In-Hospital Safety and Effectiveness of Bivalirudin in Percutaneous Peripheral Interventions: Data from a Real-World Registry

Purpose: To present real-world data to evaluate the safety and effectiveness of bivalirudin, a direct thrombin inhibitor, in an unselected group of patients undergoing percutaneous peripheral interventions (PPI). Methods: Data were extracted from a prospectively collected peripheral vascular registr...

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Bibliographic Details
Published in:Journal of endovascular therapy 2010-02, Vol.17 (1), p.31-36
Main Authors: Shammas, Nicolas W., Shammas, Gail A., Jerin, Michael, Dippel, Eric J., Shammas, Andrew N.
Format: Article
Language:English
Subjects:
Aged
Aged, 80 and over
Angioplasty - adverse effects
Anticoagulants - adverse effects
Anticoagulants - therapeutic use
Chi-Square Distribution
Constriction, Pathologic
Data bases
Female
Hemorrhage - chemically induced
Heparin - adverse effects
Heparin - therapeutic use
Hirudins - adverse effects
Humans
Inpatients - statistics & numerical data
Iowa
Ischemia - diagnostic imaging
Ischemia - etiology
Ischemia - therapy
Logistic Models
Male
Middle Aged
Patient safety
Patients
Peptide Fragments - adverse effects
Peptide Fragments - therapeutic use
Peripheral Vascular Diseases - complications
Peripheral Vascular Diseases - diagnostic imaging
Peripheral Vascular Diseases - therapy
Radiography
Recombinant Proteins - adverse effects
Recombinant Proteins - therapeutic use
Registries
Regression analysis
Retrospective Studies
Risk Assessment
Risk Factors
Severity of Illness Index
Standard deviation
Treatment Outcome
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Description
Summary:Purpose: To present real-world data to evaluate the safety and effectiveness of bivalirudin, a direct thrombin inhibitor, in an unselected group of patients undergoing percutaneous peripheral interventions (PPI). Methods: Data were extracted from a prospectively collected peripheral vascular registry developed for quality assurance measures at 2 centers. Of 398 consecutive patients (195 men; mean age 69.4±11.3 years) who underwent PPI in a 2-year period, 369 (92.7%) received bivalirudin (0.75 mg/kg bolus followed by a 1.75 mg/kg/h infusion) and 29 (7.3%) received unfractionated heparin (UFH). In the bivalirudin sample, critical limb ischemia was present in 28.0% of patients, TASC D lesion in 29.5%, and angiographic thrombus in 7.8% of vessels. Demographic, clinical, procedural, and angiographic variables and in-hospital complications were analyzed. All in-hospital adverse events were independently adjudicated. Results: Procedural success (
ISSN:1526-6028
1545-1550
DOI:10.1583/09-2810.1