabetes Mellitus / epidemiology*
Drug Therapy, Combination
Female
Hemorrhage / epidemiology
Heparin / therapeutic use
Hirudins
Humans
Male
Myocardial Infarction / epidemiology,  prevention & control
Peptide Fragments / therapeutic use
Platelet Aggregation Inhibitors / therapeutic use*
Prospective Studies
Recombinant Proteins / therapeutic use
Retreatment
Thrombocytopenia / chemically induced,  epidemiology
Tyrosine / analogs & derivatives,  therapeutic use
Chemical
Reg. No./Substance:
0/Anticoagulants; 0/Hirudins; 0/Peptide Fragments; 0/Platelet Aggregation Inhibitors; 0/Recombinant Proteins; 128270-60-0/bivalirudin; 144494-65-5/tirofiban; 55520-40-6/Tyrosine; 9005-49-6/Heparin

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


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